World Intellectual Property Day to talk about pharmaceutical patents!

April 26 is World Intellectual Property Day Around the topic of intellectual property, 23 ministries and commissions such as the State Intellectual Property Office will jointly hold the national intellectual property publicity week The theme of this year's publicity week is "strengthening the protection and application of intellectual property and accelerating the construction of a strong intellectual property country" This year's World Intellectual Property Day comes on schedule, with the theme of "digital creativity, reshaping culture" At present, we are in the era of digital information New industries such as the Internet, big data, cloud computing and other new technologies and new formats have brought profound changes to our production and life, but also brought many new problems in the protection and application of intellectual property At this time, we need to adapt to the development of the times and find practical solutions In the pharmaceutical industry, intellectual property rights are crucial New drug R & D is a field with high investment cost, high risk and long cycle The profit of new drug R & D in pharmaceutical industry largely depends on the degree of protection of drug patents If we do not pay attention to the protection of drug patents, the R & D investors are likely to lose their lives Under the new situation, how to maximize the protection of intellectual property within the scope permitted by laws and regulations and extend the period of intellectual property protection as far as possible are the most concerned issues of every obligee What patents do drugs need? Drug patents usually include drug product patents, drug preparation process patents, drug use patents and other different types Drug patents mainly include drug compounds, western medicine compound preparations, Chinese medicine prescriptions and active ingredients of Chinese medicine, etc The patent of drug method mainly includes the preparation method of drug compound, the preparation method of Western medicine compound preparation, the extraction method of Chinese medicine active component, the quality control method and the method of changing dosage form of old medicine Invention patent for drug use refers to a patent applied for and authorized for the use itself when a new unknown use is found for a known drug In addition to the "core patent" and "derivative patent" mentioned above, the "peripheral patent" is also needed to strengthen the listing of new drugs The peripheral patent can not only prolong the patent protection cycle, but also prevent other obligees from "attacking" the products Continuous technical improvement of existing patents and application for new patents can effectively resist the competition of generic drugs, such as dosage form improvement, new formula, new drug delivery system, drug strength (concentration) improvement, new drug delivery path, etc In addition, new or improved drug manufacturing processes can also obtain patent protection, especially when more stable drugs can be obtained after the application of new or improved manufacturing processes The classic case of "gefitinib" explains how to lay out the patent Gefitinib (trade name: Iresa) is a key drug of AstraZeneca company It was officially listed in China in February 2005, and is suitable for the treatment of local advanced or metastatic non-small cell lung cancer that has received chemotherapy or is not suitable for chemotherapy For the new chemical entities discovered, they usually apply for "compound patent" in the pre clinical research stage The basic compound patent of gefitinib is nearly 7 years earlier than the subsequent peripheral patent, and gefitinib appears in claim 9 of the authorized text, which is put at the end of the specific compound claim for protection, which will cause certain obstacles to the follow-up research of other enterprises Obstruction For the preparation method, two synthesis routes have been published before, but they are only suitable for the synthesis of a small number of products in the laboratory Until 2003, a key intermediate was further disclosed, which enables the preparation of gefitinib with high quality and high yield in large-scale industrial production I don't know whether the previous two routes are smoke bombs, making other enterprises suffer in the process After applying for the compound patent, AstraZeneca did not immediately apply for a large number of peripheral patents of gefitinib, but only after nearly seven years, did it carry out the layout of the patent network around gefitinib This application strategy is closely related to the development progress of gefitinib With the development of clinical research on gefitinib and the promising prospect of drug market, AstraZeneca applied for a series of related patents of gefitinib before its first listing in 2002, including crystal type patent, composition patent and pharmaceutical preparation patent Then, in 2003, he applied for intermediate patent, composition patent and analysis method patent At this time, a huge protection network has begun to take shape For the application of peripheral patents, AstraZeneca did not immediately carry out after the discovery of a new chemical entity, because in a case where the prospect of drug listing is not clear, it is bound to increase the investment cost to carry out large-scale follow-up research and development Therefore, after a certain pharmacodynamic or clinical study, the company has a good prospect for the listing of the drug, and just started a series of peripheral studies around gefitinib and applied for patents It has to be mentioned that the so-called "compulsory patent licensing system" refers to a legal system in which the patent administration authority issues a license to a third party without the consent of the patentee according to certain conditions, including the production, sale, import of relevant patent products and implementation of patent methods, and the licensee pays certain compensation to the patentee In China, when it comes to public interests or public health considerations, the State Intellectual Property Office can grant a compulsory license to implement the invention patent, which can effectively solve the contradiction between the protection of drug patent and public life and health Take the drug "Tamiflu" for example, one is about 30 yuan, while the commonly used anti influenza drugs, such as white plus black, are only 1 to 2 yuan The consequence of this situation is that many patients who really need special drugs to treat diseases are "deterred" from high-priced drugs In this regard, Guangzhou Baiyunshan Pharmaceutical Co., Ltd issued a public notice many years ago If the prevention and control of influenza A epidemic is very urgent, the company has submitted a report to the State Food and drug administration, "accept the registration application of our factory's imitation of oseltamivir phosphate raw materials and capsules in advance", hoping to start the green channel and approve the bioequivalence test in advance Although there is no clear answer in the end, the answer should be yes Personal experience: when studying, for individuals, the concept of patent and intellectual property is not strong, but more attention is focused on SCI, influencing factors and other contents The concept of "patent protection" goes deep into the mind and gradually becomes an important reference and research object for the project Many scientific research work in our country does not have a strict patent layout Today, it is a pity that achievements are easily "stolen" by others For example, artemisinin, which just won the Nobel Prize, has won the glory of passing down for our country, but as a drug, it is more or less regrettable that the loss of rights and interests is caused by the lack of patent protection In the future work, today we should "choose projects and produce products without forgetting patents", enlarge the intellectual property as much as possible, and lay the foundation for the future game with international pharmaceutical giants! 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