Health and Human Services (HHS) Secretary Xavier Becerra may consider himself a lucky man (which would probably sound ironic to him at the moment). He just received three letters which aptly summarize the fork in the road he faces in deciding which way to turn in a critical policy decision. On June 23, Senator Elizabeth Warren (D-MA) and Rep. Lloyd Doggett (D-TX), joined by 98 of their Democratic Congressional colleagues, sent him the latest in their series of letters urging him to use alleged existing authorities so that copycats can make expensive drugs to lower health care costs. That triggered an immediate rebuttal from six associations representing research universities and hospitals (including the Bayh-Dole Coalition, which I lead) and another from the Licensing Executives Society, USA & Canada, Inc. (LES), representing the licensing profession. It seems appropriate to let the letters speak for themselves, so let’s start with the Congressional letter, urging the Secretary to use tools they allege he already has to cut the Gordian Knot to lower drug costs.
Earlier today, the U.S. Senate Committee on the Judiciary convened a brief executive business meeting to discuss a series of judicial nominees selected by the Biden Administration, as well as a pair of proposed bills. One of those bills, the Interagency Patent Coordination and Improvement Act of 2022, follows various efforts to limit certain patent rights in the pharmaceutical industry and was passed favorably out of the Committee via voice vote toward a full vote on the Senate floor.
Yesterday, Chief Judge Orlando Garcia of the U.S. District Court for the Western District of Texas issued an order that, in Garcia’s words, will “equitably distribute” new patent cases among 12 district judges. This order is an effort to address “the volume” of new cases assigned to the Waco Division’s Judge Alan Albright. Albright’s court is viewed as patent owner friendly and he has been under fire recently from both the U.S. Court of Appeals for the Federal Circuit (CAFC) and Congress on different fronts for his policies and procedures, which do tend more often than not to give patent owners their day in court.
This week in Washington IP news, committee hearings at the U.S. House of Representatives focus on several topics related to technology including improvements to civil space procurement activities to promote cybersecurity in space systems, the use of facial recognition technology by U.S. Customs and Border Patrol, as well as technological recommendations advanced by the House Select Committee on the Modernization of Congress. Over in the Senate, the Judiciary Committee will debate a proposed bill that would establish an interagency task force for sharing communication on drug patents between the U.S. Patent and Trademark Office and the U.S. Food and Drug Administration. Elsewhere, the Center for Strategic & International Studies explores how last year’s bipartisan infrastructure law is being leveraged to create a regional clean hydrogen hub in Houston, the Brookings Institution discusses the future of crypto regulation following the stablecoin crash, and the USPTO closes out the week with a regular quarterly meeting of the Trademark Public Advisory Committee.
The House Judiciary Committee’s Subcommittee on Courts, Intellectual Property, and the Internet today held Part II in a series of hearings to consider reforms to the Patent Trial and Appeal Board (PTAB) 10 years after it was created by the America Invents Act (AIA). The hearing, titled “The Patent Trial and Appeal Board After 10 Years, Part II: Implications of Adjudicating in an Agency Setting,” coincided with the release of a preliminary report by the U.S. Government Accountability Office (GAO) that was commissioned in June of last year by IP Subcommittee Chair Hank Johnson (D-GA) and Ranking Member Darrell Issa (R-CA) to investigate PTAB decision-making practices. The GAO’s preliminary findings revealed that “the majority of [administrative patent] judges (75 percent) surveyed by GAO responded that the oversight practiced by U.S. Patent and Trademark Office (USPTO) directors and PTAB management has affected their independence, with nearly a quarter citing a large effect on independence.”
This week in Washington IP news, the House Committee on the Judiciary’s IP Subcommittee takes a second look at the Patent Trial and Appeal Board after 10 years of existence, with a special focus on issues with adjudicating legal matters in an agency setting. The full House Judiciary Committee also hosts a hearing to explore government access to consumer personal data. Elsewhere, the Information Technology & Innovation Foundation debates ways that cultural changes at federal agencies can improve IT modernization efforts, and the U.S. Patent and Trademark Office hosts a Southeast Asia Intellectual Property Roadshow to educate business owners on how they can leverage their IP rights for business success in that region of the globe.
Earlier this month, IP diversity advocacy group Invent Together announced that it had launched an online learning platform known as The Inventor’s Patent Academy (TIPA), an e-learning course designed in collaboration with Qualcomm to educate inventors from diverse and underrepresented backgrounds about the benefits of engaging with the U.S. patent system. This online academy is the latest of several efforts by Congress and patent system stakeholders in recent years to unlock the innovative potential of women, people of color, LGBTQIA, and low-income inventors to benefit the U.S. economy.
The idea of patented inventions brings to mind machines fully realized – flying contraptions and engines with gears and pistons operating in coherent symphony. When it comes to artificial intelligence (AI), there are no contraptions, no gears, no pistons, and in a lot of cases, no machines. AI inventors sound much more like philosophers theorizing about machines, rather than mechanics describing a machine. They use phrases like “predictive model” and “complexity module” that evoke little to no imagery or association with practical life whatsoever. The AI inventor’s ways are antithetical to the principles of patent writing, where inventions are described in terms of what does what, why, how, and how often.
Recently, we submitted comments for the record to the Senate Judiciary Committee’s IP Subcommittee in response to its June 22 hearing on the Patent Trial and Appeal Board (PTAB), titled: “The Patent Trial and Appeal Board: Examining Proposals to Address Predictability, Certainty and Fairness.” The hearing focused on Senator Leahy’s PTAB Reform Act, which among other changes, would eliminate the discretion of the Director to deny institution of an inter partes review (IPR) petition based on an earlier filed district court litigation involving the same patents, parties and issues. Here is the net of what we told them:
The U.S. Supreme Court has denied certiorari in American Axle v. Neapco Holdings, Inc., leaving it up to Congress and the U.S. Patent and Trademark Office (USPTO) to restore any semblance of clarity on U.S. patent eligibility law for now. Many expected that the Court would grant the petition after the U.S. Solicitor General in May recommended granting review. The SG’s brief said that inventions like the one at issue in American Axle have “[h]istorically…long been viewed as paradigmatic examples of the ‘arts’ or ‘processes’ that may receive patent protection if other statutory criteria are satisfied” and that the U.S. Court of Appeals for the Federal Circuit “erred in reading this Court’s precedents to dictate a contrary conclusion.”
This week in Washington IP news, subcommittee hearings at the U.S. House of Representatives will explore the leading role that Michigan has taken in addressing cybersecurity risks in state and local governments, as well as ways to promote data privacy despite the growth of biometric tracking systems. Elsewhere, the Hudson Institute takes a closer look at the background and potential impacts of small claims for copyright infringement filed at the recently established Copyright Claims Board, while the U.S. Patent and Trademark Office hosts the inaugural meeting of the Artificial Intelligence and Emerging Technologies Partnership Series.
One day after the Senate Judiciary Committee’s IP Subcommittee met to discuss the PTAB Reform Act and other ways to improve the Patent Trial and Appeal Board (PTAB), the U.S. House of Representative’s Subcommittee on Courts, Intellectual Property, and the Internet held a similar hearing featuring six witnesses with varying views on the PTAB about how to improve the system. Representative Thomas Massie (R-KY), who last year introduced a bill that would repeal the PTAB entirely, grilled the witnesses about the effects of the PTAB on U.S. investment in innovation and national security, and expressed skepticism that the system has succeeded in its intended goal of providing a cheaper, faster forum, particularly for small businesses and independent inventors.
Senator Thom Tillis yesterday wrote to Food and Drug Administration (FDA) Commissioner Dr. Robert Califf, asking for a third time that the FDA conduct “an independent assessment and analysis of the sources and data that are being relied upon by those advocating for patent-based solutions to drug pricing.” Tillis expressed his frustration with the lack of response thus far, explaining that no formal reply has yet been received despite his first letter being sent in January 2022, and calling it “unacceptable” that the FDA apparently “refuses to reply to emails or to engage.”
Today, the Senate Committee on the Judiciary’s Subcommittee on Intellectual Property met to hear testimony from four witnesses about proposed changes to the Patent Trial and Appeal Board (PTAB) as outlined in the recently announced PTAB Reform Act. Subcommittee Chairman Senator Patrick Leahy (D-VT), Ranking Member Thom Tillis (R-NC) and Senator John Cornyn (R-TX) introduced the bill last week. Those testifying generally agreed the bill represents compromise and, at Tillis’ prompting, on a scale of green to red, scored it a green to yellow overall.
U.S. Patent and Trademark Office (USPTO) Director Kathi Vidal and outgoing Acting Deputy Director Drew Hirshfeld joined IPWatchdog’s CEO and Founder Gene Quinn today to discuss Hirshfeld’s nearly 30-year career with the Office, as well as Vidal’s philosophy as she embarks on her journey as the new Director. Vidal emphasized the importance of dialogue in shaping USPTO practices and processes but said she also will not wait around indefinitely on input over doing “what’s right for the country.” She said: “We will get feedback [but] that’s not going to stop us from acting.” Hirshfeld, who spoke with Quinn on his last day in office, joined the USPTO in 1994.