Patent Dance of Original Research Drugs and Similar Drugs

The main force on the global blockbuster drug list-small molecule drugs are gradually being replaced by biological drugs. The global biopharmaceutical market is growing rapidly, with the United States accounting for 46% of the global market.

In recent years, the original research pharmaceutical companies have faced the problem of patent cliff, the attack on biosimilars (or biosimilars) developed into a prominent school. According to a research report Publication by Kelly Scientific, it is estimated that 50% of biological drugs will face patent expiration by 2019. By 2020, the market size of biosimilar drugs in the United States will reach 11 billion US dollars, making it a battleground for military strategists.

According to the authoritative data of Thomson Reuters, the number of biological similar drugs under research in China has already ranked first in the world. Among them, the champion is Suzhou's Corning Jerry (28), the runner-up is Qilu Pharmaceutical (10), while Jiahe Biology, CITIC Guojian, Harbin Medicine and Xiamen's Tebao Biology are tied for third place with 8 biological similar drugs under research. As the products are expensive, the traditional path of "rural surrounding cities" from China to Africa to emerging countries to developed countries is not easy to go through. With the landing of the regulations on biological analogs in the United States, "urban to rural areas" has become the only way for the internationalization of biological analogs. The United States is the most promising market for biosimilar drugs, so it is important to be familiar with its relevant regulations and patent provisions.

The rapid approval path of biosimilar drugs in the United States is regulated in the "Biologics Price Competition and Innovation Act" (Biologics Price Competitionand Innovation Act, referred to as "BPCIA"). In addition to the relevant provisions of the approval, the bill also establishes a system for resolving patent disputes between original research drug companies and similar drug companies, which is called "patent dance 」.

Due to the complexity of the relevant provisions of the patent dance, the major biosimilar pharmaceutical companies in the United States are still measuring the various possibilities of regulatory elements and interpretations, trying to find out what is most beneficial to them. If Chinese enterprises want to develop biosimilar drugs and plan to list them in the United States, they have to pay close attention to the regulatory and practical trends in this field.

1.BPCIA Patent Dance Program

The patent dance in BPCIA can be roughly divided into three parts: identification, reinforcement and encouragement. Identification is left to the parties in early patent litigation to negotiate back and forth to identify biopharmaceutical patents and possible infringers; patent reinforcement is to strengthen the effect of biopharmaceutical patents on possible infringers by some means; and finally, to encourage biosimilar drug applicants to market as soon as possible and bring about market competition.

2. "patent dance" can not dance

The rules of "patent dance" can be described as complicated. There is a lot of interaction between analog manufacturers and original research manufacturers. This is a dance that both parties are reluctant to participate in. Therefore, judging from the currently approved analogs, many companies are trying to avoid such complicated channels.

According to the current interpretation of the Federal Circuit Court of Appeals on BPCIA, it can be expected that there are three advantages of avoiding the "patent dance": first, it can avoid disclosing the company's commercial secrets before litigation. If the original research drug company wants to know the manufacturing process details of similar drugs, it can only obtain them through the evidence discovery procedure (Discovery) of the US litigation, but the premise is that, the original research drug company must indeed hold a patent related to the manufacturing process in order to require the defendant to disclose the manufacturing process information, which will make the original research drug company have to file a lawsuit without knowing whether the other party is infringing, and bear more variables. Second, according to the provisions of the BPCIA patent dance, similar drugs may face more than two lawsuits before they are actually listed. The first time is the completion of information exchange. After the two parties coordinate the scope of the first lawsuit, the second time is after the similar drug company submits a pre-listing notice. Failure to follow the procedure of the patent dance may force the original research drug company to file all patents for litigation at the beginning, merging the patents originally divided into two lawsuits in one settlement. Third, avoiding the patent dance may shorten the time to resolve patent disputes.

If a similar drug company does not provide complete information to the original research drug company within 20 days after receiving the FDA's notice of acceptance of the review, the original research drug company is likely to file a lawsuit at an earlier time. For example, in the case of Amgen against Sandoz, Amgen filed a lawsuit against Sandoz on the 109th day, which is much earlier than waiting nearly 8 months for the first lawsuit according to the patent dance procedure.

Although according to the latest development, avoiding patent dance can avoid some procedural troubles, the winning or losing of real original research drugs and similar drug companies is still seen in the battlefield of litigation, which is more important than who has a higher degree of mastery of patent information and regulations. Therefore, if you want to enter the U.S. biopharmaceutics market, how to master and control patent risks and collect favorable evidence in advance is still the most important issue. Otherwise, bringing the lawsuit forward is just an early exit.

3. How to jump the part of "patent dance"

The "patent dance" is to resolve patent disputes and is part of BPCIA. Applying for biological analogs is still subject to most of the rules of the game set by BPCIA. For example, before the application for approval, generic drug companies still can not file a confirmation lawsuit.

However, in addition to resolving patent disputes in the United States through the courts, there is also a patent review system that can be used. The latter is heard by the Patent Trial Appeals Board (PatentTrialandAppealBoard, referred to as PTAB) under the U.S. Patent Office. Biosimilar companies may still file a post-grant review (PostGrantReview, referred to as PGR) or a multi-party review (InterPartesReview, referred to as IPR) with the Patent Trial Appeals Board before filing an application for approval. The advantage is that the cost is less, it may only cost one tenth of the litigation cost, and it also has the advantage of time schedule. The Patent Trial Appeal Board generally decides whether to accept the trial within 6 months after receiving the petitioner's request, and the review result will be made within 12 months after the decision is accepted. The entire review procedure is only 18 months at most, which is much faster than the litigation time.

In June 2013, Hospira filed a multi-party review request for the patent (U.S.Pat.6,747,002) for the therapeutic method of erythropoietin (epoetinalfa) in Janssen (Janssen), successfully forcing Janssen to voluntarily abandon the patent-related claims in September of the same year. In addition, in December 2014, Ingelheim (BoehringerIngelheim) filed a multi-party reexamination of Genentech (Genentech)'s three rituximab (Rituximab) treatment patents (U.S.Pat.7,976,838, U.S.Pat.7,820,161, U.S.Pat.8,329,172), but the Patent Trial Appeal Board finally accepted only the reexamination request US7976838 the patent and half of the claims of the US7820161 patent, it is still under trial.

In any case, the U.S. patent review system provides a fairly good tool and tactic for biosimilar drug companies. Generic drug companies have the opportunity to turn passive into active and remove the patent threat of the original research drug company before submitting an application for approval of biosimilar drugs. Many original research drug companies fear that their patents will eventually be invalidated, and it is also common for them to seek settlement from applicants for review. Generic drug companies take this initiative to advance, which will help to enhance their negotiation advantages, increase their bargaining chips, and achieve commercial purposes in exchange for commercial benefits.

News source:http://news.bioon.com/article/6685970.html

This news was re-edited and reorganized by the Huaxun team and added analytical comments.