The 4th amendment of China’s Patent Law on PTA

The patent term adjustment (PTA) system was implemented by the 4th revised Patent Law, which permits an innovation patent in China to have a patent protection period that is longer than the statutory protection length of 20 years under specific situations.

More specifically, for an invention patent granted after four years from the date of application and three years from the date of requesting substantive examination, the CNIPA shall compensate the patentee for any unreasonable delay during the granting process of invention patents, excluding unreasonable delays caused by the applicant, at the patentee’s request.

The patentee may request a PTA within three months of the announcement of a patent right, according to a draft modification of the Patent Law’s implementing regulations. After the Revision of the Implementing Regulations takes effect, the CNIPA will evaluate the above-mentioned request.

The unreasonable delay time in the granting procedure is computed from the date of the innovation patent application filing date and three years from the date of the request for substantive examination to the date of the patent right announcement.

Suspension processes, preservation measures, administrative litigation proceedings, and reexamination procedures in which the applicant makes revisions are not considered unjustified delays in the granting process, according to the draft Revision of the Examination Guidelines.

The effective date of the request for substantive examination is the date of issuance of the notification of entry into the substantive examination stage of the invention patent application, according to the draft revision, and the date of the request for substantive examination is the date of issuance of the notification of entry into the substantive examination stage of the invention patent application.

In practice, because the detailed Implementing Regulations of the Patent Law and examination guidelines are still pending, it is preferable to calculate PTA based on a rough time period of four years from the filing date of the invention patent application and three years from the date of the request for substantive examination to the date of announcement of the patent right, rather than calculation based on the date of the request for substantive examination.

Patent linkage system for drugs

The patent linkage system was introduced as a principled provision in the 4th amended Patent Law, clarifying that patentees or parties of interest are allowed to file a lawsuit or request an administrative ruling on patent disputes involving drugs that have been submitted for marketing authorization.

In July 2021, the National Medical Products Administration (NMPA), the China National Intellectual Property Administration (CNIPA), and the Supreme Court (SPC) all released implementation measures and judicial interpretations explaining the patent linking system’s operation.

Briefly, under the patent linkage system, generic medicine firms must submit a patent statement together with their generic applications, disclosing any relevant patents listed on NMPA’s patent information platform.

If the generic drug company makes a statement that its product does not fall within the scope of the relevant patent, or the relevant patent shall be invalidated, the patentees or the interested person may take action within 45 days after the publication of such statement, by filing a claim either with the court (judicial approach) or with the CNIPA (administrative approach).

For chemical medications, such action will result in a nine-month hiatus during which the NMPA will not approve the generic pharmaceuticals in question. The generic medication would not be approved until the relevant patent expires if the patentee or interested party can get a favorable court ruling or a decision from the CNIPA within the stay period.

The patent linkage system also lays out the requirements and processes for certification of non-infringement and a 12-month marketing exclusivity term for the first generic business that successfully challenges a patent and receives marketing authorisation clearance.

In July 2021, the NMPA established a patent information platform listing the patents relevant to brand-name drugs approved in China, as the basis for the patentees to assert their rights. Since then, patents involving over 1,000 drugs have been listed thereon.

The first patent linkage case was filed with the Beijing IP court in November 2021, involving a medicine called eldecalcitol from Chugai Pharmaceutical Co., Ltd, and a patent claiming the eldecalcitol formulation. Wenzhou Haihe Pharmaceutical Co., Ltd is the defendant, and they filed a generic medicine application in August 2021, asserting that their product would not be covered by the asserted patent. The Beijing IP court ruled in favor of the generic drug business five months after Chugai filed the action, in April 2022, opining that the generic medication is not the technological solution described by the asserted patent.

From the administrative side, by the end of October 2021, 12 administrative cases under the patent linkage system were filed with the CNIPA. In April 2022, CNIPA announced it has made rulings on the first batch of cases involving the drug oxycontin. The rulings support the generic company’s statements, determining that the generic drug does not fall within the scope of the asserted patents.

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