CODING FOR LIFE - SHOULD ANY ENTITY HAVE THE EXCLUSIVE RIGHT TO USE AND SELL ISOLATED DNA?

Douglas L. Rogers

Abstract


Myriad Genetics, Inc. ("Myriad") obtained patents in the 1990s on two "isolated" human breast and ovarian cancer susceptibility genes ("BRCA").  Myriad did not list all the isolated sequences it claims to have a right to monopolize, but instead claims a patent on the physical phenomena itself  -- all DNA segments that code for the BRCA1 polypeptide, even the sequences Myriad has not identified and even those someone else in the future creates or isolates the sequences of through a method or methods not contemplated by Myriad. An impressive array of non-profit medical societies, doctors and patients sued to have the Myriad patents declared invalid.  In 2010, the District Court for the Southern District of New York held in Association for Molecular Pathology v. United States Patent and Trademark Office that the claimed product patents for isolated DNA segments constituted unpatentable subject matter under 35 U.S.C. §101.  On July 29, 2011, a divided panel of the Federal Circuit reversed the District Court and held that the isolated DNA segments constituted patentable subject matter.  Of the three member panel, Judge Lourie concluded that the isolated DNA was markedly different than the native DNA, so constituted patentable subject matter.  Although Judge Moore agreed that certain DNA segments constituted patentable subject matter, she believed that the longer isolated DNA segments probably did not constitute patentable subject matter.  However, primarily in light of the fact that the US Patent and Trademark Office has been granting patents for isolated DNA  for years, Judge Moore concurred in the judgment of Judge Lourie.  Judge Bryson concurred on one of the product claims  (for synthetic cDNA) but dissented on claims pertaining to the isolated DNA segments on the grounds that isolated DNA did not differ markedly from the native DNA and that the function of the isolated DNA was identical to the function of the native DNA.The Supreme Court stated that "Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the  public domain, or to restrict free access to materials already available."  This article argues that the Federal Circuit - not Congress - has done just that and has given Myriad a wall to restrict free access to materials that have literally been in humans for centuries.  The isolated DNA segments of claim 1 do exactly the same coding as do the native segments--nothing more; nothing less.  The segments of claim 1 do not act as primers or probes, so they do not have markedly different characteristics or utility than native DNA, which the Supreme Court has ruled courts must consider.  Moreover, the functioning of the sequence of the nucleotide bases is a physical phenomenon that Myriad has not created but has captured in its claim.  Judges Lourie and Moore disregarded Supreme Court precedent and the fundamental principle that physical phenomena are not patentable subject matter.

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DOI: http://dx.doi.org/10.5195/tlp.2012.93

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