[Ip-health] Al Engleberg on the legacy of Hatch-Waxman, in Stat

James Love james.love at keionline.org
Wed Dec 30 11:21:31 PST 2020


This is a 2880 word article by Al Engleberg in Stat, on the Hatch Waxman
Act, a law that he played an important role in shaping.

The article ends with several of Al's endorsed reforms, including those
directed at "minor changes" to a drug.

One is to stop granting patents for minor changes, and to eliminate the
presumption of validity in USPTO inter partes reviews.

He wants FDA regulations changed "to prevent non-essential changes to a
drug that serve to delay generic competition."

Third, he wants to eliminate injunctions "for infringement of patents
claiming minor changes to a drug after the patents claiming the drug itself
or its medical use have expired."

This last reform is a limitation on the remedy to infringement.   Patent
holders could seek compensation or remuneration for the use of the patented
inventions, but not block their use.

Governments that are WTO members can implement such a limitation on the
availability of injunctions, under Article 44 of the TRIPS, and there are
already such limitations in U.S. law, for some other purposes, such as the
government's use of a patented invention, or a limitation on remedies when
a biologic drug maker does not provide timely disclosure of patent
landscapes to competitors.

Engleberg notes that the Supreme Court has held that "aninjunction for
patent infringement is discretionary and should not be granted when it
would do a disservice to the public interest," (the eBay v Mercexchange
case), and he proposes "Congress can make a legislative determination that
it is not in the public interest to enjoin generic competition after the
patent claiming a new drug or its medical use expires — at least in those
instances where an injunction is sought due to the existence of a secondary
patent claiming subject matter that is not material to the safety or
efficacy of a drug as originally approved."

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