No images? Click here
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.
Was this email forwarded to you by a friend? Sign up for The SNIP.
THE LATEST FROM HUDSON
Hudson Senior Fellows File Comments with the European Commission on the Regulatory Regime for Standard Essential Patents
In June and August 2023, Hudson Senior Fellows Thomas Duesterberg and Adam Mossoff submitted their respective comments to the European Commission (EC) on the proposed regulation regime for the licensing and litigation of standard-essential patents (SEPs). The proposal would impose extensive, top-down regulations on SEPs, including the setting of royalty rates and caps. In their comments, Duesterberg and Mossoff advocated evidence-based policymaking on SEPs, which is essential for growing innovation economies and for securing national security interests against global competitors like China. They explained that the proposed regulatory regime is not based on marketplace evidence, and thus it threatens Western technological leadership and the national security interests of both the U.S. and Europe.
The SNIP: Hudson senior fellows urge the European Commission to not adopt a massive regulatory regime for SEPs licensing and litigation.
Learn More:
READ: “Comment on Regulation of the European Parliament and of the Council on Standard Essential Patents, Amending Regulation (EU) 2017/1001,” Adam Mossoff, European Commission (August 10, 2023).
READ: “Comments on EC New Regulation for SEPs,” Thomas Duesterberg, European Commission (June 14, 2023).
READ: “European Commission Undermines Western Innovators, Boosts Chinese Dominance of Telecom Sector,” Adam Mossoff and Thomas Duesterberg, The Heritage Foundation (May 4, 2023).
Hudson Senior Fellow Adam Mossoff Submits Comments to NIH
On August 18, 2023, Hudson Senior Fellow Adam Mossoff submitted comments to the National Institutes of Health (NIH) for its workshop on tech transfer and patent licensing that it held on July 31. Professor Mossoff addressed his comment to proposals by some of the participants in the NIH workshop, such as James Love, that the NIH can use the Bayh-Dole Act or 28 U.S.C. § 1498 to impose price controls on drug patents through its own licenses to generic drug manufacturers. He explained that neither the Bayh-Dole Act nor § 1498 authorizes agencies like the NIH to impose price controls on drug patents. He urged NIH to focus instead on evidence-based policymaking given that reliable and effective patent rights have been a key driver of the U.S. innovation economy.
The SNIP: Hudson’s Adam Mossoff urges NIH to resist calls to impose price controls on prescription drugs and to instead engage in evidence-based policymaking.
Learn More:
READ: “Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer,” NIH Workshop (July 31, 2023).
READ: “Comment for Workshop on Transforming Discoveries into Products: Maximizing NIH’s Levers to Catalyze Technology Transfer Report,” Adam Mossoff, National Institutes of Health (August 18, 2023).
READ: “The False Promise of Breaking Patents to Lower Drug Prices,” Adam Mossoff, 97 St. John’s Law Review (Forthcoming 2023).
Hudson Senior Fellow Adam Mossoff Pens Op-Ed on Recent Bill to Weaken the International Trade Commission
On August 18, 2023, Hudson Senior Fellow Adam Mossoff published an op-ed in The Hill, critiquing the recently introduced Advancing America’s Interests Act (AAIA). The bill would limit the rights of patent owners to file complaints with the International Trade Commission (ITC), an agency that ensures the legality of imports into the United States. Professor Mossoff explained that Big Tech companies wrongly claim that the bill is necessary to prevent frivolous infringement claims by patent owners. He explained that the AAIA promotes only the interests of Big Tech companies with supply chains in foreign countries like China that engage in predatory infringement of patented technologies created by American innovators. The AAIA is classic Washington double-speak: it actively harms the interests of American innovators while supporting strategic and economic competitors like China.
The SNIP: Hudson’s Adam Mossoff explains how bill to limit ITC’s ability to hear patent infringement complaints would harm American innovators.
Learn More:
CASE DEVELOPMENTS
Numerous Lawsuits Filed Challenging Drug Price Setting Policies Under Inflation Reduction Act
In June 2023, the first lawsuits were filed contesting the constitutionality of the Medicare Drug Price Negotiation Program, introduced under the Inflation Reduction Act (IRA), which provides that Medicare set caps on prescription drug prices after a mandated “negotiation” process. Drugmakers, policy groups, and industry organizations claim that the IRA violates a slew of constitutional provisions, such as the Due Process and Takings Clauses in the Fifth Amendment, the freedom of speech in the First Amendment, the prohibition against excessive fines in the Eighth Amendment, as well as the structural constitutional principle of the separation of powers. They also warn that the program will have deleterious consequences on research and development, stifling healthcare innovation.
The SNIP: Many lawsuits have been filed challenging the constitutionality of price controls on drugs mandated by the Inflation Reduction Act.
Learn More:
READ: “Inflation Reduction Act’s Unintended Consequences,” PhRMA (2023).
READ: “Drugmakers, Trade Groups Push Back Against Medicare Drug Price Negotiations,” Lauren Gardner, Politico (August 29, 2023).
READ: “FACT SHEET: Biden-Harris Administration Announces First Ten Drugs Selected for Medicare Price Negotiation,” The White House, (August 29, 2023).
District Court Agrees with Copyright Office that Purely AI-Created Works Are Not Protectable
On August 18, 2023, a district court upheld the decision of the Copyright Office to refuse registration of a work created purely by artificial intelligence. The plaintiff, Stephen Thaler, attempted to register a work created by his AI computer program “Creativity Machine.” The Register of Copyrights denied registration on the ground that there was no human authorship because Thaler played no role in the creation of the work. The district court agreed, emphasizing the foundational principle that “authorship centers on acts of human creativity.” The court held that “Creativity Machine” could not be the author, nor could Thaler claim ownership under common law property doctrines such as accession and first possession.
The SNIP: District Court upholds the Copyright Office’s refusal to an AI-generated work that lacked any human authorship.
Learn More:
READ: Thaler v. Perlmutter, No. 22-1564, 2023 WL 5333236 (D.D.C. Aug. 18, 2023).
READ: “DC Court Says No Copyright Registration for Works Created by Generative AI,” Franklin Graves, IPWatchdog (August 19, 2023).
READ: “No Copyright for Certain AI-Generated Works, but Maybe Yes for Others, If Prompts are Detailed Enough,” Eugene Volokh, Reason (August 21, 2023).
