Myriad Genetics Ruling That DNA Is Patent-Eligible

We’re seeing significant interest in the Myriad Genetics case, Association for Molecular Pathology v. U.S. Patent and Trademark Office, following the July 29, 2011, Court of Appeals for the Federal Circuit ruling that isolated DNA are patent-eligible subject matter. We’ll continue to update this reading list as additional commentary and analysis comes in:

A Non-infringing Party Who Had Rejected a License Had Standing to Sue for Declaratory Judgment of Patent Invalidity (Venable LLP):

“Most of the publicity surrounding that decision naturally focused on the court’s holdings on the patentability of isolated DNA molecules and various claims to testing methods. However, the court’s resolution of the threshold issue of declaratory judgment jurisdiction also deserves attention. The panel unanimously found that one of the many plaintiffs — a non-infringing party who had rejected a license more than ten years ago – had standing to challenge the validity of Myriad’s patents. Slip. Op. at 8. The panel’s reasoning suggests that the result would have been the same if the plaintiff was a current licensee – which has implications for all patent-holders.” Read more»

Isolated DNA Molecules Are Patentable Chemical Entities, and Patent-Eligible Diagnostic Methods Must Include Transformational Steps (Sutherland Asbill & Brennan LLP):

“In a vindicating win for the biotechnology industry, the Court of Appeals for the Federal Circuit in Assoc. for Molecular Pathology v. Myriad Genetics, Inc. (Fed. Cir. No. 2010-1406) on July 29, 2011, reversed the lower court and held that “isolated” DNA, including genes and sequence-specific probes for detecting breast and ovarian cancer, are patent-eligible subject matter, since these molecules are “markedly different” new chemical entities that do not exist in nature. The Federal Circuit further found Myriad’s method claims for screening therapeutic candidates to be patent-eligible since the claims recite transformative steps, rather than merely mental comparisons between sequences, but found the diagnostic method claims to be too abstract.” Read more»

Federal Circuit Decides Myriad: Holds Isolated Genomic DNA Patentable (Dechert LLP):

“On July 29th, the Federal Circuit handed down its decision in the much-discussed Association for Molecular Pathology v. U.S. Patent and Trademark Office (commonly known as the “Myriad Genetics” case). The Federal Circuit split the baby — finding Myriad’s isolated BRCA DNA claims patentable, but its method claims for analyzing patients for mutations in these genes unpatentable.” Read more»

Federal Circuit Reverses N.Y. District Court: Claims to “Isolated” DNA Are Eligible for Patent Protection (Duane Morris LLP):

“The district court ruling had unsettled the biotechnology industry by invalidating certain patent claims directed to the genes BRCA1 and BRCA2, which, if mutated, increase susceptibility to breast cancer, and to methods of diagnosis using BRCA sequences. The plaintiffs, including the ACLU, a number of medical associations and doctors, and the Public Patent Foundation, challenged Myriad’s patents as invalid and unconstitutional, and the district court granted their motion for summary judgment. The district court reasoned that isolated DNA was patent-ineligible because it is a product of nature and the claims to diagnostic methods were ineligible because they constituted nothing more than natural phenomena. Myriad appealed.” Read more»

Federal Circuit Validates Claims Drawn to Isolated DNA, Invalidates Claims Drawn to Analyzing or Comparing DNA without Transformation Step (Wilson Sonsini Goodrich & Rosati):

“Several factors in this case mean that it is “business as usual” for claims involving isolated DNA sequences. First, the claims drawn to isolated DNA were upheld as valid, so older patents with such claims are still valid and newly filed or pending applications with such claims will continue to be examined by the U.S. Patent and Trademark Office (PTO) under the same rules that have been in place for decades. Second, the method claims held invalid in this decision do not recite any machine, apparatus, or transformative step—limitations that post-Bilski claims typically contain. Thus, diagnostic companies typically will be in the same legal position as they were prior to this decision.” Read more»

Federal Circuit Holds that “Isolated DNA Molecules” Are Patentable Subject Matter and Method Claims Merely “Comparing” or “Analyzing” Are Not (Sheppard Mullin Richter & Hampton LLP):

“In the 55-page opinion, written by Judge Lourie, the Federal Circuit held that composition claims covering two isolated human genes are patentable subject matter but method claims devoted to methods of “analyzing” or “comparing” a patient’s isolated DNA sequence with the “normal” sequence are not patentable subject matter. The challenged composition claims cover isolated genes BRCA1 and BRCA2 (collectively, “BRCA1/2” or “BRCA”) and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers.” Read more»

Federal Circuit decision reversing District Court under Section 101 – Isolated DNA is Patentable (Kevin Buckley / RatnerPrestia):

“On the merits, the Court reversed the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature. The Court also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle. However, the Court affirmed the district court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.” Read more»


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