Gene patent critics achieved a victory in a recent district court ruling having potentially far-reaching consequences for enterprises that use gene sequences to produce diagnostics, therapeutics, and other biotech products. On March 29, 2010, U.S. District Judge Robert Sweet ruled that certain isolated DNA molecules encoding cancer genes, as well as certain diagnostic and screening methods using those genes, are not patentable subject matter. See Association for Molecular Pathology, et al. v. USPTO, et al., 2010 U.S. Dist. LEXIS 30629 (S.D.N.Y., Mar. 29, 2010). The case involved seven patents issued by the USPTO and held by co-defendants Myriad Genetics and the University of Utah Research Foundation. While the decision will almost certainly be appealed, and it will likely be some time before the case is resolved, there are actions and strategies that biotechnology inventors and investors should be employing now to strengthen the validity and value of their intellectual property in this field.

Background

The decision stems from a lawsuit brought in May of 2009 by a coalition of scientists, physicians, patients, professional societies, and public interest groups challenging certain of Myriad’s patent claims as violating both US patent law and the US Constitution. The claims in question are directed to “isolated DNA” of the BRCA1/2 genes, which relate to a person’s predisposition to develop breast or ovarian cancer, as well as methods of “comparing” or “analyzing” a subject’s genes for cancer diagnostics and screening. The decision is part of an escalating debate in science, law and government about whether “gene patents” promote scientific progress, or whether they create an unreasonable burden to medicine and research.

“Isolated DNA”

Judge Sweet’s decision is based on a new application of precedent on the patent eligibility of purified natural substances. The judge ruled that “purification of a product of nature, without more, cannot transform it into patentable subject matter” and that “the purified product must possess ‘markedly different characteristics’” in order to be eligible for patenting. Judge Sweet considered the structural and functional differences between the isolated BRCA1/2 DNA and DNA in the body, but found that these differences were insufficient to establish patent eligibility. At the heart of the judge’s decision is the notion that DNA is different from other chemical compounds because it stores biological information. In reaching this finding, Judge Sweet considered the argument that all molecules inherently convey information in their structure, but concluded that this position “ignores the biological realities of DNA” because the “information encoded in DNA is not information about its own molecular structure incidental to its biological function [but, rather] the information encoded by DNA reflects its primary biological function: directing the synthesis of other molecules in the body.” Thus, the judge concluded that isolated DNA, just like DNA in the body, “serves as the physical embodiment of laws of nature – those that define the construction of the human body” and that because isolation does not change this function, it is not appropriate to allow the patenting of isolated DNA.

Methods of “comparing” or “analyzing” DNA

Two types of method claims were at issue in the suit: most were directed to diagnostic uses of the isolated DNA and one was directed to a drug screening method using the isolated DNA. Judge Sweet’s decision to invalidate these claims relied on two recent Federal Circuit cases: In re Bilski (2008), which established the “machine-or-transformation” test for demining patent eligibility; and Prometheus Laboratories Inc. v. Mayo Collaborative Services (2009), which established that the transformation induced by the metabolic, chemical changes in a blood sample, which were central to a test for determining the level of a metabolite in the patient’s body, satisfied the requirements of the machine-or-transformation test. The judge found that Myriad’s claims failed the machine-or-transformation test because they were “directed only to the abstract mental processes of ‘comparing’ or ‘analyzing’ gene sequences” and that even if the claims were read to cover a transformation, it would be “no more than ‘data-gathering step[s]’ that are ‘not central to the purpose of the claimed process.’”

Implications

The Myriad case has cast a cloud of uncertainty on the validity of many issued patents that claim isolated gene sequences, as well as broad methods based on their use, and has raised questions regarding aspects of the biotechnology business model that rely on gene patent exclusivity. While some fear that lack of patent protection for DNA will diminish investment, remove economic incentives to develop new tests, and delay the move toward personalized medicine, others believe that freedom from gene patents will actually spur the invention and development of newer, more complex, multi-gene and whole-genome methods.

Regardless, the reach of Judge Sweet’s decision is limited for now to the Southern District of New York and to the specific patent claims at issue in the case. It is not formal precedent in other courts, nor is it binding on the US Patent Office. We will be watching closely to see if the judge’s decision is overturned on appeal or adopted in other district courts.

Furthermore, the Bilski “machine-or-transformation” test, on which Judge Sweet based his opinion of Myriad’s method claims, was appealed to the US Supreme Court and a ruling is expected later this year. Thus, the continued viability and influence of the judge’s decision will depend in part upon how the Supreme Court rules in Bilski.

Gene patent holders will have to wait for the Myriad case to make its way through appeal before getting clarity on the legal status of their isolated DNA claims. However, they should review their portfolios now because the same patents and pending applications may contain or be amended to contain composition of matter claims that would likely survive Judge Sweet’s test for patent eligibility. For example, do the patents also include claims directed to the isolated DNA bound to a linker, probe, or substrate? Do the patents also claim non-natural mutations of the isolated DNA having altered or improved function, or non-natural preparations, like a new analytical reagent including the isolated DNA? The classical “isolated DNA” claims need not be cancelled or abandoned because the law is not yet settled on their patent eligibility. However, applicants should consider if new claims or continuation applications are needed to ensure that the invention is strategically claimed.

Holders of genetic diagnostic patent portfolios should take the occasion of the upcoming Bilski decision from the Supreme Court, and the Myriad decision to the extent that it is still viable after Bilski, as an opportunity to review their patent portfolios for method claims to “comparing” or “analyzing” DNA (or other molecules and information). Claims centered on merely making a comparison or analysis of data that do not include a chemical or physical reaction, like the metabolism of a drug, may be vulnerable. As with isolated DNA, where patent applications are pending, applicants should consider if new claims or continuation applications are needed to ensure that the claims to any diagnostic inventions are strong.

The implications for patents directed to the use of genes for drug discovery, therapies, or other methods are similar to the implications for diagnostic patents: the claim language should go beyond the collection and manipulation of data, and should focus on the concrete physical and chemical acts and changes that capture what makes the invention work.

Regardless of what ultimately happens in the Myriad case, inventions based on the discovery and understanding of isolated genes will continue to be patentable through strategically crafted patents that appreciate both the continuing advances in the science and developments in the law.