This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
In a 9-0 decision (with brief concurrence by Justice Scalia) in Association for Molecular Pathology v. Myriad (‘Myriad’), argued April 15, 2013 and decided June 13, 2013, the U.S. Supreme Court both strikes down and upholds selected gene patents. Delivered by Justice Clarence Thomas, the Court’s decision:
- Invalidates gene patents relating to the isolated BRCA1 and BRCA2 genes on the basis that they are naturally occurring, and
- Allows gene patents for synthetic DNA created in the laboratory and known as complementary or cDNA given that it is not identical to DNA in its natural state.
With regard to the BRCA1 and BRCA2 gene patents, Myriad patent claims identified the location and sequence of these genes in the human body and claimed the isolated DNA coding itself as the invention without any further inventive step. The holding of the Court explains why these claims fail meet the statutory requirements for patentability under the Patents Act (35 USC §101):
Myriad’s DNA claim falls within the law of nature exception. Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes. Diamond v. Chakrabarty, 447 U. S. 303, is central to the patent-eligibility inquiry whether such action was new “with markedly different characteristics from any found in nature,” id., at 310. Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.
The Myriad decision distinguishes the BRCA1 and BRCA2 patent claims from those relating to cDNA, upholding as permissible the patenting of genetic inventions that “create or alter” genetic information, including synthetic DNA created in the laboratory and known as complementary or cDNA. The Court notes that cDNA “contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins.”
The Court emphasizes the role of human agency, noting that “the lab technician unquestionably creates something new when cDNA is made.” cDNA production, though, may take place without human agency. (For example, retroviruses like HIV-1 and HIV-2 produce cDNA for integration in the host genome, a fun fact that the Myriad decision does not address.)
All in all, the Myriad decision should not adversely affect the patentability of a broad swath of gene-based inventions. The ability of a patent applicant to avoid the law of nature exception, i.e, to “create or alter” DNA – whether via cDNA or through use of plasmids – limits the prospective impact of the case.
And, while referencing USPTO past practice in issuing the BRCA1 and BRCA2 gene patents, the Court skirts the issue USPTO practice with regard to utility or inventive step. In fact, the USPTO implemented heightened utility requirements that disallowed patent applications for a newly discovered gene without a clearly demonstrated and specific use, effective January 5, 2001. This heightened utility requirement should narrow considerably the universe of gene patents affected by the Myriad decision.
Finally, Justice Scalia’s brief concurring opinion states that he is unable join in the entirety of the Court’s opinion due to lack of personal knowledge of, or belief relating to, “fine details of molecular biology.” While his candor is praiseworthy, it also underscores the clear need for continuing judicial dialogue on biotechnology, other advanced technologies and the intersection of science and commerce.
Susan K. Finston is President of Finston Consulting LLC, and, together with biotechnology pioneer Ananda Chakrabarty, is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivoresearch. She is currently preparing to launch her first Crowd Funding campaign for Amrita Therapeutics first-ever therapeutic oncology medical device. For more information see AmritaTherapeutics.com or FinstonConsulting.com.
Thank you for a very clear exposition – and god luck with your crowd funding and on-going research.