The Greater China IP Updates ˇV Jan 2023

By Lyndon 

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Highlights of Chinaˇ¦s Amendments to the Regulations for the Implementation of the Drug Administration Law

There have been some updates to the regulations concerning the section Intellectual Property Protection for Pharmaceutical Products in the Drug Administration Law as follows:

1. Article 38 states when there is a patent right dispute during the application for marketing approval of drugs, the relevant parties may file a lawsuit to the court or request an administrative adjudication to the CNIPA. Moreover, the examination for the application does not pause during a legal action. For a chemical drug that passed the examination, the National Medical Products Association (NMPA) will eventually grant a marketing approval or not according to the courtˇ¦s judgement, verdict, or settlement agreement, or the CNIPAˇ¦s administrative adjudication. If the NMPA does not receive the abovementioned documents within a certain period of time, they may grant a marketing approval independently. Also, the NMPA has the legal authority to run and supervise a pharmaceutical drug patent information registration platform to disclose patent status associated with a drug, where the marketing approval applicant/holder is responsible for the authenticity, accuracy and completeness of the uploaded patent information.
2. Article 39 discusses promoting the development of generic drugs by providing market exclusivity to the first successful chemical generic drug which wins in a patent linkage dispute. That means the NMPA would not grant approval to another generic copy within 12 months from the date of the first successful generic drugˇ¦s approval. However, the market exclusivity term cannot exceed beyond the expiry of the challenged patent term.
3. Article 40 looks at data exclusivity. For 6 years, the NMPA will not grant approval to another application which cites the same data of the previous market approval. This will protect the market approval holderˇ¦s submitted undisclosed experimental data or other data for some drugs from unfair commercial use by others. Such data will not be made public by the NMPA unless there is some pressing public interest according to the regulations.
4. Article 28 focuses on encouraging developments in pediatric medicine. Market exclusivity will be granted to the first approved drug of new variety, dosage form, and strength specifically designed for children, or to an existing drug with newly added indications or administration routes. During such time, no other drugs of the same variety will be approved. Furthermore, the review process for the applications for market approvals of pediatric drugs will be prioritized.
5. Article 29 guarantees a market exclusivity of 7 years to an approved orphan drug to treat a rare disease if the marketing approval holder promises an uninterrupted supply of the drug. Failure to do so means the exclusivity will be terminated. Likewise, to encourage the research and innovation of orphan drugs, studies for drugs that treat rare diseases will be supported and developments for treating new indications of rare diseases by already marketed drugs will be fostered. Also, the review process for the applications for market approvals of orphan drugs in urgent needs for clinical uses will be prioritized. .

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Number of Patents Increases in China in 2021

According to the latest annual figures for 2021, out of all the countries, China had the most patents in force with 3.6 million. The global total in 2021 was 16.5 million. China also had 37.2 million active trademarks (compared to a global total of 73.7 million) and 2.6 million industrial design registrations (compared to a global total of 5.3 million). IP filing remained strong during the height of the Covid-19 pandemic in 2020 and soared in 2021. Innovators around the world filed 3.4 million patent applications in 2021, up 3.6% from the previous year with offices in Asia receiving 67.6% of all applications worldwide. An estimated 13.9 million trademark applications covering 18.1 million classes were filed worldwide in 2021, and the China National Intellectual Property Administration (CNIPA) had the highest volume of filing activity with a class count of around 9.5 million, followed by the United States Patent and Trademark Office (899,678), and the European Union Intellectual Property Office (497,542). An estimated 1.2 million industrial design filings were made worldwide in 2021. Global intellectual property filings for patents, trademarks and designs reached new heights in 2021, showing the resilience of the global innovation ecosystem during the pandemic, according to the same report published by the World Intellectual Property Organization in November 21, 2022.

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Highlights of Amendments to the China Patent Law

The CNIPA recently issued a summary of the updates to the Amendments to the China Patent law originally issued in June, 2021.  The major aspects are as follows:

1. The amended Patent Law increased the statutory sum of damages to a range between RMB 30,000 and 5,000,000.  The increase is taking into account the difficulties faced by the patentee when trying to collect evidence of infringement.
2. The system regarding design patents has been improved.  Protection on partial design is now allowed.  The protection period of design patents has been extended to 15 years.  Also, within six months of filing the first domestic design patent application, an applicant can claim priority when filing another domestic application for the same subject matter.
3. Pharmaceutical patent term restoration, a compensation for the amount of time taken up by the review and approval process for new drugs, has been introduced.  For invention patents related to new drugs that have received permission, term restoration shall be granted in response to the request of the patentee.  The extended term shall be no more than 5 years, and the total effective term of the patent after the launch of the drug shall be no more than 14 years.  Further, during the process of the review and approval process of a new drug, when disputes regarding patents of the new drug occur, the applicant, the relevant patentee or other interested parties can file a complaint with the court to request a ruling on whether the new drug falls within the protection scope of patents owned by other patentees.
4. The new Patent Law introduced the Open Licensing system.  A patentee can make a declaration to the relevant authorities, stating the willingness to authorize any institution or individual the right to implement the patent, and specifying the amount of royalties and the payment schedule.

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