On 11 September 2020 an exposure draft for the Implementation Measures for Early Resolution Mechanism of Pharmaceutical Patent Disputes (for Trial Implementation), which was jointly drafted by the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA), was released to solicit public opinion until 25 October 2020.
The measures are the first legal document explicitly addressing the pharmaceutical patent linkage system in China since the idea was first floated by the NMPA in its Policies on Encouraging Drug and Medical Device Innovation and Protecting Innovator Interests (Draft for Public Comment) in May 2017. This article examines the measures' key takeaways.
Establishment of patent information registration platform for marketed drugs
Although the NMPA is tasked with establishing a Patent Information Registration Platform for Marketed Drugs in China (Rule 2), its affiliate Centre for Drug Evaluation (CDE) is believed to be the agency running the operation of this platform (Rule 3).
Rules 3 and 4 enumerate the information to be registered with the platform and the time limit to record any changes.
Registration scope for pharmaceutical patent information
When seeking regulatory approval for chemical drugs, applicants can register with the platform patent information on active ingredients, pharmaceutical composition and pharmaceutical uses (Rule 5).
Applicants for biological products can register patent information on sequence structures while applicants for traditional Chinese medicines (TCM) can register patent information regarding composition, extract and pharmaceutical uses (Rule 12).
Generic drug applicants must file patent status statements
When filing for regulatory approval, chemical generic drug applicants must make a statement with reference to each drug patent whose information has already been registered with the Patent Information Registration Platform for Marketed Drugs in China (Rule 6). Such statement is categorised as follows:
- There is no existing patent relating to the generic drug application.
- The patent to be exploited by the generic drug has expired or has been declared invalid.
- There is an existing patent relating to the generic drug application and the generic drug manufacturer agrees to seek regulatory approval on the expiration of such patent.
- The validity of the patent to be exploited by the generic drug should be declared invalid or the generic drug does not fall into the patent's scope of protection.
The granting of regulatory approval for chemical generic drugs hinges on the technical assessment outcome, should a category (I) or (II) statement is filed. Regulatory approval (on the expiration of the pertinent patent) could be granted to a chemical generic drug that has passed technical assessment in case of a category (III) statement. In a category (IV) statement, the granting of regulatory approval is premised on the affirmation of patent invalidity and the determination of non-infringement (Rules 9 and 10).
Similarly, the granting of regulatory approval for biosimilars and TCM with identical names and formula hinges on the technical assessment outcome. Apart from the technical assessment decision, the NMPA will also refer to the court or administrative adjudication decision, provided that a proceeding is duly initiated to ascertain whether the technical solutions of such drug fall within the scope of patent protection (Rule 13).
Time limit for patentee or interested party to raise objection
The patentee or an interested party contesting a statement filed by the generic drug applicant may file a lawsuit before the court or request an administrative adjudication before the CNIPA within 45 days from the publication date of the generic drug application (Rule 7).
Delays in generic drug approvals
Rule 8 provides a nine-month stay for chemical generic drug applications, should a patent dispute arise in the approval process; however, technical evaluation will not be suspended during the nine-month stay.
Encouraging generic drug patent challenges
Rule 11 provides 12-month exclusivity to the first generic drug applicant that succeeds in challenging the validity of a chemical pharmaceutical patent and acquiring the first regulatory approval.
China's pharmaceutical patent linkage system is on the horizon. Over the years, the legislature has introduced a few aspects of the pharmaceutical patent linkage system into China's patent and drug legal framework.
Article 69.5 of the current Patent Law established the 'Bolar exemption', which enables any party that manufactures, uses or imports a patented medicine or medical apparatus, or any party that manufactures or imports a patented medicine or medical apparatus specifically to provide information needed for regulatory review and approval, to be exempted from patent infringement.
The revised Measures for the Administration of Drug Registration allow manufacturers of generic drugs that are eligible for exemption of clinical trials to file for regulatory approval, as long as such generic drugs pass a therapeutic equivalence evaluation (Rule 35).
The newly promulgated Regulations for the Implementation of the Drug Administration Law provides a six-year exclusivity period for the protection of experimental and other data (Rule 35.2).
The second draft of the Patent Law amendment, which was published by the Standing Committee of the National People's Congress of China on 3 July 2020, makes available the adjustment of the patent term for new pharmaceutical product patents to compensate for the curtailment of the effective patent term as a result of the regulatory approval process. The adjustments will be limited to no more than five years and thus limit the resulting effective patent term to no more than 14 years from the date of regulatory approval in China (Article 42.3).
It remains to be seen how the pharmaceutical patent linkage system will be shaped in the finalised text of the fourth amendment to the Patent Law and the Implementation Measures for Early Resolution Mechanism of Pharmaceutical Patent Disputes.
