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 expand its jurisdiction to laboratory developed tests (“LDTs) performed by clinical laboratories. Continue reading this entry
Tag Archives: Diagnostic Test
What’s Patentable After Prometheus? USPTO Issues Interim Response
Posted in Diagnostic Methods; Genetic Testing; PrometheusThe 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 advised to follow the Guidance Document in examining process claims in which a law of nature, a natural phenomenon, or naturally occurring relation or correlation (collectively referred to as a “natural principle” in the Guidance Document) is a limiting element or step. The revised procedure is effective as of its date of issuance, July 3, 2012.Continue reading this entry
Personalized Multiplex Test on Market
Posted in UncategorizedA multiplex test that can analyze tumors for over 200 genes is now available from Foundation Medicine Inc., the Wall Street Journal reported today. The test will be used by Novartis, Sanofi SA, Johnson & Johnson and Celgene to analyze patients in early-stage clinical trials of new cancer drugs to identify patients most likely to benefit from the drug and to accelerate the drug approval process. Continue reading this entry
Video Interview: Discussing Mayo v. Prometheus With LXBN TV
Posted in Companion Diagnostics; Gene Patents; Genetic Testing; PrometheusThe 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 on what this means for the Myriad “gene patenting” case.
Personalized Medicine Market Growing Amid Challenges
Posted in Biomarkers; Companion Diagnostics; Genetic TestingOn 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
Mayo Reported To Start Pilot Study To Provide Whole Genome Sequencing
Posted in Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic TestingThe 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 Laboratories’ patents on medical diagnostic methods. This challenge is currently awaiting resolution by the U.S. Supreme Court (see our December 7th post).
Patent-Eligibility of Medical Methods Considered By U.S. Supreme Court
Posted in Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic TestingThis 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. At its core, the case addresses whether certain patent claims directed to diagnostic methods or methods of optimizing therapeutic efficacy for treatment recite patent eligible subject matter under 35 U.S.C. § 101.
U.S. Patent Reform – USPTO Solicits Public Comment Regarding Genetic Testing Study
Posted in Biomarkers; Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic Testing; Patent ReformAs 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 of the 1952 Patent Act.
U.S. Patent Reform – What Does It Mean To Personalized Medicine?
Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Diagnostic Methods; Gene Patents; Genetic Testing; Patent ReformYesterday, 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 by President Obama, who has already promised to sign the bill.
Most provisions in the bill impact U.S. patent practice generally, including moving towards a first-to-file system, expanding prior user rights as a defense to infringement, eliminating interference proceedings, and creating new USPTO proceedings for post-grant review. One aspect of the bill, however, in a section entitled “Study on Genetic Testing,” impacts the personalized medicine industry in particular. See previous discussion on this provision on our June 26 post and August 3 post.
Top Twelve Practice Tips Following Myriad and Prometheus
Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Diagnostic Methods; Gene Patents* 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 “gene patenting” case. For more discussion, see July 29 post and July 31 post. The majority (Judge Lourie, joined by Judge Moore) held all “isolated DNA” claims at issue patent-eligible under 35 U.S.C. §101. The majority (joined by both Judges Moore and Bryson) also held as patent-ineligible certain diagnostic method claims that in effect recited only “comparing” or “analyzing” DNA sequences. Notably, each of the three judges on the panel wrote a separate opinion. In doing so, each expressed a different view, even if two of the three judges agreed on the ultimate holding regarding “isolated DNA,” and all judges agreed regarding the method claims at issue.
Patent Eligibility of Diagnostic Method Claims – What Have Courts Considered So Far?
Posted in 35 U.S.C. 101; Biomarkers; Companion Diagnostics; Gene PatentsEven 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 how to proceed when drafting relevant claims, and which existing diagnostic method claims are viable, remain unclear to many.
It is possible that the Federal Circuit and/or Supreme Court may provide additional direction in cases yet to be decided. Such cases include the AMP et al. v. USPTO et al. (Myriad) “gene patenting” case (pending at Federal Circuit after oral argument on April 4, 2011), Classen Immunotherapies v. Biogen IDEC (pending at the Federal Circuit after remand by the Supreme Court in 2010) and Prometheus Labs., Inc. v. Mayo Collaborative Servs. (awaiting decision by Supreme Court on certiorari petition-again).
In the meantime, patent attorneys glean what they can from cases decided before and after Bilski v. Kappos (2010), such as In re Grams (Fed. Cir. 1989), Justice Breyer’s dissent from dismissal of the grant of certiorari in Lab. Corp of America Holdings v. Metabolite Labs., Inc. (2006), as well as the most recent Federal Circuit decision in Prometheus Labs., Inc. v. Mayo Collaborative Servs. (Fed. Cir. 2010) (albeit cert. pending at Supreme Court).
While such pending and decided cases are not an exhaustive list of ones that may impact patent eligibility of diagnostic method claims, it is informative to look at claims at issue in these cases. Below provides a brief summary of representative claims, and what the courts have said about them so far.
Diagnostic Method Claims Invalid for Lack of Written Description and Anticipation
Posted in Diagnostic MethodsIn 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 by/licensed to the alleged infringers.
The two patents-in-suit owned by Billups present a genetic test for Type I hereditary hemochromatosis, an iron disorder characterized by excessive iron absorption by the body. The first patent, U.S. Pat. No. 5,674,681 (the ’681 patent), teaches that a gene causing the disorder is located near to the A locus of the human major histocompatibility complex (HLA-A) on human chromosome six. According to Billups, the ’681 patent specification describes the location of the gene and relevant mutations “within less than 300 base pair regions of a defined exon of a well studied multi-gene family.” Opinion, page 10. Claim 2 is a representative claim of the ’681 patent (emphasis added):