Litigation Involving Drug Patents in Recent Years: Case Sharing (I)

In the pharmaceutical industry, patent protection is undoubtedly one of the important indicators to ensure that companies can continue to invest in research and development and bring drugs to the market. It enables pharmaceutical companies to use the results of new drug patents to recover the billions of dollars invested in research costs. At the same time, it also encourages these pharmaceutical companies to carry out new research and development projects so that patients can continue to obtain new drugs for better treatment. This is an important direction for the development of the pharmaceutical industry in any country, it is also a guarantee for the development of new drugs.

Now,I...China has the highest number of patent registrations in the field of biotechnology in the world, since.From 2017 onwards,I...In order to promote the innovation of drugs and medical devices and protect the rights and interests of inventors of innovative products, the government has implemented a six-year protection period for clinical and preclinical research results of chemical synthetic new drugs, and a policy of extending the patent protection period of new drugs by up to five years.

It's here.In 2021,I...China has further extended the protection period of drug patents and introduced a patent protection period compensation system to protect innovative drugs from generic competition. in addition,I...China has also introduced mechanisms such as patent registration and patent linking, which have had a positive impact on China's biotechnology industry, encouraging more innovative research and product development, and providing inventors with longer patent protection periods, which has inspired more people to invest in this field. At the same time, the improvement of transparency and the guarantee of legal certainty provide clearer guidance for the registration of reproduction drugs and biologics, and promote the development of the industry.

At the same time, discussions have been taking place in Russia for several years on the establishment of a patent registry.In 2021, the Russian Ministry of Economic Development and the Russian Patent Office (mineconomy and Rospatent) developed a Federal Act entitled "On the Register of Active Substances with Pharmacological Activity Protected by Patents. In recent years, the number of litigation cases related to the protection of the interests of rights holders has been increasing, and the results of these cases are often unpredictable. Intellectual property litigation is highly technical and specialized. Both parties to the litigation may hire professional lawyers and patent experts. Complicated legal arguments and technical evidence make the case more complicated.

For example,Tofacitinib (trade name yakvinus in the Russian market) was registered in Russia in 2013 and has been fully produced by polisan company since 2018. The drug is mainly used for the treatment of rheumatoid arthritis and has also been recommended by the Ministry of Health of the Russian Federation for the treatment of COVID-19. According to the procurement data in the Russian Information System data, government agencies have purchased 1.44 billion rubles worth of the drug as of 2021, in addition, according to the DSM Group, sales of the drug in the pharmacy reached 37.8 million rubles in the same period.

InAt the beginning of 2020, the Russian pharmaceutical company PSK Pharma submitted an application for a generic drug for Tofacitinib under the trade name tofara, and under an offset agreement (offset aggrement) with the Moscow authorities, the company began production of this generic drug.

Tofara's drug license application enabled Pfizer to file a patent infringement lawsuit with the Moscow Arbitration Court in June 2021. The court banned PSC Pharma from entering the market before the patent term expires in December 2021. PSK Pharma filed an appeal. However, on May 14, 2022, the Russian Patent Office (Rospatent) invalidated Pfizer's Eurasian patent (Eurasian Patent) in Russian territory (Pfizer, Inc.). The patent relates to Tofacitinib (the trade name is yakvinus in the Russian market), which was originally valid until November 2025. The Patent Dispute Committee of the Russian Patent Office supported the objection raised by the PSK Pharma of the Russian pharmaceutical company. The case has attracted wide attention and is considered as a rare case, which is of great significance in the Russian patent dispute.