A GVR order was recently issued in the Association of Molecular Pathology v. Myriad case in light of the recent Mayo v. Prometheus Supreme Court ruling.  The Federal Circuit is to analyze the applicability of the Supreme Court case of Mayo v. Prometheus to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent.

In 2010, the Molecular Pathology Court held that seven out of 23 patents related to the genes BRCA1 and BRCA2 linked to breast and ovarian cancer jointly owned by Myriad Genetics and the University of Utah Research Foundation do not qualify as patentable subject matter under 35 U.S.C. 101.

Myriad’s gene patents claim “isolated DNA” encoding the BRCA1 and BRCA2 genes and methods of detecting BRCA mutation and the use of cells transformed with BRCA to screen for potential drugs.  The Court, in ruling that “isolated DNA” does not qualify as patentable subject matter, compared isolated DNA to DNA in nature, stating that the patents were “improperly granted” because they involved a “law of nature,” even though the genes were isolated, which merely “circumvents the prohibition of the direct patenting of DNA in our bodies but which, in practice, reaches the same result.”

In 2011, the Molecular Pathology Federal Circuit overturned in part and upheld in part the District Court’s decision.  Specifically, the Federal Circuit overturned the District Court’s finding that the claims covering isolated gene sequences are invalid and overturned the invalidity of some of the diagnostic claims finding the claims for the diagnostic methods that only compare or analyze sequences, without a transformative step, are invalid.

In 2012, the ACLU filed a writ of certiorari which was eventually granted.  In light of Mayo v. Prometheus, the judgment of Molecular Pathology has been vacated and the case was remanded to the Federal Circuit for further evaluation.

Expect the Molecular Pathology Court to fully analyze the patentability standards of the claims associated with isolated DNA (defined as “substantially separated from other cellular components which naturally accompany a native human sequence”) in a restrictive Mayo v. Prometheus mindset.  The ruling could potentially have a huge impact on more than three decades of case law which holds that “anything under the sun that is made by man is patentable” (Diamond v. Chakrabarty, 447 U.S. 303, 309, 1980) and that natural substances are patentable if they are claimed as “isolated” or “purified” because such forms do not exist in nature (In re Kratz, 592 F.2d 1169, 1174, CCPA, 1979).

Stay tuned…

– Justin Ward


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