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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."

High prices, poor access: What is Big Pharma fighting for in Brussels?

Big Pharma's lobby machine ground into top gear to defend its privileges, doing its best to remove or weaken regulatory measures. A close relationship with the Commission –which fails to take undue industry influence seriously– has played a key role, as has the lobbying firepower of Big Pharma. The top ten biggest spending companies, for example, have increased their lobby budget by €2 million since 2015, and Big Pharma's main lobby group EFPIA (European Federation of Pharmaceutical Industries and Associations) sits on eight of the Commission’s advisory groups. Big Pharma has also rolled out a PR offensive harnessing the powerful emotions around illness, designed to deflect criticism and narrow the scope for debate. Thanks to this lobbying arsenal, the industry has succeeded in influencing the review into pharma incentives and rewards (such as intellectual property rules), as well as a change to a type of patent extension called an SPC (supplementary protection certificate) which allows companies to extend the period of monopoly pricing. It has also affected a proposal for EU collaboration to assess how effective new medicines and health technologies are relative to existing ones, something which helps member states negotiate prices. Drug companies promote the use of ‘new’ drugs because they still have patent protection, and are therefore more expensive, over old ones that don't, even if the new product is not an improvement in medical terms.