Highlights of Third Amendment to China’s Patent Law.pptVIP

* * * * * * * * * Public Health Compulsory Licensing – “When” Law: Article 49 Where a national emergency or any extraordinary state of affairs occurs, or where the public interest so requires, the patent administrative department of the State Council may grant a compulsory license to exploit the patent for invention or utility model. [Unamended] Article 50 For the purpose of public health, for patented medicine, the patent administrative department of the State Council could offer compulsory license for making, and exporting to those countries or regions which are in conformity with the relevant international treaties participated by P.R. China. [see definition of “patented medicine”] [New Article] Public Health Compulsory Licensing – “What” Proposed Regulations: Rule 80: “Medication” in [former] Article 51 of the Patent Law refers to any patented product or any product obtained by a patented method, including active ingredients for the manufacture of the product and diagnostics for the employment of the product, which are needed in the medical field for the purpose of public health. Public Health and Compulsory Licensing – “How” is It Granted? Interagency Process – including: Request of Potential Licensee Approval Ministry of Health Approval by SFDA License by SIPO WTO Process by MofCOM Source: Yin Xintian, question raised by Mark Cohen at U.S. Ambassador’s IPR Roundtable 2008. Import/Export Compulsory Licensing for Public Health: Under “What” Conditions? Arts. 81/82 – Draft Implementing Regulations Insufficient Capability to Manufacture: “A CL “allowing the licensee to import from a member of the World Trade Organization the said medication manufactured under a compulsory license issued by the member and exported to China” “Exhaustion” of CL’s. Proof of lack of manufacturing ability Certificate against re-exportation Exploitation Fees for Public Health CL: “How Much?” Article 57 The entity or individual that is granted a compulsory license for exploitati