On November 18, the Quality Brands Protection Committee of China Association of Enterprises with Foreign Investment (QBPC) Agricultural IWG held a seminar on the Bolar Exception[1] in the pesticide industry, which was moderated by IWG Coordinator Sam Fan. IWG members and experts discussed the issues related to the application of the Bolar exception under the patent law in the field of pesticides. During this meeting, the participants reached preliminary consensus on relevant issues.
The meeting discussed the origin and legislative background of the Bolar exception provisions, relevant legislation status, judicial cases and practice in multiple foreign countries and jurisdictions, the background and status quo of patent infringement cases involving the use of pesticides for plant protection, as well as the focus of relevant legal disputes and basic viewpoints. The participants agreed that the current patent law was very clear about the application of the Bolar exception, which was limited to drugs and medical devices. However, it remained inconclusive whether the Bolar exception should apply to the pesticide industry and other industries that required government approval, such as veterinary medicine, special chemicals and cosmetics. It required further improvement at the legislative level in the future while considering whether to introduce similar systems such as a drug patent extension protection mechanism.
[1] Bolar exception, also known as Bolar exemption, it means that when a patent is implemented in a specific way solely to obtain and provide information needed for administrative approval of a drug or medical device, it does not constitute infringement. Article 75 (5) of Patent Law stipulates that those who manufacture, use, or import patented drugs or medical devices in order to provide the information needed for administrative approval, and those who manufacture or import patented drugs or patented medical devices specifically shall not be deemed to be infringement of patent rights.