September 30, 2022

Volume XII, Number 273

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New Patent Eligibility Bill May Impact What Subject Matter Is Patentable

On August 2, 2022, Senator Thom Tillis (R-NC) introduced the Patent Eligibility Restoration Act of 2022. Senator Tillis’s bill addresses patent subject matter eligibility by modifying 35 U.S.C. § 101 to mitigate areas in which it has been considered problematic in view of recent judicial decisions/exceptions construing it while retaining its core features. For some in the biotechnology space, “problematic” Supreme Court decisions have included May Collaborative Services (2012), Myriad Genetics (2013), Alice Corp. (2014) and their Federal Circuit progeny.

The core features for eligibility will remain in the statute as: “[w]hoever invents or discovers any useful process, machine, manufacture, or composition of matter, or any useful improvement thereof, may obtain a patent therefore.”

The bill provides express exceptions, including:

  • A mathematical formula, apart from useful invention or discovery

  • An unmodified human gene, as that gene exists in the human body

  • An unmodified natural material, as that material exists in nature.

However, the bill further states that genes or natural material that are “purified, enriched, or otherwise altered by human activity, or otherwise employed in a useful invention or discovery,” would not be considered unmodified and would be eligible for patents. One of the goals of the bill is to override case law that has made it  difficult to receive patents on diagnostics inventions and otherwise blurred the line between what inventions are considered abstract.

Processes that are excluded from eligibility under the bill include:

  • Nontechnological economic, financial, business, social, cultural or artistic processes

  • Mental processes performed solely in the human mind

  • Processes occurring in nature wholly independent of, and prior to, any human activity.

Under current law, the question of what constitutes a technological solution that would render an otherwise abstract idea patent eligible is a hotly contested one often determined on a case-by-case basis. The European Patent Convention’s eligibility exclusions include presentations of information and mathematical methods. However, if there is a technical use applied to those types of inventions, they are patent eligible.

The bill was reportedly drafted following three years of work by Senator Tillis’ team, including a series of US Senate hearings in 2019 with Senator Chris Coons (D-DE) and meetings with an array of industries. Updates will be posted to the IP Update blog as legislative developments warrant.

Practice Note: Readers are encouraged to check out the IP Update report that discusses a recent presentation by the PTO that shares recommendations for dealing with § 101 rejections during prosecution, which can be found here.

© 2022 McDermott Will & EmeryNational Law Review, Volume XII, Number 230
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About this Author

Brian J. Malkin Biotech Lawyer McDermott Will & Emery Law Firm
Partner

Brian Malkin counsels pharmaceutical and biologic clients on Food and Drug Administration (FDA) regulatory matters and intellectual property (IP) law, with an emphasis on patent litigation. His practice at the intersection of FDA- regulated products and patent law makes him a valuable partner to drug manufacturers, biotechnology clients, medical device companies and cannabis companies as they develop new products and protect their innovations though life cycle management, bring their products to market and pursue transactional opportunities.

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202-756-8045
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