Nutter Attorneys Represent Seven Major International Biotech Industry Associations at the U.S. Supreme CourtPrint PDF
A broad coalition of the biotechnology industry associations filed an amici brief in a seminal patent case Sequenom v. Ariosa, currently pending petition for review by the U.S. Supreme Court. Nutter attorneys filed the brief on behalf of the UK BioIndustry Association (BIA), EuropaBio, AusBiotech, Swiss Biotech Association, HollandBio, BioteCanada, and the Japan BioIndustry Association. The amici expressed a broad worldwide support urging the U.S. Supreme Court to reconsider the interpretation of patentable subject matter under 35 USC 101 and arguing that the current approach hinders investment in the development of new diagnostics and life-saving medicines.
The brief as filed can be accessed here.
“The current U.S. jurisprudence puts the U.S. out of synch with the rest of the industrialized world,” said Konstantin M. Linnik, Ph.D., partner in Nutter’s Intellectual Property Department and one of the authors of the brief. “It effectively deprives the emerging field of personalized medicine of any intellectual property protection in the U.S., while most other countries are taking a different approach.”
The coalition of the biotech associations, collectively representing thousands of member companies across the world, expressed concerns over the disparity of patent-eligibility standards in the U.S. and equivalent issues by courts and patent offices in Europe, Australia, Canada, and Japan. The recent legal developments in the U.S. frustrate the long-standing international efforts to harmonize intellectual property laws. Such harmonization is essential to support the development of new diagnostics and personalized medicines in an increasingly interconnected, global market.
Sequenom’s new procedure, which is already available to patients, eliminates the need for risky amniocentesis which was previously used to assess genetic abnormalities during pregnancy.
In 2015, the Federal Circuit ruled that Sequenom’s fetal DNA test was not eligible for patenting. It found that under the Supreme Court precedent, the patented technology was not an invention, but merely the application of a well-understood, routine technique applied to the natural phenomenon of paternally-inherited fetal DNA present at low levels in the mother’s blood. However, Sequenom claims that the idea of applying the detection method to their ground-breaking discovery was new and therefore patentable. In addition to the U.S. patent, Sequenom was awarded similar patents in Europe, Canada, Japan, and Australia.
The brief submitted by Nutter argues that the ruling of the lower court in Sequenom is the result of an over-broad interpretation and application of the U.S. Supreme Court’s 2012 decision in Mayo v. Prometheus. If left unchanged, the prior ruling could prevent patents on any method that involves something naturally occurring–a fragment of a gene, a biomolecule, a correlation of biomarkers, or new disease treatments relying on the same. As currently stands, U.S. patent case law on patent eligibility is inconsistent with laws in Europe, Canada, Australia, and Japan, among others.
The Nutter attorneys who co-authored the brief with Linnik include Lana A. Gladstein and Isaac A. Hubner, Ph.D. The U.S. Supreme Court is expected to rule in June whether to take the case up for review.
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