The Supreme People’s Court clarified in two cases concerning disputes over confirmation of whether a technology falls within the protection scope of patent that, under the Early Resolution Mechanism for Drug Patent Disputes, where the technical scheme of an originator drug does not fall within the protection scope of the patent, the court shall rule to dismiss the action. The summary of the case is as follows:
Company A is the patentee of two invention patents (“patents in suit”). The originator drug in suit, i.e., the reference drug for the generic, has been approved by the National Medical Products Administration to be used in combination with Y for the treatment of rheumatoid arthritis (RA). The marketing authorization holder of the originator drug in suit has registered the relevant information of the patents in suit on the patent information registration platform.
Company A initiated a lawsuit in the court of first instance against Company B regarding injection X for which Company B had applied for marketing authorization (hereinafter referred to as “the biosimilar in suit”), alleging that: 1) the originator drug in suit has been approved by the National Medical Products Administration to be used in combination with Y for the treatment of rheumatoid arthritis; 2) relevant information of the patents in suit relating to the originator drug in suit has been registered and publicly disclosed on the patent information registration platform; and 3) X is the MRA as defined in the claims of the patents in suit, and Company B intends to use the biosimilar in suit in combination with Y for the treatment of rheumatoid arthritis, with the same administration and dosage as the originator drug in suit. Therefore, the technical scheme of the biosimilar in suit falls within the protection scope of the patents in suit.
Company B argued that: the technical scheme of the originator drug in suit does not fall within the protection scope of the claims of the patents in suit, the patents in suit do not constitute “relevant patents” under Article 76 of the Patent Law, and Company A is not entitled to initiate proceeding under the provisions, thus the action should be dismissed.
Upon trial, the court of first instance ascertained that: (i) considering the claims of the patents in suit as a whole, a person skilled in the art would understand “use of MRA and Y in the preparation of a pharmaceutical composition for treating rheumatoid arthritis” solely as the combined use of MRA and Y in treating rheumatoid arthritis, rather than preparing a single formulation from the two; (ii) the technical scheme employed by the originator drug in suit falls within the protection scope of the claims of the patents in suit; and (iii) the technical scheme of the biosimilar in suit for which Company B applied for marketing authorization falls within the protection scope of the claims of the patents in suit owned by Company A. Accordingly, it was held that the technical scheme of the biosimilar in suit falls within the protection scope of the claims of the patents in suit.
Dissatisfied with the first-instance judgment, Company B appealed to the Supreme People’s Court on the grounds that the patents in suit are not “patents related to the drug for which marketing authorization is applied” under Article 76 of the Patent Law, and Company A is not entitled to initiate the present proceeding.
The Supreme People’s Court held that: 1) only where the technical scheme of the originator drug falls within the protection scope of the patent claims can a lawsuit initiated by the patentee or interested party be deemed to have a legal basis under Article 76(1) of the Patent Law, which is the inherent intent of the Patent Law regarding such type of litigation; 2) the patents in suit should be interpreted as use of MRA and Y in preparation of a pharmaceutical composition product in a specific packaging form for treating rheumatoid arthritis. The originator drug product in suit is X injection, it is only recited in the description that it can be used in combination with Y. That is, it involves only a single substance and does not constitute a pharmaceutical combination product in a specific packaging form, thus it necessarily does not fall within the scope of the claims of the patents in suit. Accordingly, the lawsuit brought by Company A does not comply with the provisions of Article 76(1) of the Patent Law and shall be dismissed. The Supreme People’s Court rendered a judgment to revoke the first-instance civil judgment and dismissed Company A’s action.
Furthermore, the Supreme People’s Court corrected the improper claim construction adopted by the court of first instance: 1) the claims of the patents in suit explicitly define a “pharmaceutical composition”, the court of first instance interpreted the corresponding content of the claims as "the combined use of two formulations” without explaining the definition of “pharmaceutical composition”, that is, without considering all the technical features defined in the claims; 2) the interpretation of the claims should be reasonable, and should not include a technical scheme that cannot be granted in the protection scope of the patent.
Through the above ruling, the Supreme People’s Court clarified that, under the Early Resolution Mechanism for Drug Patent Disputes, only where the technical scheme of the originator drug falls within the protection scope of the patent claims can a lawsuit initiated by the patentee or interested party be deemed to have a legal basis under Article 76(1) of the Patent Law. When determining the protection scope of the claims, all technical features recited in the claims shall be considered, and the interpretation of the claims should be reasonable.
(2023) Zui Gao Fa Zhi Min Zhong No(s). 2, 3
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