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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."

ip-health mailing list Archives

Discussions of Intellectual Property and Health Care "To see the collection of prior postings to the list, visit the Ip-health Archives." This is one of the very best places to learn about the battle -access to medicines vs drug patents and the drug cartel. If you saw the film "Fire in the Blood" you saw how, in this era of global epidemics and corporate greed people must stand up for the rights of human beings to lifesaving drugs at affordable and not extortionate prices. This URL brings one straight to the list archives.

"Fire in the Blood": Millions Die in Africa After Big Pharma Blocks Imports of Generic AIDS Drugs (Democracy Now)

(From Democracy Now) The new documentary, "Fire in the Blood," examines how millions have died from AIDS because big pharmaceutical companies and the United States have refused to allow developing nations to import life-saving generic drugs. The problem continues today as the World Trade Organization continues to block the importation of generic drugs in many countries because of a trade deal known as the Trips Agreement. We're joined by the film's director, Dylan Mohan Gray, and Ugandan AIDS doctor Peter Mugyenyi, who was arrested for trying to import generic drugs, and is

Access to Medicines: Panel Discussion at Georgetown University about the "Crime of the Century" the disastrous murder by drug prices, of millions shown and discussed in the award winning film, Fire in the Blood

Doctors Without Borders and the O'Neill Institute for National and Global Health Law at Georgetown University screen (the 2013 film) Fire in the Blood and a discussion of challenges and opportunities for access to medicines, featuring a panel of distinguished speakers representing a range of expertise in the field of access to medicines.