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Are Human Genes Patentable? It depends,

Posted in Biotechnology, Development & Commercialization of Technology, Intellectual Property Litigation, Nanotechnology, Patent Counseling & Strategies, Technology News & Events, Technology Transactions

On June 13, 2013, the U.S. Supreme Court issued a unanimous decision on the issue of whether or not human genes are patentable.  In Association for Molecular Pathology v. Myriad Genetics, Inc. (the Myriad decision), the Court unanimously held that naturally occurring deoxyribonucleic acid (DNA) segments are products of nature and not patent eligible, even in isolated form.  However, the Court held that complementary DNA segments (also known as cDNA) are patent eligible because they are not naturally occurring (i.e., not products of nature)[i].

The Myriad decision creates clarity and uncertainty.  For instance, the Myriad decision creates clarity regarding the lack of patentability of isolated gene sequences.  However, the Myriad decision creates uncertainty for other classes of naturally occurring molecules that are regularly isolated and utilized for biological applications (e.g., antibodies, antisense RNA, interfering RNA, etc.).  In particular, the patentability of certain isolated molecules may now fall into question.

Nonetheless, inventors can be able to protect their biomolecular inventions by using language that distinguishes their inventions from naturally occurring molecules.  Furthermore, inventors can still pursue inventions that pertain to methods of utilizing or applying isolated gene sequences.   In fact, the Myriad decision made it clear that method claims utilizing or applying isolated gene sequences could still constitute patent eligible subject matter.


[i] By way of background (and as set forth in the Myriad decision), human genes are encoded as DNA.  DNA takes the shape of a “double helix”, where each “cross-bar” in the helix consists of two chemically joined nucleotides.  Sequences of DNA nu­cleotides contain the information necessary to create strings of amino acids used to build proteins in the body.  The nucleotides that code for amino acids are “exons.”  The nucleotides that do not code for amino acids are “introns.”  Sci­entists can extract DNA from cells and isolate specific DNA segments. Scientists can also synthetically create exon-only strands of nu­cleotides known as complementary DNA (cDNA).  cDNA contains only the exons that occur in DNA.  cDNA omits the intervening introns.