Posts Tagged: "AMP v. Myriad"

Seventy-two companies and organizations, ranging from Tivo to Bristol-Myers Squibb and from the American Conservative Union to the Alliance of U.S. Startups & Inventors for Jobs (USIJ)— as well as retired Federal Circuit Chief Judge Paul Michel—have sent a letter to Senators Thom Tillis and Chris Coons and Representatives Hank Johnson, Doug Collins, and Steve Stivers in support of the current draft language to reform Section 101 of the U.S. Patent Act. The letter comes as the patent community eagerly awaits a new version of the bill, following three hearings and 45 witnesses in which most voiced their general support for the approach taken in the draft, but several sticking points were identified. The next iteration is expected soon after Congress’ July 4 recess.

Last week, all eyes were on the first two days of historic Senate Judiciary IP Subcommittee Hearings, led by Senator Thom Tillis (R-NC), Chair of the Subcommittee, and Senator Chris Coons (D-DE), Ranking Member of the Subcommittee. The purpose of the hearing was simple: to determine a fix for the disaster foisted upon the industry by the patent eligibility jurisprudence of the Supreme Court of the United States. The testimony of the first 30 witnesses has already been summarized, so there is no need for me to dive into the particulars of who said what here. Suffice it to say that the Subcommittee heard a range of opinions—some better supported than others.

The U.S. Supreme Court’s 2013 ruling in Association for Molecular Pathology v. Myriad Genetics changed the landscape of what is considered patentable material in the context of genetic inventions. In the five years since Myriad, companies have pushed the boundaries of patenting certain types of genetic materials. Despite Myriad’s express statement that it was not considering “the patentability of DNA in which the order of the naturally occurring nucleotides has been altered,” the courts have not yet established the contours of how much nucleotide sequences need to be altered in order to “create something new” in order to be patentable. However, as we discuss in the next section, we expect the Court to address these questions as biotechnology companies increasingly invest resources into emerging, expensive technologies involving genes and seek to protect their investments through patents.

The chaos created by this forum shopping was exacerbated by differing views of what in these rulings by SCOTUS was holding, and what was simply dicta.  Together with the enactment of Bayh-Dole (which sought to alleviate the prior dismal record of commercialization of federally-sponsored research where the federal government retained the patent rights), Congress created the United States Court of Appeals for the Federal Circuit as the successor to the CCPA, as well as to supplant all other circuit courts as the arbiter of patent law jurisprudence, effective as of 1980.  Creation of the Federal Circuit was also at least an implicit (and more likely, explicit) warning to SCOTUS to tread carefully on patent law jurisprudence and to let the Federal Circuit do the heavy lifting without significant interference or meddling from the highest court in the land. For almost two decades, SCOTUS seemed to heed that warning, rarely interfering with Federal Circuit precedent… But beginning with the eBay case in 2006, SCOTUS started an almost relentless series of rulings which meddle with, chastise, and overturn longstanding Federal Circuit precedent, often using the rubric that the Federal Circuit’s ruling/precedent was “too rigid,” or “too inflexible.”

In a research project funded by the Austrian Science Fund (FWF), evidence emerged that a higher expression of the GIRK1 protein in malignant tissue samples was linked to higher relapse and mortality rates in breast cancer patients who have gone through surgery. The novel use of the GIRK1 protein as a biomarker could have a great impact on breast cancer diagnostics and treatments and further research could yield more discovery on the interdependence of GIRK1 with other important biological pathways critical to cancer management… Unfortunately, discovery of GIRK1 as a biomarker for breast cancer diagnostics would run into 35 U.S.C. § 101, the basic threshold statute for determining patentability of subject matter, under the Supreme Court’s March 2012 ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc. In that case, the Court held that processes involving correlations between blood test results and patient health is not patent-eligible subject matter because the process incorporates laws of nature. This would seemingly render any processes involving the application of GIRK1 as a biomarker for breast cancer prognoses unpatentable as well as the expression of GIRK1 occurs naturally.

These revisions favor patent owners, according to Palmer, but not everyone is supportive. For instance, Bilski, Mayo, Myriad, and Alice have given several accused infringers an additional tool for fighting non-practicing entities. So. the level of support for these revisions will depend where you fall on this spectrum. That being said, Palmer does not think the Court will change its eligibility analysis in the foreseeable future, and Congress is not likely to take up these anytime soon.

Essentially, the Supreme Court told the Federal Circuit that they needed remedial reading lessons. The statute is clear: “may” means district courts have discretion. The Supreme Court also seemed instruct the Federal Circuit to stop making stuff up that clearly isn’t found within the statute. It is truly ironic, even downright funny, how the Supreme Court can so clearly see that the Federal Circuit is not being true to the simple, easy to understand, straight-forward terms of a statute but at the same time lack the capacity to similarly see that they are themselves doing the very same thing. If intellectual honesty means anything the Supreme Court would hold themselves to the same standard and stop applying judicial exceptions to patent eligibility that enjoy no textual support in the statute.

While Justice Scalia served on the Supreme Court for nearly three decades, his contributions to the area of intellectual property law were quite limited. Scalia did famously refer to patents as “gobbledegook” during the KSR v. Teleflex oral arguments. Scalia was the only Justice not to sign onto an opinion in Bilski v. Kappos that would have recognized that at least some software is patent eligible. But Justice Scalia did not author any of the major patent decisions considered by the Court during his tenure. The passing of Justice Scalia does not seem likely have much of an impact on intellectual property cases, particularly patent cases. Having said this, I could see legislative history becoming more relevant than anyone would have anticipated just a week ago when the Supreme Court considers Cuozzo Speed Technologies v. Lee.

The idea that the Supreme Court is at all capable of understanding — let alone deciding — issues of a technical nature is ridiculous. Yet their individual and collective lack of knowledge hasn’t prevented them from reaching misguided decisions in a variety of cases. Like an Emperor without any clothes the Supreme Court seems blissfully ignorant of their own ignorance. Indeed, you would have to go out of your way to find nine less qualified people to decide issues of a technological nature.