Case Brief

The respondent is a Sino-foreign joint venture enterprise primarily engaged in the research and development, production, and sales of pharmaceutical intermediates, active pharmaceutical ingredients, and finished drugs. Its product categories include cardiovascular drugs, nervous system drugs, and anti-tumor drugs.

Daiichi Sankyo Company Limited (hereinafter referred to as "Daiichi Sankyo") alleges that the technical solution for the medication related to thrombosis prevention and treatment, which was applied for registration by the respondent, falls within the scope of protection of the involved patent titled "Pharmaceutical Composition". Additionally, Daiichi Sankyo contends that the technical solution documentation for the medication submitted by the respondent is insufficient in terms of authenticity and completeness. Based on this, Daiichi Sankyo has filed a request for administrative adjudication regarding drug patent disputes in accordance with the Patent Law and the Administrative Adjudication Measures on the Early Resolution Mechanism for Drug Patent Disputes.

After accepting the respondent's commission, Unitalen formed a drug patent dispute team that meticulously examined the petition and evidentiary materials submitted by the petitioner, and reviewed the examination history of the involved patent and the filing and approval status of the relevant drugs. On this basis, the team explicitly pointed out that, in light of a prior invalidation decision concerning the involved patent, due to the amendments to claims in the invalidation procedure, the judgment of whether the technical solution for the medication falls within the scope of protection of the involved patent should not be based on the granted claims of the involved patent, but on claims 2 and 11 which were upheld as valid in the invalidation decision. Subsequently, the team elaborated that the "starch hydrolysis oligosaccharides" in the technical solution for the medication were neither identical nor equivalent to the "mannitol" specified in the involved patent.

Regarding the relevant evidence, especially the filing materials for drugs, the team specifically stated to the collegial panel that the said evidence constitutes confidential materials, and all involved parties bear strict obligations to keep the information they obtain confidential. At the same time, based on the examination history of the involved patent, the team argued that the claims of the involved patent had been amended during the substantive examination process and specific sugar alcohols had been defined in the claims. Therefore, according to the "prosecution history estoppel" principle, Daiichi Sankyo should not introduce other sugar alcohols, or even substances completely different from sugar alcohols, into the scope of protection. At the same time, the team actively communicated with all parties and prepared supplementary experimental data to prove that the technical solution for the medication is fundamentally different from the involved patent. In addition, the team also submitted patent applications filed by the respondent's shareholders in Europe, as well as common knowledge evidence to support the defense arguments.

Attorney's Analysis

Ultimately, after trial, the collegial panel of the CNIPA held that starch hydrolysis oligosaccharides and mannitol do not constitute substantially the same means within the technology of the involved patent. Furthermore, if the evidence submitted by the generic drug applicant sufficiently demonstrates a high likelihood that the technical solution for the generic drug does not fall within the scope of protection of the involved patent, it would be unfair to further require the respondent to provide additional materials without justified reasons, and such a requirement would be counterproductive to the early resolution of disputes. Consequently, the final adjudication determined that the respondent's technical solution for the medication does not fall within the scope of protection of the involved patent.

Therefore, being familiar with the administrative adjudication review procedure and adept at leveraging patents to initiate adjudication requests or effectively defending against adjudication requests will enable effective protection of the legitimate rights and interests of the petitioner or respondent.