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北京律诚同业知识产权代理有限公司
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Supreme People's Court rejects retrial application and Lecome wins Orencia (Abatacept) patent invalidation administrative lawsuit for client
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Supreme People's Court rejects retrial application and Lecome wins Orencia (Abatacept) patent invalidation administrative lawsuit for client

  • Number of Views:
  • Date:2020-04-01

(Summary description)No. 01812229.9 patent relates to an anti-rheumatic drug, CTLA-4-IgG1 fusion protein of Bristol-Myers Squibb (BMS), trade name Orencia (Abatacept). Orencia is a soluble fusion protein produced by recom

Supreme People's Court rejects retrial application and Lecome wins Orencia (Abatacept) patent invalidation administrative lawsuit for client

(Summary description)No. 01812229.9 patent relates to an anti-rheumatic drug, CTLA-4-IgG1 fusion protein of Bristol-Myers Squibb (BMS), trade name Orencia (Abatacept). Orencia is a soluble fusion protein produced by recom

  • Number of Views:
  • Date:2020-04-01
Information

  On March 6, 2020, the Supreme People's Court issued an administrative ruling of (2019) SPC Administrative Application No. 7300, rejecting the re-examination application of Bristol-Myers Squibb, thus maintaining the invalidation decision of the State Intellectual Property Office (Patent Reexamination Board) and the judgments of the courts of first and second instance. After six years, or even longer (nine years, if counting the first invalidation challenge), the patent invalidation challenge came to an end, and now there are only one year and three months to go before No. 01812229.9 patent expires. It is a really hard journey!

  Drug background of the patent

  No. 01812229.9 patent relates to an anti-rheumatic drug, CTLA-4-IgG1 fusion protein of Bristol-Myers Squibb (BMS), trade name Orencia (Abatacept). Orencia is a soluble fusion protein produced by recombinant DNA technology. It was approved by the FDA in 2005 and the European Union in 2007. FDA-approved therapeutic indications include: (1) adult human rheumatoid arthritis (RA). Orencia can be used as a monotherapy or in combination with disease-modifying antirheumatic drugs (DMARDs, not including TNF antagonists) for adult patients with moderate to severe active RA. It can reduce disease symptoms and signs, induce major clinical remissions, inhibit the progression of structural damage, and improve physical function; (2) Juvenile idiopathic arthritis (JIA). Orencia can be used as a monotherapy or in combination with Methotrexate (MTX) for patients with moderate to severe active polyarticular JIA who are 2 years of age or older to reduce disease symptoms and signs. (3) Treatment of adult patients with active psoriatic arthritis (PsA). The therapeutic indications approved by the European Union are: (1) rheumatoid arthritis and juvenile idiopathic arthritis; (2) ORENCIA and methotrexate (MTX) are used in combination for adult patients with rheumatoid arthritis who have not undergone previous treatment with MTX; (3) ORENCIA alone or in combination with methotrexate for adult patients with active psoriatic arthritis (PsA) who do not respond well to previous anti-rheumatic drugs (DMARD) and do not require systemic treatment of skin lesions.

  Orencia's sales was US $ 2.479 billion in 2017, US $ 2.71 billion in 2018, and US $ 2.977 billion in 2019, maintaining an annual increase of about 10%.

  Abatacept as primary drug has completed market approval in China, and will be launched soon. There are many domestic pharmaceutical companies doing biosimilars, yet none of them has yet applied for listing.

  Patent background

  The application of the original sequence patent of CTLA4-Ig fusion protein has not been filed in China, but BMS filed No. 01812229.9 patent application on July 2, 2001 for "the use of soluble CTLA4 molecules in the preparation of pharmaceutical compositions for the treatment of rheumatic diseases". On May 30, 2007, the patent right was granted. The granted patent contains up to 90 claims, claiming the pharmaceutical use of CTLA4Ig fusion protein to treat rheumatoid arthritis, divided into the following groups:

  1) treatment with CTLA4Ig alone

  2) CTLA4Ig + DMARD treatment

  3) CTLA4Ig for treating rheumatoid arthritis after DMARD treatment failure

  4) mutant molecule of CTLA4Ig.

  Patent Invalidation Challenge

  In July 2011, Lecome initiated the first invalidation challenge against the patent on behalf of the client, filing a patent invalidation application for the claims in group 1) and 2). The Patent Reexamination Board made No. 18780 invalidation decision in June 2012, invalidating the claims in Group 1) and partially invalidating the claims in Group 2). "CTLA4Ig + corticosteroids, non-steroidal anti-inflammatory drugs, or prednisone combined therapy for rheumatism" in Group 2) remained valid, while other plans were invalidated. The patentee did not appeal.

  In March 2014, the Lecome team initiated the second invalidation challenge against the patent on behalf of the client, and filed an invalidation application for the claims in Group 3). In November 2014, The Patent Reexamination Board made No.24329 invalidation decision, invalidating the claims in Group 3).

  The patentee appealed against this decision. After the trials of the first and second instance, both courts made a decision to uphold No. 24329 invalidation decision. The patentee refused to accept the final judgment and applied for a retrial. After an open court investigation, the Supreme People's Court made a ruling rejecting the application of retrial.

  Attorney’s notes

  It took 9 years and 5 oral trials / hearings. The patentee submitted up to 16 counter-documentary materials with a total thickness of more than 20cm. The challenge of invalidating Orencia's patent is the longest way one can take and it is a case of the most complete procedure. The grounds in the invalidation decision are related to the support of claims in Article 26 (4) of the Patent Law and the provisions of Article 22 (2) about novelty and Article 22 (3) about inventiveness. A few interesting perspectives:

  The patent specification has more than 130 pages with 90 claims. In order to make up for the lack of patent protection of CTLA-4-Ig fusion protein in China, the patent contains multiple sets of technical solutions mingling with each other. Understanding the specification and clarifying the scope of claims is a very brain-burning task, and it is even more painful to go through these brain-burning questions before each oral examination or court hearing;

  The counter-proof submitted by the patentee in the first instance trial was used by the court to support the invalidation decision, reminding agents to treat evidence with caution.

  Huang Renmin was the patent attorney for this patent invalidation case.

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  • Beijing Law Intellectual Property Agency Co., Ltd.
    Beijing Law Intellectual Property Agency Co., Ltd.

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    Beijing Law Intellectual Property Agency Co., Ltd.

    Copyright: Beijing Law Intellectual Property Agency Co., Ltd.          Powered by www.300.cn​         京ICP备09099344号-1