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Half a loaf, maybe
WASHINGTON, D.C.—In the case that has become generally familiar within the pharma/biotech community, the U.S. Supreme Court heard arguments last month seeking to invalidate Myriad Genetics' patents on two BRCA genes associated with hereditary breast and ovarian cancer.
After previously having been set aside by a district court, the patents were upheld by the Federal Circuit Court, both initially and after remand for reconsideration by the Supreme Court, which then agreed to take up the case itself.
The lawsuit was filed by the American Civil Liberties Union (ACLU) and the Public Patent Foundation (PUBPAT) on behalf of a long list of researchers, patients, breast cancer and women's health groups and medical professional associations.
While patent attorneys we spoke with were uniformly cautious about reading too much into the tea leaves based on oral arguments, they all expressed doubt that, having taken up the case, the court would reaffirm the Federal Circuit Court's twice- articulated decision. Instead, the best bet seems to be a sort of triangulation reminiscent of the Clinton Administration, where the court will come down on the side of a "third way" close to the position articulated by the Obama administration's solicitor general.
According to a summary by Morrison & Foerster's patent lawyers, the solicitor general's "amicus brief on behalf of the United States, nominally supporting neither party, but … in practical terms, is seen as supporting the challengers." In a departure from the position of the Patent Office, the Solicitor General argues that "isolated but otherwise unmodified DNA is not patent-eligible."
According to the Solicitor General, the "public's ability to study and use native DNA would be unduly compromised if changes caused by the extraction of naturally occurring substances from their native environments were sufficient to trigger patent eligibility." The Solicitor General departs from the challengers when it comes to "complementary DNA" molecules, which the government describes as "synthetic molecules built by scientists to include, in a single contiguous DNA segment, only the exons of a naturally occurring gene, without the introns and regulatory regions that are normally interspersed with exon sequences in genomic DNA."
Kevin E. Noonan, a biotechnology patent lawyer and partner with McDonnell Boehnen Hulbert & Berghoff LLP in Chicago, also thinks the court may take the advice of the solicitor general, one reason being that the court might be reticent to make a more sweeping decision because the justices seem to appreciate that they lack a detailed understanding of the science at issue. Noonan also points out that the BRCA genes are something of a special case in terms of their impact on cancer rates. In breast cancer, for example, a single BRCA mutation drives the cancer rate from 9 percent to 90 percent. More typically, a half-dozen or more mutations are involved.
"Unlike BRCA, if the genetic profile is complicated enough," he says, "the inventor can decide not to disclose the pattern of mutations, hide it on a gene chip and make it very difficult to reverse engineer. Currently, universities do the work and get the patents. This might tip the scale to companies doing their own development and patent filings. A LabCorp or Quest could examine 100,000 samples of stomach cancer cells, determine what's different and what they have in common, then develop the test on a gene chip, encrypted, with false negatives and positives. "
Jennifer A. Camacho, a patent attorney and shareholder at Greenberg Traurig LLP in Boston, finds it interesting that oral arguments did not include much discussion of Mayo vs. Prometheus, a case in which Prometheus' patents were invalidated amidst much concern for what this decision implied for the development of personalized medicine based on patented diagnostic tests. She thinks this may be another indication that this time, the Supreme Court will decide as narrowly as they must to answer the question, perhaps focusing on the wording of the claim or the DNA in some version of the solicitor general's amicus brief.