Posts Tagged: "Knowledge Ecology International"

As Knowledge Ecology International and its allies await the decision of the National Institutes of Health (NIH) on their latest attempt to misuse the Bayh-Dole Act for the government to set prices on any product based on a federally funded invention, they’re growing more uneasy. And that’s understandable. If you’d bet the house on an ivory tower theory that’s been summarily rejected for the past 18 years every time it’s been trotted out, you’d be uneasy too. They know that if the Biden Administration rejects the pending petition to march in on the prostate cancer drug Xtandi because of its cost, this leaky vessel can’t be credibly refloated again.

Thirty-one signatories from 29 center-right public policy organizations have written U.S. Health and Human Services Secretary Xavier Becerra, urging him to deny a petition from Knowledge Ecology International that requests use of march-in rights under the Bayh-Dole Act against the prostate cancer medicine, Xtandi. The conservative organizations represented on the letter include some of the most prominent center-right groups, such as the American Conservative Union, Americans for Prosperity, Americans for Tax Reform, the Competitive Enterprise Institute, Eagle Forum Education & Legal Defense Fund, FreedomWorks Foundation and Heritage Action for America. Conservatives for Property Rights led the letter initiative.

Some say the definition of insanity is doing the same thing over and over while expecting a different outcome. That would appear to be the case with the recent refiling of a petition by Knowledge Ecology International (KEI) to the National Institutes of Health (NIH) asking it to march in under the Bayh-Dole Act to force licensing to additional parties of the prostate cancer drug Xtandi, because of its cost. The law allows academic institutions, companies and federal laboratories to own and license inventions made with government support. Similar petitions were rejected by NIH and the Department of Defense (which funded the research on the underlying invention) in the Obama/Biden Administration for a simple reason: the law is for the commercialization of federally funded inventions; it does not allow the government to set prices for successful products.

On May 12, Frederick Reinhart published an article titled “Knowledge Ecology International Letter Misleads on March-In Rights.” Reinhart is a past president of the Association of University Technology Managers (AUTM), and his views echo those expressed by many in the university technology transfer field, including a frustration that not everyone acknowledges and appreciates the considerable investments and risks undertaken by the for-profit companies that license patents to inventions funded by the federal government. Knowledge Ecology International (KEI) recognizes the importance of the private sector in bringing therapies to the market, even when federal funding of R&D has played a role, and also that robust returns on those investments have a positive impact on innovation.

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.

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.

While those in the military are often thanked for their service, let’s also thank researchers like Dr. Rosenberg and his colleagues who spend their lives trying to alleviate human suffering. But that can only happen when their discoveries are commercialized– otherwise they are merely generating interesting research papers. Rather than deserved accolades, NCI and Kite Pharma got a pie in the face from the NY Times.