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Author | kevindy
The patent linkage system originated in the "Hatch-Waxman Act" of 1984 in the United States, aiming to balance the interests of innovative drug companies and generic drug companies
.
China’s drug patent linkage system has been implemented for more than one month.
Can this system design, which aims to promote healthy competition between generic drug companies and original research drug companies, really promote domestic drug research and development? Who will become the first company to challenge patents after the implementation of this system? How about a successful company becoming the first to eat crabs?
Patent linkage system
Patent linkage systemThe patent linkage system originated in the "Hatch-Waxman Act" of 1984 in the United States, aiming to balance the interests of innovative drug companies and generic drug companies
.
The so-called patent link refers to the "link" of the generic drug that is applied for on the market with the patent of the original research drug it imitates
Article 11 of the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" stipulates that "the first chemical generic drug that successfully challenged the patent and was approved for marketing shall be granted a period of market exclusivity
.
The same kind of generic drugs will not be approved for marketing within 12 months from the date of approval, except for the successful joint challenge of patents
Crab Eater
Crab EaterAs of August 6, 2021, a total of 89 patent declarations of generic drug companies have been queried on the Chinese listed drug patent information registration platform, including 87 chemical drugs, 2 biological products, and no Chinese medicines
.
The statistics of the types of patent declarations are shown in Figure 1.
Distribution of number of patent declarations
Jiangsuhausen
JiangsuhausenThe first company to declare to challenge the patent was Jiangsu Hausen, and the declared product was dapagliflozin
.
The patent layouts of the original research manufacturers of this variety are compound patents, crystal form patents and preparation patents, and their patent protection periods are 2023, 2027, and 2028, respectively
Source: China listed drug patent information registration platform
Biopharmaceuticals
BiopharmaceuticalsThe second pharmaceutical company to challenge the patent was Beijing Biopharma.
The declared product was an ibuprofen suspension, and it was also a generic drug company to challenge
.
However, judging from the drug number of the ibuprofen suspension approved by the patent enterprise and the registered patent protection content, the registered patent protects the compound preparation of Chinese and Western medicine made of ibuprofen and Chinese medicine ingredients.
Source: China listed drug patent information registration platform
Huahai Pharmaceutical
Huahai PharmaceuticalThe third pharmaceutical company that raised a patent challenge was Huahai Pharmaceutical, and the declared product was lurasidone hydrochloride tablets
.
The two patents of the original manufacturer of the product are both pharmaceutical composition patents and belong to the relationship between the original case and the divisional case.
Source: China listed drug patent information registration platform
With the implementation of this system, it is believed that more and more pharmaceutical companies will challenge patents, and more and more pharmaceutical companies will successfully challenge patents
.
Compared with the success of challenging patents, I think we need to pay more attention to the implementation of favorable measures after the success of subsequent challenges
We will wait and see who will be the first person to eat crabs!
references:
"Implementation Measures for Early Resolution Mechanisms for Drug Patent Disputes (Trial)"
"Quick Look! In-depth interpretation of China's patent linkage system! 》
