Posts Tagged: "patent eligibility"

Recent debates about AI patentability have focused on whether the outputs of an AI system, such as a neural network, can be patented. Such debates have been spurred not only by recent general advances in the power of AI but also by Dr. Stephen Thaler’s “Artificial Inventor” project’s attempts to obtain patents on devices generated using his neural network-based DABUS software. If you thought that whether an AI-generated output can be patented is a cutting-edge question, then consider whether an input to an AI system, such as a prompt to a large language model (LLM), can be patented.

The U.S. Supreme Court’s Alice decision alleges that “…merely requiring generic computer implementation fails to transform that abstract idea into a patent-eligible invention.” And the Patent Eligibility Restoration Act (PERA) of 2023 alleges that “adding a non-essential reference to a computer by merely stating, ‘do it on a computer’ shall not establish such eligibility.” Clearly, it is assumed that “merely” doing something on a computer or “merely” saying “do it on a computer” is not a desirable thing in the eyes of some; a computer supposedly invalidates the inventive effort and “merely” doing something on a computer is undeserving of even consideration of a patent.

On Monday, the United States Supreme Court denied inventor Jeffrey Killian’s petition for a rehearing in his case asking the Court to provide clear guidance on – or else throw out – the Alice/Mayo test for patent eligibility. The Supreme Court denied Killian’s original petition in early October, but Killian filed a request for rehearing several weeks later. Killian first filed a petition for writ of certiorari to the Supreme Court in April, after the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed the Patent Trial and Appeal Board’s (PTAB)’s ruling rejecting claims of his U.S. Patent Application No. 14/450,042 under Section 101.

Innovation has been the driving force behind our country since its inception. So much of our nation’s success has flowed from U.S. ingenuity and innovation. Yet much remains to be done on this front. Indeed, in a few short years, we will be celebrating the Semiquincentennial (also called the Sestercentennial)—250 years since the signing of the Declaration of Independence. We need the same approach moving forward, and we have the opportunity to do so with pending legislation, which brings me to a chance to reflect on some important questions of intellectual property and innovation policy.

The U.S. Supreme Court on Monday denied certiorari to review a February ruling of the U.S. Court of Appeals for the Federal Circuit (CAFC) that held claims of ChromaDex, Inc.’s patent on an isolated form of vitamin B3 are directed to unpatentable subject matter under Section 101. The CAFC affirmed the Delaware district court’s grant of summary judgment for Elysium Health that the relevant claims of U.S. Patent No. 8,197,807, titled “Nicotinamide riboside kinase compositions and methods for using the same,” were invalid under Section 101 as being directed to a natural phenomenon, specifically, “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk.”

Recently, members of the Senate Judiciary Committee’s Subcommittee on Intellectual Property released a draft of the ‘‘Patent Eligibility Restoration Act of 2023” (“PERA”) for the purpose of addressing the judicially-created exceptions to patent eligibility plaguing the country. Among the Senate’s findings are that patent eligibility jurisprudence requires significant clarification, the judicial exceptions are rendering an increasing number of inventions ineligible for patent protection, and Alice/Mayo is confusing and inconsistent. None of this is surprising. Alice/Mayo has been a resounding failure. However, of particular importance, the Senate bill has declared “All judicial exceptions to patent eligibility are eliminated.”

Judicial rulings have muddied the waters of patent eligibility, with judges themselves expressing uncertainty. In the case, Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, U.S. Court of Appeals for the Federal Circuit judge Kimberly Moore openly shared the challenge of applying Section 101 consistently, explaining that “the majority’s blended 101/112 analysis expands § 101, converts factual issues into legal ones and is certain to cause confusion for future cases.” This haze has driven innovators to tread cautiously, often sidelining potential patents for fear of 101 rejections—stifling the American dream of groundbreaking innovation. Stakeholders craft tactics to dodge these pitfalls while lawmakers propose reforms.

The Supreme Court decided Amgen Inc. v. Sanofi on May 18, 2023, nearly nine years after its decision in Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014). Amgen was concerned with the enablement statute of the patent law, 35 U.S.C. § 112. In comparison, Alice was concerned with the eligibility statute of the patent law, 35 U.S.C. § 101, and has been highly criticized for creating a mess of patent eligibility. At first glance, these cases are distinguishable from one another, since they deal with different aspects of the patent laws. However, statutory interpretation and analysis should be the same in both instances.

The U.S. Supreme Court today denied the petition for certiorari brought by CareDX, Inc. in May asking it to review a 2022 decision holding certain claims of its patents directed to detection levels of donor cell-free DNA (cfDNA) in the blood of an organ transplant patient patent ineligible. Justice Bret Kavanaugh would have granted the petition, according to the Order List.

PERA is no doubt an ambitious bill. In terms of its design, the proposed legislation attempts to deal with each of the Supreme Court’s decisions in Alice, Mayo and Myriad, plus all of their progeny applications thereafter engendered by the Federal Circuit, the Patent Trial and Appeal Board (PTAB), all the way down to the U.S. Patent and Trademark Office (USPTO) examining corp. In a nutshell, the bill, if passed, would return us to a time when Bilski was the law of the land, which will no doubt be welcomed by many innovators.

Artificial intelligence (AI) is a field of computer science that creates software or models that mimic human reasoning or inference. Machine learning is a subset of AI which uses algorithms trained on massive amounts of data to allow the computer to learn with gradually improving accuracy without explicitly being programmed. The biopharmaceutical and healthcare fields produce massive amounts of data, including properties and characteristics of drug compounds, biological, genomic, and clinical data, efficacy of treatments, adverse events and risks, and electronic health records. The data may come from many sources, both public and proprietary. AI systems trained on such data can streamline and optimize the drug development process, including drug discovery, diagnosing diseases, identifying treatments and risks, designing clinical trials, and predicting safety and efficacy profiles, leading to increasing efficiency and reducing costs. 

On day two of IPWatchdog LIVE, J. John Lee, Chief Counsel for Intellectual Property for the U.S. House of Representatives, Committee on the Judiciary, told those who are skeptical of the chances for Senators’ Tillis and Coons’ Patent Eligibility Restoration Act (PERA) to move forward that a House version of the bill is likely to be introduced in the near future. Lee, who is principal advisor on IP issues and helms the Subcommittee on Courts, Intellectual Property, and the Internet, was speaking on a panel titled “Politics, Policy and Legislation at the Intersection of Intellectual Property,” which also featured David Jones of the High-Tech Inventors Alliance; Joe Matal of Haynes Boone, LLP and former U.S. Patent and Trademark Office (USPTO) Acting Director and Acting Solicitor; and Eli Mazour of Harrity & Harrity.

The third annual IPWatchdog LIVE conference opened with panels examining global trends in IP policy and a review of U.S. Supreme Court case law, as well as the presentation of the third annual Paul Michel Award, which each year honors a respected industry leader and advocate for fairness in the IP community. On a panel that detailed some of the most recent U.S. Supreme Court’s IP decisions, retired U.S. Court of Appeals for the Federal Circuit (CAFC) Judge Paul Michel described the arguably contradictory holdings in Google v. Oracle and Warhol v. Goldsmith as “useless” in terms of substantive guidance from the Court. “These two cases represent a failure on the part of the Supreme Court to provide meaningful guidance to users who need it now,” Michel said. Professor Llew Gibbons of the University of Toledo College of Law explained the holdings in each of the cases and concluded that “I couldn’t find a principled reason other than ‘we want to come out differently’” for the Court’s ruling in Warhol, considering the Google decision.

The Canadian Federal Court of Appeal (FCA), in Attorney General of Canada v. Benjamin Moore & Co. [2023 FCA 168], a 3-0 decision, recently set aside the test on subject matter eligibility of computer-implemented inventions laid down by the Federal Court [2022 FC 923] last year. Acclaimed by patent professionals as a “favorable decision for Canadian applicants who have computer-implemented inventions,” the test had, for the first time, presented a declaratory relief and guidance for examining subject-matter eligibility, particularly for computer-implemented inventions. While the setting aside of the test relays subject matter assessments back to the procedure set by the Commissioner of Patents (Canada), the FCA clarified some key areas associated with the claim construction and patentability analysis.

Confusion and misunderstanding among some independent inventors might slow or stall progress of the excellent eligibility reform bill recently introduced by Senators Chris Coons (D-DE) and Thom Tillis (R-NC). Titled the Patent Eligibility Restoration Act (PERA), the legislation would overturn Supreme Court and Federal Circuit decisions that scrambled settled law, excluding many worthy classes of inventions, such as medical diagnostic methods and advanced computer applications.