On June 6, 2019: S&E Held a Study Group on Intellectual Property in China and Taiwan
On June 6, 2019: S&E held a study group on the Intellectual Property in China and Taiwan at Sonderhoff and Einsel’s firm office.
Ms. Xiaofen Wu (Chinese patent attorney) of S&E gave a presentation on the “Patent Linkage System in China and Taiwan”, in which many Japanese pharmaceutical companies have shown great interest.
In China, which ranks second after the United States in the global pharmaceutical market, reforms of the pharmaceutical industry have been progressing to expand and develop the industry.
In this study group, Ms. Wu explained the situation surrounding the pharmaceutical industry in China, the latest information on the legal system related to pharmaceutical patents, and the patent linkage system in detail. She also described a system in Taiwan which was introduced for the purpose of participating in the TPP (Trans-Pacific Partnership) in the future.
The study group lasted about an hour, and given that there was a lively exchange of questions and opinions, we believe this study group was highly successful. S&E also had a reception after the study group to allow participants further opportunities for communication with Ms. Wu and our other patent attorneys.
On May 13, 2019 and in Frankfurt on May 16 (Frankfurt), 2019: The China IP Law Seminar was held by the Hamburg Office.
The Chinese
Patent Law Seminar organized by the Hamburg Office was held on May 13, 2019
(Hamburg) and May 16 (Frankfurt).
At this
seminar, patent attorneys from the Hamburg, Beijing, and Tokyo offices provided
an overview of the latest trends in China’s patent law and patent practice that
are changing dynamically.
Dr. Zhao (Chinese
attorney at law) of the Hamburg Office gave a presentation on the “Revisions of
the Patent Law and the Opportunities for Patent Infringement Litigation in
China” Ms. Wu (Chinese patent attorney) of the Tokyo office explained the “Pharmaceutical
Patent Linkage System in China”, and Mr. Zhao (Chinese patent attorney) of the Beijing
Office presented on the “Latest Information on the Practice of Patent Prosecution
in China”.
Seven participants
attended the seminar in Hamburg and 22 participants joined the seminar in
Frankfurt. During the Q&A session, there was a lively exchange of questions
and opinions, and we believe the seminars were highly successful.
IP Practice: “Update of Patent Linkage System for Pharmaceutical Products in China”
We are pleased to announce the December 2017 issue of Sonderhoff & Einsel China IP Newsletter.
Patent linkage is a system where a country links drug marketing approval of a generic drug to the status of the patents related to the originator’s product. In China, there have been a series of regulations that have been released for public comment which indicate that China will soon be introducing a patent linkage system: on May 12,2017, the China Food and Drug Administration (CFDA) announced for public comment “Policies regarding the Promotion and Protection of Innovators’ Rights in Pharmaceutical Products and Medical Devices” (“Announcement No. 55”); 2) on October 8, the General Office of the CPC (Central Committee) and the General Office of the State Council of the People’s Republic of China published an “Opinion on the Promotion of Reformation regarding Examination and Approval System as well as Innovation of Pharmaceutical Products and Medical Devices” (“Opinion”) for extensive implementation of reforms; and 3) on October 23, the CFDA released for public comment “Administration Regulations for Registered Pharmaceutical Products” (“Proposal for Revision”).
This system hopes to ensure a stable supply of pharmaceutical products by taking the patent term of an original drug into consideration by, for example, negotiating with the original drug manufacturers prior to the approval of generic drugs. Since 2007, generic drug applicants are obliged to declare that their generic drug products do not infringe the patent right of the original drug. However, there is no mention of the punishment or penalty for non-conformance with this obligation. Since the CFDA is not capable of examining whether the generic drug infringes a patent right in response to the approval application for generic drugs, it is highly probable that the CFDA will approve the generic drug without clarifying the possibility of patent infringement. The linkage system will attempt to resolve these issues, but as commented below, the new set of regulations will still be insufficient and advantageous for generics as a whole. Therefore, generic drug manufacturers are expected to mount a more vigorous challenge to original drug manufacturers’ patent rights and original drug manufacturers are expected to file lawsuits in response to these challenges. Thus, disputes regarding patent rights are likely to increase further after introduction of the patent linkage system.
For details, please check the following PDF.