On September 11, 2020, China’s  National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued the draft Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Trial for Implementation) (Draft for Public Opinions) (药品专利纠纷早期解决机制实施办法（试行)( 征求意见稿)).  Patent linkage refers to the process by which a country links drug marketing authorization to the status of the patent(s) corresponding to the originator’s product. Typically, marketing authorization for a generic drug will not be granted prior to the expiration of the patent on the branded equivalent, or until the relevant authority has determined that the branded drug’s patent will not be infringed or is invalid.

Some of the highlights include:

Establishment of an “Orange Book”

Similar to the U.S.’ orange book, the draft proposes establishment of an information disclosure platform for patentees to list drug-related patent information.  Specifically, when applying for a listing, applicants should provide:  drug name, related patent number, patent type , patent status, patentee, marketing license holder, expiration date  of patent protection , correspondence address, contact person, contact information, etc. Patents that can be listed include those for Active Pharmaceutical Ingredients (APIs), compositions containing APIs, formulations, biologics (sequence structure patent) and Traditional Chinese Medicine.

The platform must be updated within 30 days of any changes (e.g., in patent status).

Generic Certifications

Generic manufacturers must submit one of the following statements when seeking marketing authorization:

1. Type I Certification: No relevant patent is listed on the platform.
2. Type II Certification: The relevant listed patent has expired or was invalidated.
3. Type III Certification: The generic drug will not enter the market before the expiration of the relevant listed patent.
4. Type IV Certification: The generic manufacturer believes the relevant listed patent to be invalid or not infringed.

Patentee Response to Certification Statement

Within 45 days of publication of a generic certification a patentee or interested party can file a lawsuit or administrative complaint with CNIPA and must submit a case acceptance within 10 days of the case acceptance date.  This will generate a 9-month moratorium on giving marketing authorization to the generic but will not halt the evaluation for marketing authorization.  If the patentee cannot get a favorable ruling from a Court or CNIPA within 9 months, the NMPA can grant marketing authorization for the generic.

Marketing Exclusivity

The first generic applicant that successfully challenges patent validity will enjoy a 12-month exclusivity period. 

Remedies

After a generic drug is approved for marketing, a patentee may still sue a generic manufacturer for patent infringement. However, marketing authorization will not be withdrawn.

Submitting Comments

Comments are due by October 25, 2020 and can be submitted by email to swzpc@nmpa.gov.cn using this feedback form.  Those in the pharma space may wish to submit comments to increase the 9-month moratorium.  In contrast, the U.S. has a 30-month moratorium and a longer moratorium would provide enough time for a Court to render a decision, especially as litigation involving foreigners often takes longer than with domestic litigants.  Further, pharma companies may also recommend requiring the generic manufacturer submitting a statement to notify the patentee of the statement, as is required in the U.S.