The United States Court of Appeals for the Federal Circuit ruled, in July 2011, that claims pertaining to deoxyribonucleic acid (DNA) and related diagnostic tests are patentable.1
Before reviewing the conclusions of this decision that reversed that of the District Court for the Southern District of New York and its impact on our side of the border, we propose to briefly review the circumstances of this judgment.
MYRIAD'S PATENTS AND DIAGNOSTIC TESTS
During the 90s, Myriad Genetics Inc. ("Myriad"), along with several university research centres, conducted studies to identify the BRCA1 and BRCA2 genes, whose mutations are associated with an increased risk of developing certain forms of breast and/or ovarian cancer. These two genes and the methods associated with the diagnostic tests used to identify these mutations were patented by Myriad and other inventors in August 1994 (BRCA1) and December 1997 (BRCA2).
Myriad has granted licences for these tests in several countries. In Canada, MDS Laboratory Services, based in Toronto, has obtained an exclusive licence for the purpose of offering these tests.
Several parties have challenged Myriad's monopoly, alleging that the exclusivity held for the identification of a mutation of these genes in a patient allowed it to charge a price that is higher than the actual cost of the tests, which, in practice, precludes certain patients from undergoing them.
ASSOCIATION FOR MOLECULAR V. PTO
In May 2009, a group composed of medical associations, researchers and patients sought a declaration that fifteen claims from seven patents held, among others, by Myriad and the University of Utah Research Foundation concerning the BRCA1 and BRCA2 genes were drawn to patent-ineligible subject matter. In order to rule on this complaint, the U.S. courts had to review the practices of the United States Patent and Trademark Office (USPTO) respecting the issuance of patents on genes and then rule on the issue of patentability.
In a decision constituting a change of paradigm, the District Court invalidated the claims in certain of Myriad's patents respecting the BRCA1 and BRCA2 genes, particularly those relating to isolated DNA sequences and the methods of DNA comparison and analysis to identify the presence of mutations.
In a split decision, the Court of Appeals reversed the District Court's decision, mainly stating that:
- The cDNA molecules (complementary DNA) and isolated DNA molecules are patentable. The three judges were unanimous on the issue of patentability of cDNA, except for very short sequences since it results from human manipulation and does not exist in nature. However, the justices were divided over the issue of the patentability of isolated DNA molecules, which have been cleaved or synthesized to consist of just a fraction of a naturally occurring DNA molecule. In fact, the justices disagreed on the scope of manipulation necessary to isolate the DNA in question: the majority was of the view that it amounted to more than a simple purification and the isolated DNA was significantly different, having an identity and chemical composition different from DNA in its natural state, while the minority justice merely saw a simple rupture of covalent bonds;
- The claims concerning the methods of using of DNA for screening therapeutic agents against cancer meet the requirements of the machine or transformation test and thus, are patentable. These claims concerned the methods for analysing the changes in cell growth with or without treatment, and, according to the Court, include transformation steps and represent functional and palpable applications for the field of biotechnology;
- The claims respecting the methods for comparison and analysis of the DNA sequences were invalidated since they failed to meet the requirements of the machine or transformation test. In fact, the Court ruled that the wording of the claims only amounted to a simple abstract mental process for comparing DNA sequences.
In doing so, the Court dismissed the approach proposed by the U.S. government who sought to have the patents respecting DNA molecules invalidated by proposing to apply an analysis based on the "magic microscope" test. According to such, if an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers unpatentable subject matter.
The Court of Appeals also refused to modify the well-established practice of the USPTO to deliver DNA-related patents on the ground that it was up to the legislators to decide whether to prohibit the issuance of such patents. The Court was of the view that to decide otherwise could have significant effects on the industry's expectations and may ultimately hinder innovation. In fact, the Court noted that in the last 29 years, the USPTO had issued 2,645 patents respecting isolated DNA and, since 2005, 40,000 patents respecting DNA without distinction were issued.
It is interesting to note that although underlying moral and ethical issues related to granting ownership rights in portions of human DNA were mentioned by a justice, the Court chose not to use its judicial power, rather referring these issues to the U.S. Congress.
IMPACT IN CANADA
In Canada, the Canadian Commissioner of Patents has issued and is still issuing patents respecting DNA. In 2004, in the Mosanto case, the Supreme Court of Canada issued a close 5 against 4 decision confirming that a gene and a cell are patentable. The Court also noted, on this occasion, that it is incumbent on the person challenging an issued patent to demonstrate that the Commissioner was erred in allowing the patent application.
In view of its potential impacts on our Canadian regime, various industry stakeholders have closely followed the Myriad case. If the U.S. Court of Appeals had invalidated Myriad's patents, it may have had significant effects on the entire Canadian biotechnological industry.
In short, we note that this decision maintains the possibility of patenting DNA in the United States, which indirectly supports the Canadian position in this respect.
1. Moreover, on September 12, 2011, the same court refused to revise its decision.
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