'Isolated DNA' and Genetic Testing Ruled Ineligible for Patent Protection

Since the enactment of the 1952 Patent Act, courts have struggled to determine whether various new technologies are eligible for patent protection. Recent Federal Circuit decisions such as In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc) [enhanced version available to lexis.com subscribers /  unenhanced version available from lexisONE Free Case Law] and Prometheus Laboratories v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009) [enhanced version / unenhanced version], have been limited to the scope of patentable processes. The question of what is a patentable "manufacture" or "composition of matter" under Section 101 of the Patent Act has received less attention. In this Analysis, Allen E. White and Gina N. Shishima discuss Association for Molecular Pathology v. United States Patent and Trademark Office (No. 09 Civ. 4515), 702 F. Supp. 2d 181 (S.D.N.Y. 2010) [enhanced version], which addressed the aforementioned question and invalidated patent claims directed to "isolated DNA" representing the human genes for Breast Cancer Susceptibility Genes 1 and 2 ("BRCA l/2") as well as to processes for conducting genetic testing on those genes. The authors write:

The Parties

     The BRCA 1/2 patents are owned by the University of Utah Research Foundation and controlled by Myriad Genetics ("Myriad"), the patents' exclusive licensee. The plaintiffs include the Association for Molecular Pathology ("AMP"), a number of other medical groups, and individuals affected by breast cancer alleging personal harm due to Myriad Genetics' control over the genetic testing covered by the BRCA 1/2 patents.

     . . . .

     The court adopted Myriad's claim construction of "isolated DNA" to mean "a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome." Nevertheless, the district court held that such "isolated DNA" is not patentable subject matter.

     The district court stated that the term "isolated DNA" has been considered by some to be a "lawyer's trick" to circumvent the prohibition on patenting DNA in the body. The court observed that "purification of a product of nature, without more, cannot transform it into patentable subject matter. Rather, the purified product must possess 'markedly different characteristics' in order to satisfy the requirements of [35 U.S.C.] § 101." Applying this "markedly different" standard articulated in Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980) [enhanced version / unenhanced version], which concerned the patent-eligibility of a man-made micro-organism, the court determined the composition claims were invalid under Section 101 . . . .

(citations omitted)

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