"Human Ingenuity" Question
The Supreme Court is only taking up the first of three questions it asked both sides in the case to answer in written briefs—namely whether the Court of Appeals for the Federal Circuit applied court precedents correctly in 2011 and again on Aug. 16 when it concluded the BRCA gene patents were defined and isolated by human inventors, and thus were “product[s] of human ingenuity ‘having a distinctive name, character [and] use.’”
The latter decision came after the Supreme Court in March remanded the case to the Federal Circuit’s appellate court. That same month, the Supreme Court unanimously ruled separately against Prometheus Laboratories, saying its methods of dosage calibration for thiopurine drugs for gastrointestinal and nongastrointestinal autoimmune diseases merely recited a law of nature, and thus were patent-ineligible. However, the high court in Mayo v. Prometheus rejected reviewing whether claims directed to the methods of screening for compounds using a genetically engineered cell line are patent-eligible.
“It’s likely that the Supreme Court is going to say that Prometheus should be read more broadly than the Federal Circuit indicated in its opinion, that it’s not limited necessarily to method claims, that one should look whether the genes are simply laws or products of nature or something more,” Gerald J. Flattmann, Jr., a partner in the Intellectual Property practice of law firm Paul Hastings’ new York office, told GEN. “The Supreme Court’s going to take a hard look at that, and it’s going to be very interesting to see where they come out.”
That "something more" could lead to a broad ruling that sets precedents beyond the Myriad case.
“What concerns me is, if that’s the basis for the Supreme Court taking up the case, this is going to go a lot further than gene patents, since the court’s decision could affect anything that could be isolated from the body and then be used in a particular way,” Lisa A. Haile J.D., Ph.D., a partner with DLA Piper U.S. and co-chair of its global life sciences practice, told GEN.
“The obvious ones would be genes and proteins. But proteins also include antibodies. The patent office doesn’t make a distinction between whether you make an antibody recombinantly, or whether you isolate it, for example. It doesn’t matter. It’s still the product that matters. Just because someone is using recombinant methods and, say, making antibodies in CHO cells, those are still naturally occurring antibodies. Those patents will be invalidated if this is the line of thinking,” Dr. Haile said.
Also vulnerable, she added, are patents like those for chimeric antibodies and humanized antibodies, where products are either isolated from the body, or even if they’re made in the lab, they’re still basically identical to what is in the body: “Potentially, any sort of what would have been a naturally occurring product is going to be affected. I do have a little bit of concern there.”
“The court will have to review the arguments and Section 101 case law supporting Myriad's position that the isolation of DNA transforms the material to create a new chemical entity, irrespective of the fact that the information contained in the isolated DNA sequences remains the same. This is countered by AMP (ACLU, et al.) arguing against patent eligibility on the basis that the material exists in nature as do leaves on a tree or minerals in a mountain,” William L. Warren, partner at law firm Sutherland Asbill & Brennan and chair of its Life Sciences team, told GEN.