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Electronic Arts pledges free use for five accessibility patents

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

The forum on "China's Intellectual Property-related Reform Measures and New Trends in Patent Litigation" will be held successfully!

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

Types of patents that are easily overlooked- Design Patent

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

Colopl Settles Patent Infringement Lawsuit with Nintendo by Paying $30 Million

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

The First COVID-19 Vaccine Approved by FDA

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

Can artificial intelligence (AI) be patent inventors?

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

Huawei and Verizon, patent litigation to reconciliation

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

Kerendia Receives FDA Approval for Slowing chronic kidney disease in Type 2 Diabetes

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

FDA approves the first C3 inhibitor for adults with serious rare blood disease

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

Hengrui Medicine's application for the listing of CDK4/6 inhibitors has been accepted

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

先发表论文导致不言放弃的中科院走红博士有了放弃

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!

江苏省专利行政裁决系统上线啦!

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!

世界知识产权日——市场专利布局IPO论坛成功举行!

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

华讯诚邀您参加世界知识产权日——市场专利布局IPO论坛

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

浅谈药品专利链接制度

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?

如何加强对职务发明人的奖酬保护?

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?

商标侵权怎么办?

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。  
肿瘤治疗新选择-中国首个选择性RET抑制剂

肿瘤治疗新选择-中国首个选择性RET抑制剂 普拉替尼获批上市

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。
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