January 31, 2013
In November, the Supreme Court agreed to hear the challenge to gene patents in the case of Association for Molecular Pathology v. Myriad Genetics (see here). The grant of review followed several years of the patentable subject matter litigation initiated by a coalition of plaintiffs that made its way through the lower courts, ending this summer with the Federal Circuit upholding the gene patents (again, following the Supreme Court remand to reconsider in view of Mayo v. Prometheus). The plaintiffs include researchers, genetic counselors, patients, cancer survivors, breast cancer and women's health groups, and scientific associations. Now, as the case gets ready for oral argument later this spring, the briefs from parties and amici are being filed. The ACLU filed the Petitioner's Brief last week at the Court. The brief outlines the arguments of the plaintiffs as to why genes are not patentable subject matter and the patent claims on the BRCA1 and BRCA1 genes should be invalidated. The Court must consider how to define an an isolated gene (isolated DNA) – as either a product/law of nature (not patentable) or a nonnaturally occurring processed product (patentable). The ACLU brief presents several arguments that invoke the Court's exclusions and apply them to the genes at issue. They further argue that although the USPTO has issued gene patents for several decades, the Court need not be guided by any deference to the USPTO. Lastly, they argue that a First Amendment issue is presented because gene patent claims can control the use of knowledge, a violation of that constitutional clause. The oral argument will likely occur around April; no exact date yet.
January 19, 2013
The Federal Circuit heard oral arguments this week in a case where organic farmers are attempting to proactively litigate any potential infringement liability related to Monsanto patents on genetically engineered (GE) seeds (see here and here). The case is Organic Seed Growers and Trade Association (OGSATA) v. Monsanto, a declaratory judgment (DJ) action in which OGSATA and other plaintiffs seek to litigate the question of whether inadvertent contamination of their crops by Monsanto (GE) seed could give rise to a potential patent infringement claim by Monsanto. The threshold issue for the plaintiffs has been to establish standing for the suit, relying on their assertions that the prospect of infringement litigation from Monsanto has caused them to limit or halt their farming activities. In 2012, a lower federal court ruled that the plaintiffs could not meet the threshold showing for sustaining a DJ action, and dismissed the case. In the appeal to the Federal Circuit, the oral argument focused on determining whether a “substantial controversy between parties having adverse legal interests of sufficient immediacy and reality" – as required by the Supreme Court in Medimmune v. Genentech (2007) – exists. If so, a DJ action allows the plaintiffs to ask a court to adjudicate whether inadvertent contamination rises to the level of patent infringement, and whether the Monsanto patents are invalid under numerous patent law doctrines. Because patent infringement is generally regarded as a strict liability tort (intention irrelevant), passive contamination of an agricultural field by a patented product could be characterized as a patent infringing use. During the oral arguments, both parties faced skepticism from the court – the plaintiffs (farmers) were challenged as to how imaginary their fear of suit might be, and whether they had real instances of legal threat or action that supported their claim; the defendant (Monsanto) faced questions over what standard they would apply to elevate a case of trace contamination into a legal complaint of patent infringement, or whether a farmer who discovered contamination could then use contaminated seed (because it might be too difficult to cull from the rest of the crop) without being accused of patent infringement, or whether farmers would need to engage in genetic testing of their fields to help defend themselves against any allegations of infringement. Without knowing how the court will rule, perhaps the litigation has provided a measure of relief for the farmers: in response to a direct question from the court in oral argument, counsel for Monsanto agreed that representations in the court regarding the lack of the company’s intention to sue for trace contamination might give rise to judicial estoppel for plaintiffs to rely on later. The litigation was undertaken because the farmers had been unable to secure any enforceable covenant not to sue from Monsanto.
January 13, 2013
The Supreme Court has turned down an opportunity to review the legal challenge to the Obama policy on federal funding of embryonic stem cell (ESC) research. In 2009, President Obama reversed the Bush-era ban on using federal funds to derive new ESC lines. In Sherley v. Sebelius, several federally funded adult stem cell researchers had challenged Obama’s policy as a violation of the Dickey Wicker amendment, which prohibits the use of federal funds for any research in which an embryo is destroyed. Earlier this year, the Court of Appeals for the D.C. Circuit upheld a lower court’s ruling that the Obama policy did not violated the legislative ban. The Supreme Court has now denied the challengers’ petition for certiorari. Researchers in the field can expect stability through the second Obama term. After that, a new executive policy in 2017 could again impair funding, but the field has advanced over these last four years. The fully funded ESC field has now generated many new ESC lines, which place the field in a stronger position than in was in 2009. The NIH Stem Cell Registry now lists about 200 available cell lines, in contrast to about 20 that were available during the Bush policy years. Nonetheless, the prospect of future volatility in funding policy remains an unwelcome distraction for the field. One only has to look at the impact that the sequestration debate in Washington (mandatory spending cuts to kick in March 1) has had on the biomedical research community as it adjusts to the fact that the NIH may be facing an 8.2% reduction in its budget if sequestration is not avoided by Congress.