A Fed. Cir. panel of Judges Dyk, Taranto and Hughes affirmed the district court’s invalidation of a Prometheus “add-on” patent (U.S. Pat. No. 6,284,770) to a method to treat a form of irritable bowel syndrome, IBS-D, with alosetron, as obvious in view of prior art related to the symptoms of the condition. The primary alosetron patent (the ‘880 patent) had expired. Although the claim did not recite optimizing the dosage of the drug, it still reminded me of the infamous claim in Mayo v. Prometheus, in that both claims were “regimen” type claims which claimed an improved method of treating a subset of patients. In Mayo, the subset was identified by determining which patients were receiving too much drug (= side effects) and which patients were receiving too little ( = not helped) – the subset was the group of patients who were (or could be) treated with the optimal amount of the drug, which was recited in the claim.
Archive for the ‘Patentable Subject Matter’ Category
Patent-Ineligible Methods of Treatment
Chisum Patent Academy
October 3, 2015
Janice M. Mueller, Patent-Ineligible Methods of Treatment, in MUELLER ON PATENT LAW, VOL. I (PATENTABILITY AND VALIDITY) (Wolters Kluwer Law & Business 2012), last revised October 2015
The Supreme Court’s sweeping 2012 decision in Mayo Collaborative Servs. v. Prometheus Labs., Inc. was soon to impact the medical diagnostics research community beyond the parties to Mayo. In the view of this author, the Mayo framework created the potential for (presumably) unintended negative consequences that may chill future medical diagnostic research (an issue raised by Prometheus and various amici in Mayo). The Federal Circuit’s June 2015 decision in in Ariosa Diagnostics, Inc. v. Sequenom, Inc., aptly illustrates the concern. Compelled by the Supreme Court’s broad language defining the second step of the Mayo framework, the Federal Circuit in Ariosa affirmed the invalidation under §101 of a groundbreaking patent on prenatal testing.
In 2011—after the Fed. Cir. decision in Myriad upholding claims to BRACA1 and 2 genes—the PTO was tasked by a section of the AIA with providing Congress with a report on the effect of patenting on confirmatory genetic testing. The report has finally been released and, predictably, has little in the way of solid conclusions – especially since hard data in this area has always been wanting. (A copy of the report is available at the end of this post.) For example, addressing the question about the effect of access to confirmatory genetic testing on the quality of medical care, the report “concluded”: “Where evidence was available, it was often not of the magnitude, quality or rigor that scientists generally consider reliable in drawing conclusions.” The report estimated that only 1-5% of patients who were genetically tested, e.g., for mutations relating to a predisposition of a pathology, needed further testing.
Significant to the IP community, the report stated that the decisions in Myriad and Mayo invalidating many of the claims of the patents that were on appeal four years ago, has “dramatically changed” the “patent landscape” and cleared “some hurdles” that may have prevented patients from getting confirmatory genetic diagnostic testing. Of course, post Myriad, the PTO and, more ambiguously, the Fed. Cir. have taken the position that most diagnostic claims are not patent eligible. That removes a lot of “hurdles” for any organization that wants to copy a diagnostic test that is, or could have been, patented not so long ago.
In re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that clones including Dolly the sheep were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different” structure requirement for patent eligibility that the PTO had proposed abandoning in December 2004:
“[According to Chakrabarty], discoveries that possess ‘markedly different characteristics from any found in nature,’ are eligible for patent protection. In contrast, any existing organism or new discovered plant found in the wild is not patentable.”
In Ariosa, Judges Renya, Linn and Wallach turned a method of isolation of cffDNA into a “natural product”:
“The method therefore begins and ends with a natural phenomenon. Thus the claims are directed to matter that is naturally occurring….Because the claims at issue are directed to naturally occurring phenomena, …the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”