On June 14, 2019, Ha Kung Wong was quoted in Law360 regarding the possible ramifications of the Terminating the Extension of Rights Misappropriated (TERM) Act, which is intended to crack down on companies obtaining multiple patents on the same drug in order to extend patent protection and prevent competing generic drugs from entering the market. The bill was introduced in the U.S. House of Representatives on June 12, 2019.
According to the article, patents are typically presumed to be valid in litigation because they have been reviewed by the U.S. Patent and Trademark Office (USPTO). Generic-drug makers must prove the patents are invalid, but the TERM Act would shift the burden and require branded drug companies to prove that their later patents are distinct from the first patent on a drug.
"Saying it's a significant change is an understatement," said Wong. "It sounds like Congress is trying to take the place of the patent office and basically saying, 'We don't trust you, patent office, so we're going to assume you're wrong.'"
Wong said he read the bill as effectively undoing the presumption of validity for later-issued drug patents. Given its broad, open-ended statement that those patents are presumed invalid, it's unclear what patentees could possibly do to defend them, and "logistically, it would be a mess," he said.
The scenario created by the bill "seems so bizarre," Wong said, since normally litigants with a burden have to overcome some existing evidence. Here, the patentee already persuaded the USPTO that the patent is valid but then must argue against a blanket congressional mandate that it should be presumed invalid, for no reason other than when it issued.