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    Home > Active Ingredient News > Drugs Articles > Greavelli encounters a "battle for protection" of patent rights

    Greavelli encounters a "battle for protection" of patent rights

    • Last Update: 2016-12-09
    • Source: Internet
    • Author: User
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    Source: China Intellectual Property News / China intellectual property information network 2016-12-09 the anticancer drug Gleevec (imatinib mesylate) is produced by Novartis Ag (hereinafter referred to as Novartis), which is internationally recognized as the first-line drug for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumor The drug has been approved for marketing in more than 110 countries and regions According to public information, in the third quarter of this year, the global sales of Gleevec reached US $2559 million, ranking at the top of the top 100 global drug sales in the third quarter of 2016 The compound patent right of ingreview has expired, and Xinwei, a generic drug of Jiangsu Haosen Pharmaceutical (hereinafter referred to as Haosen pharmaceutical), has been approved for listing, and obviously shares the market share of ingreview In order to prevent Xinwei from entering the market, Novartis filed a lawsuit with the second intermediate people's Court of Beijing, accusing Howson Pharmaceutical Co., Ltd of infringing the patent right of Novartis (Patent No.: zl01817895.2, which protects the second medical use of Gleevec in the treatment of gastrointestinal stromal tumors) Subsequently, hausen pharmaceutical launched a counterattack and filed a patent invalidation request to the Patent Reexamination Board of the State Intellectual Property Office (hereinafter referred to as the Patent Reexamination Board) on September 5, 2014 On October 23, 2015, the Patent Reexamination Board made a decision on the examination of the request for invalidation, believing that the patent involved in the case did not possess the inventiveness specified in paragraph 3, Article 22 of the patent law of China, and declared all the patent rights of the invention invalid According to the analysis of the insiders, the price of ingravei is very expensive, and all relevant patent rights are declared invalid, which will have an important impact on the availability and economy of the medicine for cancer patients in the future The Patent Reexamination Board's ruling on this case has made clear the examination standards for the novelty and creativity of pharmaceutical inventions, especially the examination standards for the novelty and creativity of the second pharmaceutical invention, which will have a significant and far-reaching impact on the patent protection strategies and commercial activities of global pharmaceutical enterprises in China in the future According to the public data of disputes over the patent of anticancer drugs, Gleevec, jointly developed by Novartis and other companies, is the first small molecule targeted drug successfully developed in human history, which can effectively control the chromosomal variation of CML patients With the emergence of Gleevec, the 10-year survival rate of patients with chronic myeloid leukemia has increased from less than 50% before to about 90% now, and the vast majority of patients can work and live normally After CML, Gleevec has been developed for the treatment of gastrointestinal stromal tumors, and patients who continue to take drugs can also obtain long-term survival At the same time, the price of Gleevec is very expensive Taking the Chinese market as an example, since it was introduced into China in 2001, the price of Gleevec is about 23000 yuan to 25000 yuan per box For families of ordinary cancer patients who need to take medicine for a long time to control their condition, the economic burden is hard to bear, especially "the first person to buy anti-cancer drugs in India on behalf of others" Lu Yong's arrest has once again aroused widespread concern about greavel, a highly prized anticancer drug In April 2013, the patent protection of Gleevec compound in China expired Hausen pharmaceutical and Jiangsu Zhengda Tianqing Pharmaceutical Co., Ltd (hereinafter referred to as Zhengda Tianqing) were approved by the State Food and drug administration to produce imatinib tablets and capsules respectively The therapeutic effect of these generic drugs is not very different from that of Gleevec, but the price is much lower The market share of Gleevec in China is significantly impacted Novartis has repeatedly said that although the patent right of Gleevec's compounds has expired, the invention patent for the treatment of gastrointestinal stromal tumors is still within the protection period So Novartis sued Zhengda Tianqing and hausen pharmaceutical Subsequently, Zhengda Tianqing and Novartis reached a settlement Hausen pharmaceutical, which refused to settle, filed a patent invalidation request to the Patent Reexamination Board on September 5, 2014 The Patent Reexamination Board set up a five member collegial panel for the case, and conducted an oral hearing on February 5, 2015 The patent involved in the case was finally declared invalid because the patent involved huge economic interests Both parties tried their best to conduct litigation and defense Both parties submitted multiple statements of opinions and nearly 50 pieces of evidence, and the types of evidence submitted were also very complex, including journal papers, web evidence, electronic mail, witness testimony, foreign evidence, etc During the three-day oral trial, the two parties had a heated debate on each evidence and counter evidence, as well as whether the patent involved was novel and creative It is particularly worth mentioning that a review document (hereinafter referred to as evidence 1) submitted by hausen Pharmaceutical Co., Ltd published in October 2000 in the Lancet Oncology has become the most controversial focus of this case In terms of publication time, evidence 1 does not indicate the specific publication date, while the patent priority date involved is October 27, 2000, which is very close to each other In terms of publication content, only a few lines of relevant words with unclear information have been published in the review literature of evidence 1, "at the time of writing, a selective tyrosine kinase inhibitor STI571 was targeted at gist We've just started with Dana Faber cancer research (in collaboration with other research centers around the world), and very early results look exciting Whether evidence 1 constitutes the prior art of the application date, and whether the patent involved is novel and creative, both parties have their own opinions Hausen believes that relevant evidence has shown that evidence 1 is earlier than the patent priority day, and the patent involved does not have novelty and creativity Novartis argues that evidence 1 It should not be regarded as the prior art of the priority date In this evidence, it is not clearly disclosed that imatinib can effectively treat gastrointestinal stromal tumors, nor is there enough instruction or enlightenment However, the invention in question has unexpected technical effect compared with the prior art and solves the long-term unsolved technical problem in the art Therefore, claim 1 of the patent in question With novelty and creativity, the patent involved shall remain valid After trial and collegial discussion, the collegial panel made decision on examination of request for invalidation (hereinafter referred to as decision) No 27371 With regard to the question whether evidence 1 constitutes the existing technology, in combination with the academic conference advertisement published in the magazine and the correspondence between the two parties and the editor in chief of the magazine, the decision considers that evidence 1 should be reasonably identified The priority of the patent involved in the case has been disclosed before the date On the basis of confirming that the evidence 1 is prior to the priority date, the decision finally confirms that the patent involved is novel, but not creative, and the patent right of the patent involved is declared invalid Multiple highlights of the review decision Members of the collegial panel of the case said that it is a very complex legal issue to judge the novelty and creativity of the claims for medical use, especially the claims for the second medical use, and there are widespread disputes The difficulties of judgment include the interpretation of the scope of protection of the claims, the extent to which the reference document can be considered as the disclosure of the standards for invention and creativity, how to grasp and not expect How to identify the technical effect of the products Although the final decision was made to declare the patent right null and void, the opinions of the petitioner were not fully adopted in terms of the interpretation of the scope of claim protection, novelty, examination standard of creativity, etc The decision made a useful exploration on the interpretation principle of the claims for pharmaceutical use and provided clear guidance, that is, "for the claims for pharmaceutical use written in the form of 'application of a substance in the preparation of a drug for the treatment of a disease', the 'treatment of a disease' should be understood as' effective treatment for a patient suffering from a disease ', but not as‘ It is effective for in vitro cell test of a disease or animal model test of a disease On this basis, the decision letter puts forward a clear examination standard for the degree of disclosure of the prior art in the evaluation of the novelty of this type of claims, that is, "the application of a substance in the preparation of a drug for the treatment of a disease" If the content disclosed in the prior art does not reflect the exact conclusion that the substance can effectively treat the patients with the disease, the medical use invention has novelty " The decision letter puts forward the evaluation standard of "reasonable expectation of success" for the situation that whether a person skilled in the art can try to obtain a technical solution in the creative evaluation, namely“ When judging whether the invention is obvious with respect to the prior art, it is necessary to consider not only whether a person skilled in the art will attempt to use a substance to treat a disease, that is, whether he will attempt the technical solution himself, but also whether the attempt has reasonable expectation of success, that is, whether he can reasonably foresee that the solution can solve the technical problem to be solved and achieve the expected technical effect Fruit If a person skilled in the art will consider trying to use a certain substance to treat a certain disease, and has reasonable success expectation, the invention for medical use does not possess inventiveness ", wherein reasonable success expectation is not equal to absolute success expectation After the issuance of the decision letter of the case, it attracted wide attention of the industry According to the analysis of the insiders, the decision made exploratory analysis and evaluation on the novelty and creative examination difficulties of medical invention, and gave clear and operable opinions, which is conducive to the industry and the public to accurately understand the patent examination standards, form clear and reasonable expectations, and has important guiding significance for similar issues in this field.
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