University of Utah Research Foundation v. Ambry Genetics Corp.
774 F.3d 755
| Fed. Cir. | 2014Background
- Myriad Genetics owns patents covering BRCA1/BRCA2-related compositions and methods; it sued Ambry for selling BRCA test kits and sought a preliminary injunction.
- The appeal challenges four composition-of-matter claims (primers) and two method claims (screening by comparing patient BRCA sequences to wild-type).
- The Supreme Court previously held in AMP v. Myriad that isolated genomic DNA is not patent-eligible, but cDNA can be; this case addresses claims not previously resolved by the Supreme Court.
- The district court denied Myriad’s preliminary injunction, finding Myriad unlikely to prevail because the claims likely cover patent-ineligible subject matter under 35 U.S.C. § 101, while also finding irreparable harm and balanced public interest.
- The primer claims claim short synthetic single-stranded DNA sequences that match natural BRCA sequences; the method claims recite comparing a subject’s BRCA sequence to wild-type using routine techniques (hybridization, amplification, sequencing).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Are primer composition claims patent-eligible under § 101? | Primers are synthetic and single-stranded (not found in body); they are inventive lab-made reagents. | Primers are structurally identical to naturally occurring BRCA sequences and therefore unpatentable as products of nature. | Primers are patent-ineligible: they are identical in sequence/function to natural DNA and fall under Myriad’s rule excluding naturally occurring DNA. |
| Are the screening method claims patent-eligible under § 101? | The methods apply Myriad’s discoveries to practical diagnostic screening and thus are patent-eligible applications. | The claims are directed to an abstract idea (comparing sequences) and add only conventional, routine laboratory steps; Mayo/Alice render them ineligible. | Claims are directed to an abstract idea (sequence comparison) and the additional steps are routine; the claims are patent-ineligible. |
| Do the asserted claims warrant a preliminary injunction? | Myriad argued irreparable harm and market exclusion justify injunction while merits resolved. | Ambry argued Myriad unlikely to succeed on merits under § 101, so injunction should be denied. | District court denial affirmed because Myriad was unlikely to succeed on the merits (claims ineligible). |
Key Cases Cited
- Ass’n for Molecular Pathology v. Myriad, 133 S. Ct. 2107 (2013) (isolated genomic DNA not patent-eligible; cDNA may be eligible)
- Mayo Collaborative Servs. v. Prometheus Labs., 132 S. Ct. 1289 (2012) (claims that merely apply natural correlations using routine steps are patent-ineligible)
- Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347 (2014) (two-step framework for abstract-idea § 101 analysis; inventive concept required)
- Diamond v. Chakrabarty, 447 U.S. 303 (1980) (patent eligibility requires a human-made markedly different composition)
- In re Roslin Inst. (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014) (cloned animals that are genetic replicas of natural animals are unpatentable)
- Gottschalk v. Benson, 409 U.S. 63 (1972) (claims to abstract mental processes or algorithms are not patent-eligible)