Examining Criteria for Pharmaceutical Use Claims from the Invalidation of Gleevec Patent

Gleevec, originally known only by people in the medical circle and patients, has entered the public eye with the release of the movie "I am not the God of Medicine" and has been hotly debated.

The magic drug Gleevec

Gleevec (imatinib), whose active ingredient is imatinib mesylate, is Novartis (Novartis) developed a tyrosine kinase BCR-ABLThe molecular targeted drug of is also the first successfully developed small molecule targeted drug in human history. It was first approved for listing by the US Food and Drug Administration (FDA) on May 10, 2001 (trade name: Gleevec). At present, the drug has been approved for listing in more than 110 countries and regions. It has opened an era of molecular targeted therapy for tumors and is praised as a milestone discovery. It is listed as one of the world's top ten scientific and technological breakthroughs in 2001 along with human genetic engineering.

Gleevec is currently used as a first-line drug for the treatment of chronic myeloid leukemia (CML) with Philadelphia chromosome positiveperiod of rapid change, acceleration, or α-In chronic phase patients after failure of interferon therapy, after chronic myeloid leukemia, Gleevec has been developed a new use for the treatment of gastrointestinal stromal tumors (GIST), and patients who continue to take the drug can also obtain long-term survival.

Gleevec patent defense case background

Gleevec's drug compound was originally patented in 2013.Year 5At the end of the month, Jiangsu Haosen Pharmaceutical's imatinib mesylate generic drug (trade name Xinwei) was approved to be listed and obviously shared the market share of Gleevec. In order to prevent Xinwei from entering the market, Novartis filed a lawsuit with Beijing No.2 Intermediate People's Court, accusing Haosen Pharmaceutical's generic drug Xinwei of infringing Novartis CN1276754C's patent right, which protects Gleevec's second medical use in treating gastrointestinal stromal tumors, the original estimated maturity date was October 2021.

Subsequently, Hausen Pharmaceuticals launched a counterattack, in 2014.Year 9May 5 filed a patent invalidation request with the Patent Reexamination Board of the State Intellectual Property Office. On October 23, 2015, the Patent Reexamination Board made an examination decision on the request for invalidation, believing that the patent involved in the case did not have creativity as stipulated in paragraph 3 of Article 22 of the Patent Law of China, and declared all the patent rights of the invention invalid.

Novartis appealed to the Beijing Intellectual Property Court,Later, the appeal was rejected and the decision of the Patent Reexamination Board was upheld. Novartis refused to accept the verdict and appealed to the Beijing High Court. In 2017On December 20, 2005, the Beijing High Court rejected the appeal and upheld the original judgment.

Highlights in the invalid decision book

The patent involved has only one claim, claim 1.It is a pharmaceutical use claim. Pharmaceutical use claims are essentially for China's patent law on the treatment of diseases do not grant patent rights to make special provisions, by providing the necessary protection space and institutional incentives for medical use inventions, balancing the interests of the public and the rights holders, such claims are usually written as "compound X."Use in the manufacture of a medicament for the treatment of disease Y "or forms similar thereto, such claims generally have three main features: compound X, preparation of compound X as a medicament, treatment of disease Y.

The decision provides clear guidance on the principles of interpretation of claims for pharmaceutical use, I .e., for claims based on "X.Substances in the preparation for the treatment of YThe medical use claim written in the form of "application of medicine for disease", "treatment of Y disease" should be understood as"Effective treatment for patients with a disease", and cannot be understood as" effective for in vitro cell experiments on a disease "or" effective for animal model tests on a disease ", on the basis of which the decision provides a clear review standard for the degree of disclosure of existing technology in the novelty judgment of this type of claim, I .e.If the contents of the prior art disclosure do not reflect the exact conclusion that the substance is effective in treating patients with the disease, the invention for medical use is novel..

The decision for the creative judgment of the analysis of the technical personnel in the field can try to obtain technical solutions, put forward"Reasonable expectations of success", that is, when judging whether the invention is obvious relative to the prior art, it is not only necessary to consider whether those skilled in the art will try to use a certain substance to treat a certain disease, that is, whether they will try the technical scheme itself, but also whether the attempt has a reasonable expectation of success, that is, whether they can reasonably foresee that the scheme can solve the technical problems to be solved and achieve the expected technical effects.If a person of skill in the art would consider attempting to treat a disease with a substance and has a reasonable expectation of success, the medical use invention is not inventive.A reasonable expectation of success is not the same as an absolute expectation of success.

Review Results of Beijing High Court

ØFight for point 1.Evidence 1Whether it has been disclosed before the priority date of the patent in question and thus constitutes the prior art of the patent in question.

ØFight for point 2.Introducing Evidence in Creative Judgment 25, 6 determine whether the knowledge and ability of the technical personnel in the field of the patent involved are legal and appropriate.

ØFight for point 3.Patent Claim 1relative to whether evidence 1 is creative.

Among them, for point 3.of the creative issues, the court held that evidence 1The trials against GIST with the selective tyrosine kinase inhibitor STI571 have been taught to be a "new systemic therapeutic approach", and the very early results of said trials appear to be exciting, so those skilled in the art are motivated to try to treat GIST with STI571, the solution recited in claim 1 of the patent concerned.

As for those skilled in the art on STI571Therapy GISWhether there is a successful expectation, Novartis raised the problem of low success rate in anti-tumor drug development and no successful precedent for single drug targeted therapy of solid tumors in the prior art. However, the court held that this did not affect the conclusion that those skilled in the art could reasonably expect ST1571 to effectively treat GIST from evidence 1. Creative judgment only requires a reasonable expectation of success, not an absolute expectation of success.

No.Hua also believes that the patent involved in the case has achieved unexpected technical effects. In this regard, the court believes that the invention has achieved unexpected technical effects, which means that compared with the existing technology, the technical effects have produced "qualitative" changes and have new performance., Or produce "quantity" changes. This kind of "quality" or "quantity" changes cannot be predicted or inferred in advance for technicians in the field, patent claims 1Recorded technical solutions relative to evidence 1New properties and effects beyond those expected by those skilled in the art are not produced.

The final decision rejected the appeal and upheld the original sentence.

Conclusion

The judgment of novelty and creativity of medical use claims, especially the second medical use claim, is a very complicated legal issue, and there has always been extensive controversy. The difficulty of judgment includes the interpretation of the scope of protection of the claims, the extent to which the comparative documents can be considered as disclosing the invention, how to grasp the standard of creativity, and how to identify the unexpected technical effect.

After the release of the judgment of the case, it has aroused widespread concern in the industry. People in the legal profession said that the judgment results of the patent cases of Novohe and Hausen have made exploratory analysis and judgment on the novelty and creative examination difficulties of the second medical use claim, and given clear and operable viewpoints, which is conducive to the industry and the public to accurately understand the patent examination standards and form clear and reasonable expectations. It has important guiding significance for similar problems in this field, it will have a significant and far-reaching impact on the patent protection strategies and business activities of global innovative pharmaceutical companies and generic pharmaceutical companies in China.

References:
https://news.pharmacodia.com/web/newinfo/information_8a2d983760a18e480160bcdc196e0ae8.html