Sihuan Pharmaceutical Subsidiary Wins Partial Patent Challenge Against Novo Nordisk’s Tresiba, Paving Way for Early Launch of Insulin Degludec Biosimilars

Recently, the China National Intellectual Property Administration issued invalidation request examination decision notices regarding two core patents of Novo Nordisk's insulin degludec. One patent was declared entirely invalid, while the other was upheld as valid. The invalidation requests were filed by Huisheng Biopharmaceutical, a subsidiary of Sihe Pharmaceutical.

According to the PharmaCube NextPat® database, the first patent CN200480021733.8 is the sequence patent for insulin degludec; the second patent CN200680053516.6 is the formulation patent for insulin degludec. Both patents are registered under insulin degludec injection in the China's Marketed Drug Patent Information Registration Platform, with detailed information shown in the figure below:

Source of the image: NextPat® database by PharmaCube

Notably, this is not the first time that Jilin Huisheng Biopharmaceutical Co., Ltd. has challenged these two patents. On January 17, 2022, the company filed a request for invalidation of the above two CN patents on the grounds of lack of inventiveness. The patent holders amended the claims of both patents, after which Jilin Huisheng Biopharmaceutical Co., Ltd. withdrew their invalidation request. Ultimately, the China National Intellectual Property Administration (CNIPA) issued a decision declaring partial invalidation of the patent rights for both patents.

On the premise that a partial invalidation decision had already been made, Huisheng Biopharmaceutical immediately filed invalidation requests for these two patents. The current invalidation request was based on the previously amended claims. In the end, the sequence patent for insulin degludec remained valid, while the other formulation patent was declared entirely invalid.

Jilin Huisheng Biopharmaceutical Co., Ltd.'s persistent patent challenges regarding these two patents are related to its multiple insulin degludec-related products (as shown in the figure below). Among them, both insulin degludec and insulin degludec/insulin aspart combination have submitted marketing applications, and another compound formulation of insulin degludec and liraglutide has also been declared for clinical trials.

Source: NextPharma® Database by PharmaCube

The sequence patent (CN200480021733.8), which has not been invalidated, is set to expire in July 2024, with only 7 months of patent protection remaining. Jilin Huisheng Biopharmaceutical Co., Ltd. submitted a Category 3 declaration when filing for the marketing approval of insulin degludec and insulin degludec/insulin aspart. Therefore, Jilin Huisheng's insulin degludec and insulin degludec/insulin aspart products are expected to be approved for marketing shortly after the expiration of the sequence patent, potentially within this year.

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