Parties live to fight another day in gene patents battle

On Monday, the United States Supreme Court set aside the Court of Appeals decision in Association for Molecular Pathology v Myriad Genetics (Myriad Genetics case), ordering the Court of Appeals to reconsider its finding that gene patents for the detection of inheritable breast cancer were valid in light of the Supreme Court’s subsequent decision in Mayo Collaborative Services v Prometheus Laboratories Inc (Prometheus Laboratories case) handed down last week.

The Court of Appeals for the Federal Circuit held in July last year that Myriad Genetics’ patents, which claimed genetic sequences for the detection of inheritable breast cancer, were valid.  The basis for this decision was that while genes are products of nature and therefore not eligible for patent protection, genetic sequences isolated from their natural environment are not products of nature and were therefore eligible for protection.  This decision must now be reconsidered in light of last week’s Supreme Court decision in Prometheus Laboratories which held that claims to a diagnostic method did not transform an unpatentable natural law into a patent eligible application of that law because the additional steps in the claimed methods added “nothing of significance to the natural laws themselves”.

The Supreme Court’s decision to remit the Myriad Genetics case means that a final ruling on the validity of gene patents under United States law will be delayed for several more months.

A summary of the Court of Appeals decision in the Myriad Genetics case can be read here.

A summary of the Supreme Court’s decision in Prometheus Laboratories can also be read here.

Click here for a link to the Supreme Court’s orders.

About the Author

James Ellsmore
James is a senior associate with King & Wood Mallesons' Intellectual Property team in Sydney. James assists clients to resolve intellectual property disputes, with a particular focus on patents, pharmaceuticals and the life sciences. He has acted for a variety of clients in matters concerning patent infringement and revocation proceedings in the Federal Court of Australia, patent opposition proceedings before the Commissioner of Patents, and matters arising from patent licence and technology agreements. James also has experience in the preparation of commercial, R&D and IP agreements for leading universities, research organisations and pharmaceutical companies. He also advises clients on regulatory issues affecting clients in the industrials, consumer and health sectors.
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