Partner Kevin Nelson was quoted on the Terminating the Extension of Rights Misappropriated (TERM) Act, proposed Wednesday in the U.S. House. The bill is intended to crack down on the practice of evergreening, the process in which drug companies obtain multiple patents on the same drug in order to extend patent protection and prevent competing generic drugs from entering the market.
Kevin said the bill was “actually one of the better efforts at curbing the evergreening problem that I've seen in a while," but added, "There are some problems with the actual practice of this if it were enacted."
Kevin said that the general presumption that all issued patents are valid would still exist, and that patent owners would likely argue that assumption neutralizes the new presumption found in the TERM Act, which may convince a judge.
"While the premise is good, the mechanism is easily undercut by just merely pointing to the presumption of validity and the fact that the patent office already reviewed the patent," he said. "To give it a little more teeth, one of the things that should be added to this is a statement that the patentee cannot rely on presumption of validity."
Opponents of the TERM Act said it would create a presumption that every subsequent patent on a drug is suspect, adding that drug makers spend a lot of time and money goes into refining a drug compound and that those innovations should be patentable.
Kevin disagreed, saying that later patents on more detailed methods of treatment and the like can be suspect, since "just because you weren't more specific doesn't mean you should get another five years of exclusivity."
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