Joe Allen is the Executive Director of the Bayh-Dole Coalition, President of Joseph Allen & Associates, and is a Featured Contributor on IPWatchdog.com, and a 30-year veteran of national efforts to foster public/private sector commercialization partnerships, and author of numerous articles on technology management for national publications.
Joe served as a Professional Staff Member on the U.S. Senate Judiciary Committee with former Senator Birch Bayh (D-IN), and was instrumental in working behind the scenes to ensure passage of the historic Bayh-Dole Act. He is our resident Bayh-Dole expert, and will write frequently about Bayh-Dole and issues surrounding the commercialization of university research.
In 2008, Joe founded Allen & Associates, through which he offers consulting services assisting clients in technology transfer issues, including developing effective communication strategies with national policy makers.
You have to give them credit. The Department of Energy (DOE) bureaucracy doesn’t give up. For more than 40 years, they’ve been resisting the Bayh-Dole Act’s mandate cutting Washington out of micro-managing the commercialization of federally funded inventions. And under the guise of increasing domestic manufacturing, they’re well on their way to reasserting control. Before 1980, federally funded inventions were strangled under laborious case by case reviews to determine whether ownership would be waived from government agencies to the inventing organization. As a result, few inventions were ever developed. Bayh-Dole cut the Gordian knot, mandating that universities, contractor operated federal laboratories and small companies could own and license their discoveries. American innovation took off, and we regained our lead over our foreign competitors.
With the planet now awash in unused vaccines, efforts are underway to extend the TRIPS waiver to our COVID diagnostics and therapeutics (terms that are poorly defined). By the way, China is considered a “developing country” that could use the waiver. The U.S. Trade Representative asked the U.S. International Trade Commission to investigate whether or not such an extension is justified. That effort includes seeking public comments, which are due by Friday, May 5, 2023. The Bayh-Dole Coalition, which I lead, just submitted to following letter to US ITC Secretary, Lisa Barton, laying out some of the many reasons why the extension would be a colossal blunder.
Just when you think you have enough things to worry about, you stumble upon one more. In its wisdom, Congress enacted a “Medicare Drug Price Negotiation Plan” as part of the Inflation Reduction Act. The program kicks in by imposing “maximum fair prices” for drugs as determined by the Centers for Medicare & Medicaid Services (CMS). In setting these prices, Congress included such factors as the R&D costs for each drug and whether they have been recovered and the current cost of producing and distributing the drug in question. But it was the third criteria which caught my eye—“Prior Federal financial support for novel therapeutic discovery and development with respect to the drug.”
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.
AUTM, which represents the academic technology management profession, just released the results of the survey of its members for 2021. Once again, the results are impressive, particularly considering that the U.S. economy was just beginning to emerge from the devastating effects of the COVID-19 pandemic…. It’s clear that despite continual attacks on the Bayh-Dole system, which allows academic institutions to own and manage federally funded inventions without Washington micro-management, our system keeps truckin’ right along, year after year, leading the world.
Last week, the Bayh-Dole Coalition held a webinar titled “The Three-Pronged Attack on U.S. Innovation and Intellectual Property.” Before we consider each prong, it’s worthwhile reflecting on a larger point. Each would deal a body blow to American innovation just as we struggle to keep the economy on track. And each would be a self-inflicted wound that must have our foreign rivals shaking their heads at our folly.
With all of the problems besetting us, you might think that the last thing we need right now is another give-away of critical technologies, but that could be about to happen. Negotiations are underway in Geneva over a proposal from “developing countries” that negating patent protections for our COVID-19 vaccines wasn’t good enough. Now they want to extend that foolish concession we agreed to earlier this year to any COVID therapy. You’d think it would be well understood by now that appeasement doesn’t foster gratitude, it only encourages the other side to push for more. We’ll soon see if we roll over again or not.
Health and Human Services (HHS) Secretary Xavier Becerra may consider himself a lucky man (which would probably sound ironic to him at the moment). He just received three letters which aptly summarize the fork in the road he faces in deciding which way to turn in a critical policy decision. On June 23, Senator Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX), joined by 98 of their Democratic Congressional colleagues, sent him the latest in their series of letters urging him to use alleged existing authorities so that copycats can make expensive drugs to lower health care costs. That triggered an immediate rebuttal from six associations representing research universities and hospitals (including the Bayh-Dole Coalition, which I lead) and another from the Licensing Executives Society, USA & Canada, Inc. (LES), representing the licensing profession. It seems appropriate to let the letters speak for themselves, so let’s start with the Congressional letter, urging the Secretary to use tools they allege he already has to cut the Gordian Knot to lower drug costs.