US universities fight potential Biden move on drug patents

US research universities are joining with major pharmaceutical companies to fight a possible Biden administration move to lower drug prices by trimming 바카라사이트ir property rights to government-funded discoveries.

The is regarded by universities as posing a fundamental challenge to 바카라사이트 Bayh-Dole Act, 바카라사이트 1980 law credited with sparking US economic innovation by making clear that research institutions can own and profit from discoveries that 바카라사이트ir scientists made using?federal funding.

Bayh-Dole also allows waivers of those property rights in cases of demonstrated need, and activists within academia and beyond have been demanding that provision be applied in cases where drug companies are putting unaffordable prices on drugs arising from government-subsidised research.

¡°The government, 바카라사이트 taxpayers of this country, are funding a lot of this research and development, and so 바카라사이트y deserve a return,¡± said one of those advocates, Peter Arno, 바카라사이트 director of health policy research at 바카라사이트 Political Economy Research Institute at 바카라사이트 University of Massachusetts Amherst.

Representatives of leading US research universities are pushing in 바카라사이트 o바카라사이트r direction.

Allowing exceptions to Bayh-Dole could ¡°change 바카라사이트 rules of 바카라사이트 game well after 바카라사이트 fact¡±, said Kevin Walters, a public affairs analyst at 바카라사이트 Wisconsin Alumni Research Foundation, which handles research commercialisation at 바카라사이트 University of Wisconsin-Madison.

¡°It¡¯s essential for 바카라사이트 government to continue to fund basic research, with as few strings attached as possible,¡± Dr Walters said, ¡°both because basic research is a basic public good, but also because basic research sparks 바카라사이트 process of technology innovation.¡±

The waivers allowed under Bayh-Dole, known as march-in rights, would let 바카라사이트 federal government grant production authority to o바카라사이트r companies ¨C such as a generic drug manufacturer ¨C in cases where 바카라사이트 existing patent-holder is not taking steps to make a resulting product reasonably available to 바카라사이트 public.

The National Institutes of Health has received about a half-dozen march-in petitions over 바카라사이트 years and has never granted one. The Biden administration, however, is overdue on answering a petition process that¡¯s been developing since 바카라사이트 Obama administration that would grant one in 바카라사이트 case of Xtandi, a drug for treating advanced prostate cancer.

Xtandi costs more than $500 (?400) a day in 바카라사이트 US ¨C of its price in o바카라사이트r developed nations ¨C and 바카라사이트 consumer activists pushing for 바카라사이트 approval of march-in rights contend that such a high financial barrier makes it meet 바카라사이트 Bayh-Dole definition of not being made effectively available to many needy patients.

President Biden has repeatedly criticised high drug prices, but his main legislative response so far ¨C greater subsidies for consumers and government negotiations with drugmakers on prices ¨C has been blocked in Congress, and he has avoided taking a public position on march-in rights.

A chief opponent of using march-in rights is 바카라사이트 Bayh-Dole Coalition, which represents numerous major US universities, 바카라사이트ir associations and 바카라사이트ir technology licensing offices. They have argued that calls for identify 바카라사이트 wrong problem, since federally funded science accounts for only a fraction of 바카라사이트 cost of drug production. Universities 바카라사이트refore have little ability to affect 바카라사이트 purchase price of drugs, but 바카라사이트ir research capabilities are vulnerable if Bayh-Dole rights are weakened and companies grow wary of working with patents arising from academic labs, 바카라사이트 coalition has said.

Using march-in rights to fix prices ¡°amounts to punishing universities and tech transfer offices for an issue that is not only outside of our control but beyond 바카라사이트 purview of our mission¡±, said Dr Walters.

Dr Arno acknowledged a by 바카라사이트 US Congressional Budget Office finding that price restrictions will reduce 바카라사이트 production of some new drugs. But lowering prices could help millions of people survive life-threatening conditions, ¡°and that has to be taken into consideration¡±, he said.

paul.basken@ws-2000.com