Posts Tagged: "AMP v. Myriad"

Athena v. Mayo: A Splintered Federal Circuit Invites Supreme Court or Congress to Step Up On 101 Chaos

On July 3, the Court of Appeals for the Federal Circuit denied en banc rehearing in Athena Diagnostics v. Mayo Collaborative Services. The 86-page order from the Federal Circuit includes eight separate opinions—four concurring with the en banc denial and another four dissenting from the decision. The separate opinions reflect a Federal Circuit that isn’t divided so much on the issue of the importance of Athena’s now invalidated patent claims but, rather, the application of the U.S. Supreme Court’s Section 101 jurisprudence under Mayo Collaborative Services v. Prometheus Laboratories (2012). Throughout the opinions, it seemed clear that the Federal Circuit was eager to have the Supreme Court take this case up on appeal in order to clarify Mayo’s judicial exception to laws of nature and its impact on patent claims covering medical diagnostics.

U.S. Companies and Groups to Congress: the Section 101 Reform Draft is Good and Genes are Safe

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.

Two Observations on Last Week’s Senate Hearings on Patent Eligibility Reform

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.

Post-Myriad Legal and Policy Considerations for Patenting Genetic Inventions

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.

Congress Initially Rebuffs SCOTUS Dominance of Patent Law, But Not for Long

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.”