National Knowledge Bureau Declares Novartis's Heavy Heart Failure Drugs All Invalid

On January 3, the Patent Reexamination Board of the State Intellectual Property Office issued a patent examination result: the patentee Novartis Co., Ltd.'s invention and creation "Pharmaceutical Composition Containing Valsartan and NEP Inhibitor" "declared all patents invalid".

The invalidation procedure was proposed to the Patent Reexamination Board by partners and lawyers of Guangdong Shenglun Law Firm in April 17. The legal provisions on which the invalidation procedure is based are mainly Article 26, paragraphs 3 and 4, Article 22, paragraph 3, of the Patent Law and Article 20, paragraph 1, of the Detailed Implementation Rules.

Next, let's look at how this blockbuster patent was invalidated from a legal point of view.

Paragraph 3 of Article 26 of the Patent Law

These two articles stipulate how to disclose the invention and how to reasonably and accurately define the scope of protection requested from the perspective of the writing of patent application documents. The specific content of its law is that "the specification shall give a clear and complete description of the invention or utility model, subject to the realization of the invention by a person skilled in the art to which it belongs; when necessary, there shall be drawings. The abstract shall briefly explain the technical points of the invention or utility model."

The applicant believes that the patent specification does not disclose and record the experimental method, the lack of corresponding experimental data, can not support the conclusion that the pharmaceutical composition has a variety of uses. However, after a series of arguments, the re-examination board decided that the patent specification met the requirement of full disclosure.

Paragraph 4 of Article 26 of the Patent Law and Paragraph 1 of Article 20 of the Implementing Regulations also stipulate how to disclose the invention and how to reasonably and accurately define the scope of protection requested from the perspective of writing patent application documents. The content of the law is that "the claims shall be based on the description and clearly and briefly define the scope of patent protection claimed." And "the independent claim shall reflect the technical solution of the invention or utility model as a whole and record the necessary technical features to solve the technical problem."

The applicant's claim does not limit the dosage ratio of valsartan and N-(3-carboxy-1-oxopropyl)-(4S)-p-phenylphenylmethyl)-4-amino-2R-methylbutyric acid ethyl ester, so that the boundary of the scope of protection of the claim is not clear. However, the collegial panel determined that the undefined dosage ratio does not affect the understanding of the technical solution by those skilled in the art. Whether the generalization method is reasonable should be discussed under the premise that the patent content is creative.

Paragraph 3 of Article 22 of the Patent Law

This article considers whether the invention has authorized value, I .e., creativity, from the perspective of technological contribution. The content of the law is "creativity, which means that compared with the prior art, the invention has outstanding substantive features and significant progress, and the utility model has substantive features and progress."

With regard to inventiveness, the requestor provides four attachments to discuss that the contents disclosed in the patent are not inventive. The patentee then provided a series of counter-proofs to illustrate the technical solution protected by the patent on the grounds that those skilled in the art had no incentive to combine the prior art provided by the claimant. However, in the end, the collegial panel supported the requestor's request, and determined that the technical solutions of claims 1 and 2 were not non-obvious, I .e., not inventive, compared to the prior art. The patent was finally determined to be invalid.

However, it is still too early to conclude that Novartis has lost its patent rights, because Novartis has the right to appeal to the Beijing Intellectual Property Court, although the possibility of overturning the case is unlikely. However, according to relevant laws and regulations, the patent is still valid because the invalid decision has not yet taken effect before the judgment of the second instance takes effect.

News source:https://baijiahao.baidu.com/s?id=1588626601667293344&wfr=spider&for=pc

This news was re-edited and reorganized by the Huaxun team and added analytical comments.