Method of Treatment Claims Are Not Invalid for Lacking Written Description or Enablement Simply Because the Treatment Is Not Safe or Efficacious in Some Patients

The Federal Circuit’s recent decision in United Therapeutics Corp. v. Liquidia Techs., Inc., No. 2022-2217, 2023 WL 4695903 (Fed. Cir. July 24, 2023), provides an interesting discussion on the written description and enablement of method of treatment claims where treatment of a subset of patients may not be safe or efficacious. Claim 1 of U.S. Patent 10,716,793, for example, reads as follows:

1. A method of treating pulmonary hypertension comprising administering by inhalation to a human suffering from pulmonary hypertension a therapeutically effective single event dose of a formulation comprising treprostinil or a pharmaceutically acceptable salt thereof with an inhalation device, wherein the therapeutically effective single event dose comprises from 15 micrograms to 90 micrograms of treprostinil or a pharmaceutically acceptable salt thereof delivered in 1 to 3 breaths.

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FTC Launches Anticipated Investigation of OpenAI Inc.

AI Letters

It was only a matter of time before the Federal Trade Commission (FTC) initiated a law enforcement investigation focusing on artificial intelligence (AI). It is not an exaggeration to say that the FTC has been hinting at, and sometimes outright foreshadowing, such actions for years. The frequency of these communications has only increased over the past few months as generative AI technology dominated headlines.

The FTC has launched an investigation of OpenAI Inc.’s generative AI technology, including whether OpenAI has engaged in “unfair or deceptive privacy or data security practices” or “unfair or deceptive practices relating to risks of harm to consumers, including reputational harm.” It is fairly rare for FTC consumer protection investigations to leak, but last week the investigation was widely reported in the media and the actual Civil Investigation Demand (CID) itself also leaked and can be seen here.

In the 20-page CID, the FTC sets forth a number of interrogatories and document requests focusing on how OpenAI has built, tested and advertised its large language model products. With respect to the training data sets, the FTC asks how OpenAI obtained the data it used to train its technology, how it vets and categorizes data, and how it filters or anonymizes personal information in the data sets. OpenAI will have to explain how it trains its models, including fine-tuning, retraining and reinforcement learning through human feedback. The FTC is asking how OpenAI handles what the industry generally recognizes as an inevitable problem of generative AI: hallucinations. The investigation will also look into the preventive and remedial measures OpenAI employs to handle the disclosure of personal information and the creation of false, misleading or disparaging statements about individuals.

The FTC is asking the same questions of OpenAI that enterprise users of ChatGPT should be considering. For businesses looking to build their own technology on top of OpenAI’s generative pre-trained transformer models, they should not rely on OpenAI to build in all the protections necessary to comply with applicable law. Instead, enterprise users should be conducting their own due diligence on their specific usage and implementation of generative AI technology.

Given the FTC’s repeated focus on a wide range of potentially deceptive or unfair features of generative AI, it is safe to assume that this is not the only AI investigation in the works and that there are many practices that could be the subject of extensive FTC inquiry. The agency continues to broadly interpret its unfairness authority, and that will likely continue as it investigates more consumer protection concerns regarding AI.

Extraterritorial Reach of the Lanham Act

The Supreme Court recently ruled in Abitron Austria GmbH v. Hetronic International, Inc. that Lanham Act (Act) remedies for trademark infringement do not extend to infringing conduct that takes place outside the United States, regardless of whether the activity creates a likelihood of confusion within the United States — and in the process vacated $96 million of a $115 million jury verdict in favor of Hetronic.

Hetronic is a United States manufacturer that builds radio remote controls for construction equipment. Abitron was originally one of Hetronic’s licensed distributors abroad. But it reverse-engineered Hetronic’s products and started selling them in Europe — still under Hetronic’s trademark. Hetronic sued under the Act’s sections 1114(1)(a) and 1125(a)(1), both of which prohibit using a mark in commerce in a way that is likely to cause confusion.

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Congress Seeks to Eliminate the Judicial Exceptions to Patent Eligibility

On June 22, Senator Thom Tillis (R – NC) and Senator Chris Coons (D – DE) introduced the Patent Eligibility Restoration Act of 2023, which seeks to eliminate all judicial exceptions to patent eligibility.[1] The bill proposes that “[a]ny invention or discovery that can be claimed as a useful process, machine, manufacture, or composition of matter, or any useful improvement thereof” should be eligible for patent protection, with the following exceptions:

  • A mathematical formula that is not part of an invention that is in a category described in subparagraph (B).
  • A mental process performed solely in the mind of a human being.
  • An unmodified human gene, as that gene exists in the human body.
  • An unmodified natural material, as that material exists in nature.
  • A process that is substantially economic, financial, business, social, cultural, or artistic.

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Watch Out for Common Law Users in Online Enforcement

Many consumer product brands seek to enroll in online enforcement programs, for example, Amazon Brand Registry and eBay VeRO. These consumer product brands often experience online infringement and counterfeiting issues, so recording their registered trademarks with brand registries and participating in an online enforcement program can help with identifying infringements and streamlining the takedown process.

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Rogers Test Not Applicable When Mark Is Used as a Trademark

Supreme Court Rules in Favor of Jack Daniel’s Over ‘Spoofed’ Bad Spaniels Dog Toy

The Second Circuit’s 1989 Rogers test sets an elevated standard for proving trademark infringement, for the purpose of protecting First Amendment interests, when a trademark is used in “works of artistic expression.” Rogers v. Grimaldi, 875 F.2d 994 (2d Cir. 1989). Where the Rogers test applies, the unauthorized use of a trademark can give rise to an infringement claim only if (1) the trademark has “no artistic relevance” to the accused work or (2) in the case of artistic relevance, the accused work’s use of the trademark “explicitly misleads as to the source or the content of the work.” Id. at 999. Where applicable, the Rogers test is a powerful defense against claims of trademark infringement and dilution.

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Podcast: NFTs and the Future of Digital Brands

Guests Jerry Ferguson and Scott Kominers discuss NFTs and how they can create opportunities for brands in the marketplace with the help of some Really Awesome Raccoons.

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What Goldsmith Means to AI Trainers

The House IP Subcommittee’s “Artificial Intelligence and Intellectual Property: Part I—Interoperability of AI and Copyright Law” hearing has two former General Counsels of the US Copyright Office squaring off over whether using copyrighted works to train artificial intelligence (AI) models would qualify as a fair use of those works under US copyright law. Sy Damle, (2016-2018 General Counsel) testified that “the training of AI models will generally fall within the established bounds of fair use.” (S. Damle introductory statement, Tr. pg. 6). This testimony prompted Jon Baumgarten (1976-1979 General Counsel) to issue a letter to the Subcommittee contesting Damle’s assertion, emphatically stating that “I could not disagree more regarding Mr. Damle’s categorical treatment of fair use.”  (emphasis original). Baumgarten asserted that “the question of fair use is subject to detailed analysis of various factors in each case,” (emphasis mine) and cited as support SCOTUS’s recent decision in Warhol Foundation v Goldsmith.

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Licensing vs. Franchising: Are You Accidentally Creating a Franchise?

A trademark license may seem straightforward. It is an arrangement that gives a licensee the right to use the licensor’s mark in some manner for some amount of time, with the licensor exercising quality control over the goods offered and services rendered under the mark. Since a license is like any other contract, the licensor can add any number of conditions to the agreement, right? Not necessarily. This could inadvertently create a franchise and subject you to civil and criminal penalties.

What is a franchise?

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Will the Supreme Court Reevaluate the Subject Matter Eligibility of Diagnostic Claims?

Since the Supreme Court’s decisions in Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66 (2012), and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208 (2014), “diagnostic” patent claims have repeatedly been held to be directed to patent-ineligible subject matter by the U.S. Patent and Trademark Office (PTO) and courts. In a 2022 decision by the Federal Circuit, for example, the court affirmed a district court’s ruling that claims to noninvasive detection of graft rejection in transplant patients were ineligible under Section 101 because they were directed to the detection of a natural phenomenon/natural law using only conventional techniques. CareDx, Inc. v. Natera, Inc., 40 F.4th 1371, 1381 (Fed. Cir. 2022). And although the Supreme Court has on a number of occasions declined to reevaluate the contours of Section 101, including the subject matter eligibility of diagnostic claims, the CareDx, Inc. v. Natera, Inc. case may have piqued the Court’s interest.

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