In a landmark patent decision that will accelerate approval of new drugs and improve treatment of patients with acute myeloid leukemia (AML), the highest court in Germany has upheld Invivoscribe Technologies Inc.’s FLT3 patent position. The decision of the German Federal Court of Justice (Bundesgerichtshof) rejected claims that the patent was invalid for lack of novelty and patentability of subject matter and leaves entirely intact 16 of the original 20 claims in the German version of the European FLT3 testing patent EP 959132, which is licensed exclusively to Invivoscribe by Takara Bio Inc. of Kusatsu, Japan.
The written grounds for the decision were served on March 18, 2016, following a January 19, 2016 court hearing that lasted more than four hours before a panel of five judges. Invivoscribe and Takara prevailed against an appeal by MLL Münchner Leukämielabor GmbH (“MLL”) of an earlier decision by the German Federal Patent Court and also prevailed on the critical issues in a cross-appeal against MLL.
Critically, the high court upheld the key testing method claim that resulted in a ruling by the Munich District Court that MLL infringed Invivoscribe’s FLT3 testing patent rights. The high court also reinstated a number of original patent claims. The Munich District Court will now determine the damages owed by MLL for its patent infringement.
Invivoscribe believes that this decision will help stimulate and accelerate additional therapeutic drug approvals, all of which should increase the current 25% five year survival rate for AML patients. Recently it was announced that the first targeted therapy for AML demonstrated a 23% increase in the overall survival of FLT3-positive AML patients treated with the new Novartis drug, midostaurin. On February 19, 2016 the FDA designated midostaurin as a Breakthrough Therapy for newly diagnosed FLT3 mutated AML. Invivoscribe’s internationally harmonized FLT3 signal ratio assay and associated software are being submitted to regulatory authorities as the companion diagnostic for this new drug, which represents the first targeted therapy for AML and the first new drug likely to be approved for treating AML in the past 25 years.
“This court ruling solidifies Invivoscribe’s vision to establish internationally harmonized FLT3 signal ratio testing in support of patient care and to promote coherent and uniform international stratification of patients for clinical trials that involve FLT3 targeted drugs and treatment regimens,” commented Dr. Jeffrey Miller, CEO of Invivoscribe. Dr. Miller added that “The underlying need for test uniformity is simple: every laboratory-developed FLT3 test generates a different cutoff and signal ratio, making it difficult to define treatment for patients based on protocols developed by insular groups that stratify patients using their lab- developed tests. Without an internationally harmonized FLT3 signal ratio assay, developed with software under design control and manufactured under cGMP, it is practically impossible to stratify and enroll patients in clinical trials in a coherent, reliable and reproducible way that both allows you to compare results of drug trials and treatment regimens and satisfies regulatory authorities. When patients are not stratified in a reproducible way at the outset there is needless ambiguity in interpreting clinical outcome data which delays getting new drugs and therapies to these critically ill patients.”
Invivoscribe’s internationally-harmonized FLT3 signal ratio test used in studies of midostaurin is currently being used to stratify and enroll patients from the United States, Europe and Asia for clinical trials of Astellas’ promising new FLT3-targeted drug, ASP2215. Invivoscribe plans to use its signal ratio FLT3 test as a basis for stratifying and enrolling patients for other trials of FLT3 targeted and FLT3 stratified therapies. In addition, Invivoscribe’s novel FLT3 minimal residual disease (MRD) assay, a next-generation sequencing (NGS) assay that can detect a single cancer cell in a million cells of peripheral blood or bone marrow, is currently being used to monitor clinical trial subjects during treatment. This NGS-based assay and the associated software are being developed under full design control so that they can be submitted to regulatory authorities for approval.
Takara (as patent owner) was represented in the German Federal Court of Justice by Vossius & Partner (Dr. Joachim Wachenfeld and Dr. Andreas Robinson, as European and German Patent Attorneys; Dr. Georg Andreas Rauh and Dr. Thure Schubert, as attorneys-at-law. Attorneys for Invivoscribe were Dr. Reiner Hall (Jordan & Hall, German Supreme Court lawyers), Andrew Simpson (Knobbe Martens Intellectual Property Law, California), and James B. Isaacs Jr. (Invivoscribe’s Licensing and Contracts Counsel).
Invivoscribe Technologies, Inc. is a privately held biotechnology company dedicated to improving the quality of healthcare worldwide by providing high quality, reliable, cutting- edge reagents, tests, and bioinformatic tools to advance the fields of personalized molecular diagnostics and personalized molecular medicine. Invivoscribe provides ISO 13485 certified cGMP manufactured PCR-based and NGS-based reagents, RUO test kits, CE-marked IVDs, including IdentiClone®, LymphoTrack® and LymphoTrack® Dx assays for clonal, MRD, and somatic hypermutation testing. Invivoscribe’s clinical laboratories in the USA, Europe and Japan provide international access to harmonized CLIA, CAP and ISO 15189 compliant clinical testing and CRO services. Additional information can be found at www.invivoscribe.com