The drugs claimed in drug invention patents must be approved by the National Medical Products Administration (“NMPA”) before entering into market. Due to the long review period for drugs, it is very likely that a patent has been granted but the marketing approval has not been completed yet. To safeguard the patentee’s rights and interests, the authorities introduced the Patent Term Compensation (“PTC”) system for drug patents, enabling the patentees to retain the patents during the compensation period after the expiration of the normal patent term. For this, while paying attention to the timing, conditions, documents and calculation of the compensation period for patent term, patentees also need to be aware of the scope of protection during the compensation period.
How to Request PTC?
The request for PTC for drug patents should be filed to the CNIPA within three months from the date of obtaining marketing approval in China; the three-month deadline is non-extendable and non-restorable. The PTC request shall meet the following conditions: the date of announcement of grant of the patent for which PTC is requested should be earlier than the date of marketing approval of the new drug; the patent is in force at the time of the filing of the request for compensation; the patent has not previously been granted drug patent term compensation; the claims of the patent for which PTC is requested include the relevant technical solutions of the new drug with marketing approval; where multiple patents exist for the same drug, the patentee may only request drug patent term compensation for one of those patents; where a single patent pertains to multiple drugs, a request for drug patent term compensation may only be made for one drug in relation to that patent.
When requesting PTC, besides the request, the following documents are necessary: a copy of the Certificate of Drug Registration and its annexes, a detailed statement on how the claims cover the technical scheme of the new drug and how long the compensation shall be; and the technical scheme that shall be protected during the compensation period. If the patentee is an entity different from the holder of Certificate of Drug Registration, a certificate/statement proving that the holder allows the patentee to request the PTC shall be filed. If more documents or information is required, the CNIPA will ask.
The calculation for compensation period: compensation period is the surplus time after deducting five years from the number of days between the filing date of the patent application (Date of filing) and the date on which the new drug obtains marketing approval in China (Date of marketing approval of new drug). The compensation period shall meet two requirements: 1) the compensation period shall not exceed five years, and 2) the total effective patent term shall not exceed 14 years from the marketing approval of the new drug.
What claims are qualified for requesting PTC?
The claims of a patent for which PTC is requested shall include the relevant technical schemes of the new drug with marketing approval. The relevant technical schemes of the new drug are the structure, composition and content of the new drug approved by the NMPA, as well as the approved manufacturing technique and indications. If the claims specified in the PTC do not include the relevant technical schemes of the new drug with marketing approval, PTC will not be approved. Therefore, the core condition for obtaining PTC is that the relevant technical schemes of the new drug with marketing approval shall match the claims.
What is the protection scope during the compensation period?
For a normal patent, the scope of protection shall be determined by the terms of the claims during the normal patent term. Also, for a drug patent with PTC, its protection scope during the normal patent term is determined by the terms of the claims.
However, during the compensation period after the expiration of the normal patent term, the protection scope of the patent shall be limited to the new drug approved by the MNPA and shall be limited to the claims with technical schemes related to the approved indications of the new drug, that is, the claims that match the technical scheme related to the new drug that has been approved for marketing.
Within the protection scope of the claims that match the technical scheme related to the new drug that has been approved for marketing, the patentee enjoys the same rights and takes the same obligation as those before the expiration of the normal patent term. The protection scope of product claims is limited to the marketed new drug products used for the approved indications; the protection scope of claims for medical use is limited to the approved indications of the marketed new drug product; the protection scope of claims for preparation method is limited to the manufacturing technique that has been recorded with the MAPA for the marketed new drug product used for the approved indications.
During the compensation period after the expiration of the normal patent term, the claims other than those matching the technical scheme related to the new drug that has been approved for marketing are not protected under patent law. When enforcing a drug patent with PTC, the patentee shall pay attention to the differences between the protection scope in the normal patent term and the protection scope in the compensation period so as to more effectively defend their legal rights.
In practice, if you have any questions on the new drug patent term compensation, protection scope during the compensation period, please contact us patent@afdip.com; bhtdlaw@bhtdlaw.com.
