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James Edwards

consults on intellectual property, health care innovation, and regulatory and policy issues. Edwards advises companies, trade associations, and conservative organizations on patent policy and is Co-Director of the Inventor’s Project. He participates in the Medical Device Manufacturers Association’s Patent Working Group. Edwards mentors start-ups and early-stage companies, largely in the med tech space, and is involved in several IP-centric projects.

Edwards served as Legislative Director to Rep. Ed Bryant, R-Tenn., then a member of the U.S. House Judiciary Committee, and handled IP legislative matters. Edwards also worked on the staffs of Rep. John Duncan, R-Tenn., the U.S. Senate Judiciary Committee, and Sen. Strom Thurmond, R-S.C. In addition, he was an association executive at the Healthcare Leadership Council. Edwards earned a Ph.D. at the University of Tennessee, and bachelor’s and master’s degrees at the University of Georgia.

Recent Articles by James Edwards

Conservatives Urge HHS to Deny Turning Bayh-Dole March-In Provision into Price Controls

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.

Eagle Forum Event Participants Delve into Patent Eligibility ‘Goulash’

The extreme uncertainty that U.S. patent eligibility “validity goulash” jurisprudence has caused is wreaking havoc on inventors, especially those working on emerging technologies. It is also hindering patent owners’ ability to enforce their property rights, investment and licensing deal-making, and giving China advantages in global competitiveness. And it’s likely to get worse before it gets better. Those were takeaways from the Eagle Forum Education & Legal Defense Fund’s (EFELDF) “The Sorry State of Patentability: ‘Anything Under the Sun Made by Man’ No More” program in Washington, D.C. The September 29 event’s panelists considered patent eligibility from the Chakrabarty decision, which ruled a manmade living microorganism was patent-eligible, to dubious, damaging, judicially-created exceptions in such cases as Bilski, Mayo, Alice, Myriad and American Axle. The participants made painfully clear that the Alice-Mayo Framework doesn’t work and course correction is long overdue.

A Closer, Evidence-Based Look at ‘Patent Quality’ Advocacy

The Patent Infringer Lobby has ramped up banging the drum about “patent quality.” They dedicated a week-long campaign to questioning “patent quality,” which its constituents regard as a huge problem. Advocates have taken advantage of the vacuum left after U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu left the building. Anti-patent advocates are exploiting the new dynamic of Senator Patrick Leahy, coauthor of the America Invents Act (AIA), who now chairs the Senate Intellectual Property Subcommittee. Leahy recently did the Infringer Lobby the favor of holding a hearing on this subject.

Commenters on Bayh-Dole Rule Object to Mention of ‘Pricing’ in March-In Provision

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.