Intellectual Property Primer

a lex-warrier initiative

Patentability of naturally occurring DNA

The question came up for its consideration before the Supreme Court of United States of America was, whether naturally occurring DNA s (Deoxyribonucleic acid) can be patented? Though, diagnostic claims were already in question, patent office of the United States used to accept patents on isolated DNA sequences as a composition of matter.

Validity of gene patents that cover isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences was challenged in Association for Molecular Pathology v. Myriad Genetics, Inc., No. 12-398 (569 U.S. ___ June 13, 2013).District court’s decision that, the claims are non-patentable was reversed by the United States Court of Appeals for the Federal Circuit and the same was challenged before the Supreme Court.

Association for Molecular Pathology v. Myriad Genetics, Inc.

Facts: Myriad Genetics, Inc. a start-up research institute in association with its research partners discovered two genes names as BRCA1 and BRCA2, which can develop breast cancer at some point of time.Myriad Genetics, Inc. claims patents on the isolated BRCA genes along with cDNA (Complementary DNA), which is a synthetic product that mirrors the coding sections of the BRCA genes, and primers used in diagnostics.

In this case it was alleged that, Myriad Genetics, Inc. only isolated the gene and it did not made any modifications to the already existing gene. Further, it was claimed that, the isolated gene performs the similar functions as that of the natural one.A narrowing or a broadening of current subject-matter eligibility will have significant effects on the incentives for inventors as well as what information is available for and usable by the general public. Supreme Court through its judgement in this case has enlarged the scope the subject matter of patent.

Opinion of the Court

While delivering the Opinion of the Court, JUSTICE CLARENCE THOMAS held that, a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring. Court further observed that, the processes used by Myriad Genetics, Inc. to isolate DNA at the time of Myriad’s patents were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach. It is also significant to note that, genes are not patentable even under 35 U.S.C. 101.

However, while dissenting the Opinion of the Court, JUSTICE ANTONIN SCALIA opined that, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the Naturally occurring DNA; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.