Can Genes Be Patented?

On Friday, the Supreme Court granted partial cert. in the Assoc. For Molecular Pathology v. Myriad Genetics, Inc., 12-398.  In other words, the Supreme Court agreed to decide only the first issue presented:

Can human genes be patented?

Myriad Genetics obtained patents for two genes, BRCA1 and BRCA2.  Mutations of these genes correlate with an increase risk of hereditary breast and ovarian cancer.  The patent claims include “every single natural variation of the genes, including those that have not yet been isolated.”

The Association for Molecular Pathology claimed the patent inhibited scientific research and prevented patients from accessing their own genes.  Further, the Association stated that because gene variation is created naturally.

Myriad claimed that the PTO has long recognized that claims to “isolated” molecules of DNA reflect human-made, patent-eligible inventions.  In fact, the PTO has issued over 40,000 patents drawn to DNA-related subject matter.

The District Court invalidated the patent on the grounds the patented genes were not “markedly different.”  The District Court held that Myriad did not “alter its essential characteristic – its nucleotide sequence that is defined by nature and central to both its biological function within the cell and its utility as a research tool in the lab.”

A divided 2-1 Federal Circuit found these genes were patentable.  On remand following the decision of Mayo, the divided panel did not change their decision.

Myriad pointed to the lead opinion’s interpretation of Mayo.  The lead opinion observed that “[w]hile Mayo and earlier decisions concerning method claim patentability provide valuable insights and illuminate broad, foundational principles, the Supreme Court’s decision in Chakrabarty and Funk Brothers set out the primary framework for deciding the patent eligibility of compositions matter, including isolated DNA molecules.”

The Association pointed to Judge Lourie’s and Judge Bryson’s statements regarding Mayo.  Judge Lourie stated that Mayo “clearly ought to apply equally to manifestations of nature (composition claims).”  Judge Bryson, in his dissenting opinion, interpreted Mayo’s method as asking whether the applicant made an “inventive” contribution to the product of nature.

The NY Times has an interesting article here.



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Filed under Appellate, courts, legal decision, Supreme Court

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