Posts in Legislation

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.

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.”

A terrible idea – wayward and ill-conceived, criticized by all economic, political and geopolitical fronts – has come to fruition. The World Trade Organization’s (WTO) TRIPs waiver on patents related to COVID-19 vaccines will disincentivize the entire industry from investing in vaccine production. To understand what happens next, let’s understand history first.

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.

Following a week of round-the-clock deliberations, the World Trade Organization (WTO) this morning announced a deal on waiver of IP rights for COVID-19 vaccine technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The final text has made almost no one happy and largely mirrors the draft text going into negotiations, with a few key changes. With respect to open questions in the draft text, the final agreement indicates that all developing country WTO Members will be considered eligible to take advantage of the waiver, but that those with “existing capacity to manufacture COVID-19 vaccines are encouraged to make a binding commitment not to avail themselves of this Decision.” This language is primarily targeted at China, which has publicly stated that it would not use the waiver provision but had objected to language based on percentage of global vaccine exports that would have categorically excluded it. The draft text had encouraged members with vaccine export capabilities to opt out rather than to make a binding commitment.

Senators Patrick Leahy (D-VT), John Cornyn (R-TX) and Thom Tillis (R-NC) today introduced the Patent Trial and Appeal Board (PTAB) Reform Act of 2022, which is meant to tackle gamesmanship at the PTAB. In April, Senators Leahy and Tillis penned an op-ed that announced such a bill would be introduced “in the coming days”, but it never materialized. The bill makes a number of key changes to PTAB procedures, including explaining that “the right to appeal shall extend at least to any dissatisfied party that reasonably expects that another person will assert estoppel against the party under section 325(e) as a result of the decision.”

How about some good economic news? That’s in short supply these days as the nation teeters on the brink of recession, driven by raging inflation and skyrocketing gas prices. But in good times and bad, our technology transfer system created by the Bayh-Dole Act just keeps chugging along. A just released study by the Biotechnology Innovation Organization (BIO) and AUTM, which represents the academic technology management profession, shows that academic patent licensing contributed up to $1.9 trillion to the U.S. economy while supporting 6.5 million jobs between 1996 – 2020. Even more impressively, this impact increased substantially since the last survey was released three years ago. That showed an economic impact of $1.7 trillion with 5.9 million jobs supported.

The World Trade Organization’s (WTO’s) 12th Ministerial Conference is set to take place this week, June 12-15, at WTO headquarters in Geneva, Switzerland. As part of the four-day meeting, discussions around the latest text of the proposal to waive intellectual property (IP) rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) for COVID-19 vaccine technology will take place around the clock, and it is expected that some agreement will be reached. TRIPS Council Chair, Ambassador Lansana Gberie of Sierra Leone, said on June 7 that “delegations have entered into real negotiation mode in the last 24 hours,” and that she is “feeling cautiously optimistic now that we will get this text ready for adoption by ministers in time for the coming weekend.”

The chaotic state of the world today makes it increasingly difficult for American companies to compete. Russian hostility has the democratic world on edge, U.S. inflation is at a 40-year high and hitting consumers hard, and China continues its aggressive push for economic and technological dominance.  To stay on top, the United States must out-innovate our competitors. America needs to lead the world in cutting-edge products and new technologies, and those are made possible by policies that support the innovation economy. The Ukraine crisis makes it clear that energy and cyber policy is crucial. Recently, the U.S. Trade Representative told Congress that supporting and protecting the full range of our innovators from China’s distortive practices is critical to our nation’s future.

All things in Washington are driven by money, media and votes. If you can deliver one or more of those things, you will get the results you want. Engaging in politics with this in mind is key to fixing the broken patent system by passing HR 5874, the Restoring American Leadership in Innovation Act (RALIA). Since no mortal can compete with Big Tech’s big bucks and their control of social media, and the media in general, the only lever remaining is delivering votes back home, or more importantly, delivering those votes to candidates who commit to supporting HR 5874.

The U.S. Chamber of Commerce yesterday published a letter it sent to members of congress expressing strong support for both the “No Free TRIPS Act” and the “Protecting American Innovation Act.” According to the letter, if enacted, these bills “would prohibit the Administration from negotiating or concluding any modifications to the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property (TRIPS) agreement, without the explicit authorization of Congress.” The Chamber is concerned about the potential impact of the proposed waiver of patent rights for COVID-19 vaccine technology. The letter comes after the European Union, United States, India and South Africa reached a compromise on language for waiver terms last month.

The National Academy of Public Administration (NAPA) has agreed to perform a study requested earlier this month by Senator Thom Tillis (R-NC) to explore “whether Congress should create a unified, stand-alone, and independent Intellectual Property Office.” NAPA President and CEO Teresa Gerton said its full-time research staff and Academy Fellows are well-positioned to do the work requested and that NAPA would begin discussions with the U.S. Copyright Office and the U.S. Patent and Trademark Office (USPTO) immediately. However, Gerton expressed some skepticism, cautioning that “our success in these negotiations depends greatly on the willing participation of these two agencies and the level of funding they agree to make available for the work.”

Earlier this month, Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT) introduced the Strengthening Measures to Advance Rights Technologies (SMART) Copyright Act into the U.S. Senate. The bill is designed to address shortcomings with some of the statutory provisions of the Digital Millennium Copyright Act (DMCA) which have failed to incentivize the development of new technical measures for preventing copyright infringement online the way that Congress originally envisioned when passing the DMCA in 1998.

Senators Thom Tillis (R-NC), Tom Cotton (R-AR) and Marsha Blackburn (R-TN) sent a letter yesterday to Secretary of Commerce Gina Raimondo expressing their “grave concerns” with the compromise language agreed on recently in the ongoing talks to waive intellectual property rights for COVID-related technology under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. On March 15, the European Union, United States, India and South Africa announced the compromise language. The text is not final and still must get official approval from all 164 World Trade Organization (WTO) member countries.

As discussed previously, the critics are in full howl now that their attempts to enact legislation controlling drug prices has failed once again. They are applying unprecedented political pressure on Secretary Xavier Becerra at the Department of Health and Human Services (HHS) to misuse the march in provisions of the Bayh-Dole Act to accomplish their goal. Nearly 100 distinguished organizations and individuals endorsed the following letter from the Bayh-Dole Coalition, which I lead, warning HHS not to take this disastrous misstep. Here’s what we said.