DNA Eligible for Patent Protection, Court Rules in Myriad (Again)

“Isolated DNA molecules are patent-eligible, reaffirmed the U.S. Court of Appeals for the Federal Circuit in Ass’n for Molecular Pathology et al. v. Myriad Genetics, Inc. et al., lifting a cloud of uncertainty over DNA composition patents.

‘The isolated DNA molecules before us are not found in nature. They are obtained in laboratory and are man-made, the product of human ingenuity,’ stated the Federal Circuit, on remand from the Supreme Court of the United States for further consideration in light of Mayo Collaborative Services v. Prometheus, Inc.” (McDermott Will & Emery)

Earlier this month, in a lawsuit remanded to the federal circuit by the U.S. Supreme Court, an appeals court reaffirmed Myriad Genetics’ right to patent its isolated genes BRCA1 and BRCA2, which have been linked to breast and ovarian cancer.

Critics, including the American Civil Liberties Union (which brought the case against Myriad), claimed that the genes were “products of nature” and as such should not be eligible for intellectual property protection. But the court disagreed.

For your reference, a roundup of commentary and analysis on this latest ruling and its implications:

Federal Circuit Breathes Life Back Into DNA Patents (McDermott Will & Emery):

“In an opinion that essentially tracked their prior analysis in 2011 before appeal to the Supreme Court, Judges Lourie, Moore and Bryson re-staked their positions. All three judges agreed that cDNAs and screening methods involving transformed cells are patent-eligible and method claims comparing or analyzing DNA sequences are not. The judges varied, however, regarding isolated genomic DNA molecules with sequences identical to those found in nature. Judges Lourie and Moore agreed that such isolated DNA molecules were patent eligible, but for different reasons.” Read on>>

Federal Circuit Renders Decision in “Gene Patenting” Case: Claims To Isolated DNA And Drug-Screening Method Claims Remain Patent Eligible, While Certain Diagnostic Method Claims Are Not Patentable Subject Matter (Phillips Lytle LLP):

“The focal questions that were before the court concerned whether claims to (i) isolated DNA, (ii) drug-screening methods, and (iii) analytical diagnostic methods fall within the judicially created ‘products of nature’ exception to § 101 eligibility. These questions were posed to the Federal Circuit on remand from the Supreme Court in view of their March 20, 2012 decision in Mayo Collaborative Services v. Prometheus, Inc.Read on>>

Association for Molecular Pathology v. USPTO and Myriad Genetics, Inc. – Federal Circuit, Again, Confirms Patent Eligibility of Isolated DNA (Bryan Cave):

“In a dissent, Judge Bryson asserted that isolating DNA from the human body is no more than ‘snapping a leaf from a tree.’ The majority found the analogy inapt: ‘[s]napping a leaf from a tree is a physical separation, easily done by anyone,’ while ‘[c]reating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.’” Read on>>

DNA Can Be Patented, but DNA Analysis Cannot: The Courts Finally Provide Clarity in Association for Molecular Pathology v. Myriad Genetics, Inc. (Bradley Arant Boult Cummings LLP):

“… this decision affirms the status quo regarding patenting DNA. However, this decision calls the future of personalized medicine into question. Based on this decision, it is clear that patent claims that merely recite mental steps such as comparing genetic information or analyzing genetic information are not valid. This is part of a larger legal trend, including the Supreme Court’s decision in Mayo, of imposing stricter requirements on patent claims that include purely mental processes.” Read on>>

On Remand, Federal Circuit Spreads Mayo on Myriad (Bracewell & Giuliani LLP):

“This decision by the Federal Circuit provides incremental guidance on the patent eligibility of medical diagnostic patents. Patent eligibility of claims that solely have comparing or determining elements associated with a natural correlation are likely in jeopardy. Claims that include steps involving the transformation of physical or informational elements appear to be in better shape to withstand a §101 attack. Additional steps such as novel testing techniques or testing reagents, or devices would strengthen medical diagnostic claims.” Read on>>

Personalized Medicine After the ACLU “Gene Patenting” Decision (Foley & Lardner LLP):

“This decision is definitely good news for the biotechnology community, at least in the short term. The patent-eligibility of isolated, naturally occurring materials remains, until further challenged at the Federal Circuit (by an en banc ruling), by appeal to the Supreme Court or by Congressional action. The court also provided further guidance on what ‘more’ is needed to transform a patent-ineligible method to one meeting the requirement of 35 U.S.C. § 101.” Read on>>

Federal Circuit Reaffirms (Again) Gene Patents in Myriad (Konstantin Linnik, JD, PhD):

“The Federal Circuit’s application of the Mayo case to Myriad’s claims on diagnostic methods provides little guidance on how to draft such diagnostic claims to secure allowance – and survive future patentability challenges. It is clear that the claims must recite something “transformative.” However, what constitutes a transformation in a diagnostic method remains to be elucidated. Moreover, the discussion of patentability for DNA sequences is far from being over. Should parties appeal in the next 90 days, the Supreme Court could again grant certiorari or there could be an en banc rehearing by the full Federal Circuit.” Read on>>

Association for Molecular Pathology v. United States Patent and Trademark Office (McDonnell Boehnen Hulbert & Berghoff LLP):

“In many ways, this decision reestablishes the status quo ante, and invites the Supreme Court to revisit its watershed decision on the expansive scope of patent eligibility, the Chakrabarty decision. Keeping in mind that Chakrabarty was decided by a vote of 5-4, this prospect, particularly in view of the (easily) perceived concerns and prejudices of the present Court, is disquieting.” Read on>>

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