Tag Archives: Diagnostic Method Claims

USPTO Extends Deadline to Comment on Subject Matter Eligibility Analysis

PatentEligibility
Yesterday at BIO’s session entitled “Patent-Eligibility from the Trenches: Practical Implications of the Supreme Court’s Prometheus (Mayo) and Myriad Decisions” a panel of experts and an engaged audience discussed the controversial USPTO “Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural Products” (2014 Guidance) and its implications for … Continue reading this entry

Supreme Court Asked for Further Clarity on Patent-Eligibility of Diagnostic Claims

Did the Federal Circuit incorrectly interpret and apply the holding of the U.S. Supreme Court’s decision regarding patent-eligibility of medical methods as set forth in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012)(“Mayo“)? Intema Ltd. (“Intema”) asserts that yes, the Federal Circuit did err when it determined that Intema’s diagnostic patent claims are invalid for failing to … Continue reading this entry

Personalized Medicine Patenting Update

Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Court’s Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the decision, as set forth in its Guidance Document distributed to patent examiners. Patent examiners are advised to follow the Guidance Document in examining … 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

Status Update on the Genetic Testing Study

The U.S. Patent Office recently announced that it will not be delivering its report on Genetic Testing as required under Section 27 of the America Invents Act (“AIA”)  by the June 16, 2012 deadline.… Continue reading this entry

Patent-Eligibility of Diagnostic Patents Reconsidered in Canada

The Canadian Patent Office released today practice guidelines regarding the patent-eligibility of medical diagnostic methods and medical methods. The practice guidance are in effect immediately and until further notice, and in place of any contrary guidance presently in the Canadian Manual of Patent Office Practice (MOPOP, the Canadian equivalent to the US MPEP, setting forth … Continue reading this entry

Mayo Reported To Start Pilot Study To Provide Whole Genome Sequencing

The Guardian reports that Mayo Clinic (“Mayo”) has announced that it is starting a pilot study to provide whole genome sequencing to patients. As reported, Mayo will launch the pilot study in early 2012 as part of an ambitious move towards an era of proactive genomics. Recall, Mayo Clinic is a named party in the legal challenge to Prometheus … Continue reading this entry

Patent-Eligibility of Medical Methods Considered By U.S. Supreme Court

This post is co-authored by Antoinette F. Konski and Jacqueline D. Wright Bonilla The U.S. Supreme Court entertained oral argument today in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The case is being closely monitored by the pharmaceutical and biotechnology industry, and in particular those in the industry that patent diagnostic methods and companion diagnostics.  … Continue reading this entry

U.S. Patent Reform - What Does It Mean To Personalized Medicine?

Yesterday, September 8, 2011, the Senate passed by a vote of 89-9 the House version of the patent reform bill H.R. 1249, also known as the Leahy-Smith America Invents Act, without amendment. Consequently, after many years of discussion, debate and hand-wringing, significant patent reform is imminent. In fact, at this point, the legislation only requires action … Continue reading this entry

In Classen, the Federal Circuit Determines That Certain Method Claims Satisfy 35 USC § 101

On August 31, 2011, the Federal Circuit issued a precedential decision in Classen Immunotherapies, Inc. v. Biogen Idec (App. 2006-1643, -1649), a patent case of significant interest to the personalized medicine industry. As with the Prometheus case, this case addresses patent-eligibility of certain types of method claims. The Federal Circuit decided Classen on remand from … Continue reading this entry

Top Twelve Practice Tips Following Myriad and Prometheus

*  Written by Kristel Schorr and Jackie Wright Bonilla, both partners in the Washington, DC office of Foley & Lardner LLP As most in the biotech industry know by now, the Federal Circuit recently issued its decision in Assn. Molec. Path. et al. v. USPTO et al., a case otherwise known as Myriad or the … Continue reading this entry

Highly Anticipated "ACLU/Myriad" Gene Patenting Case Decided by Federal Circuit

Subject Matter Patent-Eligibility of Isolated DNA and Diagnostic Methods Addressed Head-on On Friday, July 29, 2011, in one of the most controversial and publicized biotech patent cases in recent years, the Federal Circuit decided the “ACLU/Myriad” gene patenting case, formally known as Assn. Molec. Path. et al. v. USPTO et al. In a majority opinion … Continue reading this entry