Welcome to The SNIP, a monthly newsletter by Urška Petrovčič, Adam Mossoff, and Devlin Hartline of Hudson Institute's Forum for Intellectual Property. The SNIP offers a brief breakdown of the latest policy issues and case developments in intellectual property.

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THE LATEST FROM HUDSON

Hudson Senior Fellow Adam Mossoff Testifies at International Trade Commission Hearing on Patent Waiver

On March 30, 2023, Hudson Senior Fellow Adam Mossoff testified at the International Trade Commission (ITC) hearing on the pending decision of the World Trade Organization (WTO) on extending the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) waiver from strictly COVID-19 vaccine technologies to COVID-19 related therapeutics and diagnostics. In his testimony, Professor Mossoff explained that there is no evidence-based justification for extending the vaccine patent waiver to therapeutics and diagnostics. He detailed the extensive evidence of how patents and other intellectual property (IP) rights facilitated the unprecedented response by the biomedical sector to the COVID-19 pandemic. Waivers of these vital IP rights would undermine the ability of biotech innovators to research, develop, and produce life-saving diagnostics and therapeutics—harming millions of people that the waiver is supposed to benefit. He urged the U.S. government to follow evidence-based policymaking, rather than follow policy-based evidence-making in opposing any extension of the patent waiver by the WTO.

The SNIP: Hudson Senior Fellow Adam Mossoff urges the U.S. government to follow evidence-based policymaking and thus to oppose an extension of the WTO’s patent waiver.

Learn More:

READ: “Industry, NGOs Spar Over Need to Extend TRIPS COVID IP Waiver at ITC Hearing,” Eileen McDermott, IPWatchdog (March 29, 2023).
READ: “Written Submission Supporting Oral Statement at Public Hearing: COVID-19 Diagnostics and Therapeutics: Supply, Demand, and TRIPS Agreement Flexibilities,” Adam Mossoff, U.S. International Trade Commission (April 12, 2023).

Hudson Panel Previews Supreme Court Oral Argument in Jack Daniel’s v. VIP Products

On March 21, 2023, Hudson Legal Fellow Devlin Hartline led a virtual discussion with Megan K. Bannigan, Ben Sheffner, and Vijay Toke on Jack Daniel’s v. VIP Products, an important dispute at the intersection of the First Amendment and trademark law. The case concerns VIP’s dog toy that copies Jack Daniel’s iconic Tennessee whiskey bottle, but with the name changed to “Bad Spaniels” and other humorous elements added. Jack Daniel’s claims that the toy infringes its trademarks and trade dress, while VIP maintains that its unauthorized use is protected expression as a parody. The panelists discussed the importance of striking the right balance between free speech and trademark protection, including whether the Ninth Circuit erred in applying a First Amendment test that gives overbroad protection to humorous products that infringe another company’s trademark rights. They also addressed whether VIP’s use is noncommercial and thus immune from liability for tarnishing Jack Daniel’s reputation.

The SNIP: Hudson panel previews the arguments in Jack Daniel’s and VIP Products, a Supreme Court battle over free speech protection for humorous uses of trademarks.

Learn More:

WATCH: “Jack Daniel’s v. VIP Products Argument Preview: The Supreme Court Takes on Humorous Uses of Trademarks,” Hudson Institute (March 21, 2023).
LISTEN: “Jack Daniel's Properties, Inc. v. VIP Products Oral Argument,” C-SPAN (March 22, 2023).
READ: “Jack Daniel’s Properties, Inc. v. VIP Products LLC,” SCOTUSblog (March 22, 2023).
READ: “SCOTUS Skeptical that Bad Spaniels is Parody, But Questions Need to Overturn Rogers,” Eileen McDermott, IPWatchdog (March 22, 2023).

Hudson Hosts Webinar on Essentiality Checks for Standard-Essential Patents

On March 15, 2023, Hudson Senior Fellow Urška Petrovčič hosted a webinar in which participants discussed methods to identify patents that are essential to practice industry standards, such as 5G or 6G. Steve Akerley, InterDigital’s vice president and deputy general counsel, addressed concerns about “over-declarations,” where a company intentionally, and in bad faith, portrays patents to be essential to practice a standard that are not essential. Dr. Katie Atkinson, chair and dean of the University of Liverpool’s School of Electrical Engineering, Electronics and Computer Science, explained why artificial intelligence (AI) and AI-assisted methodologies haven’t reached a development stage where they could determine the essentiality of patents. Industry analyst Keith Mallinson noted that humans are also failing to provide consistent results when determining essentiality and raised his concerns about false positive determinations inflating essentiality rates for companies that over-declare. He also noted that examining only small samples of patents can result in large sampling errors—particularly when essentiality rates are low.

The SNIP: Hudson webinar explores the benefits and drawbacks that have been proposed to identify patents that are essential to practice an industry standard.

Learn More:

WATCH: “What Are the Patents that Power Your Connected Devices? Discussing Methods for Identifying Essential Patents,” Hudson Institute (March 15, 2023).

Hudson Senior Fellow Adam Mossoff Submits Comments on the Potential USPTO-FDA Collaboration

On March 10, 2023, Hudson Senior Fellow Adam Mossoff submitted comments on a potential collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA). Professor Mossoff presented evidence of the key role of reliable and effective patents as drivers of innovation and economic growth, especially in the biopharmaceutical sector. Professor Mossoff also detailed how drug patent numbers published by the Initiative for Medicine, Access, and Knowledge (I-MAK) are unreliable and infected with serious questions concerning their veracity given vast discrepancies between I-MAK’s drug patent numbers and the drug patents listed in official, publicly accessible databases. In conclusion, Professor Mossoff urged the USPTO to engage in evidence-based policymaking before adopting new regulations that impede the ability of innovators to create and commercialize new drugs.

The SNIP: Hudson Senior Fellow Adam Mossoff identified serious concerns with the proposed collaboration between USPTO and FDA.

Learn More:

READ: “Comments on Joint USPTO–FDA Collaboration Initiatives,” Adam Mossoff, U.S. Patent and Trademark Office (March 10, 2023).

Hudson Senior Fellow Adam Mossoff Submits Amicus Brief in Arbutus v. Moderna

On March 2, 2023, Hudson Senior Fellow Adam Mossoff, the Honorable Susan Braden, and other patent law experts filed an amicus brief in Arbutus Biopharma Corp. v. Moderna Inc. In this first patent infringement lawsuit over the mRNA platform that created the COVID-19 vaccines, Moderna argued that Arbutus cannot sue it for infringement given that it sold the vaccines to the U.S. government through Operation Warp Speed. According to Moderna, Arbutus’ sole relief is against the federal government under § 1498. After the court rejected Moderna’s argument last fall, the U.S. government unexpectedly filed a Statement of Interest in support of Moderna, prompting the court to reconsider its first decision. Their amicus brief explained that Moderna and the U.S. government misread § 1498, which is an eminent domain statute that is inapplicable to government purchases of drugs solely for use by private citizens. The court affirmed its original decision in favor of Arbutus, and it referenced the amicus brief in its March 10, 2023, opinion.

The SNIP: Adam Mossoff, Judge Braden, and other patent law experts explain in patent infringement lawsuit on mRNA vaccine that Operation Warp Speed did not trigger § 1498.

Learn More:

READ: “Letter Brief from Amici Curiae Law Professors, Scholars, and Former Government Officials,” Arbutus Biopharma Corp. v. Moderna Inc. (March 2, 2023).
READ: “Memorandum Opinion,” Arbutus Biopharma Corp. v. Moderna Inc. (March 10, 2023).
READ: “Ex-Judges Worried About Where COVID Vax IP Row Will Go,” Andrew Karpan, Law360 (March 3, 2023).

LEGISLATION & POLICY DEVELOPMENTS

European Commission Issues Proposed Regulations on Standard-Essential Patents

On April 27, 2023, the European Commission (EC) released a proposed regulation that would create an administrative tribunal to determine what count as standard-essential patents (SEPs) and address potential disputes regarding the licensing terms for those SEPs. The EC claims that this new, extensive administrative regime is needed to address increasing disputes over SEPs and mitigate inconsistency in the decisions issued by EU courts. Opponents claim that there is no evidence of systemic inefficiencies in SEP-reliant industries like mobile telecommunications that justify a new regulatory regime displacing private licensing practices and litigation in courts. Several commentators, including a bipartisan group of former U.S. public officials, have urged the EC to halt its plans, reasoning that they are unnecessary and potentially harmful as they would endorse a blueprint for China to undermine Western innovation.

The SNIP: The European Commission releases a proposal for a massive, new regulatory regime for SEP licensing and litigation.

Learn More:

READ: “EU Patent Body to Oversee Tech-Standard Patent Royalties–EU Draft Rule,” Foo Yun Chee, Reuters (March 28, 2023).
READ: “New EU Regulatory Regime for SEPs Will Upend Mobile Telecommunications Sector,” Adam Mossoff, IPWatchdog (April 12, 2023).
READ: “Comments on European Commission’s Draft ‘Proposal for Regulation of the European Parliament and of the Council Establishing a Framework for Transparent Licensing of Standard Essential Patents,’” Christine A. Varney, Mark Delrahim, David J. Kappos, Andrei Iancu, Walter G. Copan, and Noah Philips (April 20, 2023).
READ: “Europe’s Schizophrenia on Standard Essential Patents,” Gene Quinn, IP Watchdog (Apr. 23, 2023).

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