Myriad's Composition of Matter and Method Claims Are Patent-ineligible: Federal Circuit | Practical Law

Myriad's Composition of Matter and Method Claims Are Patent-ineligible: Federal Circuit | Practical Law

In University of Utah Research v. Ambry Genetics Corp., a case addressing the same patents, but different claims, considered by the US Supreme Court in Association for Molecular Pathology v. Myriad Genetics, the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Utah's denial of plaintiff Myriad's motion for a preliminary injunction on the basis that the asserted patent claims were directed to patent-ineligible subject matter under 35 U.S.C. § 101.

Myriad's Composition of Matter and Method Claims Are Patent-ineligible: Federal Circuit

by Practical Law Intellectual Property & Technology
Published on 19 Dec 2014 • USA (National/Federal)
In University of Utah Research v. Ambry Genetics Corp., a case addressing the same patents, but different claims, considered by the US Supreme Court in Association for Molecular Pathology v. Myriad Genetics, the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Utah's denial of plaintiff Myriad's motion for a preliminary injunction on the basis that the asserted patent claims were directed to patent-ineligible subject matter under 35 U.S.C. § 101.
On December 17, 2014, in University of Utah Research v. Ambry Genetics Corp., the US Court of Appeals for the Federal Circuit affirmed the US District Court for the District of Utah's denial of a motion for a preliminary injunction on the basis that the asserted patent claims were directed to patent-ineligible subject matter (Nos. 2014-1361, -1366, (Fed. Cir. Dec. 17, 2014)). The Federal Circuit remanded the case to the district court for entry of an order consistent with its opinion. While this case involved the same patents previously considered by the US Supreme Court in Association for Molecular Pathology v. Myriad Genetics, the claims are different (133 S. Ct. 2107 (2013)).
For more information on Myriad, see Practice Note, In Dispute: Ass'n for Molecular Pathology v. Myriad Genetics.
Myriad's (plaintiff) invention involved the BRCA genes, mutations of which were correlated with an increased likelihood of certain cancers. The six claims at issue in the preliminary injunction motion included:
  • Four composition of matter claims directed to single-stranded DNA primer molecules.
  • Two method claims describing steps to compare a patient's BRCA gene sequence with the wild-type BRCA sequence.
The Federal Circuit held that the disputed composition of matter claims were not distinguishable from the isolated DNA found patent-ineligible by the Supreme Court in Myriad because DNA primer molecules were structurally identical to the ends of DNA strands found in nature. The Court further explained that:
  • Synthetically replicating the primer gene sequences does not make them patent-eligible.
  • Separating DNA strands or sequences from surrounding genetic material does not constitute an act of invention.
  • The primer does not perform a significantly different function than naturally occurring genetic sequences.
Consequently, the court held that the composition of matter claims were patent-ineligible under Section 101 of the Patent Act (35 U.S.C. § 101).
The Federal Circuit next held that the disputed method claims were also patent-ineligible. The court made this determination based on the two-step analysis set out in the Supreme Court's decision in Alice Corp. Pty. Ltd. v. CLS Bank Int'l (No. 13-298, (S. Ct. June 19, 2014)). Specifically the court separately treated the first and second paragraphs of the claims and determined that:
  • The first paragraph, which describes comparing BRCA sequences with the wild-type DNA sequences and determining alterations, with no restriction on the purpose of the comparison or the alteration being detected, is directed toward a patent-ineligible abstract idea.
  • The second paragraph, which describes the techniques to be used in making the comparisons, constitutes well-understood, routine and conventional techniques a scientist would use to compare two gene sequences.