While the pharma industry sorts out what impact a Biden administration is likely to have on drug pricing, another consideration meaningful for the sector is the trade relations between China and the U.S. — and how they may affect drug patent law.
As part of recent trade negotiations, Chinese authorities agreed to change their intellectual property system for drugs, aligning their system with the Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, in the U.S.
China formally committed to the first phase of a trade agreement with the U.S. on Jan. 15, 2020, which requires the country to resolve patent disputes before approving generic drugs. The revised patent law is slated to take effect on June 1, 2021.
“It will be interesting to see if relations between a Biden administration and the Chinese become more antagonistic,” said Dominick Conde, chair of the intellectual property division at Venable LLP. “Will the Chinese roll back some of those [IP system] changes or not?”
Regarding trade negotiations, Biden has said he would not immediately remove the 25% tariff that Trump imposed on many Chinese exports to the U.S.
While there has been positive movement in terms of China’s patent reform regarding pharmaceuticals in recent years, the U.S. pharma industry would like to see further progress in ensuring more patent protection for innovative drug development.
China “didn’t have a regulatory scheme that is comparable to ours,” Conde said. Creating one that is similar would “create more incentives for innovators to make drugs and sell them in China,” he said.
China had written a draft proposal to require China’s equivalent to FDA, the National Medical Products Administration (NMPA), to create a drug patent information registration platform. The registry would resemble the FDA publication known as the Approved Drug Products with Therapeutic Equivalence Evaluations, commonly called the “Orange Book.”
China has continued to update its patent laws this year to strengthen IP protection and improve enforcement of patent rights, passing a fourth amendment to Chinese Patent Law.
While the changes to China’s patent system would strengthen U.S. pharmaceutical companies’ intellectual property rights in China, a Biden administration is likely to use more multilateral and multi-international attempts to enforce intellectual property rights than in the past. “In terms of where we think the Biden administration will go, we think IP enforcement, particularly regarding China, will be looked at through a lens of enforcing rights through a global trade policy,” said Justin Pierce, a partner and co-chair of Venable’s intellectual property division.
“One area where we are likely to see IP protection action is biotechnology,” Pierce said.
In the U.S., there is likely to be “continued bipartisan agreement about IP enforcement, with divisions most likely to occur involving specific sectors or industries,” Pierce said.