Last fall Myriad Genetics, Inc. had something celebrate, but it cannot breathe a sigh of relief just yet. On Monday, March 26, the Supreme Court set aside a decision by the U.S. Court of Appeals for the Federal Circuit that allowed Myriad to patent two genes that have been linked to breast and ovarian cancers: BRCA1 and BRCA2.  Myriad filed to patent the genes, which account for a large portion of inherited breast cancer, over 16 years ago, but the issues presented are unique and have far reaching implications for the medical diagnostics industry.

The case was set aside for further consideration in light of the Supreme Courts decision in Prometheus, rendered on March 20, 2012. Prometheus Labs of San Diego, CA owned diagnostic patents which covered the process of administering thiopurine drugs to see whether patients received the appropriate dose. The Supreme Court held that the patent claims merely identified a law of nature (not patentable) and that the process was not transformative, a prerequisite to patenting technology. The decision sent ripples throughout the biotechnology industry, which seems concerned about the consequences of the decision on the development of personalized medicine.

The Court ordered the Court of Appeals to review the Myriad decision in light of its decision in Prometheus. Some have distinguished Myriad Genetic’s composition claims and believe the Court of Appeals will reaffirm the Myriad case, but the industry will likely have to wait until late 2012 or early 2013 to get the new decision. Others think the differences are minimal but wonder whether the Court of Appeals will interpret Prometheus broadly enough to reverse its previous decision. If the Court of Appeals refuses to change its opinion in the case, it is possible the Supreme Court would reverse the decision anyway because two of the organizations cited in Prometheus (American College of Medical Genetics and the Association for Molecular Pathology) are plaintiffs in Myriad and are arguing that the patents inhibit patient care by limiting the use of scientific data. While the Supreme Court offered little guidance about when patent claims go too far, it appears to be warming to the argument that overly broad claims can interfere further medical research, which leaves many questions for industry. What do you think? Will the new decisions help or hinder medical research?

Samara C. Pals Cramer

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3 Responses to The end of diagnostic patents?

  1. Katie Kuhn says:

    As the court continues to grapple with advances in biotechnology and genetics, it will be crucial to distill just how natural law effects patentability. As you aptly highlight, the court’s analysis on that point may be driven by policy concerns, particularly that “overly broad claims” could interfere with, or potentially deter, future medical research. We need only look back to Moore v. Regents of the University of California to see how the possibility of chilling medical advances puts a thumb on the scale of judicial analysis.

  2. Swathi Padmanabhan says:

    By remanding the case back to the CAFC, an argument could be made that Myriad has won “Round 2″ of the battle. Because the court likely won’t make a decision for another six months at least, Myriad has extended its monopoly over the market. This really brings to the forefront the product with gene patents and the obstacles they pose to downstream development. Until this case is resolved, other drug manufacturers can’t develop or market BRCA genetic tests. My guess is that the price of the test will remain artificially high until market competition forces can take effect.

  3. Francie Kammeraad says:

    Thanks for this interesting blog, Samara. In the Prometheus, both parties (surprisingly!) said they wanted the same thing: more scientific innovation. Prometheus, in defending its patents, argued that patent protections prevent other companies from merely imitating the tests and processes that previous scientists have already created. In other words, patents incentivize research. However, the Mayo Clinic argued that patent protections hinder innovation by denying researchers access to these scientific tests and processes. Both parties wanted the same result but through different means–economic incentives via patents as opposed to accessibility. The court, in a unanimous ruling against Prometheus, sent a strong message, and I’ll be excited to see how this effects the Myriad decision.