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.
Posts Tagged ‘biotechnology law’
Coming soon after the High Court’s “Myriad decision” in Australia, the Australian Patent Office has proposed guidelines that would effectively limit the ban on patent-eligibility of DNA sequences to nucleic acids that code for polypeptides. While cDNA is still considered to be banned along with naturally-occurring RNA, man-made constructs such as iRNA, primers and probes are patent-eligible, even if their sequences occur naturally.
The Guidelines go even further in addressing some of the “Bergy issues” on the patent-eligibility of “natural products” in proposing that both microorganisms such as viruses and bacteria, as well as proteins, antibodies and small molecules isolated from natural sources will be patentable subject matter.
The USPTO could have taken a similar tack, particularly in view of the Supreme Court’s language in Myriad: “We merely hold that genes and the information they encode are not patent eligible under s.101 simply because they have been isolated from the surrounding genetic material.” Instead, the Office issued Guidelines that, in effect, banned patenting any substance or even specifically formulated mixtures of substances that were “isolated from the surrounding [jungle of nature]”. Myriad was not the appropriate decision for the USPTO to repudiate any reliance on In re Bergy particularly in view of the dicta in the Fed. Cir. Myriad opinions that stated that Bergy was not applicable. There is an urgent need for the Fed. Cir. to reaffirm or repudiate Bergy (as well as to clearly state that methods of medical treatment or “medical procedures” are still patent eligible, if they are.)
You can read the article from Fisher Adams Kelly here.
On September 24-25, 2015, the Chisum Patent Academy held a two-day seminar at the offices of Kaye Scholer LLP in Washington, DC to discuss and debate current developments in U.S. patent law. The roundtable seminar group was limited to ten persons; sessions were led by treatise authors and educators Donald Chisum and Janice Mueller.
Our attendees comprised an outstanding group of experienced patent professionals from law firms, corporations, and government agencies in the D.C. area and elsewhere on the East Coast. With many hot-button topics to discuss, our attendees had plenty to discuss and debate! The complexity of the U.S. patent system and its numerous traps for the unwary were recurring themes.
Here’s our recap of the takeaways from the D.C. seminar:
- Supreme Court and Federal Circuit En Banc Blockbusters; Claim Interpretation Post-Teva; Patent Eligibility and the Ongoing Fallout from Alice; Dealing with System and Method Claims Including Divided Infringement Issues; Exhaustion and Related Uncertainties Spawned by Quanta:
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.