biolink Legal Column - September 2014
Wednesday, September 24, 2014
Isolated Genes are Still Eligible for Patent Protection Outside of the U.S.
Rebecca Cantor, Associate, Brooks Kushman
In the mid-1990s, Myriad Genetics, in collaboration with other institutions, discovered the BRCA1 and BRCA2 genes, which can be used to predict whether an individual will develop certain types of breast and ovarian cancer.i After discovering these genes, Myriad filed a number of patent applications that claimed, among other things, the isolated sequences for these genes.ii Using these patents, Myriad was able to maintain a monopoly on diagnostic testing for the BRCA1 and BRCA2 genes.iii As a result, diagnostic testing for mutations in these genes became very expensive.iv Many diagnostic laboratories, patients, and other advocacy groups did not believe that it was appropriate for Myriad to be able to claim an isolated gene sequence, and filed a lawsuit against Myriad seeking to have the claims directed to the isolated gene sequences declared invalid.
In 2013, the case, styled Association for Molecular Pathology v. Myriad Genetics, Inc., wound up in front of the U.S. Supreme Court, which held that isolated genes did not qualify for patent protection.v In particular, the Supreme Court found that isolated gene sequences were a natural phenomenon and thus were not patent eligible subject matter under 35 U.S.C. § 101.vi, vii As a result, isolated gene sequences can no longer obtain patent protection in the United States.
Recent events in Australia, however, show that claims directed towards isolated genes may remain viable in other countries. Like in the United States, the patentability of Myriad’s BRCA patents was challenged in Australia. On September 5, 2014, the Federal Court of Australia found that isolated gene sequences could be patented, and upheld the validity of the BRCA patents.viii The Australian Court even went so far as to criticize the U.S. Supreme Court’s ruling stating:
With respect, the Supreme Court’s emphasis on the similarity of “the location and order of the nucleotides” existing within the nucleic acid in nature before Myriad found them is misplaced. It is the chemical changes in the isolated nucleic acid which are of critical importance, as this is what distinguishes the product as artificial and economically useful.ix
While this ruling can still be appealed to the High Court of Australia, at least for the moment isolated genes are patent eligible subject matter in Australia.
The European Patent Office also allows for the patentability of isolated gene sequences. This policy is sent forth in a directive issued by the European Union on July 6, 1998, which confirmed that isolated biological materials, such as gene sequences, are patentable subject matter.x This directive has since been implemented by all European Union member states.xi It should be noted, however, that while isolated gene sequences are considered patentable subject matter in Europe, they must still meet all other requirements for patentability, particularly the industrial application of the gene sequence.xii
Countries around the world are continuing to grapple with the costs and benefits of allowing isolated gene sequences to be patented, and it seems likely that the law on this subject will evolve over the coming years. For the time being, however, isolated genes remain patentable subject matter in many countries, despite their lack of patentability in the United States.
i Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. C.t 2107, 2112-13 (2013).
iii Id. at 2114.
v Id. at 2117-20.
vi 35 U.S.C. §101 provides that “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” The Supreme Court had long held that this section prohibits patent protection for laws of nature, natural phenomena and abstract ideas. See Myriad, 133 S. Ct. at 2116.
vii The Supreme Court did note that their decision in Myriad did not implicate “new applications of knowledge about the BRCA1 and BRCA2 genes,” which could be patent eligible subject matter under 35 U.S.C. §101. Id. at 2120.
viii D’Arcy v. Myriad Genetics Inc.,  FCAFC 115.
ix Id. at ¶215.
x See EU Directive 98/44/EC at ¶ 20, which states that:
Whereas, therefore, it should be made clear that an invention based on an element isolated from the human body or otherwise produced by means of a technical process, which is susceptible of industrial application, is not excluded from patentability, even where the structure of that element is identical to that of a natural element, given that the rights conferred by the patent do not extend to the human body and its elements in their natural environment.
xi http://www.epo.org/news-issues/issues/biotechnology.html, accessed September 12, 2014.