United States: Supreme Court to Clarify What Can Be Patented

Originally published in Massachusetts High Tech, April 10, 2006
Copyright © Finnegan, Henderson, Farabow, Garrett & Dunner, LLP

On March 21, 2006, the U.S. Supreme Court heard oral arguments in Laboratory Corporation of America v. Metabolite Laboratories, U.S. No. 04-607, a case that could have far-reaching consequences for the biotechnology and medical research community. For the first time in almost a quarter of a century, the court will consider what types of inventions and discoveries may be patented. Essentially, the Supreme Court has been asked to determine whether Metabolite's patent claim, directed to a diagnostic test for detecting vitamin B deficiency, was construed so broadly that it covers natural phenomena in violation of the statute that defines patentable subject matter.

Research in biotechnology often results in discoveries that correlate a particular disease or medical condition with certain biological processes or physical phenomena. A wellknown example is the discovery of a genetic mutation that has been shown to correlate with the development of breast cancer in women. For years, the U.S. Patent Office has allowed these types of discoveries to be patented in the form of diagnostic test and/or research tool patents. And, the claim now at issue before the Supreme Court, sometimes called a test-plus-correlate claim, is a common strategy for broadly protecting this subject matter. If the Supreme Court should decide that this subject matter is not patentable, it would call into question perhaps thousands of patents.

The patent at issue in the case is based on the discovery of a relationship between elevated levels of total homocysteine and a deficiency in either cobalamin or folate. The patent claim recites two steps: (1) testing a body fluid for elevated levels of homocysteine, and (2) correlating an elevated level of total homocysteine with a deficiency of cobalamin or folate. While LabCorp provides the test for detecting elevated levels of homocysteine, it does not evaluate the results. Instead, LabCorp passes the results on to physicians for interpretation. Thus, the direct infringers are physicians who order the tests and correlate the results of those tests.

In its brief before the Supreme Court, LabCorp argued that the Federal Circuit found LabCorp liable for induced infringement merely because it provided doctors with basic medical facts used for patient care (in the form of literature explaining the relationship between elevated levels of homocysteine and deficiencies in cobalamin and folate). LabCorp also argued that if the court finds that such acts constitute patent infringement, any person who discovers a new correlation useful in medicine will gain the right to demand royalties from people who think or tell others about it, thereby discouraging researchers from developing new testing methods and chilling medical practice, future discovery and scientific discourse. LabCorp urged the Supreme Court to rule that correlations are elemental tools of all science or natural phenomena, and as such are free to all and patentable by none.

Both Metabolite and the solicitor general argued that the claim recites more than a relationship in nature between elevated total homocysteine and deficiencies in B vitamins, but also recites a diagnostic method. That is, the patent claim requires two distinct steps, an assay step and a correlating step.

Thus, it is not the correlation itself that is being claimed as the invention, but rather the use of that correlation to assess or identify a vitamin B deficiency. Metabolite further urges that such correlations are the basis of diagnostics and that disallowing such patents would stifle research and development of new tests. In its amicus curiae brief in support of Metabolite, the American Intellectual Property Law Association urged the Supreme Court to remember that although laws of nature, natural phenomena and abstract ideas are, in isolation, unpatentable, the court has previously distinguished unpatentable abstract ideas from inventions that involve the practical and therefore patentable application of such discoveries.

As the discovery of new and more specific biomarkers for disease, elucidation of genetic profiles for subgrouping diseases and patient populations, as well as prediction of an individual's response to therapy, ushers in a new era of personalized medicine, the industry relies more and more heavily on patent exclusivity for financial stability and the incentive to stimulate research into and commercialization of new diagnostic tools. If the Supreme Court chooses to use this case to refine the definition of patentable subject matter, diagnostic and medical testing innovations may be hampered for years to come.

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