The recently negotiated Economic and Trade Agreement between the US and China has delivered significant outcomes on pharmaceutical patent protection and sets the scene for an ongoing global debate over data protection.
The two countries announced the agreement last week. Its negotiation, which is described as phase one, follows months of public disagreement between the two countries over trade.
The agreement includes a number of significant provisions on patents and biopharmaceutical-related intellectual property.
China has agreed to provide patent term extensions to compensate for 'unreasonable' delays in granting approvals.
Australia provides a five-year extension to the standard 20-year patent term in recognition of the significant time it takes to develop a biopharmaceutical product and the time to navigate the approval process.
China has also agreed to establish a mechanism to enable the early resolution of potential biopharmaceutical patent disputes, including a cause of action to allow a patent holder to seek expeditious remedies before the marketing of an allegedly infringing product. This grants patent holders significant power to enforce their rights.
China has also agreed to address a number of additional issues relating to biopharmaceutical-related intellectual property, including with respect to data protection for biopharmaceuticals.
US BIO welcomed the agreement. According to President and CEO, “We are currently reviewing the details, but we are pleased to see important commitments for agricultural biotechnology, biopharmaceuticals, and GM microorganisms, in addition to commitments related to forced technology transfer and intellectual property. We look forward to working closely with the Administration to monitor the implementation and enforcement of these provisions."
Any decision by China to adopt a data protection period could have significant global implications for other trade agreements. It would also represent a significant turnaround and achievement for the US given its recent backdown on data protection in the US-Mexico-Canada Agreement (USMCA).
Canada has Mexico agreed to a minimum 10-year data protection period for biologics in the USMCA but it was scrapped in the renegotiated agreement that was recently backed by the US Congress.