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Unaffordable prescription drugs: the real legacy of the Hatch-Waxman Act

By ALFRED ENGELBERG -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."