The Supreme Court has announced that it will hear LabCorp’s appeal of a case relating to the scope of patentability in the U.S. Specifically, the court will review the question of whether a patent can claim rights to a basic scientific relationship used in medical treatment if that claim is limited to correlating test results. Here is a link to a patent law blog that discusses the case in detail and from which I have extracted information about this case. Here is another link to a patent law web site on which I have also relied heavily for content. The points below are a little dense but worth wading through because of the importance of this case for lab medicine.
- It is well established in patent law that the laws of nature, including a patient's biological processes, cannot be claimed or owned.
- A patent infringement lawsuit involving LabCorp is asking if a laboratory can patent the correlation between the level of an amino acid measured in a patient with the levels of vitamins in that same patient.
- Researchers at University Patents Inc.(UPI) in the early 1980s discovered a relationship between elevated levels of the amino acid homocysteine and the deficiency of two B vitamins, folate and cobalamin.
- These vitamins help form homocysteine and the researchers noted that unusually high homocysteine levels often signaled very low levels of these vitamins.
- In 1986 UPI filed a patent on a method for testing homocysteine levels in body fluids. In claim 13 of that patent, UPI sought to license the correlation between homocysteine levels and vitamin deficiency, describing a two-step process of first testing for the amino acid and then correlating the level with the B vitamin levels in the body.
- LabCorp obtained a sub-license for the patent from Metabolite Laboratories. Beginning in 1992, LabCorp paid Metabolite a royalty every time it reported to a doctor the results of a homocysteine test. After LabCorp began using another company’s testing method in 1998, Metabolite sued LabCorp for patent infringement.
- The jury in a November 2001 trial awarded Metabolite almost $5 million in damages after finding LabCorp liable for breach of contract and patent infringement.
- LabCorp appealed to the Court of Appeals for the Federal Circuit, arguing the following: for the “correlation” step of the patent (claim 13) to have any meaning, a doctor must confirm the vitamin deficiency through additional diagnostic steps and other analytical methods -- simply thinking about the relationship should not violate the patent.
- A panel of the appeals court rejected this argument, holding that an infringement “only requires association of homocysteine levels with vitamin deficiencies.” The supreme court will hear LabCorp's appeal of this decision.
All of this boils down to whether a patent describing a non-enabling correlation step can validly claim a monopoly over a physiological relationship essential to medical diagnosis and treatment such that a physician infringes on the patent merely by thinking about that relationship after viewing a test result. I am not a lawyer but, to me, the notion of patenting a correlation between a test result and some pathological state such as a vitamin deficiency is very shaky, given that this step is the very essence of lab medicine and clinical diagnosis.
:: Update on 4/3/2006
You can listen to or download here a 17-minute podcast about "Patenting Ideas" that makes specific reference to the LabCorp patent litigation. The program aired originally on NPR's Science Friday.