A patent corresponding to the generic drugs that have been marketed in China and registered on the Patent Information Registration Platform for Marketed Drugs constitutes the "related patent" referred to in Article 76, Paragraph 1 of the Patent Law.
If a patent corresponding to an original drug that only differs from the generic drug in specifications has been registered on the Patent Information Registration Platform for Marketed Drugs, the generic drug applicant should, in principle, make a declaration in accordance with the registered patent related to the original drug.
Company A is the patentee of the invention patent involved in the case. The protection scope of the patent involved in the case covers all dosage forms of drugs containing the active ingredient of palbociclib, including palbociclib capsules and palbociclib tablets.
On June 30, 2021, Company A registered the patent involved in the case as a patent related to palbociclib capsules in three specifications of 75mg, 100mg and 125mg on the Patent Information Registration Platform for Marketed Drugs (hereinafter referred to as the Patent Information Registration Platform), and the registered claims are 1-4. The original drug “palbociclib” with specifications of 25mg and 125mg and dosage form of tablets were approved for marketing in China on August 10, 2022. On September 6, 2022, Company A registered the patent involved in the case as a patent related to palbociclib tablets with the specifications of 25mg and 125mg on the Patent Information Registration Platform, and the registered claims are 1-4.
Pharmaceutical Company B filed an application for registering the generic drug Palbociclib tablets with three specifications of 75mg, 100mg and 125mg and the dosage form being tablets on the Patent Information Registration Platform. The National Medical Products Administration accepted the registration on April 12, 2022. In response to the patent involved in the case, Pharmaceutical Company B made a Type 1 Declaration on the Patent Information Registration Platform, that is, there is no relevant patent information of the generic drug on the Patent Information Registration Platform.
Company A filed a lawsuit and claimed: the Type 1 Declaration made by Pharmaceutical Company B was false and inaccurate. Pharmaceutical Company B had filed an invalidation request against the patent involved in the case, so its true intention was a Type 4.1 Declaration. Company A requested to confirm that the technical solution of the generic drug involved in the case that Pharmaceutical Company B applied for registration fell in the protection scope of claims 1-4 of the patent involved in the case.
Pharmaceutical Company B argued that: for the palbociclib tablets with specifications of 75mg and 100mg that were applied for, there were no corresponding generic drugs or the related patents published on the Patent Information Registration Platform. For the palbociclib tablets with specifications of 125mg that was applied for, the related patent was published later than the time of its declaration. In addition, its invalidation request and the administrative litigation against the patent involved in the case was filed before the implementation of China's drug patent linkage system, and also earlier than the application date of the generic drugs in question. Therefore, Company A's opinion that its declaration on the patent in question should be a Type 4.1 declaration lacked basis. Therefore, Company B had factual and legal basis for making a Type 1 Declaration, and Company A's lawsuit did not meet the statutory conditions.
The first instance court made a civil ruling to dismiss Company A's lawsuit. Company A was dissatisfied and appealed, claiming that: "The generic drugs" are not limited to drugs approved for marketing, and the applicant for generic drugs should make a declaration for each "related drug patent" corresponding to the generic drugs registered on the Patent Information Registration Platform. The case is special, as the patent involved in the case has been registered on the Patent Information Registration Platform, and the technical solution of the generic drug fell within the protection scope of the patent. Pharmaceutical Company B, while knowing the above facts, made the Type 1 Declaration, so the Declaration was untrue and inaccurate, and in essence belonged to the Type 4.1 Declaration. The Supreme People's Court made three final civil rulings on September 20, 2023: dismissing the appeal and upholding the original ruling.
The court's effective judgment held that:
First, from the perspective of system interpretation, Article 2 of the Implementation Measures for Pharmaceutical Patent Disputes stipulates that the holder of a drug marketing authorization should register "the relevant patent information of drugs registered and marketed in China" on the Patent Information Registration Platform; Article 4, paragraph 1 stipulates that the specific content to be registered includes "the corresponding relationship between the drug and the relevant patent claims". It can be seen that the patents registered according to the Implementation Measures for Drug Patent Disputes should correspond to the drugs that have been marketed in China. Article 6, paragraph 1 of the Implementation Measures for Drug Patent Disputes further stipulates that "when a chemical generic drug applicant submits an application for drug marketing authorization, it shall make a declaration for each drug patent related to the generic drug in accordance with the patent information disclosed on the Patent Information Registration Platform for Marketed Drugs". When interpreting "each drug patent related to the generic drug" in this Article, the above interpretation principle shall continue to apply, and the relationship between "generic drug" and "related drug patent" should meet the conditions of such a corresponding relationship stipulated in the above Article 4, paragraph 1, and the patent claims with such a corresponding relationship have been registered on the Patent Information Registration Platform. Therefore, the "generic drugs" here should refer to the generic drugs that have been marketed in China, and the "related drug patent" should refer to the patents registered on the Patent Information Registration Platform corresponding to the generic drugs that have been marketed in China.
Secondly, from the perspective of purpose interpretation, the early resolution mechanism for drug patent disputes established by Article 76 of the Patent Law and the Implementation Measures for Drug Patent Disputes is a special mechanism that takes into account the interests of original drug patent holders, generic drug applicants and the general public. It is not the only way to resolve drug patent disputes. In principle, the scope of drug patents subject to this special mechanism shall not be expansively interpreted. If, according to Company A's understanding, "relevant patents" are interpreted as any patent that may be included on the Patent Information Registration Platform, it may inappropriately increase the burden on generic drug applicants to determine the type of the declaration, affecting the smooth and effective operation of the mechanism.
Finally, the invalidation request and administrative litigation filed by Pharmaceutical Company B against the patent involved in the case were both earlier than the implementation of China's drug patent linkage system and the application date of the generic drug involved in the case. Therefore, the above-mentioned behavior cannot be interpreted as a Type 4.1 Declaration of the patent involved in the case by subsequent laws, judicial interpretations and administrative regulations.
In summary, the "related patents" referred to in the paragraph 1 of Article 76 of the Patent Law should be understood as patents registered on the Patent Information Registration Platform corresponding to the generic drugs that have been marketed in China. Since the patent involved in the case is not a patent registered for the corresponding palbociclib tablets that have been marketed in China, it does not belong to the "related patent" of palbociclib tablets. Therefore, Company A's lawsuit does not meet the conditions stipulated in Article 76 of the Patent Law and should be rejected.
Furthermore, although in China's current drug management system requires separate applications and different approved batch numbers for chemical drugs that only differ in specifications, generic drugs of the same dosage form may use original drugs of different specifications as reference preparations, and use the data demonstrating consistency in quality and efficacy with the reference preparations as the basis for registration. Therefore, when the original drug that differs from the generic drug only in specifications has been registered on the Patent Information Registration Platform, the generic drug applicant should, in principle, make a declaration in accordance with the relevant patents registered under other specifications of the generic drug registered on the Patent Information Registration Platform.
(2023) Zui Gao Fa Zhi Min Zhong Nos. 1233, 1234, 1235
AFD China Newsletter is intended to provide our clients and business partners information only. The information provided on the newsletter should not be considered as professional advice, and should not form the basis of any business decisions.
