UNIVERSITY OF UTAH RESEARCH V. AMBRY GENETICS CORP. 3 F. SUPP. 3D 1213
FACTS
- The plaintiffs are the University of Utah Research Foundation, The Trustees of the University of Pennsylvania, HSC Research and Development Limited Partnership, Endorecherche, Inc., and Myriad Genetics, proclaimed encroachment of three of their patents. The University of Utah is the co-owner of three of the patents issued Patents. The patents cover the BRCA1 and the BRCA2 genes.
- The respondents, Ambry Genetics are a clinical diagnostic and genomic services company, they offer medical tests which claim to possibly detect genes that show breast and ovarian cancer related risks.
PROCEDURAL HISTORY
- Myriad appealed from a decision of the District Court for the District of Utah denying Myriad’s motion for preliminary injunction, which was requested with a view to stop Ambry’s sale of the cancer test kits. The District Court denied the said Preliminary injunction because it stated that the subject matter in question was patent ineligible.
ISSUE
- Whether the subject matter is patent eligible and therefore, whether Plaintiffs can prevent Ambry Genetics from selling the kits on the basis of infringement of patent?
HELD
- In the case Association for Molecular Pathology v. Myriad Genetics (2013), it was established that Myriad and its partners discovered the precise locations and sequences of the BRCA1 and BRCA2 genes, mutations of which are linked to hereditary breast and ovarian cancers. The Supreme Court held that "genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material." The court stated that the subject matter is ineligible because they are isolated DNA strands, which are naturally occurring and distinguished from the rest of the human genome, and thus, are natural phenomena.
- Primers do not alter the underlying, naturally occurring DNA sequence that is being read. Therefore, they do not alter the underlying DNA's functional properties or identity for the purposes of genetic testing. The primers in question in this case were not found to be very different from the isolated DNA fount to be patent ineligible in the Association for Molecular Pathology v. Myriad Genetics
- In the present case, the Court first observed that Myriad did not "create or alter": 1) "any of the genetic information encoded in the BRCA1 and BRCA2 genes," as the "location and order of the nucleotides existed in nature before Myriad found them". Hence, the Court held that the subject matter in question is patent ineligible because it is not ‘inventive’ in nature. Thus, all the asserted claims were held to be patent-ineligible.
- In regards to the methods claims, the Court cited Mayo Collaborative Services v. Prometheus Laboratories Inc. case, ‘a that a process focusing on a law of nature, natural phenomenon, or an abstract idea may be patent eligible, but only if it incorporates another "inventive concept"’. In the present case, the Court held that the method claims were ineligible – because they encompassed the detection of any BRCA1/BRCA2 mutation for any purpose did not recite significantly more than a patent-ineligible “abstract idea’. The two method claims involved comparisons between the wild-type BRCA sequences with the patient’s BRCA sequences. The court reasoned that these method claims were ineligible because “the only ‘inventive concepts’ in the method claims are the patent ineligible naturally occurring BRCA1 and BRCA2 sequences themselves.”
- The Court also cited the case Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014), laws of nature are not the only implicit exception to patentable subject matter identified by 35 U.S.C. § 101. Natural phenomena and abstract ideas are also not patentable. Conclusion: The claims on appeal are directed to ineligible subject matter in violation of 35 U.S.C. § 101. Therefore, the district court properly denied Myriad’s motion for preliminary injunction. We remand to the district court for an entry of an order consistent with this opinion; Affirmed and remanded.