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Posts Tagged: "march-in rights"

The Washington Post Misses the Mark on March-In Rights

The National Institute of Standards and Technology recently indicated in its “Return on Investment Initiative draft green paper” that it would issue regulations effectively ending attempts to misuse march-in rights to assert government price controls over successfully commercialized federally-funded inventions. Such an announcement was bound to elicit a reaction. That it came in The Washington Post shouldn’t be a surprise. The paper’s April 18 article, “A rare deterrent to limitless drug price increases may die under Trump” gives coverage to both sides, but the takeaway is that something nefarious is underway: “As drug prices have soared, lawmakers and patient advocates have pushed the federal government to deploy for the first time a powerful deterrent: a legal provision that allows it to suspend a drugmaker’s patent and license someone else to produce the drug. Now, responding to industry alarm over those demands, the Trump administration is proposing to strictly limit the little-known power,” said the article. There’s a reason why this “little-known power” has never been used—it doesn’t exist.

Special Interests are Watching Academic Tech Transfer

The original motivation for the Bayh-Dole Act was to encourage the commercialization of academic innovation so that new technologies could be available for the benefit of all. Yet today, I feel compelled to call attention to a compliance landscape that is significantly different than that of the past four decades—one that could have dire consequences for institutions if they choose to be complacent. Not only do sponsoring agencies have an interest in how tech transfer complies with Bayh-Dole regulations, other entities have entered the competitive landscape looking for opportunities to turn lack of compliance to their advantage. In just the past two years we’ve seen a spike in requests for the government to exercise march-in rights by a variety of non-governmental advocacy groups (NGOs). These NGOs are staffed by PhDs who are well-versed in the academic tech transfer ecosystem and they actively seek out pockets of non-compliance. An attempt is then made to extricate key technologies using non-compliance as a lever and the NGOs become the primary influence on how innovation is put into the marketplace. I would ask the question, “Who will pick up on these inventions?” If you follow this chain of events we may find ourselves in a situation where innovation is not freely available to all (the original intent of Bayh-Dole) but an endpoint where NGOs and their backers control how technologies get into the marketplace.

Examining the Truvada #BreakThePatent Debate: Gilead Responds

In July 2012, the U.S. Food and Drug Administration (FDA) first approved Truvada, an acquired immunodeficiency syndrome (AIDS) treatment manufactured by Gilead Sciences as a daily pre-exposure prophylactic (PrEP) treatment to reduce the risk of contracting human immunodeficiency virus (HIV) in sexually active individuals. Recently, this HIV PrEP treatment and its patent have been thrust into the spotlight thanks to a commercial for Truvada that Gilead ran during the January 27 broadcast of Rent: Live on the Fox television network. While many were encouraged by the fact that a national TV network was raising awareness about PrEP treatment, the commercial sparked a return to a debate over the high price of Truvada. As of June 2018, news reports indicated that once-daily Truvada treatment cost about $1,500 per month, or around $18,000 per year. Although the cost of Truvada is often covered by health insurance, the treatment hasn’t been adopted as widely as was expected when the drug was approved. Between January 2012 and March 2014, a review of half of U.S. pharmacies by Gilead showed that only 3,253 had begun a PrEP regimen during that time, far less than the estimated 500,000 people who would make good candidates for Truvada. That number has expanded rapidly to 77,120 U.S. PrEP users in 2016 and an estimated 136,000 users by the end of 2017’s first quarter, but that’s still far short of the estimated 1.2 million American adults at high risk of HIV infection who could benefit from PrEP. “Based on feedback from partners and our work in the field, we believe that one of the greatest barriers to Truvada for PrEP access today is limited awareness of Truvada for PrEP’s role in HIV prevention,” Gilead told IPWatchdog. “Data from our patient support programs do not suggest that cost is a primary obstacle to treatment. The majority of people receiving Truvada for PrEP today who utilize our co-pay coupons pay less than $5 per bottle.”