Tag Archives: Diagnostic Method Claim

Patent Subject Matter Eligibility – Impact on Litigation and Prosecution

Personalized medicine relies on diagnostic technologies to accurately evaluate a patient’s clinical or genetic signature to guide treatment decisions. Protecting innovation by patenting the diagnostic methods and tools that inform clinical intervention and treatment has been the traditional means to protect investment in these important technologies. Recent U.S. Supreme Court decisions have challenged inventors’ ability … Continue reading this entry

Protecting Diagnostic Innovation – Two Actor Infringement Liability

In Akamai Techs. Inc. v. Limelight Networks, Inc., (August 13, 2015 Fed. Cir.) an en banc Federal Circuit unanimously held that direct infringement under Section 271(a) can occur: ”where all steps of a claimed method are performed by or attributed to a single entity…Where more than one actor is involved in practicing the steps, a … Continue reading this entry

Myriad’s Continuing Patent Debate

On October 6, 2014, the U.S. Court of Appeals for the Federal Circuit entertained oral argument in the interlocutory appeal of the district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. If you missed oral argument, the … Continue reading this entry

What's Patentable After Prometheus? USPTO Issues Interim Response

The USPTO has just issued guidelines for its patent examining corps to assist them in determining whether a process claim is patent-eligible in light of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (“Prometheus”) decision. A copy of the guidance document (“Guidance Document”) is attached. [2012_interim_guidance] The examiners are … Continue reading this entry

Video Interview: Discussing Mayo v. Prometheus With LXBN TV

The other day I had the opportunity to speak with Colin O’Keefe of LXBN TV on the subject of Mayo Collaborative Services v. Prometheus Laboratories, Inc. In the short interview, I explain the background of the case, offer my thoughts on why Prometheus’ patent wouldn’t have a detrimental impact on medical research and give my thoughts … Continue reading this entry

Patent Eligibility of Diagnostic Method Claims - What Have Courts Considered So Far?

Even for patent attorneys who specialize in personalized medicine, confusion still exists as to the best way to pursue and enforce diagnostic method patent claims in light of patent eligibility considerations under 35 U.S.C. §101.  While the Supreme Court and Federal Circuit have provided some guidance regarding patent eligibility of certain method claims, details of … Continue reading this entry

Diagnostic Method Claims Invalid for Lack of Written Description and Anticipation

In Billups-Rothenberg, Inc. v. Associated Regional and University Pathologists, Inc. (ARUP) and Bio-Rad Labs., Inc., the Federal Circuit affirmed a district court summary judgment that diagnostic method claims in two patents were invalid as either failing the written description requirement under 35 U.S.C. §112, or being anticipated under 35 U.S.C. §102 by a patent owned … Continue reading this entry