Posts Tagged: "Bayh-Dole Act"

Former Senator Robert Dole turned 97 last week, but he’s still very much engaged in what’s going on right now. He just wrote a powerful op-ed, Innovation is key to defeating COVID-19. Subtitled “Enacted 40 years ago, the Bayh-Dole Act is helping facilitate the development of coronavirus therapies today,” Senator Dole reviews how the law he crafted with former Senator Birch Bayh revolutionized the commercialization of federally-funded inventions. Bayh-Dole paved the way for companies like Moderna to create critically needed therapies to combat our raging pandemic. But there’s another message Senator Dole delivered that’s just as topical.

Our current experiences with COVID-19 in the United States, together with headlines warning of major efforts by the Chinese and Russian governments to hack corporate, academic and federal laboratories to steal information on pending therapies, underline the importance of maintaining the U.S. lead in the life sciences. It’s not just our health at risk—it’s also our security. We’ve just had a taste of what it’s like depending on China for medicines and protective gear. We also face an internal threat posed by “drug populists” calling for arbitrary government price controls while blaming patents for costs and blocking innovation. Ironically, a perfect example of this school of thought appeared in the  New York Daily News the same day as an important new report issued from the Information Technology & Innovation Foundation (ITIF). Titled “Ensuring U.S. Biomedical Competitiveness”,  the report is a treasure trove of critically needed information.

On June 23, the Eagle Forum Education & Legal Defense Fund celebrated 40 years of the Bayh-Dole act with a virtual briefing, titled: “The Bayh-Dole Act at 40 Years: How the ‘Most Inspired Piece of Legislation’ of a Half-Century Has Turned American Basic Research Discoveries into Products, Startups and Economic Growth.”  The event was moderated by Jim Edwards, the Eagle Forum Education & Legal Defense Fund Patent Policy Advisor and featured remarks by Courtney Silverthorn, the Acting Director, National Institute of Standards and Technology O?ce of Technology; Joseph Allen, IPWatchdog contributor and the Executive Director of Bayh-Dole 40th Coalition and Former Senate Judiciary Aide to Sen. Birch Bayh; Hans Sauer, the Deputy General Counsel and Vice President for Intellectual Property for the Biotechnology Innovation Organization; Jennifer Gottwald, the Senior Licensing Manager at the Wisconsin Alumni Research Foundation (WARF);  and David Korn, the Vice President of Intellectual Property (IP) and Law for the Pharmaceutical Research and Manufacturers of America (PhRMA).

With two-thirds of the world in lockdown and no clear way out of the novel coronavirus crisis, it’s increasingly obvious that biopharmaceutical innovation will play a pivotal role. A new treatment that can mitigate the worst effects of COVID-19, and ultimately a preventative vaccine, could, literally, save the world. Such life-saving technology is less likely to be forthcoming if, in their panic, governments sacrifice intellectual property (IP) rights for new COVID-19 therapeutics and vaccines. The signs are not promising. IP-skeptic governments in Chile and Ecuador have taken preemptive measures by permitting compulsory licensing of any new COVID-19-related technology. Otherwise innovation-friendly Canada and Germany have passed legislation to issue compulsory licenses more easily. Even in the United States—the center of modern biopharmaceutical innovation and a major player in ongoing COVID-19 research and development (R&D) efforts—there is pressure to break patents.

In this age of polarization, it’s almost impossible to imagine Congress enacting bipartisan legislation that would benefit businesses, higher education, and consumers alike. But that is exactly what happened 40 years ago, and it is worth remembering. As has been outlined elsewhere on IPWatchdog in 1980, Democrat Senator Bayh and Republican Senator Dole wrote a bill that seemed simple, but changed the face of American innovation. Prior to the Bayh-Dole law, anyone who accepted government funding of their research had to give any resulting patent rights to the government. Superficially, that sounded fair – if taxpayer money paid for research, the taxpayer should get the benefits. But the reality was that no one benefitted. Few companies had any interest in investing the substantial resources necessary to transform an early invention into a product when the underlying patents were held and controlled exclusively by the government. And those inventions that were developed simply sat on the shelf in government offices with no plans to bring them to market. Senators Bayh and Dole recognized this problem and their bill allowed research institutions to keep possession of the patent rights their research produced.

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.

Trying to rationally address hot button issues in an election year is always a dangerous proposition. That’s particularly true as we approach what promises to be one of the nastiest political years in history. Because so much time will be taken up campaigning, for legislation to pass it needs to get moving soon. It shouldn’t be long before we know whether anything meaningful will happen with attempts to reduce the costs of drugs, where intellectual property rights are in the crosshairs. Let’s keep our fingers crossed that, if action is taken, it’s based on careful consideration of all the related issues rather than raw emotion. While this may be wishful thinking, several thoughtful new articles contain important warnings against jumping down some of the beckoning gopher holes. Critics of the Bayh-Dole Act, which provides the incentives of the patent ownership to commercialize federally funded inventions, claim that the government is developing drugs from its R&D and giving them to companies that then make “obscene profits.”Despite numerous rebuttals, this red herring is continually deployed as the justification for the government setting the price of drugs coming out of public/private sector partnerships.

I recently visited Egypt as part of a team led by the Departments of State and Agriculture, supported by the good folks at the AUTM Foundation. Egypt, like many countries, is looking at our model for integrating research universities into their economy. I was asked to speak about the Bayh-Dole Act and thought it was important to emphasize that there were many factors required beyond enacting a law to reverse an entrenched national policy. On returning, I was struck by Gene Quinn’s article “It May Be Time to Abolish the Federal Circuit.” After leaving the Senate staff, I became Executive Director of the Intellectual Property Owners Association (IPO). Our highest priority was creating the Court of Appeals for the Federal Circuit (CAFC) to restore confidence in the U.S. patent system. Framed in my office is a very gracious thank you note from Judge Howard Markey, who inspired this effort and went on to become the first Chief Judge of the new court. Judge Markey was the only person I ever met with an unending supply of funny patent jokes, but that’s another story. Unlike Bayh-Dole, that effort appears to have gone off track. So why did one change stick and one not?

Recently, Knowledge Ecology International sent to Congress a letter objecting to the draft “Green Paper on Unleashing American Innovation” disseminated by the National Institute of Standards and Technology (NIST) in December, 2018. The KEI letter was signed by 10 other organizations* (the Organizations). The letter, unfortunately, is full of misstatements, distortions, falsehoods and disingenuous arguments. It would be easier to focus on the letter’s one accurate statement:  that high drug prices are a serious concern for people everywhere. It is very unfortunate that KEI, in my opinion, utilizes tactics which continually sacrifice fair and constructive dialog in favor of apparently achieving goals “by any means necessary.” The most disturbing element of the letter is KEI’s advocacy of inappropriate and unjustified use of government march-in rights under the Bayh-Dole Act as a purported means of controlling drug prices. In doing so KEI and the Organizations are threatening medical advances and thereby undermining their own missions.

High prescription drug prices and their impact on costs borne by the government in Medicaid, Medicare Part D and other federal programs, is a front burner topic in Washington. The President has committed to reducing the price of prescription drugs, and pressured drug companies to hold the line. The Department of Health and Human Services (HHS) has proposed two regulatory initiatives—price disclosure in drug advertising and foreclosing rebates from manufacturers to pharmacy benefits managers (PBMs)—aimed at pushing prices down. Some Democrats have urged more sweeping actions, such as having the government negotiate Medicare drug pricing as a single buyer or regulating drug prices by reference to an international index based on government-negotiated drug prices abroad. These proposals cannot solve the drug pricing problem. The Administration’s proposals merely tweak the status quo and put no effective restraint on new drug prices. Jawboning by the Executive has had a minimal impact. Disclosure of manufacturers’ list prices, unless accompanied by numerous and inherently confusing caveats highlighting the difference between those prices and the co-pay an insured consumer must bear at retail, is potentially misleading and, in any event, has no direct impact on prices. Eliminating rebates, as HHS’s rulemaking acknowledged, will inevitably raise health insurance costs now partly paid for by rebates while manufacturers’ pricing power remains unabated. The Democrats’ call for government power buying or price regulation would impact drug prices but also require politically sensitive government determinations about the “worth” of prescription drugs to patients—a significant step on the road to government-allocated health care. 

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.

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.

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.

This week on Capitol Hill and in the Washington D.C. area, the Supreme Court grants cert in Iancu v. NantKwest; the U.S. House of Representatives will hold several hearings on important topics in technology, including electronic health records modernization for veterans, cybersecurity measures for voting systems and research on the nexus between energy and water. House committees will also explore ways to improve broadband access for small businesses and promote generic competition to reduce branded pharmaceutical prices. Drug pricing, which often involves a focus on patents, is the subject of a two-part hearing series in the U.S. Senate. Other Senate hearings this week will look at data breaches in the private sector and IP issues related to Chinese trade. The week is book-ended by a pair of events hosted by the Information Technology & Innovation Foundation, including a Thursday event that looks at the impact of the Bayh-Dole Act of 1980 and controversial calls to enforce certain provisions of the law to reduce drug prices.

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.”