Writer: Minhua Chu
Editor: Justin Fischer
After a nearly nine months of deliberation, the National Medical Products Administration (NMPA) and China National Intellectual Property Administration (CNIPA) jointly issued their “Implementation Measures for the Early Settlement Mechanism of Pharmaceutical Patent Disputes (for Trial Implementation)” on July 4, 2021.
On the same day, China's patent information registration platform was established for marketed drugs. Similar to the the Orange Book in the US, it made data from 475 patents public, including chemical drugs, biological products and traditional Chinese medicine (TCM).
Both events marks the official implementation of China's drug patent linkage system.
Available only to patents registered on the platform
The regulation specifies that the marketing authorization holder (MAH) can register patent information on the platform within 30 days after obtaining its drug registration certificate. The platform is overseen by the NMPA's Center for Drug Evaluation (CDE) of NMPA.
Patent registration is not mandatory, but unregistered patents will not be eligible for the new patent linkage system.
The CDE will conduct a substantive review of the registration information. The regulation mentions the MAH will assume legal liabilities for “intentional misregistration” as well. However, the definition of intentional misregistration and the opposition proceeding have not yet been clarified. There is no active error correction mechanism yet either.
According to the interpretation documents issued by the NMPA and CNIPA, registrable patents do not include patents on intermediates, metabolites, crystal structures, preparation methods, testing methods, etc.
The document does, however, list the types of drug patents that can be registered:
· Chemical drugs
o Patents for active pharmaceutical ingredients (API)
o Patents for pharmaceutical compositions containing active ingredients
o Patents for pharmaceutical uses
· Biological products
o Patents for active ingredients sequences
o Patents for pharmaceutical uses
Generic drug applicants may make patent declarations
According to the regulations, when a generic drug developer submits a market application, it should make a declaration for each relevant patent of the reference drugs, not just for partial patents.
The declarations include four classes:
· Class I: No patent
· Class II: Patent has been terminated or invalid, or has obtained a patent implementation license
· Class III: Commitment to not market the drug before the expiration of the patent period
· Class IV: Patent shall be declared invalid, or the generic drug is not within the scope of patent protection
The CDE shall disclose the generic drugs' market application information and related patent declarations within 10 working days after the application is accepted. And the generic drug applicants shall notify the MAHs of the reference drugs with the declarations by mailing or e-mail. However, the document does not specify the period of notification.
If the patentees or interested parties disagree with the Class IV declaration, they may, within 45 days from the disclosure date of the generic drug marketing application, file a lawsuit or request an administrative ruling from the CNIPA on whether the related technologies are within the scope of the patent protection. Moreover, patent owners or interested parties shall notify the CDE within 15 working days from the date of filing or acceptance by the CNIPA. Generic drug applicants should also be notified.
Litigations and administrative rulings will trigger a nine-month waiting period
After receiving a copy of the notice of acceptance from the court or CNIPA, the CDE shall set a waiting period of nine months for the market application of generic drugs. In contrast, the lawsuit filings or administrative ruling requests by generic applicants does not trigger the waiting period.
This waiting period is much shorter than the 30-month stay period in the United States. The waiting period for a marketing application for the same generic drug is set only once.
During the waiting period, the CDE will not stop the technical review. Instead, it will suspend the administrative approvals. Then, once the applications have passed technical review, the CDE will process the application according to the ruling results. If the drug is confirmed to be within the scope of the relevant patent rights protection, the administrative approval process is pending until the expiration of the patent period.
For Class I and Class II declaration, the CDE will make the market approval decisions based on the conclusion of the technical review. For Class III declaration, even if the relevant drugs got the market approvals, they cannot launch the market until the expiration of the corresponding patent period and the market exclusivity period.
First successfully challenged patents and marketed generic drugs will enjoy a 12-month exclusivity period
For the first generic drug that successfully challenges the patents and is the first to obtain market approvals, a market exclusivity period of up to 12 months is granted. According to the document, a successful patent challenge means that the generic applicant submits a Class IV declaration, and the relevant patent right is invalidated based to its request.
The exclusivity period is calculated from the approval date, but will not exceed the term of the original patent for the challenged drug. This 12-month exclusive period is longer than that in the United States (180 days) and South Korea (nine months). Multiple companies can enjoy the market exclusivity period if they sucessfully challenge the patent together.
During this market exclusivity period, the CDE may not approve the same generic drug, but it will not stop the technical review either. It will restart the administrative approval process when the market exclusivity period expires.
System for biologicals not yet complete
However, the patent linkage system for biologial products is currently “imcomplete”.
Unlike generic drugs, there is no waiting period or market exclusivity period for the market application of biosimilars. The CDE may approve based on the conclusions in the technical review. This is not affected by the court decision or the CNIPA’s administrative ruling results.
Biosimilar drugs deemed within the scope of patent protection are regarded as a Class III declaration. In other words, the CDE may grant market approval, but must it must enter the market after the expiration of the patent rights and market exclusivity period.