AUTM Advocacy: 2017 in Review

Advocacy is a key component of AUTM’s commitment to strengthening the technology transfer environment by working with key policymakers. This has been one of our most active years in Washington. Here are the highlights of the Association’s work to advance our industry agenda.

Drug Pricing was on the front burner all year, as both Congress and the Trump administration discussed the problem and how to deal with it. Several bills were introduced in Congress, and multiple efforts were again pushed at the National Institutes of Health to force the agency to use its “march-in” authority to control pricing. This authority to “march in” and take back a patent is limited to rare circumstances when a patent would be needed to mass-produce vaccines, or when a patent holder sits on a patent without developing the drug or technology.  The authors of the Bayh-Dole legislation, which was enacted in 1980, never envisioned use of march-in for price controls.

While most efforts failed, Sen. Angus King (I-ME) inserted report language into the Senate’s defense authorization bill to force the Department of Defense (DoD) to act when pricing is deemed too high. It is unclear how the DoD can comply with this language, given that it falls in direct conflict with the Bayh-Dole law. AUTM will continue to work with its sister organizations (the Association of American Universities (AAU), the Association of Public and Land-grant Universities (APLU), the Council of Governmental Relations (COGR) and the Association of American Medical Colleges (AAMC)), to oppose this inappropriate use of Bayh-Dole’s march-in rights to regulate drug pricing.

The Patent Trial and Appeal Board/State Sovereign Immunity issue emerged as complaints continued to mount about the fairness of the inter partes review (IPR) process at the Patent and Trademark Office (PTO). The huge number of patent rejections by IPRs, and the different threshold for doing so, has had a negative impact on American innovation, in the view of many. In the wake of Allergan selling its patent to a Native American tribe and then licensing it back to avoid the IPR process, Congress held hearings and will consider action next year – affecting not just Native American tribes, but potentially states’ sovereign immunity, as well.  

Educational Software. The Department of Education issued long-awaited rules regarding the licensing of copyrighted software using Department of Education funding. The ruling sets a potentially damaging precedent by requiring that software inventors using Ed research funding to open-license their inventions. Its impact has yet to be assessed. Higher-ed groups, including AUTM, were able to soften this language.

The STRONGER Patents Act, pro-patent Senate legislation that focuses on the many shortcomings of IPRs, will soon be introduced into the House. The legislation will continue to pressure the PTO to make needed reforms.  

PTO Leadership. Before she left her post, PTO Director Michelle Lee met with AUTM and other higher-ed association representatives seeking input on IPRs. That meeting led to AUTM filing comments with PTO, listing a number of proposed changes to the process that would make the IPR process fairer. Once the new PTO Director, Andrei Iancu, is confirmed and sworn in, AUTM will continue to advocate for needed improvements.

Supreme Court Briefs. AUTM was active, through its Public Policy Legal Task Force (led by Eric Guttag), to sign onto important amicus briefs on key cases before the High Court. Most notable among those were briefs on the TC Heartland v. Kraft Foods case, as well as the Oil States v. Greene’s Energy et al case. The former case affected venue for filing patent cases. The latter challenges the constitutionality of the entire inter partes review
process. AUTM is approached regularly for its expertise on key matters related to patents and tech transfer.

DC Presentations. AUTM leaders participated in several forums in Washington, DC. AUTM also joined with BIO in June to co-host a luncheon for Hill staff, where a standing-room-only crowd learned about technology transfer, and met two successful spin-off CEOs who discussed their work and how patents play a key role in attracting the capital needed to inventions to the marketplace. The Congressional Tech Transfer Caucus sponsored the event.  

Other Communications. AUTM used its position to weigh-in on such issues as the U.S.’s participation in the World Intellectual Property Organization and FDA rules on Bayh-Dole, and provided testimony with Canadian Parliamentary members on technology transfer issues.

Mike Waring, is the Chair of AUTM’s Advocacy and Alliances Portfolio, and Executive Director of Federal Relations for the University of Michigan since 2000. Mike is based in Washington, DC.