Posts Tagged: "Bayh-Dole Act"

Perhaps after their favorite theory was blown apart again, as it has been every time it’s been trotted out over the past 20 years, the critics of the Bayh-Dole Act learned a painful lesson. Their carefully constructed thesis that the law contains a hidden provision allowing the government to set prices on successfully commercialized products has been summarily rejected by every Democratic or Republican Administration which has considered it. They say the definition of insanity is doing the same thing repeatedly while expecting a different result. But that didn’t keep the proponents from refiling the same petition which was rejected three times in the Obama-Biden Administration. So once again, the National Institutes of Health (NIH) denied the request that it should “march-in” under the law against the prostate cancer drug, Xtandi, because critics felt it is not “reasonably priced.” Apparently, the petitioners thought that the fourth time would be the charm. Now they know better. And this time, NIH included a subtle, but fatal blow to attempts to go down this path again.

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.

You might think the last thing the President needs as his poll numbers are plunging is pressure to make an unforced blunder crippling U.S. innovation. Under the pretext of expanding U.S. manufacturing capability, some are pushing a provision to a pending Executive Order on manufacturing allowing the bureaucracy to micromanage our technology transfer system. That’s already happened at the Department of Energy (DOE), and the disastrous consequences are just becoming apparent. This is being sold as a way of increasing domestic manufacturing capacity, which is rightly a priority of President Biden. But extending a flawed idea across all R&D agencies undermines the public/private R&D partnerships which restored our technological leadership—without doing a thing to broaden our manufacturing base.

What would you say about a technology commercialization system that kept on performing even through the worst pandemic in over a century? How about if it improved its performance over the previous year and was a critical factor in developing desperately needed therapies to protect people around the world? Would it seem reasonable that this was something that all of us should highly value and want to protect? You might think so, but some in Washington apparently don’t agree.

The Biotechnology Innovation Organization (BIO) recently submitted comments in support of a National Institute of Standards and Technology [NIST] rulemaking on “Rights to Federally Funded Inventions and Licensing of Government Owned Inventions.” The proposed rule caps a nearly three-year effort by NIST, through engagement with stakeholders, to improve federal technology transfer and the commercialization of federally funded inventions. That effort resulted in a comprehensive Green Paper, “Unleashing American Innovation” in April 2019, which reviewed federal research efforts and made detailed recommendations to maximize the taxpayers’ return on investment.

As we scan the press attention around medical intellectual property (IP) during these pandemic times, an impassioned debate centers on whether there should be a reprieve on patent rights for COVID-19 vaccines. This threat to longstanding agreements and investment in public/private sector partnerships undermines not only the ownership of IP but also sets a dangerous precedent in terms of downstream consequences. An additional challenge to patents owned by academic medical centers and pharmaceutical companies is posed by activist groups that are lobbying our government to exercise march-in rights to influence pricing of medicines in the United States. Working with medical research centers around Bayh-Dole Act compliance has uncovered, time after time, a more systemic risk that eats away at the health of the research portfolio and could add fuel to the fire for diluting IP protection, thereby undermining the foundation of innovation.

On January 12, the National Institute of Standards and Technology (NIST) published a request for comments on proposed changes to regulations that support the University and Small Business Patent Procedures Act of 1980, which is more commonly known as the Bayh-Dole Act. At the time, NIST explained that this important update to Bayh-Dole represents a key element of the Return on Investment Initiative, which seeks to maximize American innovation arising from the federal government’s more than $150 billion annual investment in research and development. Monday, April 5, was the deadline to submit comments to NIST on the proposed rule revisions. Below are a handful of excerpts to comments submitted, together with links to the full text of the comments.

It’s hard to believe that, not too long ago, alliances between the public and private sectors were unheard of unless the government was picking up the entire tab. After World War II, the policy was that if the government funded even a small percentage of the research, it would take any resulting inventions away from those who created them to make the discovery readily available to anyone and everyone. While that might sound noble, it was a death knell for commercialization because then, like now, these discoveries required significant private sector effort and investment to turn into commercial products. The result was that not only were few government funded inventions ever developed, but even worse, companies avoided alliances with government funded institutions.

Two organizations with which I work have filed comments with NIST on its Bayh-Dole regulatory proposals. The National Institute of Standards and Technology, or NIST, approaches completion of its two-and-a-half-year effort known as the Return on Investment Initiative, as the regulatory revision stage nears its close. NIST has conducted a commendable process and proposed mostly constructive or reasonable updating to rules associated with the Bayh-Dole Act. But one proposal puts at risk the continued success of the storied law for democratizing technology transfer and commercializing inventions coming from federally sponsored research. That is, this law facilitates bringing to practical use inventions that otherwise would sit on shelves.

How many people or organizations could undergo an exhaustive investigation into everything they’ve done over the past 30 years and emerge unscathed? That’s what just happened to the technology transfer operations at the Department of Health and Human Services (HHS), with the spotlight primarily focused on the National Institutes of Health (NIH). Of course, an exercise like this has to find something, so the report that resulted from this exercise is titled “NIH Should Publicly Report More Information about the Licensing of Its Intellectual Property”. After extensive digging, all it uncovered are some pretty small potatoes.

Almost two weeks after election day, it’s still not entirely certain who won (has there ever been a crazier year than 2020), but it appears increasingly likely that a new administration will take office in January. They are going to run smack into two overarching problems: how to gain control over the COVID-19 pandemic and how to reignite the U.S. economy. These problems are interrelated. We will only get out of this mess through American ingenuity and that’s already hard at work 24/7 developing promising solutions to protect public health, which releases the brake on the economy. So, here’s some advice: don’t listen to those who want to throttle down the engine driving that effort—don’t mess with the Bayh-Dole Act.

It’s an honor to be sharing a virtual stage today with Senator Bob Dole and with Chris Bayh in celebrating the 40th anniversary of the passage of the Bayh-Dole Act.  I’d like to thank the Bayh-Dole 40 Coalition members for their tireless advocacy as champions for the enduring impacts of this seminal legislation. 40 years ago, Senators Birch Bayh and Bob Dole had a shared vision – that innovations arising from federally funded research could have monumental economic and societal impacts for American citizens.  They led the bipartisan charge in writing the Patent and Trademark Law Amendments Act of 1980, which today is widely known by their names – the Bayh-Dole Act.

The Bayh-Dole 40 Coalition and IPWatchdog today jointly presented a video webinar commemorating the 40th anniversary of the Bayh-Dole Act— officially the “University and Small Business Patent Procedures Act”—which became law on December 12, 1980. The webinar was hosted by Joseph Allen, a regular IPWatchdog contributor and former Professional Staff Member on the U.S. Senate Judiciary Committee for former Senator Birch Bayh (D-IN). The event included remarks from Senator Bob Dole, who served as Republican Senator for Kansas from 1969-1996 and co-authored the Bayh-Dole Act; Senator Bayh’s son, Chris Bayh; IPWatchdog Founder and CEO Gene Quinn; and many other speakers from across the political, technology transfer, university research, and legal spheres.

By now, everyone in the IP arena has heard about the demands of more than 30 state and territorial attorneys general (AGs) regarding the promising COVID treatment remdesivir. These AGs seem to disrespect the exclusive rights of limited duration that patents afford. California Attorney General Xavier Becerra (D) and Louisiana Attorney General Jeff Landry (R) led a bipartisan effort getting colleagues to write the U.S. Department of Health and Human Services and call for what’s tantamount to eminent domain on intellectual property. To a conservative who works on IP matters, this demand in and of itself is troubling. Bedrock conservative principles include property rights, free enterprise and the rule of law. The AGs advocate government’s abrogation of all three of these foundational principles.

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.