9 drugs facing 4.1 patent challenges under China's drug patent linkage system

Author: Autumn Grass

On June 1, 2021, the revised Patent Law was formally implemented.

Article 6 of the "Measures" stipulates that when applying for a drug marketing license, an applicant for a chemical generic drug shall make a statement regarding each related drug patent of the generic drug in accordance with the patent information that has been published on the Chinese drug patent information registration platform

The first type of statement: there is no patent information related to the generic drug in the Chinese listed drug patent information registration platform; the second type of statement: the patent related to the generic drug included in the China listed drug patent information registration platform has terminated or has been declared invalid, or a generic drug The applicant has obtained the relevant patent implementation license of the patentee; three types of declarations: the patent information registration platform for listed drugs in China has included the patents related to the generic drugs, and the generic drug applicant promises that the generic drugs applied for before the expiration of the corresponding patent rights will not be temporarily Listing; Four types of declarations: The patents related to the generic drugs included in the Chinese listed drug patent information registration platform shall be declared invalid, or the generic drugs do not fall into the scope of protection of the related patents

Type I, Type II, and Type III declarations are all generic drug companies going on the market without valid related patents, and there is no patent challenge.

If the patentee or interested parties have objections to the four types of patent declarations, they may, within 45 days from the date of publication of the drug marketing authorization application by the National Drug Evaluation Agency, determine whether the relevant technical solutions for the listed drugs fall within the protection scope of the relevant patent rights File a lawsuit with the people's court or request an administrative ruling from the patent administration department of the State Council

Recently, we have sorted out the drug information of the four types of patent claims in the Chinese listed drug patent information registration platform, especially the drug information of the 4.

Table 1 Drugs with 4.

Data source: Medical Rubik's Cube NextPat

Among them, lacosamide tablets, ticagrelor tablets and metronidazole sodium chloride injection have no registered patent numbers, and no further analysis will be made

Regorafenib tablets: Regorafenib is a new type of oral multi-kinase inhibitor.

Nilotinib Capsules: Nilotinib is a second-generation BCR-ABL tyrosine kinase inhibitor developed by Novartis.

Oxycodone Hydrochloride Sustained-Release Tablets: In 1995, Oxycodone Hydrochloride Sustained-Release Tablets (Oshikondine) were launched and developed by Purdue Pharma.

Carfilzomib for injection: Carfilzomib is a proteasome inhibitor developed by Proteolix and later acquired by Onyx Pharmaceuticals.

Idoxaban tosylate tablets: Idoxaban is a new anticoagulant drug developed by Daiichi Sankyo that can directly act on coagulation factor Xa.

Tocilizumab injection: Tocilizumab injection is developed by Chugai Pharmaceutical (Roche Pharma), using mammalian cell (CHO) expression of anti-human interleukin 6 receptor monoclonal antibody preparation

According to the provisions of the new patent law, the above-mentioned drugs will be declared for marketing in China before June 1, 2021.

Table 2 Drug-related patent information mentioned in category 4.

Among them, Jiangsu Hausen has initiated an invalidation request for the compound patent of Carfilzomib.
However, after searching, it was found that Jiangsu Hausen made invalidation requests for two patents CN200580033600.
7 and CN201110145272.
7.
Documents issued on September 16, 2021 maintain the validity of the patent rights
.

Data source: Medical Rubik's Cube NextPat

The patent information registration platform for listed drugs in China has been in operation for several months, and there are currently 9 drugs facing 4.
1 patent challenges.
However, only the Jiangsu Hausen family has launched an attack on the original research drug company, and it ended in failure
.
So, will Jiangsu Hausen continue to file a lawsuit, or will it give up? Are other pharmaceutical companies ready to invalidate the patents of the original drug companies? Who will be the first company to obtain a 12-month period of domestic market exclusivity? We will wait and see!