KEI and UAEM file brief as amici curiae in BRCA gene patent case

On Friday, June 15, 2012, Knowledge Ecology International (KEI) and Universities Allied for Essential Medicines (UAEM) filed as amici curiae in the case Association for Molecular Pathology, et. al. v. United States Patent and Trademark Office, et. al which is currently being heard before the Court of Appeals for the Federal Circuit. The full brief is available for download here.

This ongoing dispute has been litigated for the past three years and involves the patent eligibility of claims directed at two human genes, BRCA1 and BRCA2. Mutations on these genes are associated with an individual's susceptibility to breast and ovarian cancer.

Approximately 1 out of ever 8 women in the United States will develop invasive breast cancer during her lifetime and testing for the presence of mutations on the BRCA1 or BRCA2 gene can help determine the best course of treatment. However, because Myriad Genetics holds the exclusive rights over the DNA claims, which were initially isolated and identified by researchers at the University of Utah through federal funds from the National Institute of Environmental Health Sciences, the test is priced at a high monopoly price. As a result, some insurance companies do not cover BRCA testing and many women cannot afford to pay for the test's high cost. Additionally, Myriad's monopoly power precludes patients from receiving second-opinion or confirmatory testing. Significantly, Myriad's initial test was shown to be flawed, failing to identify all known mutations, particularly for women of non-European ancestry.

Over the past three years, the case has been considered by three courts. The case first came before Judge Sweet from the District Court for the Southern District of New York. He ruled in favor of the plaintiffs, finding that the claims were not patent eligible because they were directed toward products of nature, a clear exclusion from patentability based on Supreme Court precedent.

Myriad Genetics then appealed the case to the Federal Circuit where a three-judge panel overturned the decision in a narrow 2-1 ruling where each judge rendered his own opinion, each based on different reasoning and interpretation of our patent laws. The three-way split in reasoning--each opinion, including the dissent, differing in its analysis from Judge Sweet's ruling--leaves little guidance for future cases.

Subsequently, the plaintiffs petitioned the Supreme Court of the United States to hear the case. The Court, having recently decided a case involving diagnostics in Mayo v. Prometheus, granted the plaintiffs' writ of certiorari, vacated the decision of the Federal Circuit, then remanded the case back to Federal Circuit to be re-heard in light of the Prometheus ruling.

The Supreme Court's decision in Prometheus was a unanimous one that rejected Prometheus' patent claims over diagnostic methods. Authored by Justice Breyer, the opinion found that the patents-at-issue merely applied a law of nature. Applicable to the Myriad case, the opinion recalled past precedent that basic tools of science are not patent eligible as they tend to tie up laws of nature and inhibit, rather than promote, the progress of science. Significantly, the Court's opinion repeatedly acknowledged the harm in impeding the flow of information has on future innovation. A more in-depth analysis of the Prometheus decision and potential implications for the Myriad case is available here.

The Federal Circuit will re-hear oral arguments in the case on July 20, 2012. In addition to the substantive questions regarding patent-eligibility of isolated DNA and human genes, the issue of whether the plaintiffs have standing to bring the case is expected to be a major issue. When considering the issue previously, the Federal Circuit affirmed jurisdiction because "at least one plaintiff, Dr. Harry Ostrer, had standing to challenge." However, Dr. Ostrer's standing is being challenged due to his change of employment.

In our brief, KEI and UAEM advance the arguments that the patents-at-issue represent products of nature and improperly preempts all other uses of the products. The brief also analyzes the implications of the Supreme Court's Prometheus ruling for the case, emphasizing the need to consider the impacts of the patents for further innovation. In addition, the brief notes the wide range of incentive mechanisms that can and should encourage investments into research and development outside of the patent system.

Additional background on the case, including a previous brief submitted by KEI in this case, is available here. Coverage from UAEM from 2010 is available here.

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Statistically speaking, the

Statistically speaking, the Court adheres to the positions presented in the government's amicus briefs, in the vast majority of cases. If this continues to hold true, the patent-ineligibility of DNA molecules -- which position the government argues in its amicus brief for this case -- looks likely to be upheld.

The case was heard previously

The case was heard previously by the Federal Circuit where the US submitted a brief arguing the same position they currently argue (that isolated DNA is not patent eligible). In fact, the plaintiffs-appellees ceded half their time at oral arguments for Neal Katyal (then acting-Solicitor General) to argue the US position. The Federal Circuit did not adopt the US position and still came down on the side of the defendants-appellants and found isolated DNA to be patent eligible.