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Discoverer of the direction of technological development
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Nanjing Huaxun Intellectual Property Consulting Co., Ltd. was founded by Lawyer Hou Qingchen. It was a supporting enterprise in Nanjing in the first half of 2013 and officially operated in early 2014.
Mainly engaged in high-level intellectual property information and consulting services, specific services include: patent search, patent analysis, patent information, intellectual property consulting, foreign-related legal consulting, etc. The main research and analysis fields are the intellectual property rights involved in biomedicine, medical equipment, semiconductors and electronic information.
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Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The
The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully! In response to the call for building a strong country with intellectual property rights, at 2 o'clock in the afternoon of October 21, the forum on "China's reform measures related to intellectual property rights and new trends in patent litigation" will be successfully held in Nanjing Jiangbei New District Industrial Technology Research and Innovation Park. The event was hosted by the Science and Technology Innovation Bureau of Nanjing Jiangbei New Area Management Committee, Nanjing Jiangbei New Area Industrial Technology Research and Innovation Park, Nanjing Intellectual Property Rights Protection Assistance Center Jiangbei New District Center, Nanjing Huaxun Intellectual Property Consultant Co., Ltd., Nanjing Intellectual Property Co-organized by the Protection Center (Nanjing Intellectual Property Rights Protection Assistance Center), Taiwan Pharmaceutical Development Association, and Gene Online. The director of Nanjing Intellectual Property Protection Center, Mou Xiaojian, delivered a speech. Director Mu expressed his warm congratulations on the holding of this event and introduced in detail the new pattern of intellectual property protection in Nanjing. He said: At present, Nanjing has implemented a rights protection assistance network in the municipal area. With full coverage, Nanjing Intellectual Property Protection Center is willing to closely communicate and interact with Nanjing's innovation entities, and provide relevant public welfare services such as rapid pre-review, rapid rights protection, and comprehensive utilization for enterprises in need. In addition, Huang Funan, CEO of Gene Online, was unable to come to congratulate due to the epidemic, and recorded a congratulatory video. In the video, he said: China Innovative Pharmaceuticals has already made many outstanding achievements on the international stage, and these are inseparable from intellectual property rights. The support of the company can also show the importance of intellectual property rights to biotechnology and pharmaceutical companies. This event invites four industry experts to focus on China's reform measures related to intellectual property rights and new trends in patent litigation, discuss with companies and universities, and make arrangements in advance. Dr. Qingchen Hou, general manager of Nanjing Huaxun Intellectual Property Consulting Co., Ltd., introduced the "Guidelines for Building a Powerful Country with Intellectual Property Rights (2021-2035)" and explained his views from four aspects: background, strategic layout, overall requirements, and organizational guarantees. . Subsequently, a detailed analysis of China's patent linkage system was carried out, and compared with the same types of cases at home and abroad, questions were raised: Why should we reward the first person who successfully challenged patents? Not the first person to file a P4 application? And have a series of discussions with you. Director Jiang Haijun of the Intellectual Property Protection Legal Committee of the Nanjing Lawyers Association gave a speech on three points: the problems after the amendment of the patent law, the enforceability of the amount of compensation, and the legal conflicts related to service inventions. Regarding the patent right evaluation report, he emphasized that the patentee, interested party or accused infringer can also proactively issue a patent right evaluation report. "Patent is a work of art that combines technology and law" is a message shared by Mr. Feng Tao from Jiangsu Junbo Law Firm at this event. Mr. Feng analyzes the big data of Chinese patent litigation cases through graphs and examples. Explore. The last topic of the event was shared by Guo Huangying, Intellectual Property Manager of Nanjing Huaxun Intellectual Property Agency (General Partnership)-China's Patent Infringement Judgment Principles and New Developments. Manager Guo explained to everyone the principles of patent infringement judgment and the necessity of patent infringement search and analysis before producing and selling products. In the intellectual property industry, ECCOM has been providing high-quality and professional comprehensive intellectual property services to enterprises and universities one step at a time. It also hopes that under the leadership of the state and the government, it will contribute to the building of a strong intellectual property nation in China. Make a contribution.
Types of patents that are easily overlooked- Design Patent In recent years, as the public’s awareness of intellectual property has increased, people have begun to consciously use the patent law to protect their intellectual property rights. However, in the process of implementation, they often only focus on invention patent and utility model patent, and tend to ignore the protection of design patent. Recently, Midea sued Haotaitai for two models of CXW-300-D998 and CXW-300-D908 Haotaitai brand range hoods In the case of suspected infringement of its design patent (patent number: ZL201930621598.X), the Guangzhou Intellectual Property Court made a first-instance judgment after hearing that it determined that the two products of Haotaitai constituted infringement, and ordered it to immediately stop the infringement and compensate Midea, The company's economic losses and reasonable expenses totaled 360,000 yuan. In fact, appearance infringement cases have occurred from time to time before, such as: "Molly" blind box design patent case, "Siemens" switch design patent infringement dispute case received a compensation of 6 million yuan, three Casio watch design patents were infringed Received a compensation of 8.8 million yuan and so on. The reason why people ignore the protection of design patents, in the final analysis, is that they have insufficient knowledge of design patents. Today, let's take a look at what is protected by design patents and what rights protections can we apply for? Design patent definition: Article 2 of the "Patent Law", design patent, refers to a new design that is aesthetically pleasing and suitable for industrial applications based on the shape, pattern, or combination of products, and the combination of color, shape, and pattern. Protected range: The shape of the product; the pattern of the product; the shape and pattern of the product; the shape and color of the product; the pattern and color of the product; the shape, pattern and color of the product. Protection period: The term of protection for design patent rights is 15 years, calculated from the date of filing. What are the conditions for applying for a design patent? The design should be aesthetically pleasing Appearance patents should be suitable for industrial applications The design patent application should be novel The design patent application should be inventiveness What are the advantages and functions of design patents? Protect the rights and interests of enterprises in product designs and fight against infringements in market competition. To enhance brand value, the quality and quantity of patents are the embodiment of the company's innovation ability and core competitiveness. Receive consumer recognition. If a company's new product appearance is filed for a patent in a timely manner, its appearance design will enjoy the exclusive right. Nowadays, consumers often choose products with trendy and beautiful appearance when buying their products. Applying for a design patent is a necessary condition for applying for a high-tech enterprise.
Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million This August, Nintendo and a game developer Colopl announced that they have settled for patent infringement regarding White Cat Project (Shironeko Project in Japanese), a smartphone game developed by Colopl. Although both companies did not publicly share exact details of the settlement, at least it is sure that Colopl agreed to pay 3.3 billion yen (about US$30.2 million) as the settlement fee for the proceedings, including the future license of Nintendo's patents. How did the battle begin? Being developed and published by a Japanese game developer, Colopl, White Cat Project is a free-to-play action role-playing game for Android and iOS systems. The mobile game was launched in July 2014 as well as got a television anime adaptation in 2020. It is incredibly popular to have more than 50 million downloads. Furthermore, the game is set to receive a Switch version titled "Shironeko New Project". In September 2016, Nintendo noted the Colopl's game and considered that the game had infringed on several of Nintendo's technology patents. The two companies communicated with each other for over a year; however, Nintendo did not accept the explanations from Colopl, and Nintendo filed a lawsuit against Colopl at the beginning of 2018. Nintendo claimed that Colopl infringed 6 of its patents. These patents protect touch-screen joystick functionality (patent no. JP3734820), multiplayer connectivity (patent no. JP5595991, JP6271692), confirmation screens in sleep mode (patent no. JP4010533), character attacks based on touch input locations (patent no. JP4262217), and a shadow effect placed on characters hidden behind the game geometry (patent no. JP3637031). These patents almost cover various ways of game technology, especially the patent JP5595991 and JP6271692. Their patent family is wide-reaching, and many divisional applications of the family are pending in Japan. They protect a communication game system and its related devices. It is not easy to detect the patent's existence and boundary since this kind of hardcore technique is so common in the gaming field and our daily lives. The five-year patent war has been settled. After a five-year dispute, the situation appeared to turn in Nintendo's favor as the Switch maker increased its monetary demands, which convinced Colopl to strike a deal that lets it use the disputed patents. Furthermore, a Switch version of White Cat Project remains in the works at Colopl. With the extraordinary losses of Colopl, the legal battle between the two companies came to an end.
The First COVID-19 Vaccine Approved by FDA On August 23, 2021, the U.S. Food and Drug Administration approved Pfizer-BioNTech COVID-19 Vaccine. As the first COVID-19 vaccine approved by FDA, it has been marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older. Since Dec. 11, 2020, this vaccine has been available under emergency use authorization (EUA) in individuals 16 years of age and older, and the authorization was expanded to include those 12 through 15 years of age on May 10, 2021. Comirnaty contains messenger RNA (mRNA), which is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material. Comirnaty is administered as a series of two doses, three weeks apart. The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The Comirnaty Prescribing Information includes a warning about these risks. To support the FDA’s approval decision, the agency analyzed effectiveness and safety data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death. The FDA’s approval of this vaccine is a milestone as people all over the world continue to battle the COVID-19 pandemic. As the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product. The Pfizer-BioNTech COVID-19 Vaccine now becomes Pfizer’s highest-selling product. The sales revenue reached 7.8 billion US dollars in the second quarter. The cumulative sales in the first half of the year were 11.3 billion US dollars. It is expected to achieve approximately 33.5 billion US dollars in revenue for the whole year. In the Greater China region, Fosun Pharma announced a strategic cooperation agreement with BioNTech as early as March 16, 2020. Fosun Pharma was authorized by BioNTech to exclusively develop and commercialize vaccine products against COVID-19 in mainland China, Hong Kong, Macau, and Taiwan based on its proprietary mRNA technology platform. In the process of global joint research and development, Fosun Pharma has conducted in-depth cooperation with BioNTech in clinical research, pharmacological data, and pharmacovigilance. The successful development of Comirnaty contains the wisdom of the Chinese scientific research team. On May 9, 2021, Fosun Pharma stated that it plans to invest in a joint venture with BioNTech to realize the localized production and commercialization of mRNA COVID-19 vaccine products. Once the approval is passed, Fosun Pharma and BioNTech will quickly promote domestic localized production and make a domestically produced mRNA vaccine.
Can artificial intelligence (AI) be patent inventors? Have you ever been aware of the inventors’ existence in patent applications? During the patent application process or in patent wars, the main point always focuses on patentees and patents themselves. However, this time inventors are in the spotlight. The decisions from the Companies and Intellectual Property Commission of South Africa and the Federal Court of Australia bombarded the patent world. It is about how technology challenges patent law. On 28th July, the Companies and Intellectual Property Commission of South Africa granted the first patent on an invention created by an artificial intelligence (AI) inventor, DABUS. South Africa becomes the first country which recognizes AI as an inventor. DABUS (device for the autonomous bootstrapping of unified sentience) is an AI system created by Stephen Thaler, an expert in the field of AI. The system imitates human brainstorming and creates new inventions, and it is capable of functioning independently and complexly. DABUS invented an emergency warning light and a food container that improves grip and heat transfer. Thaler has filed the patent application listing DABUS as the inventor in patent offices around the world, including the US, the UK, Europe, Australia, and South Africa; however, only South Africa granted the patent. The other countries stated that inventors on a patent application must have “legal capacity” or must be “natural persons”. On the other hand, on 30th July the Federal Court of Australia ruled an artificial intelligence (AI) system can be an inventor under the Australian Patents Act. The decision in Thaler v Commissioner of Patents [2021] FCA 879 is the first judicial determination in favor of AI inventorship. The Honorable Justice Beach said, “First, an inventor is an agent noun; an agent can be a person or thing that invents. Second, so to hold reflects the reality in terms of many otherwise patentable inventions where it cannot sensibly be said that a human is the inventor. Third, nothing in the Act dictates the contrary conclusion.” The Justice considered that patentable inventions are not all created by humans, and further explained, “……that position confuses the question of ownership and control of a patentable invention including who can be a patentee. …… Only a human or other legal person can be an owner, controller or patentee. That of course includes an inventor who is a human. But it is a fallacy to argue from this that an inventor can only be a human. An inventor may be an artificial intelligence system, but in such a circumstance could not be the owner, controller or patentee of the patentable invention.” Following the court’s decision, Thaler’s application will be sent back to the Australian Patent Office to reconsider the reasons for their rejection. Whether AI can be listed as an inventor in AI-generated inventions is still debating. In addition, based on the decisions from South Africa and Australia, they brought us back to rethinking not only inventors’ position but also what inventors mean in the patent field.
Huawei and Verizon, patent litigation to reconciliation Huawei and Verizon Communications have agreed to settle two lawsuits alleging patent infringement, it was reported on July 12, Beijing time. Over the past 20 years, Huawei has reportedly conducted extensive cross-licensing negotiations with major patent holders in the telecom industry, and has signed more than 100 patent licensing agreements with major ICT manufacturers in the United States, Europe, Japan and South Korea. Together of the two separate cases, already in Texas last week trial. But late on Sunday local time, Huawei and Verizon filed joint motions in two US courts to dismiss both cases, as well as Verizon's counterclaim. In February 2020, Huawei sued Verizon, accusing the company of unauthorized use of more than a dozen Huawei patents in computer networks, download security, and video communications, seeking damages and royalties. In response to today's settlement, Huawei said in a statement: "We are pleased that the two companies have reached a settlement that ends their patent litigation. The terms of the agreement are confidential." People familiar with the matter said huawei's claims could exceed $1 billion. Huawei also noted that it has "more than 100,000 patents in force worldwide, including approximately 10,000 in the United States." Verizon has yet to comment, but said last year that the lawsuits were little more than a public relations stunt. In addition, Verizon has countersued Huawei for patent infringement. "We simply ask Verizon to respect Huawei's investment in research and development and either pay for the use of our patents or refrain from using them," Huawei said last year. Since 2015, huawei won the intellectual property rights of income accumulative total more than $1.4 billion, history accumulated more than 6 billion dollars to pay royalties for legitimate use other company's patent, with 80% paid to American companies. Only high investment can bring high return. The technology that leads the world is huawei's money. Billions and billions of research and development of a technology, with what provided free of charge to each other. So the royalty fees charged by huawei won't give up, how many patent verizon specific to huawei is unknown, but can be seen from the attitude of tough royalties huawei, technology is the absolute principle. With technology, we can promote the development of science and technology, and with technology, we are not afraid of intransigence. Huawei will insist on research and development, more technical breakthrough, form a larger system of patented technology.
Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes This month FDA announced that they have approved Kerendia (finerenone) tablets for the treatment of patients with chronic kidney disease associated with type 2 diabetes. Kerendia is indicated to delay chronic kidney disease progression. It is able to reduce the risk of kidney function decline, kidney failure, cardiovascular death, non-fatal heart attacks, and hospitalization for heart failure in adult diabetic patients. Now the drug has also been submitted for marketing authorization in China, European Union and other countries. There are 422 million people with diabetes, and there are up to 40% of all patients with type 2 diabetes develop chronic kidney disease. Diabetes is one of the most common causes of chronic kidney disease and kidney failure. Chronic kidney disease is the gradual loss of kidney function over a period of months to years. It occurs when the kidneys are damaged and cannot filter blood normally, and sometimes can progress to kidney failure. The patients are also at high risk of heart disease because of defective filtering. Kerendia is the first and only nonsteroidal mineralocorticoid receptor antagonist (MRA) for Type 2 diabetic patients with chronic kidney disease, compared to SGLT2 inhibitors, Farxiga (dapagliflozin) and Invokana (canagliflozin). It blocks overactivation of the mineralocorticoid receptor (MR) which contributes to fibrosis and inflammation. The drug is able to target fibrosis and inflammation to slow kidney disease progression. The efficacy of Kerendia was evaluated in a randomized, multicenter, double-blind, placebo-controlled in the phase III trial. There were 5,674 patients in the study. The study found that Kerendia beat placebo when it came to kidney function. That included fending off or slowing progression to kidney failure and kidney death. Furthermore, the study also found that Kerendia reduced the risk of cardiovascular death, non-fatal heart attack, and hospitalization for heart failure. Kerendia received priority review and fast track designations for their application, and it will be commercially available in the U.S. by the end of July. 資料來源： https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-drug-reduce-risk-serious-kidney-and-heart-complications-adults-chronic-kidney-disease https://www.pharmalive.com/bayers-kerendia-receives-u-s-fda-approval/ https://finance.yahoo.com/news/bayers-kerendia-scores-long-awaited-111105329.html https://www.businesswire.com/news/home/20210709005441/en/Bayer%E2%80%99s-KERENDIA%C2%AE-finerenone-Receives-U.S.-FDA-Approval-for-Treatment-of-Patients-with-Chronic-Kidney-Disease-Associated-with-Type-2-Diabetes https://www.healio.com/news/endocrinology/20200710/finerenone-delays-diabetic-kidney-disease-progression-fideliodkd
FDA approves the first C3 inhibitor for adults with serious rare blood disease On May 14th, 2021, Apellis Pharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved a new injection treatment, EMPAVELI™ (pegcetacoplan), for adults with paroxysmal nocturnal hemoglobinuria (PNH). It is the first and only PNH medication that targets C3, the central protein in the complement system. Paroxysmal nocturnal hemoglobinuria, PNH in short, is a rare, acquired, life-threatening blood disorder. The key features of the disease are red blood cell destruction, blood clots, and impaired bone marrow function. PNH results from gene mutations that affect red blood cells. Patients with mutated PIGA on the X chromosome have abnormal hematopoietic stem cells which produce defective red blood cells. The destructive blood cells can be detected and destroyed by the immune system, which results in hemolytic anemia, or other symptoms, such as red discoloration of the urine. The prevalence rate is about 1 to 1.5 people per million. Individuals are typically diagnosed around ages 35 to 40, and the PNH patients have an average survival of 8-15 years after diagnosis. Nevertheless, around 25% of the patients may live more than 25 years with only minor symptoms. As the first and FDA-approved targeted C3 therapy, EMPAVELI (pegcetacoplan) has better effectiveness than C5 inhibitors. It can treat PNH adults who have never undergone PNH treatment or the patients who previously took C5 inhibitors, Soliris® (eculizumab), or Ultomiris® (ravulizumab). The approval of Empaveli was based on data from a multi-center, randomized, head-to-head Phase III study (ClinicalTrials.gov: NCT03500549) which compared the efficacy and safety of Empaveli to Soliris in 80 adults with PNH. The patients were divided into two groups which were randomly assigned to received either Empaveli 1,080 mg/20mL twice weekly or their current dose of Soliris for 16 weeks. The severity of anemia was compared in the two treatment groups which had the average 8.7 g/dL hemoglobin at baseline. Normal hemoglobin values in adult men and women are more than 14 g/dL and 12 g/dL respectively. After the 16-week treatment, patients in the Empaveli group averagely increased 2.4 g/dL of their hemoglobin. Meanwhile, patients in the Soliris group averagely decreased 1.5 g/dL of their hemoglobin. Moreover, 85% of the Empaveli -treated patients were transfusion free compared to 15% of the Soliris-treated patients over 16 weeks. Empaveli is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (Empaveli REMS; https://empavelirems.com/#Main) due to the risk of serious infections. In addition, the most common side effects are injection site reactions, viral/ microbial infections, diarrhea, abdominal pain, respiratory tract infection, and fatigue. It must be said that Empaveli is a significant milestone that boosts the development of C3 therapies for rare diseases. The approval of EMPAVELI not only gives more treatment options of PNH but also brings new promise for the PNH community.
Hengrui Medicine's application for the listing of CDK4/6 inhibitors has been accepted On April 27, the Center for Drug Evaluation (CDE) announced that the new drug listing application submitted by Hengrui Medicine's Class 1 new drug CDK 4/6 (cyclin-dependent kinase 4 and 6)inhibitor SHR6390 tablets has been accepted, and the indication is: combined with Fulvestrant for hormone receptor (HR) positive and treatment of recurrent or metastatic breast cancer that is negative for human epidermal growth factor receptor 2 (HER2) after endocrine therapy. Breast cancer is the most common cancer among women worldwide. The most common subtype is the HR positive/HER2 negative subtype, which accounts for 70% of the total number of Breast cancer patients. Approximately 30% of patients diagnosed with HR-positive and HER2-negative early breast cancer are still at risk of cancer recurrence. At present, the combination therapy of CDK 4/6 inhibitors and endocrine drugs has become a new model for reversing the resistance of endocrine therapy, significantly improving the prognosis of patients with HR-positive advanced Breast cancer. CDK 4/6 is a key regulator that drives cell division. Studies have found that CDK 4/6 is overexpressed in many cancer cells, leading to uncontrolled cell division cycles and unlimited proliferation. Clinical studies have confirmed that more than half of breast cancer patients overexpress cyclin D (cyclin D), and most of them are HR-positive breast cancer patients. Because cyclin D directly acts on CDK 4/6, CDK 4/6 has become an important molecular target for patients with HR-positive metastatic breast cancer. SHR6390 is an oral, high-efficiency and selective small molecule CDK 4/6 inhibitor developed by Hengrui Medicine, which is a Class 1 new drug. It can selectively inhibit CDK 4/6 kinase activity, thereby blocking the CDK 4/6-retinoblastoma protein (Rb) signaling pathway, thereby inducing tumor cell G1 blockade, and selectively inhibiting the high expression of Rb Of tumor cells proliferate. Therefore, SHR6390 plays a decisive role in blocking the process of cells from G1 phase to S phase, thereby effectively inhibiting tumor cell proliferation, achieving the effect of anti-tumor and prolonging the survival of patients. Public information shows that SHR6390 has reached the pre-designated superiority standard in a multi-center, randomized, controlled, double-blind phase 3 clinical study named SHR6390-III-301. Compared with placebo and fulvestrant, it accepts SHR6390 combined with Fulvestrant can significantly prolong the progression-free survival of patients. The arrival of Hengrui Medicine SHR6390 is expected to bring new treatment options for breast cancer patients.
先发表论文导致不言放弃的中科院走红博士有了放弃 最近几天，中国科学院自动化研究所黄国平博士的论文致谢刷屏。他自强不息，一路拼搏走出小山坳，与命运抗争的故事打动了很多人。我们作为“知识产权人”，看到在学业上不言放弃的黄博士在专利申请中有了放弃，即放弃了答复审查意见，进而导致专利申请“视为撤回”。 黄国平在中国科学院自动化研究所就读博士期间曾经以第二发明人（第一发明人是自动化所的老师/导师）申请过4篇中国专利。除了2014年11月21日申请的CN104462072B被授权之外，其他3件在2016年12月16日递交的专利申请CN106844332A、CN106649289A和CN107066451A都处于“视为撤回”的失效状态。 这3篇申请“视为撤回”的原因都是：未在规定期限内答复专利审查意见。不言放弃的黄博士放弃了答复的究竟是怎样的审查意见？查阅发现，在这些被放弃答复的审查意见中，审查员指出，上述专利申请的全部权利要求均缺乏创造性；而审查员检索到的对比档，正是黄博士自己在先发表的学术论文。 用作对比档的两篇论文标题分别为“Learning from User Feedback for Machine Translation in Real-Time”和“A Simple, Straightforward and Effective Model for Joint Bilingual Terms Detection and Word Alignment in SMT”，第一作者都是Huang Guoping，即黄国平博士；论文其他作者的音译，也与专利发明人相匹配；单位也都是中科院自动化所。这两篇论文的公开日都是2016年12月2日，比专利申请日早了两周，分别构成了上述3件专利申请的现有技术。 虽然，论文作者和专利发明人是同一拨人，论文公开的方案和专利申请的技术方案也存在一定差异；但是，审查员认为，上述3篇专利的技术方案在论文+公知常识的基础上是显而易见的，因此不具有创造性。最终，黄博士放弃了答复审查意见，随后专利申请被“视为撤回”。 现有技术是指：在申请日以前在国内外为公众所知的技术。现有技术包括在申请日（有优先权的，指优先权日）以前在国内往外出版物上公开发表、在国内外公开使用或者以其他方式为公众所知的技术。构成现有技术，破坏自己专利申请新颖性、创造性的，不但可能是他人先发表的论文、在先申请的专利，还有可能是自己先发表的论文，在先申请的专利等。 黄博士放弃答复专利审查意见反映了令人遗憾却又很常见的典型案例：申请人、尤其是高校申请人先公开论文再申请专利，从而导致自己在先发表的论文构成自己在后申请专利的现有技术，导致在后申请专利缺乏创造性，致使专利申请失败、技术方案得不到专利保护。这大多是由于对专利的不了解所致，希望未来随着专利知识的普及，再没有人陷入这样的困局。
江苏省专利行政裁决系统上线啦！ 2021年4月20日，是一年一度的知识产权日，在今天省政府为贯彻落实党中央、国务院和省委省政府关于强化知识产权保护的部署和要求，进一步加强专利行政裁决工作，规范全省行政裁决办案流程，经研究，决定启动本次行政裁决工作培训，并正式启动行政裁决系统。我公司有幸参加本次会议，会议是以视频形式召开，具体内容为： 1.省知识产权局知识产权保护处处长肖桂桃作2020年全省专利行政裁决工作总结和2021年工作部署，宣读《关于启用江苏省专利行政裁决系统的通知》 2.省知识产权局二级巡视员黄志臻讲话 3.国家知识产权局知识产权保护司执法指导处四级调研员陶颖作“专利行政裁决案件办理”专题辅导。 4.国家知识产权局知识产权保护司综合处四级调研员作朱丹作“专利行政裁决案件信息报送”专题辅导。 5.省知识产权保护中心工作人员作江苏省专利行政裁决系统使用教学和现场答疑。 会议中其中提到一点，就是公民个人也可以进行网上报送知识产权案件，案件取证、审核等一系列过程全部可以通过网络进行，既提高了办案效力，解约了审查资源，又方便群众，官网有具体详细的操作流程和视频，详细的讲授了每一步的方法，让每一位使用人员都可以毫无障碍的操作，并且如果有疑问和系统故障还有热线电话可以拨打咨询。真正做到了为心系人民，为人民服务！值得点赞！
世界知识产权日——市场专利布局IPO论坛成功举行！ 为迎接第21个世界知识产权日，提升专利布局在科技企业自身发展过程中的重要性，4月20日，世界知识产权日-市场专利布局IPO活动在南京江北新区产业科技研创园成功举行。 在南京江北新区管理委员会科技创新局的指导下，本次活动由南京江北新区产业技术研创园主办，南京自贸片区知识产权法律保护联盟协办，南京市知识产权维权援助中心江北新区分中心、华讯国际知识产权与涉外法律服务平台承办。 南京江北新区管理委员会科技创新局副局长李小春到场致辞，李局简单介绍了南京江北新区管理委员会科技创新局的职能内容，并预祝本次活动取得圆满成功。南京江北新区产业技术研创园副处级干部童庆松也受邀出席本次活动。 在分享会前，北京大学法学院教授、北京大学国际知识产权研究中心主任易继明就全面加强知识产权保护工作进行了视频发言。 为了加强各企业对拟上市规划在知识产权方面了解未雨绸缪，提前布局的重要性，本次活动共邀请了四位分享嘉宾：南京华讯知识产权顾问有限公司总经理侯庆辰、江苏三法律师事务所合伙人杨冬、竞天公诚律师事务所合伙人任华，以及健策知识产权顾问南京有限公司总经理黄时显。 侯庆辰先生着重介绍了知识产权的价值，通过阿里巴巴、滴滴、小米等专利侵权的实例来告诉大家，专利信息在投资中的专利风险以及专利信息对投资的重要性。“在高科技，技术是项目的核心价值，而技术是最终透过专利包装后以无形资产方式呈现。 因此分析专利以确认该无形资产的价值，是投资评估的必要环节。特别是在新药开发的领域，一款药往往只有一两个核心化合物专利，这一两个核心专利若有任何瑕疵，将对这药的价值产生重大影响。此外，高科技项目常会使用技术方无形资产入股方式形成早期的股权架构，若该专利事后被无效，对项目的资本组成将有毁灭性影响。” 杨冬律师就知识产权的刑法保护展开了演讲，列出了侵犯知识产权的八大罪名，并且明确表示刑法修正案十一加强了对注册商标和著作权的保护，对于假冒、销售假冒、非法制造、销售的行为，法定最高刑从七年提升至十年；对于侵犯著作权与非法销售相关侵权产品的行为，法定最高刑分别从七年和三年提升至十年和五年。 任华律师从A股上市的基本条件、A股上市过程中知识产权问题相关案例、A股上市知识产权问题、相关证券监管要点，以及交易所对知识产权问题的关注要点及公司回复等方面全面讲解了A股上市过程中的可能遇到的知识产权问题。 黄时显先生表示“IP是有价值的，而且是无法预期的价值，企业应该随着市场的变化灵活运用知识产权所能带来的附加价值，只有善用资源，专业分工，才能达到事半功倍的效果”。 本次活动旨在提高科技企业加强知识产权保护意识，在自身发展的各阶段，对专利布局进行重点策划，消除不必要的专利隐患、掌握好IPO的节奏，以顺利完成科创板上市计划。 本次活动线上全程直播，吸引近上万人次观看。华讯国际知识产权与涉外法律服务平台致力于知识产权保护的推广，希望越来越多的人认识并重视知识产权，为中国知识产权保护添砖加瓦。
华讯诚邀您参加世界知识产权日——市场专利布局IPO论坛 近来，因为专利等知识产权问题，一些科创板企业上市前被喊“暂停”。专家认为，科创板定位于“拥有关键核心技术， 科技创新能力突出”的企业，而关键核心技术和科技创新能力的核心评价指标之一就是专利、技术秘密等知识产权，因此拟上市企业在知识产权方面应当做到未雨绸缪，提前布局。 日期：2021年4月20日（周二） 时间：14:30-17:00 地点：腾飞大厦2楼报告厅 活动流程 13:00--14:00 签到 14：00--14:05 介绍与会领导嘉宾 14:05--14：10 江北新区领导致辞 14:10--14:40 专题分享一 【投资中的专利风险以及专利信息对投资的价值】 侯庆辰 南京华讯知识产权顾问有限公司总经理 14:40--15:50 专题分享二 【知识产权的刑法保护】 杨冬 江苏三法律师事务所合伙人 15:10--15:30 茶歇 15:30--16:00 专题分享三 【上市过程中的知识产权问题关注点】 任华 竞天公诚律师事务所合伙人 16:00--16:30 专题分享四 【企业全球知识产权布局策略】 黄时显 健策知识产权顾问南京有限公司总经理 嘉宾简介 侯庆辰 北京大学-法学博士(知识产权专业) 台湾大学-法律硕士 政治大学-智慧财产权硕士 美国宾夕法尼亚大学-法学硕士 加州大学伯克利分校-访问学者 纽约哥伦比亚大学-访问学者 曾任:富士康艺墨文创担任法务长、负责凌阳科技股份有限公司、威盛电子股份有限公司的法务部门、国际通商法律事务所(Bakermckenzie)律师。 现任南京华讯知识产权顾问有限公司-总经理、庆辰(台湾)法律事务所-创所律师与执行合伙人、台北科技大学智慧财产权研究所-兼任副教授。 杨冬 江苏三法律师事务所合伙人（派驻江北新区分所） 三法刑辩中心主任 江苏省律协刑事法律业务专业委员会副主任 南京市律协刑法专业委员会主任 南京市十佳律师 南京市政协委员 任华 任华律师毕业于北京大学法学院及日本九州大学法学院，并于2008年取得律师资格。 任华律师主要从事境内外证券发行、并购重组、跨境投融资、风险投资等业务，在境内外资本市场领域具有丰富的业务经验，曾荣获Legal Band 2015年中国律届俊杰30强。 黄时显 黄时显博士现职于健策知识产权顾问南京有限公司总经理。在此之前，他曾担任日本山本特许法律事务所的首席技术官。在大阪总所的五年期间，他处理过上百件专利诉讼、纠纷、无效、侵权等不同类型的案子。 除了在知识产权领域，他目前还为多期有影响力的SCI科学杂志担任科研论文的外审专家。 他在加拿大多伦多大学攻读博士学位期间曾与美国疾病控制中心及多所美国和中国大学进行过合作，并担任病毒传染研究（包括H1N1和H7N9）的项目主管。
浅谈药品专利链接制度 药品是与公众健康和社会福利息息相关的重要产品，也是知识产权冲突的集中领域之一。药品市场中存在原研药企与仿制药企之争，集中体现在其专利侵权纠纷上。 药品专利链接制度是指将申请审批上市的仿制药与其所仿原研药的专利“链接”起来。简单来说，就是在仿制药上市审评审批期间确认仿制药的技术方案是否落入原研药的专利保护范围，从而在仿制药上市前提前解决其可能存在的专利侵权问题。 2020年10月17日，全国人大通过了中国专利法第四次修改，将于2021年6月1日生效，其中第四十二条和第七十六条，分别对药品专利有效期补偿及药品专利链接做出了原则性规定。对于在中国获得上市许可的新药发明专利，国务院专利行政部门可以应专利权人的请求给予期限补偿。对因申请注册的药品相关的专利权产生纠纷的，相关当事人可以向人民法院起诉，国务院药品监督管理部门会同国务院专利行政部门制定药品上市许可审批与药品上市许可申请阶段专利权纠纷解决的具体衔接办法，报国务院同意后实施。 这是我国专利法中首次出现药品专利有效期补偿及建立药品专利衔接制度的法律条文，为我国逐步建立药品专利链接及配套制度迈出了重要的一步。 药品专利链接制度有什么作用和意义呢？ 药品专利链接制度是药品监管部门的行政审批与司法裁判的相互链接。药品专利链接制度设定目标在于以更有效率的方式在药品上市批准前明确是否侵权或作出侵权预警，尽量避免药品批准后发生侵权纠纷，避免造成双方的实质性损失。 构建合乎国情的药品专利链接制度通常具有以下4个方面的重要意义：保护原研药专利权；鼓励仿制药专利挑战；建立规范的药品市场准入秩序，防止恶意竞争；将专利纠纷解决在既定侵权事件发生前，有利于降低社会违法成本。 药企如何应对医药专利制度的变化？ 对于原研药企业，要做好高价值专利布局工作，形成严密高效的专利保护网。建立预警与防控机制，定期关注中国上市药品专利信息登记平台，及时对仿制药企业登记信息进行侵权与否的判断，若确定仿制药品侵权，按照药品专利链接制度提起诉讼或行政裁决。 对于仿制药企业，做好充分的信息调研准备工作，专利侵权风险评估是最为重要的环节之一，仿制药企业应核查清所仿制药物的所有相关专利状态，确定这些专利是否会对产品上市构成障碍，并根据评估结果结合制度，选择合适的策略。 药品专利期限补偿与药品专利链接制度的实施，对医药企业的专利工作提出了更高的要求，无论原研药企业还是仿制药企业，都要更加重视专利的创造、运用、保护及管理。
如何加强对职务发明人的奖酬保护？ 国家知识产权局日前发布了《关于规范申请专利行为的办法》，该局发布的相关公告表示该办法是为了全面提高专利质量，确保实现专利法，鼓励真实创新活动的立法宗旨，恪守诚实信用原则[1]。 过去国家知识产权局采取过一系列措施以促进专利质量提升，如国知发保字〔2021〕1号文《国家知识产权局关于进一步严格规范专利申请行为的通知》中就规定了很多详细措施，在该文中国家知识产权局甚至痛下决心规定“2021年6月底前要全面取消各级专利申请阶段的资助。……各地方要逐步减少对专利授权的各类财政资助，在2025年以前全部取消”[2]。此外，原国家知识产权局第75号局令公布过修订的《关于规范专利申请行为的若干规定》[3]。2016年，国家知识产权局还出台过《专利质量提升工程实施方案》，从创造、申请、代理、审查、保护、运用等各个环节着手，全面提升专利质量[4]。 虽然目前以《专利质量提升工程实施方案》为核心的上述系列文件，规定了大量促进专利质量的措施，但笔者认为唯独缺失了保障发明人权益的措施。笔者认为，切实保障发明人利益，不但能激励发明人的创造热情，还能有效降低非正常申请、虚假转让等现象，助力提升专利申请、专利权的质量。在保障发明人权益方面，当务之急是强化职务发明创造发明人奖励报酬权，赋予发明人选择权；强化职务发明创造发明人的优先受让权，用行政措施保障优先受让权。 一、强化职务发明创造发明人奖励报酬权，赋予发明人选择权 即将于2021年6月1日实施的新修订的《专利法》规定：国家鼓励被授予专利权的单位实行产权激励，采取股权、期权、分红等方式，使发明人或者设计人合理分享创新收益。立法者使发明人或者设计人合理分享创新收益的想法是好的，但规定这样的措施最终能不能让发明人得到实惠，则要打个问号。 实际上，一些单位一直在规避给发明人任何奖励报酬。单位之所以规避给发明人奖励报酬，原因包括单位和发明人合谋搞虚假发明，这种情形下单位当然会规避给发明人奖励报酬。 也有发明人真实做出了有竞争力的发明创造，相关专利实施后也产生了经济效益，但单位就是不给奖励报酬。因为这些单位对发明人是用完则弃的思想，发明人因此离职的话，单位还能招聘更加年轻有活力的技术人员。 这种想规避发明人奖励报酬的单位，根本不等专利法规定实行产权激励的条款实施，早就以用人单位的优势地位，与发明人签署了各种没有任何实际好处的所谓奖励报酬合同，或者颁布了不合理的奖励报酬规章制度，并且依法优先适用了这种合同或规章制度。笔者就曾经见过某单位涨价五千多倍卖期权给发明人的合同，发明人真买这样的期权的话，不是获得奖励报酬，而是在送钱给单位了。该单位知识产权管理人员还挖空心思颁布以虚名代替实利的奖励报酬的规章制度，即给发明人各种头衔（但工资、上下级关系、工作内容都不变），作为奖励报酬。匪夷所思的是，某市法院于2013年发布的《职务发明创造发明人或设计人奖励、报酬纠纷审理指引》就支持以提高职位作为专利奖励报酬。 笔者建议，改变目前在发明人奖励报酬方面单位与发明人的约定优先的做法，赋予发明人选择权，即选择约定优选还是法定优选，以此强化职务发明创造发明人奖励报酬权。在发明人有选择权的情况下，虚假发明也会相应减少，因为专利奖励报酬将变成不可避免要付出的成本，单位造假时也会有所顾忌。赋予发明人选择权才能真正保障发明人合理分享创新收益，才能真正形成良好的创新生态，激励发明创造，达到专利法的立法目的。 此外,强化专利奖励报酬权,还要破除一些让发明人奖励报酬落空的规定,如某市法院于2013年发布的《职务发明创造发明人或设计人奖励、报酬纠纷审理指引》规定,对于委托开发，“约定申请专利的权利归委托方时，由委托方享有申请专利的权利。专利被授权后，受托方因不享有专利权而不涉及职务发明创造奖励与报酬支付；委托方虽享有专利权，但发明人、设计人不是委托方的职工，故亦不涉及职务发明创造奖酬支付”。这种规定让相当一部分发明人得不到专利奖励报酬，实际上这种规定也在指引单位如何合法规避专利奖励报酬。 二、强化职务发明创造发明人的优先受让权，用行政措施保障优先受让权 《中华人民共和国民法典》第八百四十七条规定：……法人或者非法人组织订立技术合同转让职务技术成果时，职务技术成果的完成人享有以同等条件优先受让的权利。这是承袭原《中华人民共和国合同法》的规定，对包括职务发明创造发明人在内的职务技术成果的完成人设立了优先受让权。 但很是遗憾，国家知识产权局目前似乎并不保障职务发明创造发明人的优先受让权。目前专利权人提交文件办理专利转让时，并不需要提交发明人知情且同意放弃优先受让权的证明文件。也许有人认为行政机关不宜干涉此事，发明人的优先受让权受到侵犯可以向法院起诉。但类比公司法设立的有限公司股东优先受让权，工商登记部门却是严格保护，没有其他股东同意放弃优先受让权，是不可能在工商登记部门办理股权向股东以外的人的转让的。国家重视投资人的产权保护，却不重视发明人的权益保护，让人感到遗憾。 因为国家知识产权局目前并不保障职务发明创造发明人的优先受让权，也就不宣传发明人有此权利。这导致广大发明人并不知道有该权利。2021年3月22日笔者在裁判文书网上民事案件、知识产权与竞争纠纷案由下，以优先受让权为关键词进行查询，共检索到28篇文书。但遗憾的是细查之下关于职务发明创造发明人的优先受让权的文书为0篇。出现这种结果，是目前发明人的优先受让权得到了充分保障吗?笔者认为恰恰相反，而是广大发明人都不知道自己有此权利，所以也就产生不了纠纷。检索结果中有多篇文书记载的内容涉及劳动合同规定用人单位对发明人的非职务成果享有优先受让权[5]，这似乎表示发明人的优先受让权在现实中已经荡然无存，反而变成了用人单位有非职务发明的优先受让权了。 也正因为专利权转让手续简单，为获取国家相应政策支持而进行虚假转让并没有什么成本，也根本不必担心发明人主张优先受让权，所以才会有虚假转让，甚至是价款为0元的虚假转让。如果发明人的优先受让权落到实处，用人单位敢以0元虚假转让专利、专利申请吗? 笔者建议国家知识产权局修改审查指南，规定专利权转让手续的文件必须包括发明人知悉转让条件并同意放弃优先受让权的文件。 此外，业界多年前就呼吁设立专利、专利申请实施许可的发明人优先受让权。如2007年陈震在《技术许可中职务发明人权益的保护研究——兼析职务发明人的优先受让权》一文中就呼吁：我国有必要明确职务科技成果完成人享有技术许可的优先受让权，不仅可以防止单位利用技术许可规避职务发明人的技术转让优先受让权，而且可以弥补我国职务发明人技术许可中权益保障的不足[6]。然而多年过去了，《民法典》也颁布了，职务发明人技术许可优先受让权的规定仍旧没有踪影。 笔者在此呼吁设立职务发明人技术许可优先受让权，并且规定国家知识产权局在登记专利、专利申请实施许可的时候，审查备案手续的文件是否包括发明人知悉许可条件并同意放弃优先受让权的文件。 综上所述，笔者完全赞同国家知识产权局将专利质量提升视为系统工程并从系统入手解决专利质量问题的做法。笔者同时认为，这个系统中应当有发明人的一席之地。忽视发明人权益去谈专利质量提升，无异于希望马儿跑但希望马儿不吃草，不太现实。国家这些年对创新虽然有种种激励措施，但笔者认为这些措施是着重对创新的投资者进行激励，对发明人的激励则要看投资者愿意不愿意、大方不大方。笔者认为这种现象继续下去，会损害中国的创新能力。因为在人力资源全球化的今天，高端科技人才是会选择对自己友好的市场环境的。为了全面提高专利质量，确保实现专利法鼓励真实创新活动的立法宗旨，我们国家应当补齐发明人权益保护的短板。 原创 黄辉 知识产权那点事
商标侵权怎么办？ 在当今社会，生活水平逐渐提升，购买力也随之提高，购买何种商品，如何进行选择，商品与商品之间的区别，可能就是因为牌子不同，而导致了销量的不同，所以有些不良商家就利用商标的谐音、形近字大做文章，造成商标混淆，手段方式层出不穷，真的是另消费者眼花缭乱，一不小心就掉进了陷阱中！有些可以当做生活中消遣的乐趣，但有些却引发严重的后果，不得不令人深思！ 商标侵权行为是指行为人未经商标权人许可，在相同或类似商品上使用与其注册商标相同或近似的商标，或者其他干涉、妨碍商标权人使用其注册商标，损害商标权人合法权益的其他行为。侵权人通常需承担停止侵权的责任，明知或应知是侵权的行为人还要承担赔偿的责任。情节严重的，还要承担刑事责任。 （一）哪些行为属于商标侵权行为？ 《中华人民共和国商标法》第五十二条规定了五种侵犯注册商标专用权： 1、未经商标注册人的许可，在同一种商品或者类似商品上使用与其注册商标相同或者近似的商标的。 该条又可分成四种商标侵权的形式： （1）被控侵权的商标与注册商标相同，被控侵权商标所使用的商品与该注册商标所核定使用的商品也属于同一种类。 （2）被控侵权的商标与注册商标相同，被控侵权商标所使用的商品与该注册商标所核定使用的商品类似。 （3）被控侵权的商标与注册商标近似，被控侵权商标所使用的商标与该注册商标所核定使用的商品属于同一种类。 （4）被控侵权的商标与注册商标近似，被控侵权商标所使用的商品与该注册商标所核定使用的商品相类似。 2、销售侵犯注册商标专用权的商品的； 3、伪造、擅自制造他人注册商标标识或者销售伪造、擅自制造的注册商标标识的； 4、未经商标注册人同意，更换其注册商标并将该更换商标的商品又投入市场的。这种行为又称之为“反向假冒”。 5、给他人的注册商标专用权造成其他损害的。 《最高人民法院关于审理商标民事纠纷案件适用法律若干问题的解释》第一条规定：下列行为属于商标法第五十二条第（五）项规定的给他人注册商标专用权造成其他损害的行为： （1）将与他人注册商标相同或者相近似的文字作为企业的字号在相同或者类似商品上突出使用，容易使相关公众产生误认的； （2）复制、摹仿、翻译他人注册的驰名商标或其主要部分在不相同或者不相类似商品上作为商标使用，误导公众，致使该驰名商标注册人的利益可能受到损害的； （3）将与他人注册商标相同或者相近似的文字注册为域名，并且通过该域名进行相关商品交易的电子商务，容易使相关公众产生误认的。 （二）商标侵权怎么处理？ 商标侵权的法律责任： 1、行政责任。 对于侵犯注册商标专用权的，依据《商标法》第五十三条、《商标法实施细则》第四十三条规定，工商行政管理机关可以采取下列措施给以处罚。 （1）责令停止侵权。具体措施如下： ①责令立即停止销售； ②没收、销毁侵权商品； ③没收、销毁专门用于制造侵权商品、伪造注册商标标识的工具。 （2）处以罚款。 对侵犯注册商标专用权但尚未构成犯罪的，工商行政管理机关可以根据情节处以非法经营额50%以下或侵权所获利润五倍以下的罚款；对侵权单位的直接责任人员，可根据情节处以1万元以下罚款。 2、民事责任 根据《民法通则》第一百一十八条规定，商标权遭受侵害的，有权要求停止侵害、消除影响、赔偿损失。根据《商标法》第五十三条规定，被侵权人可以要求侵权人立即停止侵权行为，赔偿损失。其中，侵权赔偿额为侵权人在侵权期间所获得的利益，或者被侵权人在被侵权期间因被侵权所受到的损失，包括被侵权人为制止侵权行为所支付的合理开支。如果前二者都难以确定，由人民法院根据侵权行为的情节判决给予50万元以下的赔偿。 3、刑事责任 除了行政责任和民事责任外，侵犯商标权还可能构成假冒注册商标罪、销售假冒注册商标的商品罪、非法制造注册商标标识罪、销售非法制造的注册商标标识罪。 在这里想要分享给读者一个比较简单高效的处理方式，那就是在遇到商标侵权时，不要慌，找一个权威的知识产权代理机构，由专业的从业人员和律师团队，为您提供全方位的、高标准的解决方案，不用费心劳力最终还取得满意的结果。
近日，国家药品监督管理局批准普拉替尼（Pralsetinib）胶囊（商品名：普吉华）作为国家一类创新药上市申请，用于治疗既往接受过含铂化疗的转染重排基因（RET）融合阳性的局部晚期或转移性非小细胞肺癌（NSCLC）成人患者。这是中国批准的首个选择性RET抑制剂。 RET是一个原癌基因，最早发现于1985年，定位于10号染色体，有21个外显子。RET所编码的RET蛋白是一种存在于细胞膜上的受体酪氨酸激酶（RTK），当生长因子与受体的胞外区域结合后就会触发一系列细胞内的链式化学反应，引起细胞的分裂、成熟并发挥相应功能。 随着研究的逐步进展，已发现多种疾病的发生与RET基因突变有关，其中RET基因融合在NSCLC患者中的发生率约为1%～2%，在甲状腺乳头状癌（PTC）中的发生率为10%，甲状腺髓样癌（MTC）中RET基因突变的发生率约为60%，其他发生RET变异的瘤种包括脑膜瘤、食管腺癌、乳腺癌、结直肠癌等。因此，RET基因变异成为“不限癌种”疗法的一个重要靶点。 近年来不断有针对RET融合的靶向药物在NSCLC患者中进行有效性和安全性的研究。其中普拉替尼是一种强效、高选择性的靶向致癌性RET变异的小分子激酶抑制剂，每日仅需服用一次，具有较好的依从性，被FDA授予治疗经含铂化疗后进展的RET融合阳性NSCLC以及需要系统治疗且没有可替代治疗方案的RET突变阳性甲状腺髓样癌的突破性疗法资格。 此外，基石药业在中国开展了全球ARROW研究的中国注册桥接试验，于2019年8月完成首例患者给药，同年12月完成了最后1例患者的入组。该项试验共纳入37例患者，中位年龄54岁（范围：26-77岁）。试验结果显示，接受普拉替尼治疗患者的总体缓解率（ORR）为56%，其中3%达到完全缓解（CR），疾病控制率（DCR）达到97%。截至2021年1月，中位治疗持续时间6.1个月（范围：0.9~9.4）；18例缓解患者的首次缓解中位时间为1.9个月，其中89%（16/18）仍在接受治疗，中位缓解持续时间（DOR）尚未成熟，6个月的DOR率为83%。安全性方面，虽然10.8%的患者因不良事件停药，但未出现因普拉替尼治疗导致患者停药和死亡。 总体来说，普拉替尼在经含铂化疗的RET融合阳性NSCLC的中国患者中显示出了优越和持久的抗肿瘤活性，安全性及耐受性良好，未出现与普拉替尼相关的不良事件导致的治疗终止或死亡，为中国RET阳性肿瘤患者提供了一个新的治疗选择。 此次普拉替尼作为中国首个选择性RET抑制剂获批上市，将使更多的中国患者获益。
2021.03.26 热烈祝贺南京华讯知识产权总经理 侯庆辰博士新书推出! Congratulations! James Hou, General Manager of CIPIC , has launched a New Book! 2017年9月，我司侯庆辰总经理所撰写「论医药专利的产业化-中国专利法专题研究」乙书发行。为了让更多国外读者了解中国专利法的精义，2021年3月，英文版隆重推出！ The Chinese version of "The Commercialization of Pharmaceutical Patents in China" written by James Hou, General Manager of CIPIC , had launched in September, 2017. Now, the English version will on sale starting from the end of March, 2021 for serving more foreign readers to realize the mystery of China's patent law. 对于想了解中国市场生物医药产业中的专利议题，本书绝对能提供非常重要的信息，涉及商业、生物医药，并与知识产权相关的从业学者、学生，甚至是创业者或管理阶层，都能在本书中找到关键的资源。 "The Commercialization of Pharmaceutical Patents in China" contains insightful information. If anyone, such as scholar, student, entrepreneur or businessman, wants to know the hottest and latest patent issues in the Chinese market and also in its pharmaceutical industry, this book will be a key resource for you. 欢迎有兴趣的读者们，现在就以下网址上网订购，并享有10–20%优惠折扣！(加入网站会员，立即享有优惠价格) Welcome to visit the website listed below and place the online order. Register your free website member account immediately to get 10–20% discount on all orders. Website: https://www.e-elgar.com/shop/usd/the-commercialization-of-pharmaceutical-patents-in-china-9781789908220.html Chapter 1 is free to read on our digital platform: https://doi.org/10.4337/9781789908237
On March 22, the Danish pharmaceutical company Zealand Pharma, established in 1998, announced that the FDA approved Dasiglucagon subcutaneous injections for the treatment of severe hypoglycemia in children over 6 years old and adults with diabetes. Hypoglycemia is caused by a severe drop in blood sugar levels, and severe hypoglycemia is generally an acute and life-threatening condition in which the blood sugar level suddenly drops when diabetic patients receive insulin therapy. Severe hypoglycemia is also the most typical complication in the clinical treatment of diabetes. It mainly occurs in type 1 diabetic patients and type 2 diabetic patients taking insulin. In the United States alone, approximately 300,000 people are hospitalized for the disease each year. Dasiglucagon is a world-first soluble stable analog of glucagon discovered and developed by Zealand. Glucagon is a hormone secreted by the islet α-cells of the pancreas. It is opposed to insulin and plays a role in increasing blood sugar. Zealand uses its unique peptide drug research platform to change some of the amino acids in wild-type glucagon to maintain its biological activity and make it have higher stability and solubility. Compared with the previously marketed lyophilized powder preparation therapeutic drugs, it can be pre-installed in the emergency pen and can be injected subcutaneously during clinical use, which is extremely convenient. The FDA approval was mainly based on the efficacy data of three randomized, double-blind, placebo-controlled, multi-center phase III trials conducted in adults with type 1 diabetes between the ages of 6 and 17 years. The data shows that whether it is an adult patient or a child patient, the median time for blood glucose levels to recover after receiving Dasiglucagon injection is 10 minutes, while that of the placebo control group is 30 to 45 minutes. In a phase III study for adults, 99% of hypoglycemia patients recovered from insulin-induced hypoglycemia within 15 minutes after using Dasiglucagon. The study confirmed the potential of Dasiglucagon to quickly and effectively rescue severe hypoglycemia in diabetic patients. Dasiglucagon expects to start marketing the drug in the United States in June, bringing new treatment options to diabetic patients. It must be said that this is an important milestone in the history of diabetic hypoglycemia treatment. Let us look forward to it!
近日，浙江省温州市中级人民法院公布了浙江首例知识产权惩罚性赔偿案件，知名品牌“阿迪达斯”二审胜诉，获赔百余万元。 原告方阿迪达斯公司拥有“adidas”系列商标权，且知名度极高。被告阮某强、阮某义于2014年在温州出资注册成立了正邦公司。正邦公司于2015至2017年期间，先后三次被行政部门查获侵犯阿迪达斯公司“adidas”系列商标权的鞋帮产品，并被处以行政处罚，累计侵权产品数量高达17000余双。 阿迪达斯公司就第三次行政违法行为对阮某强、阮某义提起民事诉讼，请求法院根据正邦公司的侵权获利并适用惩罚性赔偿制度赔偿判。一审法院认定正邦公司构成侵权，并赔偿阿迪达斯公司经济损失(含合理费用)人民币20万元。后阿迪达斯公司不服，提起上诉。 温州中院二审认定天猫网、京东网adidas官方旗舰店中标注“adidas”系列商标的可供参考的正品鞋子的售价自189元/双到1799元/双不等。阿迪达斯公司2017年度会计报表披露阿迪达斯公司的毛利润率为50.4%。最终通过计算，法院认定阿迪达斯公司因侵权所遭受的利润损失为345779.28元。 而正邦公司曾于2015年、2016年先后两次因生产、销售侵犯阿迪达斯公司商标权的鞋帮产品被处以行政处罚，且阮某强因本案侵权行为接受行政机关询问时表示知道被查获的鞋帮侵犯他人注册商标权，但是这些鞋帮销路好、利润高，表明其主观恶意明显，法院认为该公司在侵权数量上具有规模性，在时间上具有持续性，在后果上具有恶劣性，符合情节严重的特点。 最终，法院决定以上述经济损失345779.28元的3倍，即1037337.84元为赔偿数额。阿迪达斯公司为本案诉讼支出了律师费等维权支出406788元，具有合理性，一并予以支持。综上，温州中院二审判决阮某强、阮某义连带赔偿阿迪达斯公司红济损失及维权合理费用107万余元。 （转自知识产权杂志）
专利界的美国队长－Andrei Iancu 随着新任美国总统－乔.拜登(Joe Biden)走马上任，美国联邦政府也迎来一波全新的气象。但在美国专利商标局(U.S. Patent and Trademark Office)，一位年轻有为的局长却在此时卸下了三年多来的重担，Andrei Iancu在USPTO掌舵的这三年多来，大刀阔斧地针对专利政策进行多项变革。我们可以说，在他的领导下，美国对于创新技术的追求与保护，又写下了崭新的一页。 Iancu最令人印象深刻的政策，便是「透明化专利申请流程，强化专利申请流程的安定性及可预测性」，透过制度的改革，多名律师认为，在Iancu上任后至今，是美国联邦政府对专利申请人态度最为友善的阶段。以往USPTO最为人诟病的，便是专利申请程序的复杂程度，以及与联邦法院裁判的不一致，上述二者皆会对专利权人造成极大的不安定。Iancu强调，美国专利权所保护的智慧财产权，不仅要求保护性，更要求专利有效性，而这一切皆应从基础的专利申请程序着手。 USPTO针对专利申请提出了多项指南，亦是为了保护专利权人。针对专利之「不合专利申请之抽象概念」就连美国联邦法院都没有详尽的定义，Iancu则着手修订USPTO版本的专利申请指南，在行政单位和司法单位的连动上，Iancu功不可没。在Iancu即将离职的2021年初，他仍大声疾呼，美国国会应针对专利审查提供更多足以担当标准的法律，毋宁说，比起个人的丰功伟业，Iancu更重视专利体系的完整程度，实有领导人之风范。 专利审判暨上诉委员会(Patent Trial and Appeal Board)之改革，也是Iancu一大政绩。自2012创始至今，PATB对于专利权人的态度便极为不友善，被戏称为「专利权人的处刑小队」，Iancu致力于使PTAB处理专利审理之判断方式，与联邦法院处理智慧财产权案例之判断方式尽量一致，俾使专利权人能透过判例去预测、修正自己专利的权利请求范围。于是在Iancu的努力下，PTAB拒绝专利申请的比例大幅降低，无形中节省许多时间和金钱成本。 「我们致力于创作一个崭新的、创新的环境，可以同时保护那些睿智的发明人、那些令人激赏的发明及可以为这社会带来的无穷利益。」Iancu如是说。虽然我们不得而知Iancu的继任者能否萧规曹随，并继续维持此种风气，但可以肯定的是，Iancu近年的改革的确使美国专利界带来一股崭新气息。
淘宝店铺链接删除类事件背后的专利侵权 随着电商平台的不断发展，在线购物已融入我们日常生活的方方面面，您是否遇到过在线上店铺购物时突然发现产品链接已删除或产品已下架，其实对于某些产品若发生上述情况很可能是因为存在专利侵权的问题。在今年，淘宝一灯具店铺就被投诉外观专利侵权。投诉方外观专利号ZL202030075422.1，专利名称吸顶灯（星球），其设计要点在于形状。将店铺的某款灯与专利中公开的吸顶灯外观做比较，除了灯芯处一个是圆柱形状一个是圆球形状外，两个灯的整体外观设计非常相似，因此该淘宝链接存在明显侵权行为，该淘宝店铺商家最终申诉失败，链接也被删除处置。 那何为专利侵权，专利侵权是指我国《中华人民共和国专利法》第60条所称的未经专利权人许可，实施其专利的行为。这里的实施是指制造、使用、许诺销售、销售、进口其专利产品或者使用其专利方法以及使用、销售许诺销售、进口依该方法直接获得的产品。其中，构成专利侵权必须以有效存在的专利为前提，实施已经被宣告无效、被放弃的专利或者专利期限已经届满的技术，不构成专利侵权。 关于专利侵权的判定，各级法院和专利行政部门在处理专利侵权纠纷时广泛采用的判断标准有以下几种：1）全面覆盖原则，即被控侵权的产品或者方法中含有权利要求书记载的全部必要技术特征；2）等同原则，即所属技术领域的普通技术人员在研究了专利权人的专利说明书和权利要求后，不经过创造性的智力劳动就能够联想得到的特征，并且与专利技术相比，在目的、功能、效果上相同或者基本相同，则应当认定侵权成立；3）禁止反悔原则，即专利权人在专利授权或者无效宣告程序中放弃的技术方案，在侵犯专利权纠纷案件中，禁止专利权人又将其纳入专利权保护范围；4）多余指定原则，即在忽略非必要技术特征的情况下，仅以权利要求中的必要技术特征来确定专利保护范围，并判定被控侵权客体是否落入权利要求保护范围的原则。 在企业生产经营的过程中，经常会遭遇被诉专利侵权的困扰，对企业的生产、销售造成重大的影响，不仅不利于企业的发展壮大，甚至会对企业造成无可挽回的负面影响，而对产品进行专利侵权检索是非常有效的规避这些风险的途径。侵权检索分为防侵权检索和被动侵权检索，防侵权检索是指为避免发生专利纠纷而主动对某一新技术新产品进行的专利检索，其目的是要找出可能受到其侵害的专利，从而采取规避、许可、无效等手段应对。被动侵权检索又称无效检索，是指被别人掌控侵权时进行的专利检索，其目的是为了要找出对受到侵害的专利提出无效诉讼的证据。可见，专利侵权检索在企业发展中同样占据重要地位。
我司总经理侯庆辰先生自2020年4月应南京捷源投资管理合伙企业（有限合伙）的聘请，担任南京江北佳康科技创业投资合伙企业（有限合伙）投资决策委员会外部专家投委。很荣幸！今年持续受邀担任原职，为项目决策评审工作贡献一份心力！ 侯庆辰，现任南京华讯知识产权顾问有限公司总经理、庆辰(台湾)法律事务所创所律师与执行合伙人、台湾台北科技大学智慧财产权研究所兼任副教授。从执业律师到走进产业，我司总经理一直以专业的知识技能和丰富的业界经验，逐渐累积各企业的认可与信赖。 在我司总经理带领下的华讯，有信心为更多的企业提供专业的知识产权与相关服务，并期待着与各企业间共谋合作，展望未来！ 南京华讯知识产权顾问有限公司
Gamma Frequency Neuromodulation for Alzheimer's Disease Alzheimer's disease (AD) is the most common neurodegenerative disease in the elderly worldwide. AD has a profound negative impact not only on patients, but also on their families, communities, and countries. In the field of AD therapy, since 2003, the US FDA has not approved any innovative drugs for the treatment of AD. However, scientists have never stopped exploring innovative treatments for AD. On March 09, Cognito Therapeutics announced at 2021 AD/PD Conference held online that the company’s innovative digital therapy for the treatment of AD through visual and auditory stimulation achieved positive results in Phase 2 clinical study. The reported Phase 2 data showed that Gamma frequency neuromodulation was safe and well tolerated. Over the 6-month period, patients in the treatment group exhibited a significant 84% slowing of functional decline in ADCS-ADL scores and a significant 83% slowing in memory and cognitive decline as measured by MMSE scores, compared to patients in the placebo group. Patients in the treatment group also demonstrated a significant 61% reduction in whole brain atrophy and volumetric loss associated with AD, compared to placebo group patients at 6 months, indicating a potential disease modifying effect. It is worth mentioning that, Cognito Therapeutics’ licensed proprietary gamma frequency neuromodulation platform technology, is a non-invasive therapy utilizing visual and auditory stimulation to treat neurodegenerative diseases, that is developed by scientific founders at MIT, Professors Li-Huei Tsai and Ed Boyden. Professor Tsai is an internationally renowned neuroscientist, and her team, published a paper in the top scientific journal "Nature" as early as 2016, showing that in a mouse model of Alzheimer's disease, using LED lights to emit flashes of special frequency can reduce Amyloid deposition in the mouse brain. Amyloid deposition is one of the hallmark features of the AD brain, and it is also the target of many drug therapies currently under study. “Our approach has translated into clinical proof of concept by successfully achieving statistically significant results in AD, with a potential for disease modification due to significant reduction of cerebral atrophy and volumetric loss,” said Dr. Tom Megerian, Chief Medical Officer, Cognito Therapeutics, “If these results are replicated in our larger, pivotal trial, this will represent a huge medical breakthrough in Alzheimer’s research.”
很荣幸在基因线上2月份专题报导的数篇文章中，引用本公司创办人侯庆辰律师书籍著作，即【论专利医药的产业化—中国专利法专题研究】乙书，并采用本公司与合作伙伴庆辰法律事务所文献数据。对内文有兴趣的读者，欢迎点击下面连结参阅： 一、中国专利法规改革带动医药产业发展（上）：学名药为大宗，转型诱因不足？ https://geneonline.news/china-patent-biomedical-industry-part1/ 二、中国专利法规改革带动医药产业发展（下）：专利连结制度、专利期限补偿 https://geneonline.news/china-patent-biomedical-industry-part2/ 三、生技人才、新创大量涌入中国？解密中国生医市场产业动态https://geneonline.news/china-pharma-trend/
《你好，李焕英》引发的商标布局思考 截止日前，电影《你好，李焕英》，票房已接近50亿，一举成为2021年春节档电影最大黑马。电影的火爆，也带动了“你好，李焕英”的商标注册情况。 其实早在电影上映前两个多月，也就是2020年12月8日，作为《你好，李焕英》出品方之一的北京京西文化公司就已经对该影视作品提前做好了知识产权保护，在45个全类别上申请了“你好，李焕英”商标注册，目前，商标注册状态均为“等待实质审查”。 然而在早期的影视作品中，由于一些企业未及时对影视作品进行知识产权的正确保护，使得商标抢注者有了可乘之机，比如周星驰导演的电影《长江7号》，就是由于片方缺乏对知识产权的保护意识，错失了“长江7号”能够为企业带来的巨大经济效益。 近年来，商标大战屡屡上演，恶意抢注商标的乱象层出不穷。从苹果公司因自己的商标在中国遭遇抢注，而不得不花费6000万美元来解决这一问题，到前段时间火爆网络的“今日油条”商标给“今日头条”带来的严重影响，再到网络红人“丁真”商标被多家公司抢注，由此可见，知识产权意识的觉醒对于企业发展有多么重要。 那么面对商标恶意抢注的行为，除了要加强商标监测和法律保护以外，企业在最初也要合理认识知识产权竞争壁垒，下好商标布局这盘棋。首先，要明确企业的哪些标识可商标化，比如：品牌名称、商品名称、宣传语或者别称（例如湖南卫视别称“芒果台”）等；其次，关于产品范围，企业要综合考虑以下几点： （1）企业现有业务范围：首选商标注册类别和商标群组项目，应该覆盖企业现有业务范围； （2）企业未来业务发展方向：结合企业发展计划和行业前景预测，提前做好商标申请或商标转让，为企业做好商标储备； （3）联合商标保护：商标注册延伸到易对企业主商标造成混淆的商品类别，避免其他商家名正言顺的“傍名牌”，影响企业利益； （4）企业声誉方面：注册预防商标，抵御不良影响损害商标价值，比如“伊利”是牛奶商标，如果别人在卫生洁具上注册“伊利”商标，一定会给“伊利”牛奶带来负面影响； （5）品牌发展地区：企业可以以主要市场活动区域为核心保护区，若企业产品有计划进入国外市场，就需要提前跨境布局。 近年来，我国知识产权行业飞速发展，社会知识产权保护意识也在不断提高，知识产权在很大程度上影响着企业的市场竞争力，所以无论在哪个行业也无论企业大小，提前做好知识产权规划，做好商标布局工作都是不容忽视的一步，企业 只有建立起牢固的知识产权保护壁垒，这样才能更好地保护自身品牌，避免自身品牌利益受到他人侵犯。
看春晚“拓荒牛”浅谈专利为企业的保驾护航 在今年央视春节联欢晚会上，一款以“拓荒牛”为设计形象的四足机器人走进了人们的视野，其背后蕴藏着中国科技企业研发的多项自主创新硬核技术，该款大型四足机器人是优必选科技股份有限公司推出的。 据了解，优必选科技已四次登陆春晚舞台，优必选在2016年因央视春晚其机器人产品与演员同台表演而受到广泛关注。优必选科技股份有限公司是一家集人工智能和人形机器人研发、软件开发及产品销售为一体的高科技创新企业。自主研发的Walker机器人被评为全球值得关注的五大人形机器人之一，针对拓荒牛的研发，依托Walker研发过程中积累的核心技术，优必选研发团队在三个月内攻克多项技术难点，未来也能够在优必选其它机器人上使用，累积拥有自主研发6大核心技术，获中国专利金奖和银奖，全球申请专利超2500件。优必选于2012年成立以来，其机器人已服务全球67个国家，3款防疫机器人为14个国家和地区提供无接触服务，帮助全球40多个国家150万学生了解、学习人工智能。通过春晚拓荒牛效应，优必选似乎找到了风口，优必选也重启开始了自己的IPO之路。 可见，对于企业来说，专利是其保持市场竞争力的关键，面对广阔的市场前景和激烈的竞争，专利是企业发展的核心，知识产权对企业来说非常重要，在专利竞争的赛道上，狭路相逢智者胜，专利的布局发挥着关键作用。优质的专利布局有两个功能，一个是防护自身的专利或非专利技术不受侵犯，二是能够成为攻击竞争对手的根据。这个专利防护网做得越好，其发挥的作用就越大。 那何为专利布局呢？通俗来讲就是对关键核心技术形成严密有层次感的专利防护网，你的这个专利技术产品在申请专利的时候，不仅仅是只保护你的这一个发明，应该考虑到未来其他的竞争对手，可能会对你的创造发明故意避开的专利申请及仿用问题。例如，美国某公司在1979年对图形用户界面技术及时申请专利作为一项技术储备，而后来该项技术构成了苹果电脑操作系统的基础，以具有前瞻性的眼光提前布局收到了意想不到的丰厚收益。还有，中兴通讯围绕其已经获得中国金奖的专利又提交了一系列专利申请，形成专利群，在世界范围内进行了专利布局，目前，相关专利已在欧洲、美国、日本等国家和地区获得授权，实现对产品更周全地保护。 在未来发展中，企业只有不断加强自身的技术创新，做好专利保护和运用工作，建立以高价值专利为核心的专利战略，强化专利的布局和运营，并将技术和专利与标准相互联动，方可进退有据，步步为营，实现对公司专利产品的进一步保护，使其在所处行业占得先机，为企业在全球行业市场上保驾护航。
国内首款CAR-T产品上市在即 复星凯特的CD19 CAR-T疗法益基利仑赛注射液有望于近期获NMPA批准上市，一旦获批，将会成为国内首款、全球第四款获批上市的CAR-T疗法产品，中国CAR-T疗法也将为国内肿瘤免疫治疗开启新篇章。 CAR-T疗法 CAR-T细胞疗法主要是利用T细胞启动人体自然宿主防御机制。与传统的癌症治疗药物不同，CAR-T通过向患者DNA中导入编码CAR的基因对T细胞进行修饰，T细胞增殖后回输患者体内表达CAR，就可以对靶细胞进行杀伤。CAR-T可以在识别肿瘤抗原时无需主要组织相容性复合体（MHC）的限制，能够识别MHC非依赖型靶标，同时通过共刺激性分子信号增强T细胞免疫的杀伤性，从而克服由于肿瘤细胞下调MHC表达或抑制共刺激分子分泌而造成的免疫逃逸。CAR-T就是一种经过基因修饰的T细胞，比普通T细胞定位攻击肿瘤细胞的能力更强。 益基利仑赛注射液 益基利仑赛注射液是吉利德/Kite制药开发的CD19CAR-T细胞注射液（商品名Yescarta），该产品将被开发用于治疗两线或以上系统性治疗后复发或难治性大B细胞淋巴瘤，包括：弥漫性大B细胞淋巴瘤（DLBCL）非特指型、原发性纵隔B细胞淋巴瘤（PMBCL）、高级别B细胞淋巴瘤和滤泡淋巴瘤转化的DLBCL。 CAR-T竞争格局 目前，全球共有三款获批上市的CAR-T细胞免疫治疗产品，包括Kite制药的Yescarta和Tecartus以及诺华的Kymriah，三者均靶向CD19。CAR-T提供了一种新的治疗手段，并且展现出突破性疗效，自体抗CD19-CAR-T细胞的临床试验在成人和儿童r/r ALL患者中获得了高达93%的缓解率，在r/r CLL患者中使用CAR-T细胞进行的临床试验表明，总有效率（ORR）高达75%，完全缓解（CR）高达66%，同样CAR-T在一些淋巴瘤患者中也展现出前所未有的缓解率。 截至目前，全球市场共有366款CAR-T在研，3款CAR-T产品获批上市。国内方面，除了复星凯特外，仅药明巨诺一家的CAR-T产品瑞基仑赛报上市。此外，有多个CAR-T处于临床阶段，其中南京传奇的BCMA靶向CAR-T已于2020年8月被CDE纳入突破性疗法程序。 虽然欧美药企在CAR-T领域走在前列，但中国药企也在努力追赶，相信复星凯特Yescarta上市后将在CAR-T市场分一杯羹。
辞旧迎新，关怀送暖 省市台办领导走访慰问莅临华讯平台 在新春佳节来临之际，为进一步增进台胞台商的情感交流，1月19日，江苏省台办副主任吴伟荣一行来到华讯国际知识产权与涉外法律服务平台走访看望台胞台商，市台办副主任李芬琴、联络处处长哈赵刚，江北新区宣传和统战部副部长杨涛，研创园相关负责人陪同参加。 由「南京华讯知识产权顾问有限公司」(以下简称「南京华讯」)副总经理李悦宁女士负责接待各位领导并重点参观了南京华讯及庆辰法律事务所驻南京代表处，期间更关怀企业台胞、员工的春节过年计划，提前致以节日的祝福和亲切的问候。 李悦宁女士汇报了华讯成立历史、团队背景资历、经营情况、典型案例、发展前景等情况，座谈会上，江苏省台办吴副主任了解到在疫情防控常态化及全球经济下行等不利因素影响下，企业的发展情况，嘱咐南京华讯负责人要做好防护工作，保护好自身安全，同时双方还就当下知识产权行业市场现状进行了深入交流。由于，南京华讯于2014年初正式运营。当年度即荣获「江苏省民营科技企业」称号，2016年更获得「江苏省科技型中小企业」称号。南京华讯经营的高阶知识产权信息与顾问服务，在重要科技及医疗产业所涉及的知识产权与涉法项目，均能提供企业所需之资源与解决方案，鉴于，中国与美国是世界上最主要的两大市场，南京华讯更将研究的知识产权着重在中国与美国的专利。并同步扩张到日本与欧洲。南京华讯的重要合作伙伴南京庆辰，更是江苏省与南京市自贸区第一家境外法律事务所，从筹办到取证，南京庆辰得获肯定，有此殊荣。南京华讯与南京庆辰的合作交流，让企业在知识产权议题与涉法项目上，能得到更全方位的专业服务。 南京华讯除了希望为未来进入江苏的台资企业树立榜样，发挥自身为桥梁的作用，更期盼能引导更多台胞人才来江苏投资兴业，为江苏的企业发展奉献一份力。
Advanced Version of New Antibiotics-Antimicrobial Peptide In 1929, British bacteriologist Fleming discovered penicillin for the first time. Since then, Antibiotics have officially entered the stage of history. During the Second World War, penicillin became a very important strategic material to prevent war wounds from being infected. However, with the development of history, more and more antibiotics have sprung up, and the fatal problems (drug resistance) caused by the large-scale application of antibiotics have gradually emerged seriously threatening people's health. Finding new types of antibiotics is an effective way to solve the problem of resistance. Antimicrobial peptide (ABP) originally refers to a class of basic peptides with antibacterial activity induced in insects. The molecular weight is about 2000-7000 and consists of 20-60 amino acid residues. According to its structure, it can be roughly divided into four categories: spiral, sheet, extended and ring. Some ABPs consist entirely of a spiral or sheet, while others have a more complex structure. The characteristic of extended peptides is the lack of recognizable structural motifs. However, they contain large amounts of specific amino acids such as arginine, tryptophan, glycine and histidine. The antibacterial mechanism of traditional antibiotics is that the antibiotics bind to the receptors of specific parts of the pathogen, so that the normal structure of the pathogen is destroyed or some biosynthesis is blocked, in order to achieve antibacterial or bactericidal effects. When the target site of its action changes, the antibiotic will lose its antibacterial effect, which is the main reason why bacteria develop resistance to antibiotics. The most common mechanism of action of ABP is to destroy the membrane potential, change the membrane permeability, and leak metabolites by binding to the cell membrane, directly destroy the pathogen cell membrane and kill bacteria, so it is not easy to develop drug resistance, Moreover, ABP also has the advantages of high antibacterial activity, wide antibacterial spectrum, many types, and a wide range of options, so it is considered to have broad application prospects in the pharmaceutical industry. In addition, a unique feature of many ABPs is their multiple mechanisms of action. For example, the antimicrobial peptide LL-37 that exists in the human body. The most common mechanism of action is to act on bacterial cell membranes, and it can also regulate inflammation and inflammation Anti-inflammatory immune response. The ability of ABP to function through multiple mechanisms and different pathways not only increases its antibacterial activity, but also reduces the tendency to develop drug resistance. Exercising effects through multiple channels can greatly reduce the possibility of bacteria acquiring multiple mutations at the same time, which makes ABP have a good therapeutic potential in drug resistance. In addition, because many ABPs act on the cell membrane sites of bacteria, bacteria must completely redesign their cell membrane structure to undergo mutations, and it takes a long time for multiple mutations to occur. In cancer chemotherapy, it is common to use multiple drugs with different mechanisms to limit the resistance of tumors. However, the use of multiple drugs increases the potential side effects and toxicity of chemotherapy. Therefore, a single ABP drug with multiple complementary mechanisms may have the same antibacterial effect with minimal side effects. Although there are currently a large number of natural ABPs that have excellent therapeutic effects, there are still many potential modifications that can be used to generate new ABPs. The global call for action to develop new antibacterial compounds to avoid the next antibacterial crisis.
Dingxiangyuan's open medical data platform covers 7 application scenarios such as medicine, disease, and diagnosis Dingxiangyuan, a leading domestic digital medical and health technology company, announced the launch of a professional-level medical data open platform. This platform is the industry's first open data platform that can fully cover multi-scenario applications such as drugs, diseases, hospitals, departments, diagnosis and treatment, and medical information. It broke the current situation of internal data fragmentation in various institutions in the medical industry. At present, more than 400 pharmaceutical companies, financial insurance companies, and Internet companies including AstraZeneca, Alibaba Cloud, and Huatai Securities have become platform partners. It is reported that the Dingxiangyuan medical data open platform is supported by the core product medication assistant, Insight database, and Dingxiang doctor big data. Relying on 20 years of medical professional-level data accumulation, tens of millions of medical knowledge such as drug diseases, institutional data and tens of thousands of Clove Professional articles produced by the park copyright provide enterprise-level users with open data services based on standardized structured data. In the era of big data, medical care is gradually opening up, but the utilization rate of data within the medical industry is relatively low at this stage. Li Ning, head of product technology at Dingxiangyuan, said that under the premise of ensuring data security, the platform avoids the fragmentation of medical data and facilitates cross-medical organization collaboration, for the development and promotion of new drugs, optimizing clinical treatment plans, and preventing excessive treatment. Provide integrated data hard core support to make medical data play a greater value, thereby saving medical resources. For medical institutions, the Dingxiangyuan Medical Data Open Platform provides prescription review and timely discovery of potential unreasonable drug use problems; for pharmaceutical companies, the medical data open platform provides basic drug data construction; for the financial and insurance industry, the medical data open platform provides risk assessment for pharmaceutical companies , Medical insurance underwriting. In addition, the Dingxiangyuan medical data open platform also provides disease science services, medication instructions query services, and professional physician identity certification. Recently, Dingxiangyuan completed a new financing of US$500 million. With the promotion of the "medical-public" dual-core drive strategy, it is accelerating the accumulation of professional forces on the upstream supply side. The realization of the medical data open platform will also continue to accumulate new data and use the data for internal product innovation, enabling all participants in the medical system to connect and collaborate more closely.
2020华讯杯·法律写作竞赛圆满落幕 法律人工作的产出很大一部分是法律文书，所以法律文书的质量良窳就成为评判一位法律人能力的最主要标准。然而国内法学教育中的学生却非常欠缺专业法律写作能力的训练。有鉴于此，南京华讯举办华讯杯法律写作竞赛，期望通过此项活动，将美国法学院行之多年的法律写作训练与文化介绍到国内，以期对法律人的写作能力提升能贡献绵力。 本次竞赛从12月15日开始，历时近一个月，终于在1月13日圆满落幕，华讯邀请到获奖的三名学生前来参加2020华讯杯法律写作竞赛的颁奖典礼，工作人员接待了同学们后带领他们参观华讯的办公环境并简单介绍了华讯的成长历程。 由于疫情的关系，华讯总经理侯庆辰先生不能到场给同学们颁奖，但通过视频连线，侯律师对本次活动的成功举行发表了贺词:非常感谢参加本次华讯杯竞赛的学生，我们期许这次尝试只是初步播种，未来能够逐渐发芽茁壮，若华讯因此能对中国大陆法律人的能力养成可以有一点贡献，那将是我们无比的荣耀。 在和获奖同学的交流中，侯律师也对三位获奖作品做出了相应评价： 评王宁宁（一等奖） 紧抓议题，观点明确，逻辑清晰，完全符合法律论理文字的结构要求。 评唐梦璇（一等奖） 逻辑能力强。作者中文功底深厚。虽不完全照西式论理模式来写，但透过个人的写作能力仍充分展现出卓越的说理能力。 评王军昌（三等奖） 基本掌握论理结构，但若能在争点提出，还有每段论理，及每段小结与大结论的逻辑上再强化，将可以更好！ 典礼的最后为同学们颁发了证书奖金并送上了鲜花。华讯希望能将华讯杯法律写作竞赛延续下去，每年都举办一届，为法学院的学生提供一个展现专业法律写作的平台。
“孤儿药”又称为罕见病药，指用于预防、治疗、诊断罕见病的药品。在美国，罕见疾病是指患病人数少于20万人的疾病。自1983年以来，美国通过《孤儿药法案》的实施，给予企业相关政策扶持，以鼓励罕见病药品的研发，获得美国FDA孤儿药资格认定之后，意味着该药将享有临床试验费用税收减免、免除NDA申请费用、获得研发资助等，特别是该药物的该适应症批准上市后可获得美国市场7年独占权，因此获得FDA孤儿药认定也一直被视为重要的全球化创新实力指标之一。 近年来中国生物医药创新力量日益崛起，而作为一直坚持全球创新的领军企业-亚盛医药，自2020年以来捷报频传，连续获得9项美国FDA孤儿药资格认证，成为了中国生物医药企业中的佼佼者。 截止目前： FDA授予HQP1351一项孤儿药资格认定，适应症为慢性髓性白血病（CML）。HQP1351是一款新型口服第三代BCR-ABL抑制剂，对BCR-ABL以及包括T315I突变在内的多种BCR-ABL突变体有突出效果，用于治疗一代、二代TKI耐药的CML患者。 FDA授予APG-2575四项孤儿药资格认定，适应症分别为华氏巨球蛋白血症(WM)、慢性淋巴细胞白血病(CLL)、多发性骨髓瘤（MM）和急性髓系白血病（AML）。APG-2575是一款Bcl-2选择性小分子抑制剂，通过选择性抑制Bcl-2蛋白来恢复肿瘤细胞程序性死亡机制（细胞凋亡）。 FDA授予APG-115三项孤儿药资格认定，适应症分别为胃癌、急性髓系白血病（AML）和软组织肉瘤（STS）。APG-115是一种口服的、高选择性的小分子MDM2抑制剂，对MDM2具有高度结合亲和力，通过阻断MDM2-p53相互作用从而恢复p53的肿瘤抑制活性。 FDA授予APG-1252一项孤儿药资格认证，适应症为小细胞肺癌（SCLC）。APG-1252为亚盛医药自主研发的新型高效小分子药物，可通过选择性抑制Bcl-2及Bcl-xL蛋白修复细胞凋亡。 这些CML、WM、CLL、MM等罕见病的治疗都是全球层面目前尚未完全满足的临床需求。因此希望在获得FDA孤儿药资格认证之后相关政策的扶持能够有助于亚盛医药公司加快这几种药物的全球临床开发与产品上市，早日惠及更多的罕见病患者。
Bayer's new anti-tumor drug BAY 2416964 received clinical approval in China According to Center for Drug Evaluation (CDE) announcement, Bayer's clinical application for BAY 2416964 tablets submitted in category 1 of chemical drugs was accepted by CDE on October 16 and received on December 17 two clinical trials have implied permission and are intended to be developed for advanced malignant tumours. This is the first time the product has been approved for clinical use in China, which means that this drug candidate is about to start clinical studies in patients with advanced malignant tumors in China. The Aryl Hydrocarbon Receptor (AHR) is a protein in immune cells, which can play an immunomodulatory role according to the integrated signals of microorganism and amino acid metabolism in human body. Because AHR is highly expressed in a variety of tumors and has immunomodulatory effects, modulators targeting AHR are considered to be one of the new types of immunotherapy. At the same time, this type of therapy is expected to be combined with other drug categories to improve the therapeutic effect. BAY 2416964 is a potent, highly selective and cross-reactive AHR inhibitor that can exert a variety of anti-tumor immunomodulatory effects. It can block the transcription of CYP1A1 mediated by different AHR agonistic ligands, and can directly interact with AHR, and can inhibit ligand-induced AHR transport to the nucleus. Studies have shown that BAY 2416964 with different doses and different dosing frequencies can inhibit specific tumor models. Bayer is currently carrying out an exploratory study on the human dose of BAY 2416964 in patients with advanced cancer. This is an open-label, phase 1, dose escalation and expansion study conducted for the first time in humans to evaluate the safety, tolerability, maximum tolerated dose, pharmacokinetics, and efficacy of the AHR inhibitor BAY 2416964 Kinetics and tumor response profile, etc. Senator Roy Blunt wrote this paragraph in the 《Cancer Development Report 2016》in the United States: "When a family is healthy, there may be many conflicts and problems. But if one of them has cancer, you have only one problem to deal with , and that's the cancer itself." I hope that the follow-up clinical development of this product will progress smoothly and bring a new treatment option to cancer patients as soon as possible.
华讯受邀生物医药（医疗器械）企业境内外上市沙龙研讨会 12月17日，华讯受邀参加生物医药（医疗器械）企业境内外上市沙龙研讨会，本次活动由南京江北新区科技投资集团有限公司、恩然创投和北京竞天公诚（南京）律师事务所主办。 由于疫情的关系，医药企业受到了全球资本市场史无前例的重视和追捧，越来越多的医药企业想要借助这次机遇进行公司上市。同时为了回应习近平总书记在中央政治局第二十五次集体学习中强调的全面加强知识产权保护工作，激发创新活力推动构建新发展格局。为此主办方特邀南京华讯知识产权顾问有限公司副总经理李悦宁女士为大家分析在企业上市的过程中，知识产权对科创板企业IPO的重要性。 研讨会上，李悦宁女士简单介绍了南京华讯知识产权顾问有限公司，为大家分析了企业在上市过程中知识产权的要求以及专利的风险，她强调：“企业科创板成功上市离不开核心专利、核心技术。追求科创板上市，不应只是所谓的“面子工程”，只有尊重科技创新、保护知识产权，高效运营发展，才能更好的推动技术进步，实现科技强国！”重点为大家介绍了企业IPO不可或缺的识产权价值实现与风控管理的专业解决方案。一、提供国内外法律事 务服务。例如一般公司法务、 投融资、知识产权纠纷等。二、 知识产权诊断。例如潜在风险排查 及应对、专利布局等。三、知识产权/法务管理体系搭建。例如制度表单与部门的建立。四、公共关系顾问服务。例如撰写文章、提供咨询服务等。五、知识产权内部培训。 华讯协助客户将技术、知识产权及法律三环结合，全方位打造一站式知识产权服务，提供最客户最精准、最专业的知识产权服务。华讯愿为各企业的上市出一份力。 华讯是您连接中国与世界、技术与市场的桥梁。
A NASH Drug Candidate ASC42 Received Fast Track Designation A non-alcoholic steatohepatitis (NASH) drug candidate ASC42, an Farnesoid X Receptor (FXR) Agonist from Gannex received Fast Track designation from the U.S. Food and Drug Administration (FDA) on 14 December 2020. The U.S. FDA’s Fast track is a process designed to facilitate new drug development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need; and its purpose is to get important new drugs to the patient earlier. This Fast Track designation represents FDA’s recognition of ASC42’s potential in addressing these unmet medical needs for NASH patients. Gannex is a wholly owned company of Ascletis Pharma Inc. and fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed, novel non-steroidal, selective, potent FXR agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis. The oral tablet formulation of ASC42 has been developed with the in-house proprietary technology and is stable at room temperature. NASH is a progressive liver disease caused by excessive accumulation of fat in the liver. It can cause chronic inflammation in the liver, trigger progressive liver fibrosis, cirrhosis, and ultimately lead to liver failure, cancer and patient death. The liver-related mortality in patients with advanced fibrosis is significantly increased. However, there are no FDA approved medicines for NASH indication yet. At present, NASH is predicted to be one of the largest drug markets in the field of drug treatment for liver diseases after hepatitis C. It is estimated that the global NASH therapeutic drug market will reach US$40 billion in 2025. In addition to Gannex’s ASC42, Potential drugs with rapid progress in clinical research include e.g., GENFIT's PPAR receptor agonist Elafibranor, Intercept's farnesol receptor (FXR) agonist obeticholic acid (OCA), Allergan's CCR2/CCR5 chemokine receptor blocker Cenicriviroc (CVC), Gilead's anti-apoptotic signal-regulating kinase 1 (ASK1) inhibitor Selonsertib, and Inventiva’s pan-PPAR agonist Lanifibranor.
血液癌症患者福音-双特异性抗体疗法 常见的血液癌症主要包括各类白血病、多发性骨髓瘤以及恶性淋巴瘤，其中白血病由于其较高的死亡率，更是被我国列为重点防治的十大恶性肿瘤之一。因此如何有效治疗血液癌症，拯救血癌患者的生命，仍然是目前医疗工作者们研究的重点。 在免疫疗法领域，双特异性抗体疗法是利用患者免疫系统中的T细胞杀伤肿瘤的一种方法，它们的一端可以与癌细胞表面的抗原相结合，另一端则通过T细胞表面的T细胞受体结合，将T细胞募集到癌细胞附近，启动T细胞对癌细胞的杀伤，由于双特异性抗体疗法的这种不同于单抗的特殊作用机制，从而使双特异性抗体成为了免疫疗法界的“新贵”。 以下为部分目前备受关注的双特异性抗体在研疗法，以及它们在治疗复发/难治性血液癌症中，取得的一些新的研究进展： 公司 藥物 靶點 適應症 最新研究進展 再生元 Odronextamab（REGN1979） CD20 x CD3 難治性B細胞非霍奇金淋巴瘤（B-NHL） 在高度難治性B-NHL患者中顯示了良好的單藥抗腫瘤活性；在惰性和侵襲性B-NHL患者中都觀察到持久的完全緩解率（CR），包括CAR-T療法難治的患者；同時，具有可接受的安全性和耐受性；目前，正在開展一項全球2期臨床。 再生元 REGN5458 BCMA x CD3 復發/難治性多發性骨髓瘤（MM） 截至2020年6月15日，有45例患者接受REGN5458治療，結果顯示：所有劑量水準組的總體有效率（ORR）為35.6％（最高劑量水準為60％），其中81.3％的應答者至少達到了非常好的部分應答；31.3％的患者具有完全緩解；有43.8％的應答者療效持續時間（DoR）>4個月，18.8％的DOR>8個月；髓外漿細胞瘤患者的ORR為16.7％；數據顯示REGN5458具有可接受的安全性和對復發/難治性MM患者的持久療效。 羅氏 Mosunetuzumab（M） CD20 x CD3 彌漫大B細胞淋巴瘤（DLBCL） 截至2020年6月3日，共36名DLBCL患者接受M加CHOP（環磷醯胺+多柔比星+長春新堿+潑尼松）方案治療，有27例在數據截止日期前至少3個月開始治療，這些患者的ORR為96%，CR為85%。 IGM Biosciences IGM-2323 CD20 x CD3 晚期B細胞惡性腫瘤 截至2020年6月12日，在一項首次在人體內進行的劑量遞增1期試驗中，8名患者接受了4個劑量水準的治療，初步結果顯示：在更高劑量下，IgM-2323安全性和耐受性得到了改善；與其它與T細胞結合的抗體相比，IgM-2323可能具有新穎的作用機制。 楊森公司 Teclistamab（JNJ-64007957） BCMA x CD3 復發/難治性多發性骨髓瘤（MM） 截至2020年7月20日，1期研究最新結果中，有84名患者接受Teclistamab靜脈注射治療，44名患者接受Teclistamab皮下注射治療，患者的ORR為63.8%，其中51%的患者達到非常好的部分緩解（VGPR），9例患者達到完全緩解。 輝瑞 PF-06863135 BCMA x CD3 復發/難治性多發性骨髓瘤（MM） 截至2020年4月15日，18例患者接受了PF-06863135皮下注射治療（劑量（μg/kg）分別為80、130、215和360），這些患者此前均接受過抗CD38單抗的治療，其中有4例患者還接受過靶向BCMA的抗體偶聯藥物或CAR-T療法的治療。截止數據截止日期，劑量增加仍在進行，但未達到最大耐受劑量（MTD）。試驗數據顯示：在全部皮下注射劑量組中，客觀緩解率為33%，在兩個高劑量組（215μg/kg和360μg/kg）中為75%；2例患者達到很好地緩解；7例患者病情穩定反應最佳；PF-06863135的暴露量隨劑量的增加而成比例增加。 Teneobio/艾伯維（AbbVie） TNB-383B BCMA x CD3 復發/難治性多發性骨髓瘤（MM） 一項劑量遞增和劑量擴展的1期人體臨床試驗研究中，入組的為MM患者，並且他們已經接受過至少3種治療方案，包括蛋白酶體抑制劑、免疫調節藥物和抗CD38單克隆抗體。截至2020年7月13日，有38位受試者服用了TNB-383B(0.025–40mg)。研究數據顯示：TNB-383B的最大耐受劑量為40mg，無需分步/分批給藥；在≥5.4mg的劑量下觀察到初步ORR為52％（12/23），儘管每3周給藥一次，仍觀察到較好的緩解和持久的（長達24周）反應。
产业小聚——半导体专利运营实例探讨会成功举行！ 11月25日，产业小聚——半导体专利运营实例探讨，在腾飞大厦2楼研习时光成功举行，本次邀请到南京华讯知识产权顾问有限公司总经理侯庆辰先生以及资深咖啡爱好者Kitty给大家做分享。 本次活动由华讯国际知识产权与涉外法律服务平台主办，南京华讯知识产权顾问有限公司、台湾庆辰法律事务所驻南京代表处、健策知识产权顾问南京有限公司协办。健策知识产权顾问南京有限公司总经理黄时显博士主持了本次的产业小聚。 第一部分由侯庆辰先生和大家一起探讨半导体专利运营的实例，侯先生首先做了简单的自我介绍，紧接着围绕台积电的知识产权运营进行分析，他提到：“中国用国家力量发展半导体产业是一个必然。90年代开始，中国政府就已经意识到半导体产业的重要性，为了避免因从国外进口芯片而产生威胁国家安全的可能性，中国有关部门相继推出多项政策，期望加强扶植自身半导体产业的发展。” 第二部分由最懂咖啡的媒体人Kitty为大家分享一些有关咖啡的知识，Kitty说，她这次不是以咖啡专家或者咖啡店顾问的角色来进行分享的，她这次是以一个资深咖啡爱好者的身份来准备这次的分享会。会上，Kitty从咖啡的种植培育到咖啡豆的挑选处理、从咖啡的分类到不同咖啡的萃取方式，为大家进行了详细的讲解。分享的最后，Kitty为大家制作了两种不同的手冲咖啡，让大家品尝。 寒冷的冬季，用一杯热咖啡温暖你我，生活的美好总能不期而遇。
本月15日，中国、日本、韩国、澳大利亚、新西兰以及东盟10国的15位贸易（商务）部长，共同签署了一份重要的自由贸易协定— 《区域全面经济伙伴关系协定》（以下简称《RCEP》）。《RCEP》所启动的东亚自贸区，是世界范围内人口数量最多、成员结构最多元的自由贸易区，是东亚经济发展近20年来最重要的里程碑。《RCEP》共20章，其中第11章专门制定了知识产权保护的举措，该章分为14节，共83条款和和过渡期安排、技术援助2个附件。《RCEP》涵盖了《民法典》规定的全部知识产权客体，如著作权、商标、地理标志、专利、外观设计等，涉及知识产权执法、合作、透明度、技术援助等多个领域。《RCEP》在世贸组织《与贸易有关的知识产权协定》(TRIPS)基础上，提升了东亚自贸区内知识产权整体保护水平，在考虑不同成员国的知识产权制度发展水平同时，针对不同的知识产权客体制定了新举措，为东亚自贸区知识产权的保护和促进提供了新方案，主要内容包括以下几点： 对著作权的权利内容进行了理清，首先，明确作者、表演者和录音制品制作者的专有权，对作者、表演者享有的信息网络传播权突出规定。其次，强调了录音制品的表演者和制作者有获得广播报酬的权利，对于直接或间接使用为商业目的而发行的录音制品进行广播，应当享有获得一次性合理报酬或收取许可使用费的权利。对广播组织专有权中“故意传播”的传播要件可以解释为“向公众再传播”。最后，对著作权进行了合理的限制，允许合适使用。譬如，为合法目的在其著作权和相关权利制度中提供适当的平衡，合法目的包括但不限于：教育、研究、批评、评论、新闻报道和为盲人、视障者或其他印刷品阅读障碍者获得已出版作品提供便利。 对有关商标保护的基础性规定进行了统一，首次，强调了集体商标、证明商标、地理标志得到保护。只要证明商标在缔约方受到保护，无须在其法律法规中将证明商标作为一个单独的类别对待。其次，确定了唯一的商标分类制度，该缔约方遵循依据《尼斯协定》制定的分类系统的翻译版本，在尼斯分类更新版本的官方翻译已经发布和出版的情况下，该缔约方应当遵循该版本。 最后，对商标注册和申请的主要流程进行了规定，要求缔约方应当设置商标注册制度，包括：向申请人提供驳回商标注册理由的书面通知的要求，书面通知可以是电子文本；申请人享有回复商标主管机关的通知，对初步驳回决定提出复审，以及对最终驳回决定启动诉讼程序。 规定专利审查的程序事项要增效提速，《RCEP》要求缔约方认识到提高各自专利制度的质量和效率以及简化和精简各自主管机关的程序的重要性，以造福于各自专利制度的所有使用者和全体公众。对专利申请、异议、撤销、注销或无效程序等，相应机关应当说明理由并采取书面形式的要求。此类决定可以以电子方式提供。 除上述内容之外，《RCEP》商业不正当竞争的情形进行了规定，确立了知识产权权利的实施与救济措施，包括一般义务、民事救济、边境措施、刑事救济，同时，还强调了7国适用《RCEP》部分条款有过渡期。根据《RCEP》的规定，该协定生效至少需要9个成员成员国批准，其中至少包括6个东盟成员国和至少3个非成员国家。目前该协议已顺利签署，RCEP各成员未来将各自通过国内法律制定、通过程序，履行《RCEP》中的各项义务，推动协定在各个成员国得到落实。
Affected by the COVID-19, global IPO activity slows down in 2020. But this year is a glorious year for China's biomedical companies. Since 2018, the Hong Kong Exchanges and Clearing Limited (HKEx) has opened its doors for the first time to biotechnology companies that have no operating income. In 2019, The Science and Technology Innovation Board (STAR Market) established by the Shanghai Stock Exchange has been officially opened for trading. It has brought new vitality to China's capital market and the development of China's technology.. The HKEx and STAR Market have become the first choice for many Chinese unprofitable biomedical companies to list. According to incomplete statistics, as of Nov 20, at least 13 Chinese biopharmaceutical companies have been listed on the HKEx and 10 companies have been listed on the STAR Market. See the table below for details: S/N Company name Stock Exchange Capital Raised Business area 1 Akeso,Inc HKEx Over $300 million Tumour、Autoimmune disease 2 Innocare HKEx About HK$2.093 billion Cancer、Autoimmune disease 3 Kintor Pharmaceutical Limited HKEx About $240 million Prostate Cancer、Breast Cancer Liver cancer、Baldness 4 Zai Lab Limited HKEx HK$5.73 billion Tumour、Autoimmune disease 5 Immunotech Biopharm Ltd HKEx HK$1.0241 billion T-Cell Immunotherapy 6 Ocumension Therapeutics HKEx HK$1.553 billion Ophthalmology 7 Hepalink HKEx HK$3.8 billion Heparin、Tumour 8 Jhbp (Cy) Holdings Limited HKEx ----- Tumour、Autoimmune disease 9 Everest Medicines Limited HKEx ----- Tumour、Autoimmune disease Cardiorenal diseases Infectious disease 10 Simcere Pharmaceutical Group Limited HKEx ----- Tumour、Central nervous system diseases、Autoimmune disease 11 Jw (Cayman) Therapeutics Co. Ltd HKEx ----- CAR-T 12 Remegen Co. Ltd. HKEx ----- Autoimmune disease、Tumour Ophthalmology 13 Antengene Corporation Limited HKEx ----- Tumour 14 Zelgen STAR Market About ¥2.026 billion Tumour、Hematopathy Hepatobiliary disease 15 Bio-Thera Solutions, Ltd STAR Market About ¥2.0 billion Tumour、Autoimmune disease 16 Sinocelltech Grou Limited STAR Market About ¥1.282 billion Monoclonal Antibody Recombination Protein、Vaccine 17 HitGen Inc. STAR Market About ¥830 million The lead drug 18 Cansino Biologics Inc. STAR Market About ¥5.2 billion Vaccine 19 Sunshine Guojian Pharmaceutical(shanghai) Co. Ltd. STAR Market ¥3.183 billion Antibody 20 Jiangsu Aidea Pharmaceutical Co.,ltd STAR Market ¥839.4 million Antidote、Tumour 21 Junshi BiosciencesCo., Ltd. STAR Market About ¥2.7 billion Tumour、Chronic disease Autoimmune disease 22 Easton BioPharmaceuticals Co.,Ltd STAR Market ¥1.335 billion Combination of generic drug development 23 Frontier Biotechnologies Inc STAR Market ¥1.845 billion AIDS antiviral treatment. Pain therapy In addition to the companies listed in the above table, other biopharmaceutical companies such as Beijing Science Sun Pharmaceutical Co.,LTD、Changchun BCHT Biotechnology Co and other companies have also submitted IPO applications to the HKEx and the STAR Market
Shanghai, China, November 11, 2020, 3D Medicines announced that it has reached a cooperation with Aravive. 3D Medicines will obtain the exclusive authorization for the clinical development and commercialization of Aravive's new drug AVB-500 in the oncology field of Greater China, and participate in the global clinical trial of AVB-500. Aravive will receive a $12 million contract and will be eligible for development and commercial milestone payments of up to $207 million. In addition, 3 will also pay Aravive a segmented sales commission based on AVB-500's annual net sales in Greater China. AVB-500, as a specific, high-affinity Fc fusion protein, is a new type of GAS6-AXL signaling pathway inhibitor. The GAS6-AXL signaling pathway is one of the important breakthroughs in the current tumor treatment field, with extremely high clinical value and huge market space. It has been confirmed in pre-clinical studies that AVB-500 can neutralize its activity by binding to GAS6, thereby selectively inhibiting the signaling pathway. At present, the clinical research of the drug is still in progress, and it has obtained fast track qualification granted by the US FDA for platinum-resistant recurrent ovarian cancer indications. In addition, AVB-500 was generally well tolerated, with no dose-limiting toxicity or unexpected safety signals. Aravive has successfully completed the Phase 1b trial of AVB-500 in platinum-resistant ovarian cancer and will enter the Phase III registration clinical study. Aravive also plans to initiate a Phase 1b/2 clinical trial of AVB-500 in clear cell renal cell carcinoma later in 2020. The product line of 3D Medicines includes differentiated biomacromolecules and small molecule anticancer drugs, and has an excellent team with international new drug development, registration and commercialization. 3D Medicines CEO Dr. Zhaolong Gong said: “As an innovative drug that can target a variety of tumors, AVB-500, combined with existing standard treatments or the company’s upcoming new drug Envafolimab, is expected to provide more convenient and more convenient Effective treatment options. We will work closely with Aravive to rapidly advance the development and commercialization of AVB-500, and bring this innovative drug with great therapeutic potential to Chinese cancer patients as soon as possible."
10月26日，保守派阵营的虔诚天主教徒巴雷特（Amy Coney Barrett），以52:48的得票获得美国参议院确认，并在美国总统特朗普的见证下，宣誓就任美国最高法院大法官。事实上从正式提名开始，大法官巴雷特始终饱受争议和批评。大法官巴雷特的任命意味着最高法院仅剩下3位自由派大法官，当晚的投票凸显出两党的巨大分歧，民主党45名参议员及2名独立参议员全部投票反对，共和党有52名参议员同意。这种争议包含对最高法院进一步保守化的担忧，现年48岁的大法官巴雷特，在拥有枪支、移民、女性堕胎等问题上持保守态度。巴雷特成为大法官后，保守派和自由派的人数变为6 : 3，这将对美国法院的保守主义带来较大的影响，大法官巴雷特对美国热点知识产权问题又是如何看待的呢？ 美国参议院知识产权小组委员会主席汤姆，于10月16日在国会就热点知识产权问题与大法官巴雷特进行了会谈，双方主要讨论了专利资格和著作权法。参议员汤姆提问，对最高法院关于专利资格的裁决有何看法以及最高法院是否应当充分解释他们做出的判决。大法官巴雷特拒绝评论具体的案件，她表示最高法院包括她本人都在努力给出明确的意见，以便能为下级法院及社会公众做出良好的指导，清楚地解释判决是一种美德。 对于著作权法的问题，参议员汤姆提出，当今社会环境发生了很多变化，最高法院花了一个多世纪的时间来解释著作权法是否涵盖如相机、钢琴播放器、移动图像、互联网等新技术领域，最高法院还是国会更适合回答这些问题？大法官巴雷特认为这些问题更像是一个政策问题，所以似乎最好由立法机关来解决。应当由民主选举产生的机构，而不是法院，来制定的政策。 美国版著作权法的落后性是无法争辩的，国会必须采取行动。从谈话中可以看出，巴雷特法官并不持有著作权激进主义理论。她认为宪法所规定的政策问题最好由国会来解决。对于专利资格的问题，巴雷特法官表明法院愿意提供明确的意见给下级法院及公众。作为保守派大法官，巴雷特法官无疑对美国知识产权司法保护环境有着举足轻重的影响，这将在后续的案例中得以呈现。
一直以来，“创新药”都存在研发难度大、投入高、周期长等难题，但从长远来看，创新药的研发能力依旧是药企的核心竞争力。在推进中国创新药走向全球的过程中，一大批以创新研发为主的药企也在飞速发展。进入2020年以来，中国新药授权交易（License in/out）数量较前几年激增，尤其是我国创新药License-out合作授权数量明显增多，可谓是License-out大爆发的一年。 10月29日，复星医药宣布，其控股子公司复创医药已与礼来公司（Eli Lilly and Company）签订《许可协议》，授予礼来对复创医药BCL-2抑制剂FCN-338在除中国大陆、香港及澳门地区之外的全球其它区域的独家权益。合作涉及金额高达4.4亿美元。 10月27日，基石药业宣布，与EQRx公司达成战略合作。基石药业将独家授权EQRx公司在大中华区以外地区开发和商业化抗PD-L1单抗舒格利单抗（CS1001）及抗PD-1单抗CS1003。合作涉及金额高达13亿美元。 9月28日，恒瑞医药宣布，已与韩国HLB Life Science公司（简称“HLB-LS公司”）达成协议，以1.057亿美元交易总额，将其具有自主知识产权的抗肿瘤药品马来酸吡咯替尼片（简称“吡咯替尼”）项目有偿许可给韩国HLB-LS公司，并获得HLB-LS公司的销售分成。 9月4日，天境生物公司和艾伯维共同宣布，双方就由天境生物自主研发、用于治疗多种癌症的创新型CD47单克隆抗体lemzoparlimab（TJC4）的开发和商业化建立全球战略合作，合作总金额或近30亿美元，刷新中国创新药企产品权益转让纪录。 8月，信达生物宣布，将授予礼来达伯舒®（信迪利单抗注射液）在中国以外地区的独家许可，礼来将致力于将信迪利单抗推向北美、欧洲及其他地区。 6月9日，康宁杰瑞宣布，与赛诺菲已签署协议达成战略合作：将共同针对HER2阳性乳腺癌患者，推进KN026与泰索帝®(Docetaxel)联合用药的临床试验。根据协议条款，在达到特定临床里程碑后，赛诺菲将有权在独占期内协商获得KN026的独家许可引进权。 6月1日，加科思宣布，与艾伯维达成一项授权交易。根据协议，双方将共同开发和商业化作用于癌细胞和免疫细胞关键靶点的蛋白酪氨酸磷酸酶（SHP2）抑制剂，艾伯维将获得加科思SHP2项目的独家许可权。 5月4日，君实生物宣布，与礼来公司（Eli Lilly and Company）签署了《研发合作和许可协议》，双方将合作研发及商业化SARS-CoV-2中和抗体（简称：君实新冠抗体，产品代号：JS016）。根据协议，礼来公司将被授予在大中华地区外对JS016开展研发活动、生产和销售的独占许可。合作涉及金额2.55亿美元。 4月20日，恒瑞医药宣布，与韩国CrystalGenomics Inc.公司签署协议，以8775万美元交易总额将PD-1单克隆抗体卡瑞利珠项目许可给CG公司，同时获得CG公司的销售分成，CG公司将获得卡瑞利珠单抗在韩国的独家临床开发、注册和市场销售的权利，被许可进行研发和销售卡瑞利珠单抗用于所有人类疾病。 4月15日，LEO Pharma宣布，与合一生技（Oneness Biotech）和中天（上海）生物（Microbio Shanghai）签署了全球独家许可协议，获得合一生技旗下一款抗体候选药物FB825的开发和商业化权益。根据协议，LEO Pharma将支付4000万美元的预付款，并提供最高5.3亿美元的里程碑付款，以及后续潜在的特许权使用费。 4月8日，成都先导宣布，与田边三菱制药株式会社（简称“MTPC”）达成一项新药研发转让协议。该转让协议囊括了一系列全新结构的小分子先导化合物，具体靶点是由MTPC指定的未披露靶点。按照协议约定，MTPC将向成都先导支付转让费，而成都先导将这些小分子化合物的后续开发及商业化权益排他性地转让于MTPC。 3月31日，复宏汉霖宣布，与Mabxience Research, S.L.订立独家许可协议。授予Mabxience在阿根廷、乌拉圭及巴拉圭就肿瘤治疗开发和商业化HLX02产品的独家许可。合作涉及金额75万美元。 3月11日，成都先导宣布，与日本科研制药株式会社（Kaken Pharmaceutical Co. Ltd.，简称Kaken）达成一项新药研发转让协议。按照协议约定，Kaken将向成都先导支付转让费，而成都先导将这些小分子化合物的后续开发及商业化权益排他性地转让于Kaken。 1月14日，信达生物宣布，将贝伐珠单抗生物类似药（IBI305）在美国和加拿大的商业化权益授权给Coherus BioSciences。合作涉及金额4500万美元。 本土药企license out交易数量的逐年增加，反映了中国本土药企的研发实力在逐渐增强。
2020年10月17日全国人大常务委员会发布了修改专利法的决定，该决定增加了第七十六条，主要内容是药品上市审评审批过程中，相关当事人可以向人民法院起诉，请求就申请注册的药品相关技术方案是否落入他人药品专利权保护范围作出判决。国务院药品监督管理部门在规定的期限内，可以根据人民法院生效裁判作出是否暂停批准相关药品上市的决定。 该法条所确立的案件类型类似于确认不侵害专利权纠纷，但是存在明显的差异，最高法院发布有关审理该类案件的规定（征求意见稿），其中许多规定不仅对法院审理该类案件有指导意义，对医药行业也产生重要影响。 一、关于管辖法院的规定 该意见稿规定，涉药品上市审评审批的专利第一审民事案件，由北京知识产权法院管辖。如果当事人（指相关专利的权利人、利害关系人和药品上市许可申请人）在提起药品上市审评审批的专利诉讼，又提起侵害专利权或者确认不侵害专利权诉讼，应当如何确定审理法院呢？ 针对同一专利权和申请注册的药品，在该药品未获得批准上市之前，当事人提起侵害专利权或者确认不侵害专利权诉讼的立案时间在涉药品上市审评审批专利诉讼的立案时间之后。同时前者不在北京知识产权法院立案的，应当移送北京知识产权法院。国务院药品监督管理部门依法批准申请注册的药品后，当事人提起侵害专利权或者确认不侵害专利权诉讼的，不再移送。 二、关于证据的特殊规定 该意见稿规定，当事人提起涉药品上市审评审批，除应符合起诉条件外，还应提交下列证据材料：（一）中国上市药品专利信息登记平台登记的相关专利的信息；（二）国家药品审评机构信息平台公示的申请注册药品的相关信息及未落入相关专利权保护范围的声明；（三）关于申请注册的药品技术方案是否落入相关专利权保护范围的初步证据。同时，药品上市许可申请人应当在一审答辩期内或者其提起诉讼时向人民法院提交其向国家药品审评机构申报的、与认定是否落入相关专利权保护范围对应的技术资料副本。 三、法院审理程序和行政裁决程序的联系 新专利法修改案中规定，当事人也可以就申请注册的药品相关的专利权纠纷，向国务院专利行政部门请求行政裁决。如果当事人同时提起涉药品上市审评审批专利和行政裁决申请，这两个程序是否会相互影响？ 该意见稿规定，当事人以国务院专利行政部门已经受理专利法第七十六条所称行政裁决申请为由，主张不应受理专利法第七十六条所称诉讼或者申请中止诉讼的，人民法院不予支持。 可以看出，该意见稿认为法院审理不应当受到行政裁决的影响，但是如果法院判决和行政裁决的结果不一致，国务院药品监督管理部门应当以哪一种结果为准，可能会在现实产生矛盾。 四、生效裁判结果对专利侵权或者确认不侵权纠纷的影响 国务院药品监督管理部门在规定的期限内可以根据人民法院生效裁判作出是否暂停批准相关药品上市的决定。法院裁判生效后，权利人是否还可以提起专利侵权或者确认不侵权诉讼？ 该意见稿规定，在药品被依法批准上市后，生效裁判认定该申请注册的药品相关技术方案落入相关专利权保护范围的，专利权人或者利害关系人可以另行提起侵害专利权诉讼。在针对同一专利权和申请注册的药品的侵害专利权或者确认不侵害专利权诉讼中，当事人主张依据该生效裁判，认定被诉侵权药品技术方案是否落入相关专利权保护范围的，人民法院一般予以支持。但是，有证据证明被诉侵权药品技术方案与申请注册的药品相关技术方案不一致或者新主张的事由成立的除外。 法院裁判生效后，权利人可以提起专利侵权诉讼或者确认不侵权诉讼，但是会受到生效裁判的影响。 目前该意见稿处于公开征求修改建议中，社会各界人士可以于12月14日前，通过书面邮寄或者电子邮件方向最高法院提出修改意见，公众应以最终发布的文件为准。最高法院针对这项新的案由，制定的相关审理规定，无疑意义重大，它将对药品（尤其是仿制药）上市产生重要的影响，相关的医药企业应当引起足够的重视，才能更好地应对审评审批中可能出现的专利诉讼风险。
On October 17, 2020, the 22nd Session of the Standing Committee of the 13th National People's Congress passed the decision on Amending the patent law of the people's Republic of China. The revised Patent Law will be implemented on June 1, 2021. This is the fourth Amendment of the patent law of China, with 29 amendments in total. This Amendment mainly focuses on three aspects: strengthening the protection of patent rights, promoting the transformation and application of patents, and improving the patent authorization system. First of all, the Amendment strengthens the protection of the legitimate rights of patentees. In the Amendment, it is stipulated that "For willful patent infringement with serious circumstances, the amount of compensation shall be determined ranging from one to five times the amount of compensation determined by the preceding methods. Where it is difficult to determine the losses suffered by the patentee, the profits which the infringer has earned through the infringement and royalties, the people's court may set an amount of compensation of no more than RMB 5,000,000 in light of factors such as the type of the patent right, the nature of the infringing act and the circumstances. "This Amendment not only increases the statutory compensation limit stipulated in the original Patent Law, the lower limit is increased from 10,000 to 30,000, and the upper limit is increased from 1 million to 5 million; it also provides for the implementation of a punitive compensation system for serious infringement of patent rights, and the compensation can be up to 5 times. The addition of punitive compensation and the increase of statutory compensation will be conducive to the protection of the legitimate rights of patentees. It also increases the cost of infringement. In addition to increasing the compensation, the Amendment also stipulates that: "In order to determine the amount for compensation, under the circumstances in which the right holder has endeavored to present evidence, and the related account books or materials are mainly in control by the accused infringer, the people's court may order the accused infringer to provide account books and materials relating to the infringing conduct; if the accused infringer does not provide or provides false account books or materials, the people's court may refer to the right holder's claims and evidence to rule on the amount of compensation. "This provision improves the rule of evidence and reduces the burden of proof on the obligee. Secondly, this Amendment adds the open license system, which stipulates: "Where the patentee declares in writing to the administrative department for patent under the State Council that he is willing to license any entity or individual to exploit his or her patent, and specifies the method and standard for payment of the licensing fee, the administrative department for patent under the State Council shall make an announcement and implement an open license. Where an opening license declaration is made on a patent for utility model or design, a patent evaluation report shall be provided." In order to encourage patentees to implement open licenses, the law also stipulates that the annual patent fees paid by the patentees will be reduced during the period of the open license. Although there are many patent applications in China, the patent conversion rate is low. The open license system can make the patentee reach a license agreement with many people, which can effectively promote the implementation of patents and accelerate the transformation of innovation achievements. Thirdly, this Amendment has also improved the patent authorization system. This Amendment improves the relevant system for the protection of design patents and adds the domestic priority to design patents. It stipulates that "where an applicant claims the priority of a design patent, he / she shall make a written declaration at the time of application and submit a copy of the patent application document for the first time within three months." Besides, the term of protection for design patents has been extended from 10 years to 15 years. In addition to the three aspects above, this Amendment also adds new provisions on the compensation period of drug patents. It provides that "The State Council may make a decision to extend the duration of invention patents of innovative pharmaceuticals which have been approved for marketing in China, to make up the time used for drug approval, and the extension period shall not exceed five years and the net effective duration of such innovative pharmaceuticals which have market launches shall not exceed fourteen years." Compared with the patents in other industries, drug patents have their own characteristics. When the drug is finally put on the market, the patent period included in the drug is not long, and the interests of the R & D pharmaceutical factory are not well protected. The newly-added drug patent compensation perio
10月17日，十三届全国人大常委会第二十二次会议表决通过了生物安全法并自2021年4月15日起施行。这是我国首部有关生物安全的法律，今年爆发的新型冠状病毒疫情给全球带来了严重的灾难，虽然目前中国的疫情得到有效的控制，但是全球的局势依旧很严峻，本次疫情让公众了解到生物安全不仅影响个体生命安全，更关乎国家公共安全，关乎人类安全。当前，随着气候的极端变化，自然环境的恶化以及人类活动流动性加大，全球生物安全的问题愈加突出，重大人类传染病、动植物疫情不断发生，生物安全的形势日益严峻，《生物安全法》的诞生顺应了时代的要求。 一、生物安全的内容 生物安全是国家安全的重要组成部分，是指国家有效防范和应对危险生物因子及相关因素威胁，生物技术能够稳定健康发展，人民生命健康和生态系统相对处于没有危险和不受威胁的状态，生物领域具备维护国家安全和持续发展的能力。与生物安全相关的活动主要包括这些内容：（一）防控重大新发突发传染病、动植物疫情；（二）生物技术研究、开发与应用；（三）病原微生物实验室生物安全管理；（四）人类遗传资源与生物资源安全管理；（五）防范外来物种入侵与保护生物多样性；（六）应对微生物耐药；（七）防范生物恐怖袭击与防御生物武器威胁；（八）其他与生物安全相关的活动。 二、《生物安全法》对维护国家生物安全的作用性 《生物安全法》是生物安全领域的基础性法律，其颁布和实施必将产生积极而深远的影响：一是有利于保障人民生命安全和身体健康。生物安全法将保障人民生命健康作为立法宗旨，明确维护生物安全应当坚持以人为本的原则，在防范和应对各类生物安全风险时，始终坚持人民至上、生命至上。二是有利于维护国家安全。生物安全法明确生物安全是国家安全的重要组成部分，把生物安全纳入国家安全体系进行谋划和布局，明确生物安全管理体制机制。三是有利于提升国家生物安全治理能力。该法要求政府支持生物安全事业发展，鼓励生物科技创新和生物产业发展，加强人才培养和物资储备，统筹布局生物安全基础设施建设，加强国家生物安全风险防控和治理体系建设，提升国家生物安全治理能力。 三、《生物安全法》建立了完善的生物安全风险防控体制 该法建立了建立统一领导、协同联动、有序高效的生物安全风险防控体制，从国家部委、地方各级人民政府、基层群众性自治组织到有关单位和个人，动员社会力量依法有序参与生物安全风险防控工作。一是由国务院卫生健康、农业农村、科学技术、外交等主管部门和有关军事机关组成国家生物安全工作协调机制，分析、研判国家生物安全形势，组织协调、督促推进国家生物安全相关工作。国家生物安全工作协调机制设立办公室，负责协调机制的日常工作；二是地方各级人民政府对本行政区域内生物安全工作负责，县级以上地方人民政府有关部门根据职责分工，负责生物安全相关工作；三是基层群众性自治组织应当协助地方人民政府以及有关部门做好生物安全风险防控、应急处置和宣传教育等工作；四是有关单位和个人应当配合做好生物安全风险防控和应急处置等工作。 同时由国家建立生物安全风险监测预警制度和风险调查评估制度，根据风险监测的数据、资料等信息，定期组织开展生物安全风险调查评估。国家生物安全工作协调机制组织建立统一的国家生物安全信息平台，有关部门应当将生物安全数据、资料等信息汇交国家生物安全信息平台，实现信息共享。 四、违反《生物安全法》的行为及相应的法律责任 违反《生物安全法》的行为主要是在生物安全相关的活动中产生，包括以下几种：（一）生物安全管理职责的工作人员在生物安全工作中滥用职权、玩忽职守、徇私舞弊或者有其他违法行为的，依法给予处分；（二）医疗机构、专业机构或者其工作人员瞒报、谎报、缓报、漏报，授意他人瞒报、谎报、缓报，或者阻碍他人报告传染病、动植物疫病或者不明原因的聚集性疾病的，依法给予责令改正、警告、暂停执业、吊销执业证书等处罚；（三）从事国家禁止的生物技术研究、开发与应用活动或者从事病原微生物实验活动未在相应等级的实验室进行等，给予警告、罚款等处处罚；（四）购买或者引进列入管控清单的重要设备、特殊生物因子未进行登记以及个人购买或者持有列入管控清单的重要设备或者特殊生物因子等行为，给予没收违法所得、警告、罚款等处罚；（五）境外组织、个人及其设立或者实际控制的机构在我国境内采集、保藏我国人类遗传资源，或者向境外提供我国人类遗传资源的行为，给予没收违法所得、罚款等处罚；（六）未经批准，擅自引进外来物种的行为，给予没收引进的外来物种、罚款等处罚。同时该法规定，构成犯罪的，依法追究刑事责任；造成人身、财产或者其他损害的，依法承担民事责任。 近期频发的国际国内生物安全事件，例如非洲猪瘟、非洲蝗灾、美国流感、新型冠状病毒等等，给人类社会带来了严重的灾难，《生物安全法》把生物安全纳入国家安全体系，将生物安全升级为国家大战略，是维护国家安全的重大举措。疫情之后，国内生物安全领域将迎来一次政策的全面推动。该法将成为防范和应对生物安全风险、保障人民生命健康、保护生物资源和生态环境、维护国家安全的一部重要法律。
On October 14, the U.S. Food and Drug Administration approved Regeneron’s Inmazeb as the first FDA-approved treatment for Ebola virus infection in adult and pediatric patients. Zaire ebolavirus, commonly known as Ebola virus, can cause a potentially fatal human disease. Ebola virus is transmitted through direct contact with blood, body fluids and tissues of infected people or wild animals, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Individuals who provide care for people with Ebola virus, including health care workers who do not use correct infection control precautions, are at the highest risk for infection. Ebola is the cause of a viral hemorrhagic fever disease (Ebola virus disease, or EVD). The viruses that cause EVD are well known to be located mainly in sub-Saharan Africa. Inmazeb, formerly known as REGN-EB3, is developed by Regeneron Pharmaceuticals, and is a mixture of the following three monoclonal antibodies: atoltivimab, maftivimab, and odesivimab-ebgn. Inmazeb targets the glycoprotein that is on the surface of Ebola virus. Glycoprotein attaches to the cell receptor and fuses the viral and host cell membranes allowing the virus to enter the cell. The three antibodies that make up Inmazeb can bind to this glycoprotein simultaneously and block attachment and entry of the virus. Inmazeb once received an Orphan Drug designation for the treatment of Ebola virus infection. Additionally, the FDA previously granted Inmazeb a Breakthrough Therapy designation for the treatment of Zaire ebolavirus infection. “Today’s approval highlights the importance of international collaboration in the fight against Ebola virus,” said John Farley, M.D., MPH, director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research. “The urgent need for advanced therapies to combat this infectious disease is clear, and today’s action is a significant step forward in that effort.”
“孤儿药”又称为罕见病药，指用于预防、治疗、诊断罕见病的药品。在美国，罕见疾病是指患病人数少于20万人的疾病。自1983年以来，美国通过《孤儿药法案》的实施，给予企业相关政策扶持，以鼓励罕见病药品的研发。 亚盛医药，作为一家旨在瞄准中国乃至全球患者“无药可医、尚未满足”的临床需求，研发具有“First-in-Class”和“Best-in-Class”潜力的国际新型原创小分子药物，以填补国内空白，并进军国际高端医药市场的原创新药研发企业，截至目前为止，亚盛医药共有4个在研新药获得6项FDA孤儿药资格。 今年五月份，亚盛医药第三代BCR-ABL抑制剂HQP1351获得FDA孤儿药资格认定，适应症为慢性髓性白血病（CML）；7月份和9月份，FDA授予APG-2575两个孤儿药资格认定，适应症分别为华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)；9月份，FDA授予MDM2-p53抑制剂APG-115孤儿药资格认定，用于治疗胃癌；10月9日，亚盛医药宣布再获两项FDA孤儿药认证：FDA授予其细胞凋亡管线在研原创新药MDM2-p53抑制剂APG-115、Bcl-2/Bcl-xL抑制剂APG-1252两项孤儿药资格认证，分别用于治疗急性髓系白血病（AML）和小细胞肺癌（SCLC）。 HQP1351是亚盛医药在研原创1类新药，为口服第三代BCR-ABL抑制剂，对BCR-ABL以及包括T315I突变在内的多种BCR-ABL突变体有突出效果，用于治疗一代、二代TKI耐药的CML患者。去年7月，该品种获美国FDA临床试验许可，直接进入Ib期临床研究。HQP1351为中国首个三代BCR-ABL靶向耐药CML治疗药物，目前已处于关键II期临床试验阶段，计划今年提交新药上市申请（NDA）。 APG-2575是亚盛医药在研的新型口服Bcl-2选择性小分子抑制剂，现已获得美国、中国、澳大利亚多项Ib/II期临床试验许可，正在全球同步推进多个血液肿瘤适应症的临床开发。其中作为单药或联合治疗复发╱难治CLL/SLL (小淋巴细胞淋巴瘤)的一项全球Ib/II期临床研究在进行中，正在美国和澳大利亚进行患者招募。 APG-115是一种口服的、高选择性的小分子MDM2抑制剂，对MDM2具有高度结合亲和力，通过阻断MDM2-p53相互作用从而恢复p53的肿瘤抑制活性。APG-115也是首个在中国进入临床阶段的MDM2-p53抑制剂，已在中国和美国展开多项治疗实体瘤及血液肿瘤的临床研究。 APG-1252为亚盛医药自主研发的新型高效小分子药物，可通过选择性抑制Bcl-2及Bcl-xL蛋白修复细胞凋亡。正在美国和澳大利亚进行针对晚期癌症患者的临床I期剂量爬坡试验，在美国进行针对联合紫杉醇治疗复发难治SCLC患者的Ib/II期试验，并在中国进行针对SCLC患者的单药临床I期剂量爬坡试验。临床数据表明，APG-1252在SCLC及其他晚期实体瘤患者中具有良好的安全性，并初步显示疗效。 慢性髓性白血病（CML），华氏巨球蛋白血症(WM)和慢性淋巴细胞白血病(CLL)，胃癌，急性髓系白血病（AML）和小细胞肺癌（SCLC）等疾病的治疗都是全球层面目前尚未完全满足的临床需求。获得FDA孤儿药资格认定是HQP1351、APG-2575、APG-115和APG-1252产品开发和商业化的重要里程碑，充分说明了美国FDA对亚盛医药产品质量以及临床效果的认可，相关政策的扶持也将有助于亚盛医药公司加快这几种药物的全球临床开发与产品上市，从而能够早日惠及更多的罕见病患者。
美国联邦最高法院大法官安东宁·斯卡利亚（Justice Antonin Scalia）在近代美国法律历史上，有着举足轻重的地位。做为一名坚定的保守派，斯卡利亚大法官对于美国宪法的解释抱持着几近偏执的本格派原旨主义思想；更为人津津乐道的，便是斯卡利亚大法官极富创意而辛辣的言词及文字，特别展现在他的不同意见书中，以逻辑推演和幽默小品点缀而成的严谨法学文字，便是斯卡利亚大法官留给美国法学界的最大遗产。 1936 年 3 月 11 日，安东宁.斯卡利亚生于美国新泽西州特伦顿。作为家中独子，斯卡利亚夫妇对独子的教育投注了极多的心血，而这些努力也确实转化成斯卡利亚学识涵养的基底及养分，经过青年时期的累积，斯卡利亚顺利进入哈佛法学院后并获得佳绩。 在经过一系列学界、政界的法律职位历练后，斯卡利亚终于迎来一个关键机会－1974 年，尼克松总统提名斯卡利亚担任首席检察官助理，负责法律顾问办公室。该部门隶属司法部并负责向行政部门提供法律建议。此时斯卡利亚以司法部的角度出发，针对行政部门的缺失提供校正的指南，在日后就任大法官时，此种法律本位的思考便是斯卡利亚意见书的宗旨－宪法不应为行政部门而恣意调整解释之方式；在哥伦比亚联邦特区上诉法院担任法官时，斯卡利亚撰写了近百份判决意见。他的判决意见文风以文辞优美、引经据典著称，同时亦为宪法原旨主义的坚定拥护者，严格按文本解释宪法，拒绝任意的为了符合行政所需而解释宪法。在上诉法院期间，斯卡利亚不断在意见书中强调政府分权原则，主张司法权应严守解释之界线，不应使行政权受到司法权之干涉。 斯卡利亚1986年被任命为美国最高法院大法官,他也成为第一个被任命为最高法院大法官的意大利裔美国人。斯卡利亚直到逝世的2016年，皆在最高法院任职，经历里根、老布什、柯林顿、小布什、欧巴马五位总统。和自由派的女大法官RGB相互辉映，作为保守派代表的斯卡利亚大法官在美国法界和政治界声望亦不落下风，美国民众对这位灵活幽默的大法官也有相当好的风评，许多幽默的重制图片即意味斯卡利亚大法官在美国民间的高声望。 (因斯卡利亚大法官以大篇幅的不同意见书著称而恶搞的趣味图) 2008年的「哥伦比亚特区诉赫勒案」，应是美国大法官史上保守派与自由派的最激烈的一次顶尖对决，主战场是美国宪法第二修正案的解释：「管理得当的民兵,乃保障自由州的安全所必须,人民持有和携带武器的权利不得侵犯。」美国宪法制定时间大约为两百多年前，为解释「民兵」、「人民」、「持有和携带武器」在该时空背景下之真实含意，大法官们在判决意见唇枪舌战、旁征博引，透过各种辞典的精密解释阐述有利于己方之论点；斯卡利亚代表保守方撰写的判决意见被许多学者评为其生涯的巅峰之作,64页的判决意见中高达28页是在针对第二修正案的文义解释，完全是宪法原旨论人士的洗炼意见。 斯卡利亚大法官与知识产权 相较于种族议题、同性婚姻权、持枪权等等社会争议议题，斯卡利亚大法官坦承他较不理解知识产权体系中之专利权，但其实仅为谦辞，斯卡利亚大法官针对专利权仍有下列贡献： 第一，确立了人类基因不能申请专利原则。在2013年的Association for Molecular Pathology v. Myriad Genetics案件中，斯卡利亚赞同主审法官托马斯的意见，认为人类基因不能申请专利，但人工复制DNA可申请专利。斯卡利亚写到：“从自然状态中分离的寻求专利的DNA部分与其自然部分DNA是相同的”，因此否定了其可专利性。 第二，降低了专利被许可人确认权利存在之诉的门坎。在2007年MedImmune v. Genentech案以前，美国联邦上诉法院对宣告判决的起诉条件遵循“合理预见即将发生诉讼原则（RAS）”，但联邦最高法院推翻了这个原则，斯卡利亚起草的判决认为要在综合考虑所有情势下确定有实质性争议之情形可提起专利被许可人权力存在之诉。 第三，扩大了对专利侵权“避风港”条款的适用范围。先是在1990年的Eli Lilly v. Medtronic, Inc的案件中，斯卡利亚将《专利法》第271条（e）款(1)项的药品或兽医生物产品扩大到医疗器械领域。又在2005年的 Merck v. Integra案的判决中，把第271条（e）款(1)项扩大到临床测试前使用专利化合物进行的试验，扩大生医产业的专利避风港条款适用范围。 第四，确立了商业方法的可专利性。2010年Bilski v. Kappos案里，九位大法官一致认为Bilski案主张发明依法不得授予专利。结果虽符合一般预期，但其法理分析却分为两派，斯卡利亚认为Bilski主张发明属抽象概念无法准予专利，但美国专利法35USC 101条文并未全面否定授予商业方法专利的可能性，故应认可其专利性。 第五，坚决反对专利流氓。早在2006年的eBay v. MercExchange案中，斯卡利亚加入罗伯特阵营，认为专利案件禁令仍要受衡平法考虑，并认为专利侵权成立前提下，专利权人曾经意图许可他人使用其专利，或者并未对其专利进行商业化利用，不能成为排除永久禁令的理由，对MercExchange进行了打击。在2015年的 Commil v. Cisco案中，他在反对意见书中甚至直接写出了“patent troll”，开了联邦最高法院之先河，也引发了很大争议。 斯卡利亚大法官的幽默轶事 斯卡利亚大法官的绰号是「喜剧之王」。除了法庭中对下级法官、律师的幽默酸言外。斯卡利亚更令人津津乐道是亲民的形象。据传有次他在华盛顿特区的一家健身俱乐部健身，健身房中一名律师觉得这个奋力运动的胖子看起来些许面熟,便问他是不是斯卡利亚大法官,没想到他笑着回答:「不是,斯卡利亚比我本人要瘦。」 这就是斯卡利亚大法官，幽默、坚毅而令人津津乐道的美国大法官。
As the world's first anti-tumor angiogenesis treatment drug, Avastin was approved in China for the treatment of colorectal cancer and non-small cell lung cancer（NSCLC） indications. On September 21, Roche announced that Avastin has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with recurrent glioblastoma (GBM). Avastin is a humanized monoclonal antibody lgG1 developed by Roche. Avastin can bind to tumor Vascular Endothelial Growth Factor (VEGF) so that it cannot stimulate the growth of blood vessels. The blood, oxygen, and other nutrients required for tumor growth are blocked, preventing their growth or spreading to other parts of the body, and ultimately achieving anti-cancer effects. Glioblastoma (GBM) is the most common and deadly primary brain tumor in adults. In the West, the annual incidence or number of new diagnoses is 2 to 3 per 100,000 people. GBM accounts for 12% to 15% of all intracranial tumors and 50% to 60% of astrocytoma. GBM can invade and infiltrate the normal surrounding brain tissue extensively, making complete resection impossible. Even with comprehensive treatments such as surgery, radiotherapy and chemotherapy, GBM patients are still very prone to relapse and die of tumors quickly. GBM is considered to be one of the most difficult tumors in the field of neurosurgery. The approval of this new indication is mainly based on a multi-center, open-label, randomized controlled, pivotal phase III clinical trial EORTC 26101. The results of this study confirmed that compared with chemotherapy alone, Avastin-based treatment prolonged the time to progression-free survival or the time to death (median PFS: 4.2 months vs. 1.5 months, HR=0.52, 95%CI: 0.41-0.64), the risk of disease progression can be reduced by 51%. During the progression-free survival period, patients in remission showed more stable global health scores and cognitive functions than non-remission patients. This means that Avastin will bring new treatment options for Chinese GBM patients. The approval of Avastin this time fills up the gap in the field of GBM treatment in China. It is of great significance to improving the level of GBM diagnosis and treatment in China, and will bring good news to patients who lack effective treatment options.
9月19日，据路透社、BBC等多家外媒报道，美国最高法院大法官露丝·巴德·金斯伯格去世，终年87岁。 据悉，金斯伯格在13日晚间出现发烧等症状，并于当晚在华盛顿特区的西布利纪念医院接受初步检查，在14日当天转院至约翰斯·霍普金斯医院。其实在今年7月份，金斯伯格曾宣布癌症复发。金斯伯格大法官的去世轰动了整个美国，不仅成千上万的民众自发到美国最高法院门口表示哀悼，美国白宫也降半旗表示致哀。 美国大法官金斯伯格的传奇一生 1933年金斯伯格出生在纽约布鲁克林，据她本人说，她的父亲是美国第一代移民，她的母亲勉强算上美国第二代移民。金斯伯格的母亲虽然读完高中之后因为家庭原因没能再进学，但是却充满智慧。金斯伯格的母亲交给她两句话：成为淑女，独立生活。不幸的是，在金斯伯格高中毕业时，她的母亲因为身患癌症去世了。 之后，金斯伯格靠着奖学金进入康奈尔大学学习。她在康奈尔大学遇见自己的丈夫马丁，他们在大三时订了婚，毕业之后就结婚了。在大学毕业之后，因为丈夫应召入伍，金斯伯格也跟随丈夫来到俄克拉荷马州，在此期间，她在当地的社会保障部门找了份补助审查员的工作，级别是5级。然而当她告知人事部门她怀孕的消息之后，她就被安排做文员的工作，级别也被降为2级。丈夫退役后，金斯伯格与丈夫马丁进入哈佛大学法学院学习。丈夫马丁毕业之后，在纽约律所找到一份工作，金斯伯格为了和丈夫一起，也转到哥伦比亚大学继续学习。可是即使金斯伯格以第一名的优异成绩毕业，毕业后她仍无法在纽约的律所找到律师的工作，原因是纽约的律所不雇佣女性。 1963年，她去了罗格斯大学任法学教授。后来在学生的要求下，新增了一门“性别与法律的”课程。在授课过程中，金斯伯格了解到美国法律中存在许多性别歧视的条款，她也越来越明白，作为女性，歧视无处不在。1972年，她在美国著名民权组织“美国公民自由联盟”旗下，成立了女性权利项目，开始长达十年的诉讼历程。她参与了超过300起关于性别歧视的案子，有6个案子上诉至美国最高法院，她打赢了5件。 1993年，金斯伯格被克林顿提名并任命为美国联邦最高法院大法官，但她没有停下为女性争取平权的脚步。1996年，一名女生想要报考弗吉尼亚军事学院，但是被告知学院不招收女学员。案子最终上诉至最高法院，在金斯伯格主笔的判决中强调不能仅因性别条件，就否定女性没有接受维吉尼亚学院军事训练的能力和毅力，以性别限制所做的政策，须受到严格的审查，为女性赢得了弗吉尼亚军事学院入学的资格。她通过一件件案子，改变着美国的性别歧视条款，也在人们心中构建女性平权的概念。 金斯伯格大法官对于专利法的独特见解 人们将金斯伯格视为一位坚持正义的平权斗士，殊不知她对于专利法也有着自己的独特见解。 2014年4月美国最高法院审理的Nautilus,Inc.v.Biosig Instruments,Inc.案。案件的争议主要是围绕《美国专利法》第112条第2款规定展开，条款规定：专利说明书在最后部分必须“提出一项或多项专门指出并且清楚声明的权利要求，其对象为申请人所指认的发明”。如何解读该条款提到的清楚且明确的要求成为了案件争议的焦点。最高法院6月份作出判决，金斯伯格大法官代表法院撰写一致意见。金斯伯格大法官在判决中写道：本案双方当事人都同意应当从拥有相关技术领域知识者的角度来判定专利权利要求是否明确；应当根据说明书和专利申请过程来加以解释；应当以专利申请之时作为判定的时间标准。但双方当事人未能达成一致的是112条第2款可以容忍的模糊程度究竟是多大。第112条所规定的明确性要求，必须考虑到语言固有的局限性。另一方面，某种程度的不确定性是“确保为创新提供适当激励的代价”；专利不是写给律师看的，甚至也不是写给一般公众看的，而是写给相关领域的技术人员看的。同时，一项专利必须对其所主张的权利要求范围做出清楚的公示，便于告知他人应该避开的区域。这里采用的标准是要求清楚，但同时承认，绝对明确是不可能达到的。这也与最高法以往的意见一致，法律根据发明的对象，要求专利权的确定性，但不会超过合理的程度。 2017年3月美国最高法院审理的Impression Products,Inc.v. Lexmark International Inc.案。案件争议的焦点主要是专利权穷尽规则是否适用海外销售与平行进口。最高院首席大法官罗伯茨主笔撰写法院意见，金斯伯格大法官撰写部分协同与部分反对意见。主笔的罗伯茨大法官认为专利权人在决定将其产品出售之后，无论是否存在合同上的限制，抑或销售行为发生于国外，该产品上的专利权均发生穷竭。专利权应当服从于有关禁止就商品转让施加限制的普通法原则。专利法的目的就是使专利权人得到经济回报从而促进创新，一旦专利权人出售其产品，专利权人就已经获得了经济回报；何况专利法也没有规定任何依据，可以对该产品的使用和受益作出限制。金斯伯格大法官同意法院关于国内用尽权的判决——专利权人销售对再利用或转售有明确限制的产品的，不得通过侵权诉讼强制执行该限制，因为在美国的销售耗尽了所售产品的美国专利权。但是金斯伯格大法官不同意法院关于国际穷竭的判决，她认为海外销售并不意味着穷竭美国发明家在美国的专利权。她在反对意见中提到专利法是属地法。当发明人获得美国专利时，该专利在国外不提供任何保护。美国专利权人必须向每一个他寻求出售其发明的专有权的国家提出申请。而且专利法因国家而异，每个国家关于发明者、竞争对手和公众在专利发明中的相对权利的法律可能都存在不同。因为海外销售独立于美国专利制度运作，所以说这样的销售耗尽了发明人的美国专利权是没有意义的。
On September 8, 2020, Pfizer made a US$25 million equity investment in Trillium Therapeutics. However, this investment by Pfizer has nothing to do with any partners or pre-emptive rights acquired by Trillium Therapeutics, and these options remain completely open. So, what kind of assets are attracting Pfizer? CD47 is a glycoprotein widely expressed on the surface of a variety of cells. It releases a "don't eat me" signal by connecting with SIRPα on the surface of phagocytes to prevent macrophages from engulfing healthy cells.However, cancer cells cunningly use this mechanism to induce immunosuppression and escape the phagocytosis of macrophages.In recent years, CD47 has gradually become a star target in the field of immuno-oncology, and investment in this field has also shown substantial growth: Trillium Therapeutics is a Canada-based immuno-oncology company dedicated to the development of innovative immunotherapies for the treatment of cancer. The company's clinical projects TTI-621 and TTI-622 are two unique SIRPαFc decoy receptors that can target CD47 and block its activity. TTI-622 is a SIRPa-IgG4-Fc fusion protein, similar to the candidate drug of I-Mab, it has very weak binding to normal red blood cells and does not cause hemagglutination. Current data show that in patients with relapsed/refractory DLBCL who have previously received multiple therapies, TTI-622 has achieved "comparable" results in a joint study with the highest dose of competing products. At the same time, the research results also show that "not all IgG4 are equal", because Xinji terminated its phase I study of its IgG4-CD47 molecule CC-90002 two years ago, and the data of TTI-622 is obviously better than analysts expected. However, using solid single-drug data as a basis makes managers more confident that their drugs will perform better in the combination. TTI-621 is a SIRPa-IgG1-Fc fusion protein, which is characterized by a very low dose to achieve great results. Now, the 1.4 mg/kg dose has been considered to be well tolerated in patients with advanced relapsed/refractory hematological cancers. Trillium Therapeutics plans to continue to evaluate these two projects. Ultimately, the company plans to enter the solid tumor field, and its CEO Jan Skvarka said that Pfizer is very interested in this field. With the revival of interest in CD47 in the pharmaceutical industry, innovative therapies for the CD47-SIRPα pathway are expected to become another fertile new world in the field of tumor immunity.
元气森林成立于2016年，是一家集自主研发、设计于一体的创新型饮品公司。因为在产品包装中使用日文“気”字代替中文“气”字，瓶身背后还标注“日本国株式会社元気森林监制”，使得许多消费者一开始都认为元气森林是一款日本产品，实际上元气森林是一家国产品牌。 近日，北京高级人民法院针对北京元气森林饮料有限公司（下称元气森林公司）在第35类广告等服务上申请注册第33084962号“気”图形商标被驳回一案作出终审判决，驳回元气森林饮料有限公司的上诉，维持由北京知识产权法院作出的原审判决。 据了解，元气森林公司于2018年8月23日申请注册了第33084962号“気”图形，但是国家知识产权局以诉争商标构成2013年商标法第三十条及第三十一条规定，决定驳回元气森林公司的商标申请。 2013年商标法第三十条规定，申请注册的商标，凡不符合本法有关规定或者同他人在同一种商品或者类似商品上已经注册的或者初步审定的商标相同或者近似的，由商标局驳回申请，不予公告。第三十一条规定，两个或者两个以上的商标注册申请人，在同一种商品或者类似商品上，以相同或者近似的商标申请注册的，初步审定并公告申请在先的商标；同一天申请的，初步审定并公告使用在先的商标，驳回其他人的申请，不予公告。 元气森林公司不服决定，向北京知识产权法院提起行政诉讼。法院认为，案件争议焦点在于诉争商标与各引证商标是否构成使用在同一种或类似服务上的近似商标。诉争商标与各引证商标的显著识别文字相比较，均容易被识别并呼叫为“气”，呼叫近似，并且诉争商标与各引证商标的含义、外观亦近似，已构成使用在同一种或类似服务上的近似商标，判决驳回元气森林公司的诉讼请求。 之后，元气森林公司不服北京知识产权法院的判决，向北京高级人民法院提起上诉。北京高级人民法院认为，商标近似是指商标的文字字形、读音、含义或者图形的构图及颜色，或者其各要素组合后的整体结构相似，或者其立体形状、颜色组合近似。认定商标是否近似，既要考虑商标标志构成要素及其整体的近似程度，也要考虑相关商标的显著性、所使用商品或服务的关联程度等因素，以是否容易导致混淆作为判断标准。诉争商标为“気”，与引证商标一“氣”及引证商标二的显著识别部分“气”呼叫相同，含义相近，故诉争商标与各引证商标若同时使用在咖啡馆等同一种或类似服务上，易使相关公众认为其服务来源于同一主体或者其来源主体之间存在某种特定联系，从而产生混淆、误认。国家知识产权局及原审法院认定诉争商标与各引证商标构成2013年商标法第三十条及第三十一条规定的使用在同一种或类似服务上的近似商标并无不当。元气森林公司的相关上诉理由缺乏事实及法律依据。北京高院最终判决驳回元气森林公司的上诉，维持原判。
继抗肿瘤创新药Lurbinectedin今年6月份在美国获批上市，用于治疗接受铂类药物化疗时或化疗后疾病进展的转移性SCLC成人患者之后，根据8月27日中国国家药监局药品审评中心（CDE）的最新公示，由绿叶制药引进的抗肿瘤创新药Lurbinectedin在中国获批临床，拟用于一线含铂化疗失败后小细胞肺癌（SCLC）患者的治疗。 SCLC是比较常见的肺癌种类之一，约占支气管源性肺癌的15%-20%。虽然相比于其他类型的肺癌，SCLC在所有肺癌中占比不高且有着更好的化疗及放疗疗效，但不幸的是，大多数的SCLC患者在初始治疗后都会出现复发及耐药性，且由于SCLC癌细胞生长迅速，易转移扩散的特点，因此当SCLC患者被确诊时，肿瘤很可能已经广泛扩散，往往很难治愈，患者5年生存率约5%，死亡率很高。 Lurbinectedin是一种海鞘素衍生物，为RNA聚合酶II的抑制剂，也是自1996年以来首个FDA获批准用于SCLC二线治疗的新药。Lurbinectedin的作用机理是：RNA聚合酶II在肿瘤细胞转录过程中往往过度活化，与DNA双螺旋结构上的小沟相结合，使得肿瘤细胞在有丝分裂过程中畸变而最终凋亡，进而减少细胞增殖。 该批准主要基于一项Lurbinectedin单药治疗105例铂类药物化疗后疾病进展的SCLC成人患者（包括铂类敏感和耐药患者）的开放标签、多中心、单臂研究的临床数据。研究结果显示，研究者评估的总有效率（ORR）达到35%，缓解持续时间（DoR）中位数为5.3个月；独立审查委员会（IRC）评估的ORR达到30%，DoR中位数为5.1个月。 Lurbinectedin除了今年6月美国获批上市以外，该药物还于近期通过特别准入机制，优先服务于澳大利亚和新加坡的SCLC患者。此外，Lurbinectedin也已相继在美国、欧盟、瑞士和澳洲等国家和地区获得了用于治疗小细胞肺癌（SCLC）的孤儿药资格。 此次Lurbinectedin在中国获批临床，意味着这款产品即将在中国进入临床开发阶段，相信Lurbinectedin有望为小细胞肺癌(SCLC)患者提供新的治疗选择。与此同时，除了Lurbinectedin外，全球范围内已有多款PD-1抑制剂获批治疗SCLC患者。此外，还有一些针对SCLC的新型疗法正在研究之中，包括RNA聚合酶II抑制剂，CDK4/6抑制剂，靶向TIGIT、Lag3、CTLA-4和OX40等的检查点抑制剂等等，这无疑让SCLC患者拥有了更多生的希望。
Following the approval of the innovative anti-tumor drug Lurbinectedin in the United States in June this year, it is used to treat adult patients with metastatic Small Cell Lung Caner (SCLC) who have progressed during or after platinum drug chemotherapy. According to the latest announcement by the Center for Drug Evaluation (CDE) of China's State Food and Drug Administration on August 27,the innovative anti-tumor drug Lurbinectedin introduced by Luye Pharma has been approved for clinical use in China and is intended to be used for the treatment of SCLC patients after the failure of first-line platinum-containing chemotherapy. SCLC is one of the more common types of lung cancer, accounting for about 15%-20% of bronchogenic lung cancer. Although compared with other types of lung cancer, SCLC accounts for a small proportion of all lung cancers and has better curative effect of chemotherapy and radiotherapy, unfortunately, most SCLC patients will have relapse and drug resistance after initial treatment. which is often difficult to cure. Lurbinectedin is an Ecteinascidins derivative, an inhibitor of RNA polymerase II, and can covalently bind to the minor groove on the DNA double helix structure. RNA polymerase II is often over-activated during the transcription process of tumor cells, which can make tumor cells aberrate and apoptosis during mitosis, thereby reducing cell proliferation. This approval is mainly based on the clinical data of an open-label, multi-center, single-arm study of 105 patients with SCLC (including platinum-sensitive and resistant patients) who have progressed after platinum-based chemotherapy with Lurbinectedin monotherapy. The results of the study showed that the Overall Response Rate (ORR) assessed by the investigator reached 35%, and the median Duration of Response (DoR) was 5.3 months; the Independent Review Committee (IRC) assessed ORR reached 30%, and the median DoR was 5.1 months. In addition to the approval of Lurbinectedin in the United States, lurbinectedin has recently passed a special access mechanism to give priority to SCLC patients in Australia and Singapore. In addition, lurbinectedin has successively obtained orphan drug qualifications for the treatment of SCLC in the United States, the European Union, Switzerland and Australia. The approval of Lurbinectedin in China this time means that this product is about to enter the clinical development stage in China. Lurbinectedin is expected to provide new treatment options for SCLC patients and to bring more hope to SCLC patients.
With the increasing incidence and mortality of tumors, the rapid and effective diagnosis and treatment of tumors have become the focus of the precision medicine industry. In clinical practice, the limitation of tissue samples has been proved to be a major obstacle to the promotion of precision medicine in oncology. It has been estimated that up to 30% of patients with advanced cancer cannot carry out gene mutation analysis by tumor tissue NGS detection to optimize treatment decisions due to insufficient or unavailable tissue samples. In this case, patients can use the biomarker information in blood and other body fluids to guide cancer treatment decisions. Recently, U.S. Food and Drug Administration (FDA) approved Guardant Health's Guardant 360 CDx for comprehensive genomic analysis of all solid tumor types. Meanwhile, FDA has approved Guardant 360 CDx as an accompanying test for the identification of patients with metastatic non-small cell lung cancer (NSCLC) carrying epidermal growth factor receptor (EGFR) gene mutations. Guardant 360 CDx is the first FDA approved diagnostic test that combines NGS and liquid biopsy techniques to guide clinical treatment decisions. Guardant 360 CDx detection mainly uses two techniques. The first is liquid biopsy. Compared with standard tissue biopsy, it is less invasive and easy to repeat, and is suitable for tumor patients who are unable to carry out standard tissue biopsy. The second technology is NGS. Guardant 360 CDx uses large panel gene sequencing technology for high-throughput tumor analysis, which can detect mutations of 55 tumor genes at the same time. Compared with the earlier detection technology, this test only needs one test, which can help clinicians better evaluate tumor gene mutation and provide better treatment decision for patients. It shortens the waiting time for patients to receive treatment and deeply understand the possible mechanisms of drug resistance. “FDA's approval of Guardant 360 CDx is a landmark decision that demonstrates the value of liquid biopsy for oncologists and cancer patients.” said Dr Helmy Eltoukhy, CEO of Guardian Health. FDA approval will help accelerate the wider adoption of genomic analysis recommended by the guidelines, enable more advanced cancer patients to receive better treatment, and promote precision medicine to a new era.
小i机器人成立于2001年，工商登记主体为上海智臻智能网络科技股份有限公司，是一家人工智能技术公司，专注于基于多语种自然语言处理、深度语义交互、语音识别和机器学习等人工智能核心技术。8月3日，小i机器人在其微博中宣称，已经正式向上海市高级人民法院提起诉讼，要求苹果公司停止Siri（智能助理）专利侵权，包括但不限于，要求苹果公司停止制造、使用、许诺销售、销售、进口侵犯ZL200410053749.9发明专利权的产品，并暂计索赔金额100亿元（人民币）。 据悉，这并非双方首次专利纠纷，早在2012年6月21日，小i机器人在上海市第一中级人民法院对苹果公司提起专利侵权，涉案专利即ZL200410053749.9。作为回应，苹果公司于11月19日向国家知识产权局专利复审委员会提出申请，请求宣告小i机器人上述专利无效；2013年9月3日，专利复审委员会做出决定，维持上述专利权有效；苹果公司不服复审决定，向北京市第一中级人民法院提起行政诉讼，请求撤销审查决定；2014年7月8日，法院依法判定维持审查决定；苹果公司上诉至北京市高级人民法院，北京高院改判撤销专利复审委的决定，要求对涉案发明专利权重新做出审查决定；小i机器人不服二审判决，向最高人民法院申请再审，2020年6月28日，最高人民法院发布行政判决书，以终审判决程序确认小i机器人ZL200410053749．9专利权的有效性。 对于新一轮的诉讼，小i机器人并没有透露更多的细节。小i机器人创始人、董事长兼CEO袁辉表示：“作为一个科技从业者，我非常尊重苹果公司，他们的产品和服务给全世界带来了很多价值和体验。但是，消费者购买的每一个苹果产品，都是付了钱的。反过来，苹果也要尊重创新，使用了我们的专利，也需要向我们支付合理费用。”可以看出，小i机器人的最终目的并非要禁止苹果公司销售相关的产品，而是希望获得合理的专利费用。涉案专利申请于2004年，在2009年获得授权。苹果公司于2010年收购Siri．Inc，在2011年12月6日，首次推出搭载了Siri系统的产品，获得了不错的市场反响。智能语音产业是以技术为导向的新兴产业，据有关资料显示，2018年中国的智能语音产业市场规模为48．6亿元，2021年将突破100亿元的市场规模。小i机器人提出100亿元的赔偿金额，尚不明确其其具体的计算依据，但该案件的审理必定是个漫长而受到广泛关注的过程。
Shandong Hualu-Hengsheng Chemical Co., Ltd. (hereinafter referred to as "Hualu-Hengsheng") is a company with fertilizers, chemicals, thermal power, and gas as its main business. On July 1, Hualu-Hengsheng announced that at the end of 2016, Sichuan Golden-Elephant Sincerity Chemical Co., Ltd. (hereinafter referred to as "Golden-Elephant Sincerity") and Beijing Yejing Technology Co., Ltd. (hereinafter referred to as "Yejing Technology") sued Hualu-Hengsheng, Ningbo Research & Design Institute of Chemical Industry Co., Ltd. (hereinafter referred to as "Ningbo Institute of Chemical Industry"), Ningbo Fareast Chemical Group Co., Ltd. (hereinafter referred to as "Fareast Group") and Yin Mingda (former chief engineer of Golden-Elephant Sincerity) for patent infringement, the patents involved are Patent Applications No. CN201110108644.9 and No. CN201010216437.0. The two plaintiffs alleged that the four defendants cooperated in the engineering design, manufacturing and construction of the melamine project, and caused infringement damage to them. Recently, the High People’s Court of Guangdong Province ruled that Hualu-Hengsheng immediately stopped infringing on the patent rights of the melamine production method owned by Golden-Elephant Sincerity and its subsidiary Yejing, and compensated the two plaintiffs for economic losses and reasonable rights protection costs totaling 80 million yuan in the first trial. During the trial of the case, the plaintiffs claimed that the contents of the "Safety Evaluation Report" and "Design Article" submitted by Hualu-Hengsheng to the relevant safety supervision department for record objectively reflected the technical scheme of the melamine project involved in the case, and it could be concluded that the four defendants had infringed on their patent rights. Hualu-Hengsheng argued that the content of the patent documents is different from the technical scheme of its melamine project, and the relevant technical scheme of the melamine project is its trade secret, so Hualu-Hengsheng clearly refused to conduct on-site inspection in the court hearing. When the court staff went to Hualu-Hengsheng factory for evidence preservation according to law, Hualu-Hengsheng took various measures to obstruct the court staff from performing their official duties and refused them to enter the project site. The behavior was judged by the court as seriously hindering civil litigation and decided to fine Hualu-Hengsheng 800,000 yuan. Evidence preservation is an important procedure in civil litigation. If the scope of evidence to be preserved involves trade secrets, the relevant right holder may request the court to take reasonable confidentiality measures. Hualu-Hengsheng's refusal to preserve evidence on site by the court had adverse effects on itself. Hualu-Hengsheng also announced that in October 2011, it signed a contract with Ningbo Institute of Chemical Industry and Fareast Group, which agreed that Ningbo Institute of Chemical Industry and Fareast Group guaranteed that all the proprietary technology and related technical materials provided by them were legally held. If a third party accused the project of Hualu-Hengsheng of infringement, the two companies in Ningbo shall be responsible for the negotiation and assume full responsibility which would have an important impact on the business activities of Hualu-Hengsheng. Hualu-Hengsheng has appealed to the Supreme People's Court against the judgment of the first trial, and the administrative litigation on the invalidation decision of the patent involved is still in progress.
山东华鲁恒升化工股份有限公司（以下简称“华鲁恒升”）是一家以化肥、化工、热电、气体为主营业务的公司，于2002年6月在上海证券交易所挂牌上市（股票代码600426）。7月1日，华鲁恒升发布公告称，2016年底，四川金象赛瑞化工股份有限公司（以下简称“金象赛瑞”）、北京烨晶科技有限公司（以下简称“烨晶科技”）以专利侵权为由起诉华鲁恒升、宁波市化工研究设计院有限公司（以下简称“宁波化工院”）、宁波远东化工集团有限公司（以下简称“远东集团”）和自然人尹明大（金象赛瑞原总工程师），涉案专利为第ZL201110108644.9号、第ZL201010216437.0号发明专利，两原告诉称四被告共同合作实施三聚氰胺项目的工程设计、制造、施工，并共同合作使用加压气相淬冷法工艺方法、组合式换热器及流化床反应器设备，侵犯了金象赛瑞发明专利专用权，给金象赛瑞造成了侵权损害。近日，广东省高级人民法院一审判决华鲁恒升立即停止侵犯金象赛瑞及其子公司烨晶科技拥有的三聚氰胺生产方法专利权，并赔偿原告经济损失及合理维权费用共计8000万元。 涉案专利主要涉及节能节资型气相淬冷法蜜胺生产系统及其工艺和组合式换热器及流化床反应器，都是加压气相淬冷法三聚氰胺生产相关技术。据金象赛瑞方面报道，涉案专利是由金象赛瑞联合烨晶科技的技术团队投入近亿元，历时10余年研发成功，目前在三聚氰胺生产技术上仍属于较高水平。 在该案的审理过程中，原告主张，华鲁恒升向有关安监部门提交备案的《安评报告》、《设计专篇》记载内容客观反映了涉案三聚氰胺项目实施的技术方案，可以认定四被告侵犯其专利权。华鲁恒升认为，记载的内容与其三聚氰胺项目实施的技术方案不同，三聚氰胺项目有关技术方案是其商业秘密，在庭审中明确表示拒绝进行现场勘验。法院依法到华鲁恒升厂区进行证据保全时，华鲁恒升采取多种手段妨碍法院工作人员执行公务，拒绝其进入项目现场，该行为被法院判定严重妨害民事诉讼，决定处罚80万元。证据保全是民事诉讼中的一项重要制度。在保全的证据范围涉及商业秘密的情况下，相关权利人可请求采取合理保密措施，华鲁恒升拒绝法院现场证据保全的行为，会对自己产生不利的影响。 华鲁恒升还在公告中称，在2011年10月其与宁波化工研究院、宁波远东共同签订合同，约定宁波化工研究院和宁波远东保证其提供的一切专有技术及相关技术资料系合法持有者，如果发生第三方指控华鲁恒升的项目侵权，由宁波这两家公司负责交涉并承担全部责任，8000万的判赔和80万的处罚最终有谁承担将会对华鲁恒升的经营活动产生重要的影响。目前华鲁恒升不服一审判决已向最高人民法院提起上诉，关于涉案专利无效决定的行政诉讼以及其他相关专利和商业秘密诉讼仍在进行中。
The official website of the US FDA shows that Sunshine Lake's abbreviated new drug application (ANDA, the US generic drug application) for the anti-flu drug oseltamivir phosphate capsules, including 30 mg, 45 mg and 75 mg doses, has been approved by the FDA on March 4. Strikingly, this is the first time domestic oseltamivir phosphate has been approved by the FDA for marketing in the United States.
Drug patents are one of the most economically valuable types of patents. In recent years, the number of patent infringement disputes has increased significantly. If the enterprise infringes the patents of others, it will not only increase the financial burden of the compensation for patent infringement, but also have a negative impact on the corporate image. Whether pharmaceutical companies improve their preparation processes or produce new drugs, they should conduct thorough investigations in advance, and analyze whether there are patents related to their products and production methods. If there are related patents, it is necessary to further determine the protection scope of the patents to know whether the companies infringe the patent rights of others. As for the preparation process of drugs, because the defendant is responsible for the burden of proof in the relevant patent infringement disputes, the pharmaceutical manufacturing enterprises must take certain measures to prevent the adverse consequences caused by the insufficient evidence.
Gleevec,whichwasonlyknowntothemedicalcircleandthepatientcommunity,catapultedintothepubliceyewiththereleaseofmovie"DyingToSurvive"andwashighlydebated."magicpotion"GleevecGleevec(Imadinib),whoseactivein
Professor Zhang Tongcun has been specializing in CAR-T field for many years and has rich CAR-T clinical experience. He is the father of CAR-T promotion in China. Professor Gu Chaojiang has more than ten years of research experience on AIDS. In 2015, the two took their respective strengths and joined forces to create a new therapy for "application of CAR-T technology to treat AIDS". On November 27, 2018, Professors Zhang Tongcun and Gu Chaojiang from the School of Life Sciences and Health of Wuhan University of Science and Technology won the invention patent of "Construction and Application of a Recombinant Gene of a Chimeric Antigen Receptor for the Treatment of HIV Infection". Is the world's first application of CAR-
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