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One of the most hotly debated topics in intellectual property rights is the patentability of genes. Since the Supreme Court’s 1980 decision in Diamond v. Chakrabarty,1 patenting DNA sequences has become common; today there are about 50,000 such patents. A 2009 lawsuit by the American Civil Liberties Union (ACLU) against Myriad Genetics threatens to undo the significant history behind the patent eligibility of gene sequences.
Myriad owns patents to both the BRCA1 and BRCA2 genes. In filing a lawsuit against Myriad, the ACLU and the Public Patent Foundation (PUBPAT) alleged that 15 claims from 7 patents assigned to Myriad are unpatentable. The lawsuite challenges patents to two “isolated” genes, BRCA1 and BRCA2, as well as methods of analyzing and comparing the gene sequences that determine whether the mutations that may confer an increased risk of breast or ovarian cancer are present.
To be patent-eligible, an invention must be a “process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.”2 Generally, anything humanly created can qualify for patent protection. On the other hand, laws of nature, natural phenomena, and products of nature are excluded.3 The question is whether Myriad’s isolated gene sequences and methods are excluded.
On March 29, 2010, U.S. District Court Judge Robert W. Sweet declared Myriad’s claims to the isolated gene sequences to be unpatentable, and thus, invalid.4
Sweet argued that isolated DNA must have “markedly different characteristics” from the DNA found in nature to be patentable. The District Court also found that because the method for analyzing or comparing covered mental processes, it failed the machine-or-transformation test — which holds that a process can be patented if it is carried out by a machine or transforms something from one state to another.
On July 29, 2011, the U.S. Court of Appeals for the Federal Circuit reversed the lower court’s decision in part and upheld it in part. The court found that isolated DNA is physically distinct from genomic DNA and thus is patentable.5 The court also found the method claim directed to screening potential cancer therapeutics to be patent-eligible because it contained “transformative steps.” The court, however, found the method claims related to “comparing” and “analyzing” DNA sequences to be patent-ineligible because they covered only mental steps.
Myriad appealed the Federal Circuit’s decision to the Supreme Court, which remanded the case back to the Federal Circuit following its recent ruling in Mayo v. Prometheus.6 After reconsideration, the Federal Circuit again found the claims to isolated DNA to be patent-eligible under 35 USC Section 101. The courts based this on the fact that the claimed isolated DNA molecules are distinct chemical entities as compared with DNA in its natural form and are thus products of human ingenuity. According to its decision on Aug. 16, 2012, the Federal Circuit held that:
“Natural DNA exists in the body as one of 46 large, contiguous DNA molecules. Each of those DNA molecules is condensed and intertwined with various proteins, including histones, to form a complex tertiary structure known as chromatin that makes up a larger structural complex, a chromosome....Isolated DNA, in contrast, is a freestanding portion of a larger, natural DNA molecule. Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule.”7
The Federal Circuit also found that the method for screening potential cancer therapeutics by changes in growth rates of transformed cells to be patent-eligible because the transformed cells arose from human effort. Similar to the cells in Chakrabarty, the host cells are derived by “altering a cell to include a foreign gene, resulting in a man-made, transformed cell with enhanced function and utility.”
The claims for comparing or analyzing DNA sequences, however, were found patent-ineligible as they encompassed only abstract mental processes. The Federal Circuit said these claims were indistinguishable from claims the Supreme Court found invalid under Mayo.
The dispute involving Myriad’s patents will continue: Plaintiffs will petition for certiorari at the Su preme Court. With respect to the isolated gene claims, the outcome will likely follow one of two possible scenarios.
Under one scenario, the governing case will be Chakrabarty, where the Supreme Court emphasized the importance of human intervention in deciding patent eligibility. Myriad argues that the process of isolating genetic material from a human DNA molecule requires “human ingenuity” and “human judgment” to decide where to cut the isolated DNA from the genomic DNA. Human intervention is, therefore, present every time a DNA sequence is isolated, regardless of whether the final sequence is distinct from that found in nature.
Under the second scenario, the governing case will be Mayo. The Supreme Court held in Mayo that laws of nature, no matter how narrow or specific, cannot be patented. In the present case, if the isolated BRCA genes are eliminated from Myriad’s claims, then the fact that the genes were isolated using conventional means known to the industry could render the claims a conventional application of nature. Gene isolation is a routine task in the biotechnology industry.
The decision regarding the patent eligibly of the method claim will likely be determined under Mayo, which held that the method claim may be patent-eligible because the steps start with a new “manufacture,” the transformed host cell — a result of human effort. On the other hand, the steps as a whole may be seen as adding nothing significant beyond the sum of their individual parts.
The Myriad case will affect access to products on the basis of their patents. If the courts uphold Myriad’s gene patents, companies relying on patenting DNA sequences will be able to demand higher prices because of limited market competition. Conversely, if the courts invalidate Myriad’s gene patents, 50,000 DNA patents already issued may be at risk of being invalidated. Companies holding those patents will be unable to block competitors from entering the market, which will, in turn, result in price reductions.
The Myriad case will also have an impact on innovation. The ability of companies to patent their assets directly affects their ability to secure investment. Invalidating the nearly 50,000 DNA patents already issued will hurt the companies that hold them — in particular, early-stage companies looking to recruit investors. Without the market exclusivity afforded by patent protection, companies will struggle to support research and development, and many potentially life-saving technologies may never come to fruition.
Broad application of Mayo could have profound implications for biotechnology and other industries. Many claimed inventions could be found unpatentable under Section 101 if analyzed under the reasoning in Mayo. Even basic method-of-treatment claims could be rendered unpatentable because it could be argued that the effect of a compound on the body is a natural phenomenon, and that the application of medicines to patients needing treatment could be conventional under Mayo. Moreover, patents for isolated natural substances may be invalidated. U.S. Patent No. 7,341,750, for instance, is directed to a compound isolated from the bark of Ginkgo biloba, a type of tree. The isolated bark is believed to have useful antiplatelet activity and thus may be important in treating vascular diseases.
If neither the isolated DNA molecules nor the proteins that are encoded by them are patent-eligible, the development of vaccines and protein drugs using isolated DNA molecules may be affected. Gardasil, for example, is based on patented claims directed to an isolated human papillomavirus (HPV) envelope protein. Without patent protection for the HPV protein, the vaccine would likely not have been developed.
The suit against Myriad represents an opportunity to resolve the patent eligibility status of DNA sequences. Ultimately, it will have important implications for drug and diagnostics innovation.
Joanna T. Brougher, JD, MPH, reports that she has no financial arrangements or affiliations with organizations or manufacturers of proprietary products mentioned in this article.
1Diamond v. Chakrabarty, 447 U.S. 303 (1980).
235 USC §101.
3Diamond v. Diehr, 450 U.S. 175 (1981); Gottschalk v. Benson, 409 U.S. 63 (1972).
4Association for Molecular Pathology v. USPTO. No. 09 Civ. 4515 (S.D.N.Y., March 29, 2010).
5Ass’n for Molecular Pathology v. Myriad Genetics Inc., No. 2010-1406 (Fed. Cir. July 29, 2011).
6Prometheus Laboratories Inc. v. Mayo Collaborative Services, 566 U.S. __ (2012).
7Ass’n for Molecular Pathology et al. v. USPTO and Myriad Genetics Inc., No. 2010-1406 (Fed. Cir. Aug. 16, 2012).