Before the fourth amendment of the Patent Law, the protection term of Chinese pharmaceutical patents was the same as that of other invention patents, both of which were 20 years. However, due to the natural modal of the R&D of clinical trials and pre-marketing evaluation of innovative drugs, it generally takes 8-10 years from project approval to success of marketing. This indirectly leads to the high prices of innovative drugs in China. In order to make up for the losses caused by the administrative examination and approval of the marketing of innovative drugs that caused the patentee to be unable to sell normally during the patent protection period, China’s fourth amendment to the Patent Law which will take effect from June 1, 2021 added the protection of pharmaceutical patents Term compensation system.
The amendment adopts patent term extension for pharmaceutical patents due to regulatory delays. Article 42(3) stipulates that in order to compensate for the time occupied by the new drug marketing review and approval of new drugs which have obtained marketing authorization in China, the patent administration department under the State Council may, upon request of the patentee, grant a compensation period for the duration of patent right. The compensation period shall not exceed five years, and the total effective duration of the patent right after the marketing of the new drug shall not exceed fourteen years.
We can obtain the following from the new regulation Article 42(3).
I. The drug involved in the patent right must be a new drug
Combining Article 2 of the "New Drug Approval Measures" and Article 12 of the "Administrative Measures for Drug Registration (2007)”, it can be seen that, firstly, "new drugs" shall be domestic; secondly, the new drugs should never been produced or sold in China.
According to the second paragraph of Article 2 of the “Drug Administration Law”, “new drugs” is drugs referring to the substance preventing, treating, and diagnosing human diseases and aiming to regulate people’s physiological functions and also stipulating indications or functional indications, usage and dosage, including traditional Chinese medicine, chemical medicine and biological products. That is, "new drugs" cover three types of medicines: traditional Chinese medicine, chemical medicine and biological products.
New drug invention patents include new drug product patents and new drug method patents. The latter includes two types of patents for new drug manufacturing methods and uses. All new drug invention patents, whether product patents or method patents, are entitled to require compensation for the duration of the patent right.
There are various types of patents related to new drugs, such as active ingredients, compositions, preparation methods, uses, intermediates, dosage forms, crystal forms, etc. Not all patents related to new drugs can enjoy term compensation. For example, patents such as intermediates and dosage forms may not be eligible for compensation. Of course, we still need to wait for the release of detailed rules or examination guidelines.
II. Legal entity, timing and requirements to start the request
The compensation procedure for the duration of patent rights in China should be initiated upon application by the patentee.
Article 42(3) stipulates that "the patent rights related to invention patents for new drugs which have obtained marketing authorization in China" have the right to claim compensation for the duration of patent rights. In fact, it is clear that the time point for the compensation procedures for the duration of patent rights for new drugs is "after obtaining marketing approval in China".
The drug and related patents shall meet the following conditions for requesting the extension: 1) if a drug has multiple patents at the same time, the patentee can only request compensation for extension of the duration of the drug patent for one of the patents; 2) If there are multiple drugs involved in a patent at the same time, only one drug can be requested for drug patent term compensation; 3) The patent has not yet received drug patent term compensation; 4) The remaining protection term is not less than 6 month.
III. Calculation and determination of patent right compensation period
According to the amended law, the compensation period shall not exceed five years, and the total effective duration of the patent right after the marketing of the new drug shall not exceed fourteen years.
But regarding the calculation of the actual patent compensation period, the author believes that, firstly, due to the differences in clinical trials and drug marketing authorization procedures for various new drugs of traditional Chinese medicine, chemical drugs and biological products, the compensation period of various new drugs should be different; secondly, the state of the Drug Administration shall regularly announce the current average cycle of clinical trials of various new drugs and drug marketing authorization; finally, the State Drug Administration and the State Intellectual Property Office shall jointly formulate the calculation method for the compensation period of various new drug patent rights.
2021-04-28
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