For the second time in less than a year, the U.S. Supreme Court has agreed to take up the more than three-year-old legal wrangle over the patenting of breast cancer susceptibility genes BRCA 1 and 2—this time, most likely to settle the issue once and for all.
At issue is the validity of the seven patents issued to Myriad Genetics for BRCA 1 and 2 by the U.S. Patent and Trademark Office (USPTO). In 2009, 20 medical associations and individual doctors led by the Association for Molecular Pathology (AMP) and assisted by the American Civil Liberties Union (ACLU) and Public Patent Foundation (PUBPAT) sued Myriad and USPTO over the patents, as well as Myriad’s method for analyzing sequences of those genes for mutations associated with breast cancer.
“Myriad devoted more than 17 years and $500 million to develop its BRACAnalysis® test. The discovery and development of pioneering diagnostics and therapeutics require a huge investment and our U.S. patent system is the engine that drives this innovation," Peter Meldrum, Myriad’s president and CEO, said in a statement. “This case has great importance for the hundreds of millions of patients whose lives are saved and enhanced by the life science industry's products.”
AMP and co-plaintiffs have said that the patents on BRCA 1 and 2 are unconstitutional and invalid, arguing that human genes are unpatentable “products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought.”
“Myriad did not invent human genes, and has no right to claim ownership of them just because they removed them from the body,” Daniel B. Ravicher, PUBPAT’s executive director, said in a statement. “The government does not have the right to give a corporation the exclusive power to control what we know about our own genetic makeup.”
"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.
Impact on Industry
Warren thinks a decision against Myriad “would not be devastating to the industry, because most patents include claims to isolated DNA and vectors for host cells, including that DNA.”
“Most patents have a variety of claims, so that the entire patent wouldn’t fall if only claims to the DNA were found to be patent eligible. But certainly there are some that would, and that would present some issues for certain specific products,” Warren said. “It would be relatively straightforward to avoid the problem by just making sure that there are many new molecular biology or gen-seq patents. You include claims more specifically related to the additional components of compositions that include the DNA—[for example,] genetically modified organisms carrying the DNA.”
Myriad has contended that a Supreme Court decision would have repercussions throughout biotechnology beyond human genes, and that the question should be decided by Congress rather than the courts.
“Altering the expectations that these useful developments will be patent-protected is the role of policymaking, not adjudication,” Myriad stated. “Many biotechnology companies’ intellectual-property endeavors, and the investors on which those companies rely, depend on patents covering isolated DNA corresponding to nonhuman genes. Advancements in these other areas allow, e.g., beverages to be clarified, food starches broken down, paper recycled, clothes cleaned and softened, and agricultural waste reduced to fuel.”
Given the potential impact, gene patent holders can be expected to sit tight as they await the case outcome: “The Supreme Court’s decision to grant certiorari creates a cloud of uncertainty over isolated DNA claims that read on human genes, at least until the Court renders its decision, which could come before the end of the Court's current term, in June 2013,” Courtenay C. Brinckerhoff, a partner with Foley & Lardner, said.