Health Law News From Arnold & Porter

Health Law News From Arnold & Porter

April 19, 2013
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BLOG: Many analogies, none quite right, emerge during Supreme Court genetic patent oral argument

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From international law firm Arnold & Porter LLP comes timely views on current regulatory and legislative topics that weigh on the minds of today’s physicians and health care executives.

Several analogies were used on April 15 during the Supreme Court oral arguments for the Association for Molecular Pathology v. Myriad Genetics trial. The court was considering whether human genes are patentable. Genes refer to a unit of DNA that is the blueprint for a functional component in an organism, and they were compared with components of chocolate chip cookies, a baseball bat, plants in the Amazon, and body organs. Probably none of these is right on target, but difficulty in finding an effective analogy to fit is no surprise in patent cases.

 

The desire to make the analogy simple for a generalist judge to grasp the invention can work against explaining its ingenuity. In this case, the difficulty of determining specific sequences in a person that are diagnostic for their particular treatment hopefully will not be lost on the justices when compared with the snipping of limbs off a tree to make a baseball bat. From that analogy, the justices seemed to grasp hold, almost exclusively, of the concept that the molecular technique of removing the particular sequence, once identified, from the entire genome was not where the ingenuity laid for Myriad.

Kristan Lansbery

While it would not have gotten Myriad all the way to why genes should be patentable, another analogy that might have been useful was that Myriad found a biological marker needle in a microscopic haystack of genomic DNA. Once the needle was identified by Myriad, others could very easily follow in their footsteps. Hopefully patent claims can be drafted so that a company can recoup its R&D costs for finding its target. In the situation here, once the knowledge of what the gene is and where it is located within the genomic DNA, isolating it is often relatively trivial. A patent claim on an isolated gene was often one of the best approaches to protect the investment required for its identification. Whatever the decision ultimately is — the court expects to rule by the end of the summer — the questions from the court certainly suggest that they will try to allow companies to recoup the incredibly large investment required to develop molecular diagnostics and other tools that, while difficult to find, are easy to copy.

Kristan Lansbery, PhD, JD, can be reached at Arnold & Porter LLP, 555 12th Street NW, Washington, DC 20004-1206; 202-942-5186; email: Kristan.Lansbery@aporter.com.