Posts Tagged: "autm"

Jamie Love Responds to Criticism of Knowledge Ecology International Letter

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.

Knowledge Ecology International Letter Misleads on March-In Rights

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.

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.

Happy Birthday, Senator Birch Bayh

Hopefully, you’ve been fortunate enough—at least once in your life—to work for someone you really admired. That happened to me as a Senate Judiciary Committee staffer for Senator Birch Bayh (D-IN), who gave me the opportunity that changed my life. He turns 91 today… Bayh-Dole not only cut through the bureaucratic red tape strangling the development of federally-funded R&D; it marked a turning point in how patents were viewed in Congress. When I first joined the Committee, patents were considered tools for big business to stifle competition. Intellectual property fell under the jurisdiction of the Subcommittee on Antitrust and Monopolies. The Senate Small Business Committee was a hot bed of anti-patent sentiment.

Fine Tuning the Trump Administration’s ROI Initiative

The Trump Administration’s Return on Investment (ROI) Initiative, which is geared toward increasing the American taxpayer’s benefits from federally-supported R&D, is potentially a big step forward. The draft recommendations were contained in a “Green Paper” open for public comment until January 9, 2019. The paper acknowledges the importance of a strong, dependable patent system and lauds the Bayh-Dole Act as the cornerstone of the U.S. technology transfer system, which leads the world in turning federally-funded inventions into new products, companies, jobs and even entirely new industries. Review of the 122-page paper confirms its overall value but also reveals some concerns.