December 9, 2020
Medical Design & Outsourcing
By Christopher C. Johns; Anthony D. Del Monaco; Eric P. Raciti
The recent Federal Circuit case American Axle Manufacturing v. Neapco Holdings LLC points out potential pitfalls for medical device manufacturers who are not cautious about how certain inventions are claimed in patents.
Recent U.S. Supreme Court decisions have made it more difficult to obtain patents. The courts are now using an “I-know-it-when-I-see-it” test for patent eligibility. This test had largely been confined to computer-implemented inventions and medical diagnostics, but in recent years has infiltrated all areas of patenting.
A recent case illustrates the potential risk to medical device manufacturers because of this shift. Careful claim drafting, however, can help to avoid the patent eligibility question.
The eligibility test (known as the “Mayo/Alice” test) can be summarized briefly as:
If this sounds vague to you, you are not alone. The Supreme Court failed to clarify what it meant by “significantly more,” and the lower courts and the U.S. Patent and Trademark Office have increasingly put more and more technological innovations in the broader “judicial exception” bin.
Most of the recent high-profile Supreme Court cases regarding patent eligibility have dealt with patents claiming concepts or properties of nature or science: software patents implementing the abstract concept of intermediated financial settlement (Alice in 2014) and hedging risk (Bilski in 2010), patents for drug administration requiring the application of a “natural law” to determine whether or not to increase dosage (Mayo in 2013), or patents for converting binary-coded numbers into binary numbers (Benson in 1972).
On July 31, 2020, the Court of Appeals for the Federal Circuit issued a revised opinion in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, finding method claims drawn to manufacturing a liner assembly for a driveline system ineligible as requiring the application of a natural law. Example liners are depicted in Figures 12-14 of the patent:
Originally printed in Medical Design and Outsourcing on December 9, 2020. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
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