Category Archives: Biomarkers

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More Than 25% of New Molecular Entities Approved in 2016 Are Personalized Medicines

The Personalized Medicine Coalition (PMC) recently reported that for the third year in a row, personalized medicines accounted for more than 25% of all new molecular entities (NMEs) approved by the US Food & Drug Administration (FDA). Personalized Medicine at FDA, 2016 Progress Report (Report). Personalized medicines are new drugs, agents or therapeutic biologics where … Continue reading this entry

EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated goal of developing and laying out appropriate genomic methodologies for use during the development and life-cycle of a drug. Past issues and problems that have been encountered … Continue reading this entry

Is Next Generation Sequencing Ready for Personalized Medicine?

Next generation sequencing[1] (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application of the information obtained from NGS is as a companion diagnostic for a therapeutic.[2] A significant reduction in the overall cost to sequence the … Continue reading this entry

FDA Issues Draft Guidance to Expedite Device Development

On November 14, 2013, the Food and Drug Administration (“FDA”) issued a draft guidance document – “Draft Guidance for Industry, Tool Developers, and Food and Drug Administrative Staff”  (“Draft Guidance”) reporting a voluntary process for the qualification of medical device development tools (MDDT) used in device development and evaluation programs in the Center for Devices and … Continue reading this entry

11 New Biomarkers Identified for Alzheimer’s Disease

A two-stage meta-analysis of genome-wide association studies (GWAS) in individuals of European ancestry identified 11 new loci associated with Alzheimer’s disease. The multidisciplinary study, recently reported in Nature Genetics, (“Meta-analysis of 74,046 individuals 11 new susceptibility loci for Alzheimer’s disease”, published online on October 27, 2013), is a significant step toward identifying genetic risk factors … 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 Market Growing Amid Challenges

On the same day that the personalized medicine testing market was reported to have exceeded $28 billion in 2011, the New England Journal of Medicine (NEJM) also reported a perceived stumble to the use of genomic tests that serve personalized medicine.… Continue reading this entry

CIRM Pledges $40 Million to Support Stem Cell Genomics Centers

The California Institute for Regenerative Medicine (CIRM) announced on January 17, 2012 that its governing board approved a $40 million initiative to fund one or two Stem Cell Genomics Centers of Excellence in California. CIRM was created by California’s Proposition 71, which authorized the state to issue $3 billion in grants over ten years to … 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

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

ACLU and Myriad Both Petition for Panel Rehearing In Myriad "Gene Patenting" Case

On August 25, 2011, on behalf of Plaintiffs, the ACLU filed a Petition for Panel Rehearing with the Federal Circuit in Assn. Molec. Path. et al. v. USPTO et al., known as the Myriad “gene patenting” case. Four days later, on August 29, 2011, Myriad likewise filed its own Petition for Panel Rehearing. Both parties … Continue reading this entry

FDA Releases Guidance Document Regarding Qualification of Genomic Biomarkers

On August 10, 2011, the Food and Drug Administration (FDA) released a guidance document describing recommendations regarding context, structure and format of regulatory submissions for qualification of genomic biomarkers. The guidance document was developed within the Efficacy Working Group of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use … 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

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

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