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.
The U.S. Supreme Court will this Friday, December 2, consider whether to grant certiorari in the case of Centripetal Networks Inc. v. Cisco Systems Inc. What began as a patent infringement case has swerved into judicial ethics waters, due to the ruling of the Federal Circuit Court of Appeals. The cert decision holds significant consequences, particularly for patent owners and inventors who find themselves the target of patent infringement, sue to assert their patent rights, and whom patent infringers then pull into a litigation vortex between federal courts and administrative tribunals at the U.S. Patent and Trademark Office (USPTO).
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.
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.
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.
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.
To those of us who breathe intellectual property and innovation, it sounds so obvious to say that consumers benefit greatly from the dynamic competition inventions and IP bring forth: new products, technologies and industrial sectors. However, many who breathe antitrust hold a different perspective — it presumes a patent confers market power, that commercialization amounts to anticompetitive conduct and that the right to exclude is equivalent to monopolization by incumbent players in a static market. Assistant Attorney General for Antitrust Makan Delrahim, who left the U.S. Department of Justice (DOJ) with the changeover of administrations, bridged this gulf. Delrahim achieved this due to his background as both patent attorney and antitrust lawyer. Delrahim offered a framework he calls the New Madison Approach. The New Madison Approach advanced through the division’s amicus program.
The 2019 USPTO-NIST-DOJ Joint Policy Statement on Standard-Essential Patents Subject to Voluntary RAND or FRAND (fair, reasonable and non-discriminatory) commitments “intended to solve [judicial] misinterpretation, and to encourage balance in our patent ecosystem, and to further strengthen patent rights,” USPTO Deputy Director Laura Peter said in her keynote at a recent IP-antitrust event. Peter delivered the remarks at an event hosted by the Eagle Forum Education & Legal Defense Fund, a conservative public policy and grassroots organization founded by the late Phyllis Schlafly, titled, “Inventing Dynamic Competition: Intellectual Property, Antitrust, and Competition” September 30 in Washington, D.C.
The Federal Trade Commission (FTC) just can’t take “no, you’re wrong” for an answer. Despite its embarrassing reversal by the Ninth Circuit Court of Appeals in August, the FTC has now appealed its Qualcomm case to the full Ninth Circuit. A three-judge appellate panel overturned the trial court’s errant ruling, giving the FTC a comeuppance in its antitrust suit against Qualcomm, the trailblazer in wireless technology with thousands and thousands of patented inventions. The sheer cliff the FTC seeks to climb features daunting crags. The appellate judges ruled unanimously. They also found fundamental problems in the trial court’s (and FTC’s) legal and factual analysis, and so they gave basic aspects of the case fresh eyes, or de novo, review. And several federal departments, including the Justice Department Antitrust Division, weighed in with the trial court in opposition to the FTC.