Category Archives: Companion Diagnostics

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FDA To Issue Final Guidance For In Vitro Companion Diagnostics in Mid-2012

Elizabeth Mansfield, Ph.D., Director of Personalized Medicine, Office of In Vitro Diagnostics, Center for Devices and Radiological Health of the Food and Drug Administration (FDA) announced today at the 2012 Personalized Medicine World Conference that the FDA is targeting the second quarter of 2012 to release the FDA’s Final Guidance for In Vitro Companion Diagnostic … 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

FDA Reports on Initiatives to Drive Biomedical Innovation

Today, the FDA issued a report, Driving Biomedical Innovation: Initiatives to Improve Products for Patients (“Report”) which outlines proactive initiatives to promote science and innovation to meet today’s and the future’s health care challenges. The Report notes that because of its role as both a regulator and a public health agency facilitating the development of … Continue reading this entry

The Genomics and Personalized Medicine Act: A Look Ahead

Institutional barriers (e.g., limitations on product reimbursement, unclear regulatory requirements and occasional government redundancies) have been faulted for relatively slow progress toward wide spread implementation of personalized medicine. In an effort to improve access to and appropriate utilization of valid, reliable genetic tests and to secure the promise of personalized medicine for all Americans, then-Sen. … 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

Subject Matter Jurisdiction Challenged in Supreme Court's Review of Mayo v. Prometheus

An international intellectual property association filed an amicus curie brief urging the U.S Supreme Court to dismiss the dispute and issue presented in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 131 S.Ct. 3027 (2011), arguing that the district court and Federal Circuit lacked subject matter jurisdiction. The amici argued that for reasons that are not … 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

USPTO - Seeking Comments On Patent Reform Bill

The U.S. Patent and Trademark Office (USPTO) announced that it is proactively seeking public comments on the Leahy-Smith America Invents Act (AIA), H.R. 1249, passed by the U.S. House of Representatives on June 23, 2011, and currently pending before the U.S. Senate.  The AIA requires the USPTO to undertake a series of rulemakings to implement the Act.  Because … Continue reading this entry

CDC Issues Requests for Comments to Assess and Implement Public Health Genomics

The Centers for Disease Control and Prevention (“CDC”), located within the federal Department of Health and Human Services (“HHS”) is seeking public comments, data or other information to assess the current research, policy and practice environment in public health genomics. The information is solicited to assist the Office of Public Health Genomics (“OPHG”) of the … 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

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

PhRMA CEO Speaks at PMC's Annual State of Personalized Medicine Luncheon

On June 9, 2011, the Personalized Medicine Coalition (PMC) hosted its Seventh Annual State of Personalized Medicine Luncheon in Washington, D.C.  As stated on its website, PMC’s mission “is to build the foundation that underpins the advancement of personalized medicine as a viable solution to the challenges of efficacy, safety and cost.”  This year’s luncheon … 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

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

Personalized Medicine - Promise, Regulation and Challenges

Personalized Medicine seeks to individualize health care by identifying the most effective or most comfortable treatment for that individual.  Finding the right treatment for the right individual at the right time can be applied preventively or therapeutically to treat disease.  In one aspect of personalized medicine, an individual’s genetic code is analyzed and used to identify the … Continue reading this entry