Posts in Legislation

If you’re reading IPWatchdog, you probably have some familiarity with intellectual property rights, such as patents, copyrights and trademarks. However, one distinct type of intellectual property is often left out and misunderstood. It’s called the right of publicity. While publicity rights are often confused with other types of intellectual property or privacy rights, or mistakenly associated only with famous individuals, they are incredibly important, far-reaching, and deserve much more attention.

The U.S. Chamber of Commerce released a report today predicting that proposals by the Biden Administration to impose price controls on certain pharmaceuticals will reduce the number of clinical trials “by thousands across all categories of research examined and by up to 75% in some therapeutic areas,” eventually turning the United States into a “research desert.” The report comes on the heels of a Federal Register Notice last week that proposed a framework for expanding the use of march-in rights under the Bayh-Dole Act to circumstances in which qualifying drugs are priced too high.

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.

An event held Monday by the Center for Strategic & International Studies (CSIS), and moderated by former U.S. Patent and Trademark Office (USPTO) Director Andrei Iancu, featured a number of high-profile political and professional figures in the intellectual property space debating approaches to strengthening the U.S. patent system, with an emphasis on national security. Representative Deborah Ross (D-NC), who serves on the U.S. House of Representatives’ Judiciary Committee’s Subcommittee on Courts, Intellectual Property and the Internet, first joined Iancu to discuss her reasons for supporting the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act.

The U.S. Patent and Trademark Office (USPTO) announced today that it is launching a pilot program to help promote semiconductor innovation by expediting examination for qualifying patents. The program is meant to support the objectives of President Biden’s Creating Helpful Incentives to Produce Semiconductors (CHIPS) and Science Act, which was signed into law in August 2022. The CHIPS and Science Act provided $280 billion in federal funding to encourage the domestic production of semiconductor products in the United States as well as to fund research and development projects in advanced technological fields like quantum computing and artificial intelligence. The law also provides for a $10 billion investment into the development of regional innovation and technology hubs and establishes other programs supporting science, technology, engineering and math (STEM) educational programs.

On September 13, the Global Innovation Policy Center of the U.S. Chamber published its “IP Principles” paper declaring the Chamber’s “Beliefs about Intellectual Property.” It was promptly endorsed and signed by 32 external IP thought leaders, including the heads of nearly all major IP associations and organizations, and individual experts such as a former Director of the U.S. Patent and Trademark Office (USPTO), two retired judges (including myself), and leading IP academics…. In my view, the Chamber was exactly right to call for a “reset” in the policy debate over IP rights.

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.

On October 30, President Joe Biden issued an executive order (EO) announcing a series of new agency directives for managing risks related to the use of artificial intelligence (AI) technologies. The EO prioritizes risks related to critical infrastructure, cybersecurity and consumer privacy but it does not establish clear directives on copyright issues related to generative AI platforms that have garnered much debate in Congress in recent months.

On  April 27, 2023, the European Commission published its proposal for how the licensing of standard essential patents (SEPs) should be governed in the EU. The draft regulation states that the initiative aims to incentivize participation by European firms in the standard development process and the broad implementation of such standardized technologies, particularly in IoT industries. The developments are of interest to any business that develops, implements or markets connective technologies.

I was not even aware of the issue below until a CPA friend of mine happened to mention it during a friendly telephone call. But unless Section 174 of the Internal Revenue Code is restored to its previous state from prior to the 2017 Trump tax cuts, U.S. innovation will be greatly impacted. Section 174 of the Internal Revenue Code has been around since 1954. It was enacted to eliminate uncertainty in the treatment of research and development (R&D) expenditures and to encourage businesses to carry on research and experimentation.

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.

IPWatchdog’s Life Sciences Masters 2023 concluded today, following three days of panels that tackled some of the most pressing issues facing intellectual property professionals in the life sciences space. In the spotlight was the Biden Administration’s recent passage of the Inflation Reduction Act (IRA) and its potential impact on future drug development in the United States. Prescription drug pricing controls are one aspect of the IRA, a landmark piece of legislation passed by Congress last August that also directs funding to be spent on clean energy projects and increased tax enforcement. The IRA authorizes the Health and Human Services (HHS) Secretary to establish a Drug Price Negotiation Program, codified at 42 U.S.C. § 1320f, to establish maximum fair prices of certain drugs that become eligible for the program because they constitute a large portion of expenditures by Medicare Part B and Part D patients. Pharmaceutical companies who do not agree to the price set during negotiations with HHS will have to pay a new excise tax codified at 26 U.S.C. § 5000D calculated based on daily sales and starting at 65%.

The U.S. International Trade Commission (ITC) released a sprawling report on Tuesday analyzing market dynamics surrounding the question of whether to extend the waiver of IP rights for COVID-19 technologies under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to diagnostics and therapeutics. The report stopped short of making any recommendations, but ultimately did not find any definitive evidence that IP rights present a barrier to access in the context of COVID diagnostics and therapeutics. However, it largely amounts to a reiteration of talking points on both sides and seemingly does little to further the debate.

Last month, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) announced that it had joined with 30 other signatories to publish a framework of intellectual property principles designed to reshape the narrative around intellectual property (IP) rights and maintain America’s global lead in innovation. Broadly speaking, the principles focus on five primary goals to be achieved by American lawmakers and policymakers: 1) national security, 2) technological leadership, 3) fostering creative expression, 4) enforcing the rule of law, and 5) ensuring full access to the innovation ecosystem for all.

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.”