In an earlier post, we discussed the patent linkage system implemented in the Fourth Amendment to the Chinese Patent Law, which will come into effect on June 1, 2021. Another important change in the amendment is the introduction of Patent Term Extension (PTE) for pharmaceutical patents.
The new PTE provision is in the 3rd paragraph of Article 42 in the amended Chinese Patent Law, which reads and is translated as follows: “In order to compensate for the time taken for regulatory review and approval of a new drug in China, the Patent Administration Department of the State Council, at the request of a patentee, may extend the term of an invention patent related to the new drug that has received regulatory approval for marketing in China. The patent term extension should not exceed five years, and the total remaining term of the patent after the regulatory approval should not exceed fourteen years.”
Specific rules for implementing PTE will be provided in the amended Implementing Regulations of the Chinese Patent Law (“Regulations”). Draft amendments to the Regulations (“draft Regulations”) were released on November 17, 2020. A final version of the amended Regulations has not been promulgated.
Below is a summary of the PTE rules according to the amended Chinese Patent Law and the draft Regulations.
The amended Chinese Patent Law provides that PTE may be available for an invention patent related to a new drug. Under Section 85-4 of the draft Regulations, a new drug can be a new chemical drug, biologic drug, or traditional Chinese medicine, and PTE is only available for patents covering the drug, methods of manufacturing of the drug, and medical use of the drug. Thus, medical device and equipment patents are not eligible for PTE.
The draft Regulations also specify that the patent related to the new drug refers to a patent related to the drug’s active ingredient that receives regulatory approval for the first time in China. However, it is not clear whether the active ingredient only includes the active moiety or also includes the salts, ester, or crystal forms of the active moiety.
The draft Regulations provide limitations on the timing of filing a request for PTE. Under Section 85-7 of the draft Regulations, a request for PTE must be filed within three months from the date when a new drug receives regulatory approval. The request should be filed with the Patent Administration Department of the State Council (i.e., China National Intellectual Property Administration (CNIPA)).
Thus, under the current version of the draft Regulations, drugs approved prior to March 1, 2021, will not be eligible for PTE. Some pharmaceutical companies have submitted their concerns on this requirement to the CNIPA. In particular, they asked for a “transition period” to include some drugs approved before March 1, 2021. They argued that drugs approved since April 2018 should be eligible for PTE consideration since the Chinese State Council executive meeting decided in April 2018 to provide up to 5 years’ term extension for patents related to drugs for which regulatory approval was simultaneously applied in China and abroad.
Another limitation on the timing is that a PTE request must be filed at least six months prior to the patent’s expiration date (without PTE). Since the amended patent law will come into force on June 1, 2021, it appears that patents expiring before December 1, 2021, will not be eligible for PTE considerations. No retrospective remedy is provided in the current version of the draft Regulations.
The calculation of PTE under the amended Chinese Patent Law is different from PTE calculation in the U.S. and is more similar to that of the supplementary protection certificate (SPC) in the European Union. Section 85-5 of the draft Regulations provides that the extended term under PTE is the time period between a patent’s filing date and the date when the drug receives regulatory approval, reduced by five years. The total time period of PTE is also subject to limits under Article 42 of the amended patent law as discussed above.
Section 85-7 of the draft Regulations further provides the following requirements and limitations on the request for PTE:
- when there are multiple patents related to a new drug, PTE may only be requested for one of the patents;
- when a patent covers multiple drugs, the term of the patent may only be extended under PTE for one drug;
- the patent has never received a PTE; and
- the remaining term of the patent (without PTE) is no less than six months (discussed above).
Also, under Section 85-6 of the draft Regulations, during a patent’s extended term under PTE, the scope of the patent is limited to the new drug and the approved indication(s) of the drug.
Along with other amendments, the introduction of PTE will strengthen IP protection for pharmaceutical patents in China. The real impact of the amendments will depend on the finalized Regulations, CNIPA’s examination guidelines, and future judicial interpretations. We will provide more updates on any further clarifications and amendments.