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Can we patent nature? US Supreme Court Set to Decide Eligibility in Genetic Tech v. Merial

Source: Grill IP patents news

tubes-with-human-DNACan nature be patented?  The US Supreme Court is set to address three patent eligibility cases in the coming months that may provide an answer. Jericho Systems Corporation v. Axiomatics, Inc. concerns the eligibility of U.S. Patent No. 8,560,836 under Section 101 of the Copyright Act while Essociate, Inc. v. Clickbooth.com, LLC calls for the clarification of ‘abstract idea’ and ‘inventive process.’ Arguably, the most compelling case is Genetic Tech v. Merial, which focuses on the role of ‘natural law’ in patent claims.

Background

    Genetic Tech’s patent (U.S. Patent No. 5,612,179) was issued at the height of gene discoveries, back in 1989. The claims of this patent centre on a technique for detecting gene alleles, and involve a method founded on an understanding of genes as associated non-coding regions of DNA (regions that do not encode protein sequences). In other words, inheriting a gene from a parent means that the inheritor will likely receive nearby non-coding regions of DNA from the same parent. This phenomenon is referred to as “linkage disequilibrium.” Genetic Tech’s method works by enhancing DNA segments with non-coding regions linked to a particular gene and checks the sequence of that segment, in search of the gene’s alleles. The plaintiff explains their process in its petition:

“Dr. Malcolm Simons discovered that, in the DNA of unrelated individuals, a polymorphism in a non-coding DNA region and a coding region allele could be inherited together. This natural phenomenon is known as “linkage disequilibrium.” The discovery prompted Dr. Simons to invent a new and useful process for detecting a coding region allele of a multi-allelic genetic locus by interrogating a non-coding DNA sequence that is in linkage disequilibrium with that multi-allelic genetic locus. Dr. Simons’ invention, as reflected in claim 1 of the ‘179 patent, was advantageous for a number of reasons, including that it was more reliable and quicker than prior art identification processes that used direct identification of allelic variants.”

Many companies have licensed the patent, but defendants Merial and Bristol-Meyers, refused to do so. The Court held that the claims under question lack patentability since they are principally concerned with laws of nature, according to Mayo Collaborative Servs. V. Prometheus Labs., Inc. (2012). The Federal Circuit affirmed the Court’s dismissal of the case, since the relationship between coding and non-coding sequences was a natural phenomenon and that Genetic Tech’s claimed laboratory techniques were routine and well known at the time.

In response, Genetic Tech asserted that patentability could be established, since no one was “using the non-coding sequence as a surrogate marker for the coding region allele” and this particular feature withstood original examination and reexamination.

The questions the Supreme Court is set to address are:

  • Whether the Federal Circuit properly concluded that the definition of a patent-ineligible concept under the Mayo/Alice framework may include both a natural phenomenon and an inventor’s ingenuity in applying that natural phenomenon to a new and useful purpose?
  • Whether a Rule 12(b)(6) motion may be properly granted based on patent-ineligibility when the record demonstrates that the claimed process inventively applies a natural phenomenon for a new and useful purpose, the process does not improperly preempt the natural phenomenon, and the claimed process is not routine and conventional?

Merial and Bristol-Myers waived their right to respond to the petition. This non-response has speeded up the case, and a conference has been set for September 26. If this case moves forward, the Supreme Court could call for a response. If no such call is issued, then the Court believes that it has all the information it needs to rule on the issue of patent eligibility in this case. These questions have serious implications for patent applicants, whose innovations incorporate laws of nature in new ways, and a ruling in favor of Genetic Tech could increase the likelihood that they can register such patents. Perhaps the Court will soon help clarify where ‘natural’ phenomena end and human ingenuity begins.   

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