David Kappos, Judge Randall Rader, Prof. Eric Priest and I submitted an “amicus brief” in the case of Takeda v. China National IP Administration (武田药品工业株式会社 v.国家知识产权局行政诉讼案) before the Beijing Intellectual Property Court on October 29, 2026.

The case involves patent term extension (PTE) eligibility for “new drugs” in China, including domestic legislative conflicts between Patent Law, the Patent Law Implementing Regulations and the Patent Examination Guidelines (PEG), and the conflicts between the PEG and international practice and Chinese commitments to the United States in the Phase One Trade Agreement.  As one possible solution, we propose that the Court decline to apply the PEG (不予适用  ) which has a lower position in the hierarchy of legal norms than law and regulations. This conflict has resulted in the filing of numerous court cases.  The cases also raise retroactivity concerns due to the narrowing of PEG eligibility compared to previously enacted laws and regulations.

The four signatories are members of the U.S.-China IP Dialogue.  We call this an “amicus brief” because it involves a case in which we have no commercial interest and our purpose is  assisting the court in recognizing the issues at stake and proposing an appropriate solution.  We also believe these filings should be made publicly available.  We previously made an amicus submission in a licensing case involving Access Advance and an earlier Supreme People’s Court trademark case involving Michael Jordan, which later became Supreme People’s Court Guiding Case No. 113.

PTE was one of five major pharma-related IP reforms that China had undertaken in the last 10 days. Many of these reforms have been implemented haltingly. My recent article on the development of Chinese pharmaceutical IP policies discusses the history of PTE and other recent pharmaceutical-related IP reforms in China.

For further information on our amicus filings, please see the original Chinese submission and an English translation.