Category Archives: Diagnostic Methods

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FDA’s Plan to Regulate LDTs

Guest Post By David L. Rosen, Nathan A. Beaver and Jennifer M. Forde   In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement during a speech on June 2, 2013, at an annual meeting of … Continue reading this entry

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the American Clinical Laboratory Association, the College of American Pathologists, and the Association for Molecular Pathology, have weighed in on whether the FDA can and should … Continue reading this entry

Are Human Genes Patentable?

As reported in my November 30th, 2012 post, the U.S. Supreme Court granted certiorari to review the issue “are human genes patentable?” The issue arises from the long-running dispute among a consortium of plaintiffs, led by the American Civil Liberties Union (collectively “ACLU”) who sued Myriad Genetics, Inc. and the Directors of the University of … Continue reading this entry

Federal Circuit Hands Personalized Medicine Patent Holders New Tool for Enforcement

If two or more actors jointly perform a patented method, is the claim infringed ? Late last week, in Akamai Technologies, Inc. v. Limelight Networks, Inc., and McKesson Technologies, Inc. v. Epic Systems Corp., __ F.3d __ (Fed. Cir. 2012)(“Akamai”) the Federal Circuit said yes, infringement can be found under 35 U.S.C. § 271(b) if a … Continue reading this entry

Personalized Medicine After the ACLU “Gene Patenting” Decision

The biotechnology industry, including those investing in personalized medicine, have been waiting for the Federal Circuit’s decision that answers the questions whether isolated DNA and use of the isolated material are patent-eligible under 35 U.S.C. § 101. As reported in our August 16th post, the same three judges (Lourie, Bryson and Moore) held that isolated … Continue reading this entry

More on Myriad -- "Gene Patenting" Debate Continues

As promised in my earlier post, today our firm issued its review of the much anticipated decision regarding the “gene patenting” case (formally known as The Association For Molecular Pathology. et al. v. USPTO et al.) The case was before the Federal Circuit on remand from the U.S. Supreme Court’s March 20, 2012 decision in Mayo Collaborative Services … 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

Dissecting Prometheus – My Wish List

In his March 23rd Patently-O blog, Dennis Crouch posted a U.S. Patent and Trademark Office memorandum to examiners setting forth the Office’s current thinking on application of the U.S. Supreme Court’s recent Mayo v. Prometheus holding to patent examination. The memorandum preliminarily advises examiners to reject a patent claim under 35 U.S.C. § 101 if the … 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

Making The Case for Personalized Medicine

The Personalized Medicine Coalition recently published the third edition of its state of the industry report, The Case for Personalized Medicine (“Report”). While the Coalition acknowledges greater adoption of the principles of personalized medicine by the health care industry and the public; technical, legal, regulatory and payor issues are highlighted for improvement to recognize the industry’s … Continue reading this entry

Winning Strategies for Personalized Medicine

On October 14, 2011 during Foley & Lardner’s life sciences conference “Winning Strategies: How to Create, Grow and Sustain a Successful Life Sciences Company”, I hosted a panel of industry experts speaking to the challenges and opportunities in realizing the promise of personalized medicine. While much progress has been made in removing legal, technical and … Continue reading this entry

Patent-Eligibility Trilogy: One of Three Reaches U.S. Supreme Court

As the U.S. Supreme Court starts its next term on Oct. 3, 2011, the biotechnology industry is awaiting resolution of at least one of three pending disputes addressing the extent to which diagnostic medical methods are patent-eligible. Per colleague Hal Wegner, respondent’s U.S. Supreme Court brief in Mayo Collaborative Services v. Prometheus Laboratories, Inc. is due Oct. 31, 2011 … Continue reading this entry

U.S. Patent Reform - USPTO Solicits Public Comment Regarding Genetic Testing Study

As most in the patent community know, last Friday, September 16, 2011, President Obama signed into law the long-awaited patent reform bill, known as the Leahy-Smith America Invents Act (“AIA”). There are many moving parts to this complicated piece of legislation—many consider it to implement the most sweeping changes to U.S. patent law since enactment … 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

FDA "Draft Guidance" for Companion Diagnostic Devices

On July 14, 2011, the FDA issued “Draft Guidance” relating to regulatory approval of in vitro companion diagnostic devices/tests, also called “IVD companion diagnostic devices.” The FDA intends the Guidance to assist those (1) who develop a therapeutic product that depends on the use of such a device/test for the product’s safe and effective use, and (2) … Continue reading this entry

Gene Patenting Debate Slips Into Patent Reform Bill

On June 23, 2011, the United States House of Representatives passed the “Leahy-Smith America Invents Act” (H.R. 1249) to amend title 35 of the United States Code, to provide for patent reform.  Within the numerous provisions related to the examination, administration and enforcement of U.S. patents is a proposed amendment that may affect the value … Continue reading this entry

Diagnostic Method Claims and Patent Eligibility - Supreme Court Has Something to Say In Prometheus v. Mayo

Today, in a short but sweet statement, the Supreme Court granted the petition for certiorari in Prometheus v. Mayo, 628 F.3d 1347 (Fed. Cir. 2010) (finding method claims relevant to personalized medicine patent eligible) (petition for cert. filed March 2011). As discussed in our previous Personalized Medicine Bulletin post, parties once again petitioned for certiorari in the … Continue reading this entry

Inducing Infringement of a Diagnostic Method: Consult the Supreme Court's New Test

The U.S. Supreme Court in Global-Tech Appliances Inc. v. SEB S.A., __ U.S. __ (2011) recently created a new test for inducement to infringe a patent claim. This is significant for patents in the medical diagnostic field and companion diagnostics where the patent holder may not wish to sue one who is literally infringing the patent, such as a hospital laboratory or medical doctor, but rather seek to enjoin or obtain monetary damages from the manufacturer of the laboratory test under the theory that selling the test to the laboratory or doctor was an inducement to infringe the patent. … Continue reading this entry