Then we have good news. On October 17, 2020, the PRC government approved the 4th Amendment to the PRC Patent Law, which will enter into force on June 1, 2021.
What does it mean? The patent legislation of the PRC is becoming friendlier, not only for the patent holder in general, but also for the applicants of original drugs.
1. Compensation for a long-term substantive examination is introduced.
If a patent for an invention is issued 4 years after an application filing or 3 years after requesting substantive examination, the applicant may claim “term compensation” for unreasonable delaying the substantive examination. Unless, of course, it is not an applicant fault)))
2. An extended protection period is introduced.
A drug patent can be renewed for at most 5 years, beyond the traditional 20 years. However, the term of the patent validity along with the renewal after the new drug approval should not exceed 14 years. Thus, the PRC has joined the cohort of countries that compensate the applicant for a long approval period by the state regulatory authorities.
3. A novelty grace period is introduced.
In the event of a national emergency, such as during the coronavirus pandemic, an applicant is able to publicly disclose information about an invention / utility model in the public interest for no more than six months BEFORE the patent application is filed. In these cases, the novelty will be assessed by patent documents disclosed six months before the filing of the application or earlier.
4. The compensation for patent infringement is increasing. Now it can be up to 500% of the original damage.
5. Similarly, punitive damages increase. Since most successfully resolved patent disputes regarding patent infringement in China end in paying punitive damages rather than compensation for actual damage or loss, such an increase is a good bonus for the patent holder.
6. There will be an opportunity to stop the entry of a generic drug on the market at the stage of its registration. According to the current law, as of today and until June 1, 2021, an applicant for an original drug can file a claim for patent infringement only after a generic drug has entered the market. However, after June 1, 2021, the inventor of the original drug will be able to stop the generic release at the registration stage if he/she proves that the marketing authorisation application for the generic is covered by the originator patent. Thus, China has made significant progress in ensuring fair and honest competition in the market.
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