Posts Tagged: "National Institutes of Health"

This Week in Washington IP: House IP Subcommittee to Hold Hearing on Arthrex; Other Committees Consider Flu Vaccine Innovation, FCC Spectrum Auction Oversight

This week in Washington, D.C., the House Intellectual Property Subcommittee will explore the  impact of the Federal Circuit’s recent Arthrex decision on the Patent Trial and Appeal Board’s (PTAB’s) administrative patent judges on Tuesday. Other House subcommittees will look at small business contributions to smart construction projects and the National Institute of Health’s (NIH’s) efforts to improve flu vaccine innovation, while the Senate Subcommittee on Financial Services and General Government will explore FCC control over the upcoming 5G wireless spectrum auction. Elsewhere in the Senate, the Energy Committee will look at several bills related to energy innovation, including an ARPA-E reauthorization bill. Off of Capitol Hill, the American Enterprise Institute will look at how the adoption of automated technologies will affect the future of employment in the U.S. Army. 

Will Bayh-Dole Survive Its 40th Birthday?

Next year marks the 40th anniversary of the passage of the Bayh-Dole Act. With election day looming, 2020 is likely to be the most politically contentious year of our lifetime. The country is divided right down the middle on many fundamental issues. Rather than debate, the opposing sides often descend into personal attacks, even questioning one another’s patriotism. This isn’t the time you want issues you care about dragged into the public arena, but patent rights and the Bayh-Dole Act have been summoned into the gladiator pit. Happy birthday, indeed.

This Week in D.C.: Competition in Digital Tech Markets, NIH Medical Research Funding and Clean Industrial Innovation

This week in the U.S. capital, the Senate will hold committee hearings on antitrust issues in digital platforms and real-time payment systems, a sector of fintech that will also be explored by the House Task Force on Financial Technology. Elsewhere in the House of Representatives, there will be hearings on Veterans’ Affairs scheduling technology, clean industrial innovations and medical research funding at the NIH. The week kicks off at the Information Technology and Innovation Foundation with a look at small business innovation funding programs. The Brookings Institution will also host events on Army modernization efforts and issues in disaggregating health data for improved policy-making.

The ‘Dragon’ Targets U.S. Biopharma Lead

Perhaps the report on China’s strategy for eclipsing the U.S. lead in biopharma from the Information Technology & Innovation Foundation (ITIF) resonated so strongly with me because of several articles in The Wall Street Journal. Taken together, they present a sobering picture of what we’re up against. The first was a book review of “Leadership and the Rise of Great Powers” by Yan Xuetong, a prominent Chinese professor. Characterized as “a window into Chinese elite thinking about the world; it is as much a political manual as an international-relations text book.”  The thesis is the inevitable rise of China as the world’s dominant power at the expense of the United States.

Bayh-Dole Rocks While the Critics Play the Same False Note

A just-released study co-sponsored by the Biotechnology Innovation Organization (BIO) and AUTM provides new evidence of the significant contribution academic patent licensing makes to the U.S. economy. The report is the most recent in a series, and the numbers are astounding. This couldn’t come at a better time. Renewed efforts are underway to subvert Bayh-Dole from an engine driving innovation into a weapon for government price controls. Even though the Bush, Obama and Trump Administrations wisely rejected their theories, the critics keep banging the drum, and some in Congress are dancing to their tune.

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.

IP and Innovation on Capitol Hill: Week of April 1: Medicare Drug Pricing, Lost Einsteins and Data Privacy

This week on Capitol Hill will include a series of hearings related to tech and innovation topics on Tuesday at the House of Representatives, where debate will focus on the 2020 budget for NASA and the National Institutes of Health, as well as on technology issues at Veterans Affairs. Senate hearings will take a look at Alzheimer’s research and funding for the Department of Energy. On Wednesday, the Senate IP Subcommittee will hold a hearing to look at gender diversity issues in the U.S. patent system. Elsewhere in D.C., the Cato Institute will look at Medicare drug pricing issues, a topic which has increasingly included discussion of patents, and the American Enterprise Institute will consider consumer data privacy issues in a two-hour event featuring officials from the Federal Trade Commission and Department of Justice.

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.

In Memory: Farewell to Senator Birch Bayh

On Wednesday, March 14, we lost Senator Birch Bayh.  We knew for several months that this day wasn’t far off, as his health rapidly declined.  I wanted to let him know one more time how grateful I am for having had the privilege of working for him. Yesterday, I spoke with a reporter from the Indianapolis Star who wanted to know what it was like working for Sen. Bayh.  I said that he was the same person in private that you saw in public.  He came to Congress to get things done and had no problem working across party lines. It was a rare Senator who didn’t like Birch Bayh.

New Study Shows Bayh-Dole is Working as Intended—and the Critics Howl

Just as the drug pricing debate on Capitol Hill is heating up, an important new study, “The Bayh-Dole Act’s Vital Importance to the U.S. Life-Sciences Innovation System,” published by the Information Technology & Innovation Foundation (ITIF), underscores the law’s contribution to the United States’ lead in the life sciences. The report warns that attempts to misuse the march-in rights provision of the law to control drug prices would have serious consequences to our competitiveness and our health. Predictably, the critics condemned the report as “A lot of myth and propaganda.” Despite being repeatedly rebuffed, they continue to argue the law authorizes the government to license competitors if a resulting product isn’t “reasonably priced.” That debate spilled over to the Capitol Hill unveiling of the study, in which I participated. What happened there sheds a lot of light on the nature of the argument.

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.”

Patents in the Crosshairs During House Drug Pricing Debate

The opening salvo in what promises to be one of the hottest debates in the new Congress was fired January 29 during a day-long hearing in the House Committee on Oversight and Reform—how to lower the price of prescription drugs. And it didn’t take long to make it clear that patents are right in the middle of the scrum. The role of patents was a prominent part of the House hearing. While cursory nods were made to the importance of encouraging innovation, the witnesses discussed how patent exclusivity, thickets, and evergreening drove up prices while promoting the greater use of Patent Trial and Appeal Board (PTAB) reviews against drug patents. The Committee was assured that curtailing patents wouldn’t harm innovation because the National Institutes of Health (NIH) is such an important funder of life science R&D.

Universities: Fallen Angels or Stewards of Bayh-Dole?

University discoveries are recognized as critical national assets because Bayh-Dole gave academic institutions the ability to own and manage inventions made with federal funding. The law helped lift the economy out of the doldrums of the 1970’s, re-establishing America’s leadership in every field of technology…. While the critics argue that Cohen-Boyer would have had the same impact without patent protection, there are other more likely scenarios. It could have languished on the shelf as did many other published, but not patented, discoveries. It took a lot of work from Reimers before U.S. companies recognized its potential. That effort would not have been made to promote a scientific paper.

Another IP Professor Attack On Patenting

I was just thinking how often someone teaching intellectual property law leads the attack on the patent system when “Racing for academic glory and patents: Lessons from CRISPR” appeared. It sounds a dire warning that “overly broad patents must be reined in” as the passage of the Bayh-Dole Act “invoking patents as a mechanism for promoting commercialization of federally funded research” set off an “often socially wasteful race…for glory in academic research and in the patent sphere.” What’s particularly striking is that neither the paper nor the articles hyping it provide any evidence the CRISPR patents are restricting research or blocking commercial development. Indeed, most signs point in the opposite direction… Doesn’t a finding by NIH that there’s no evidence of any problems with how universities are licensing their CRISPR patents deserve to be mentioned? It seems like a pretty important point.

When Big Brother Comes Marching In: Patent Challenges on Entrepreneurial Campuses

Bayh-Dole has recently come under attack, as some are trying to highjack certain provisions to be used as a cost control measure for novel therapeutics as the cost of drugs skyrocket. Should the federal government actually march in on an exclusive license covering a federally funded technology, there will be rippling effects throughout many industries. Academic institutions would reassess the value in investing resources and energy in the commercialization process if they struggle to secure a licensee for their federally funded technologies. The biggest effect, however, will most likely be felt by the general public, as they will no longer benefit from the research their tax dollars have funded for decades, but will instead be on the hook for funding the development of once promising, but now languishing, inventions.