Posts in Legislation

The safe harbor provision set forth in 35 U.S.C. § 271(e)(1) immunizes many types of activities in pursuit of a Food and Drug Administration (FDA) submission from patent infringement claims. Research tools are frequently used in pursuit of an FDA submission, such as drug development, testing and screening. But research tools themselves generally are not subject to FDA or other regulatory approval. Depending on the circumstances, using research tools to submit data to the FDA may not be protected by the safe harbor provision and thus may expose companies to patent infringement claims.

A webinar hosted on Tuesday, January 12, by The Federalist Society’s Regulatory Transparency Project featured former U.S. Patent and Trademark Office (USPTO) Directors Andrei Iancu and David Kappos, as well as Duke University Professor of Law and former USPTO Administrator of the Office of External Affairs Arti Rai, discussing the proposal to the World Trade Organization (WTO) to waive IP rights under the Trade-Related aspects of Intellectual Property Rights (TRIPS) Agreement for certain COVID-19 technologies. While all three panelists agreed that the IP waiver discussion has become a distraction that will not solve the fundamental problems, Iancu and Kappos were especially passionate that the precedent set by the U.S. government’s decision to back the proposal could do very real harm, rather than good.

In the United States and other countries, there is a growing awareness and increasing appreciation of the purpose and value of amicus curiae practice as an aid in adjudicative decision-making. The role of an amicus curiae (“friend of the court”) brief in support of a party, or in support of no party, is to supply, voluntarily, the presiding court or other tribunal in cases of controversy with pertinent information, insights, or arguments in a formal, publicly accessible manner. Toward that end, a well-written amicus brief is one that is useful to the decision-maker(s) in calling attention to relevant or material factual or legal aspects of the issue(s) in contention – aspects that the decision-maker(s) or the party-litigants may not have been aware of or able to develop fully.

Even as Europe and the rest of the world continued to face the unprecedented challenges of the COVID-19 pandemic in 2021, the development of 5G and other Standard Essential Patent (SEP)-enabled technology standards has continued at an unabated pace. While the year has not yet ended, more than 100,000 technical contributions have already been submitted at 3GPP meetings for 2G, 3G, 4G and 5G in 2021 – a near-record yearly contribution count. The invention and standardization of massive, complex communication technologies continues to generate significant numbers of SEPs. According to IPlytics data, the cumulative number of self-declared SEP families has surpassed 72,000 in 2021, indicating a five-fold increase in just 10 years.

Over the past several years, Congress has raised a long overdue microscope to Big Tech and its worst practices and as a result, the relationship between Washington, DC and Silicon Valley has changed tremendously. Rather than being feted by policymakers, Big Tech is now being forced to answer tough questions. Elected officials are now more aware of Big Tech’s reach and impact on our elections, security, and data collection – and they are not liking what they see.  These companies have intruded on nearly every aspect of American lives and have avoided any responsibility or accountability.

In the wake of the development of COVID-19 vaccines, the Biden-Harris Administration has suggested major shifts in U.S. policy concerning patent protection. In May of this year, Ambassador Katherine Tai, the U.S. Trade Representative (USTR) announced the Administration’s support for waiving intellectual property protections for COVID-19 vaccines. Most recently, the National Institutes of Health (NIH) Director Dr. Francis Collins accused Moderna of excluding three NIH scientists as co-inventors of a key patent for the COVID-19 vaccine. This article explores an alternative possibility of the Administration exercising certain rights in the COVID-19 vaccine invention under the 1980 Bayh-Dole Act—one day after the bill’s co-sponsor, Senator Bob Dole, passed away—and whether such an exercise of rights is in line with past precedent or would be a violent disruption to the status quo.  

Following four letters sent by Senator Thom Tillis (R-NC) to United State Trade Representative (USTR) Katherine Tai regarding the proposed waiver of intellectual property rights under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, Tai on November 8 replied to a July 14  letter sent by Tillis and Senator Tom Cotton (R-AR). That letter referred Tai and Commerce Secretary Gina Raimondo to a May 19 letter in which Tillis, Cotton and 14 other senators requested responses to 10 questions on the proposal to waive IP rights for COVID-19 related technology. The May 19 letter had requested Tai and Raimondo’s responses by July 19, 2021.

Representative Thomas Massie (R-KY) on November 5 introduced a bill, titled the Restoring America’s Leadership in Innovation Act of 2021 (RALIA), HR 5874, that would repeal the Patent Trial and Appeal Board (PTAB), return the patent system to a “first-to-invent” model, rather than first-to-file, and would end automatic publication of patents. Inventor groups such as US Inventor and conservative groups are supporting the legislation.

The full Senate Judiciary Committee convened today for a hearing titled, “Cleaning Up Online Marketplaces: Protecting Against Stolen, Counterfeit, and Unsafe Goods,” in which witnesses explained the continuing challenges of policing stolen and counterfeit products in online marketplaces. The panelists included small business owners, internet platform advocates, academics and retail store representatives.

In response to intense lobbying for patent litigation reform, Congress was convinced that a substantial amount of district court patent litigation involved “poor quality” patents that were clearly invalid. Images of extortionist patent trolls were widely portrayed as a primary threat to U.S. innovation. The high cost of patent litigation, years to reach a judicial resolution and reliance on lay juries to determine highly technical issues were cited as evidence of a broken system. In response, Congress passed the Leahy-Smith America Invents Act (AIA) in 2011…. The current IPR system as implemented has caused severe damage to an important segment of our innovation community. Congress instructed the USPTO Director, in 35 USC§ 316(b), to “consider the effect of any such regulation on the economy, the integrity of the patent system, the efficient administration of the Office, and the ability of the Office to timely complete proceedings instituted under this chapter.” It is time for the Director to reevaluate the effect of IPRs.

Last week, at a meeting of the Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS), World Trade Organization (WTO) members had an opportunity to engage in small group and bilateral meetings to discuss the proposals by South Africa and India to waive patent and trade secret protections relative to COVID-19 innovations, as well as the proposal from the European Union regarding the use of current TRIPS compulsory licensing provisions during a pandemic. Some delegations believed the discussions were encouraging, while others expressed more skepticism, pointing out that a deal will not be achieved “unless delegations are able to make some real compromises.” See Members pursue convergence for IP COVID-19 response.

During a hearing of the Senate Judiciary Committee’s IP Subcommittee today, Senators Chris Coons (D-DE) and Mazie Hirono (D-HI) were the only senators present to question the Pride in Patent Ownership Act’s (PPOA’s) approach to penalizing patent owners who fail to record accurate ownership information within 90 days after the issuance date. The hearing included testimony from four witnesses on the topic of the PPOA introduced by Senators Patrick Leahy (D-VT) and Thom Tillis (R-NC) in September. Leahy explained in his introduction that the same fundamental principle of disclosure that underpins issuance of a patent should extend to patent ownership information. There is presently no requirement that ownership information be publicly available after a patent issues.

Several weeks ago, Senators Patrick Leahy (D-VT) and John Cornyn (R-TX) introduced the Restoring America Invents Act, which would reverse the reforms of the Patent Trial and Appeal Board (PTAB) introduced by former U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu. The Senators claim that the legislation is necessary, among other reasons, to prevent undermining the Congressional intent in enacting the Leahy-Smith America Invents Act (AIA). According to Senator Leahy specifically, Director Iancu’s reforms politicized inter partes review (IPR) decisions by exercising discretion not to institute every IPR challenge filed by petitioners. “[Andrei Iancu] took actions that were designed to undermine the IPR process,” Leahy explained at a ceremony in September commemorating the 10th anniversary of the AIA. “[The Iancu reforms] hamstring the ability of the public to challenge poor-quality patents.”

Dear Ambassador Tai: I write you again today for the fourth time about the Biden Administration’s waiver of international obligations under the Trade-Related Aspects of Intellectual Property Rights, or TRIPS agreement. Last week, several open-content organizations wrote to President Biden and argued that your proposed TRIPS Waiver should cover not just patents, but also copyright and other intellectual property rights. These organizations ask that you include copyright simply because it may apply to software, medicine labels, manuals, or “tools” associated with vaccines. The letter fails to address the importance of these protections to the economy, trade, and employment, the limitations placed on protections to ensure a balanced system, and how copyright protection facilitates the very innovation, creativity, and knowledge sharing that will make it possible for us to end this once in a lifetime pandemic. The inclusion of copyright is both unsubstantiated and unwarranted, and would impose devastating consequences on American creators, businesses and workers, while doing nothing to advance the objective of combatting COVID.