MLL Münchner Leukämielabor GmbH (“MLL”) Laboratories has been found guilty of patent infringement in a matter involving FLT3 testing patent rights licensed exclusively to Invivoscribe Technologies, Inc. (“Invivoscribe”). In a judgment issued the day of the April 25, 2013 hearing before a panel of three judges of the German District Court in Munich, Invivoscribe prevailed on the merits. The Court also declined to stay enforcement of its decision.
The Court ruled that MLL‘s testing for internal tandem duplication or length mutations in the juxtamembrane region of FLT3 violates claim 7 of the German part of the issued FLT3 testing patent owned by Takara Bio of Otsu, Japan and licensed exclusively to Invivoscribe [EP 959 132 B1 - “Nucleic acid encoding a mutant receptor type protein kinase”]. The Court rejected MLL’s argument that sequencing and identification of a specific internal tandem duplication mutation is a prerequisite step for the patent claim to apply. According to the judgment, MLL must cease and desist from such testing during the lifetime of the patent. Quantification and assessment of damages will follow in a separate procedure, with the Court ordering MLL to disclose extensive data regarding past FLT3 testing.
The Judgment is subject to review by the Munich Court of Appeal, and the German part of the FLT3 EP patent at issue is subject to challenge in a separate pending nullity action before the Federal Patent Court. However, the panel of three German District Court judges addressed those possibilities and then declined to stay or otherwise delay immediate enforceability of the infringement case judgment that they issued in favor of Invivoscribe. The Court's judgment is preliminarily enforceable against MLL after having deposited a bond and Invivoscribe will begin immediately with said enforcement measures.
Invivoscribe has a worldwide exclusive license (ex-Japan, where Invivoscribe's license is partially exclusive) to Patents that cover testing for internal tandem duplication mutations in the juxtamembrane region of FLT3. The patents apply whether testing is done by sequencing, by analysis of length, or by any other method. Institutions conducting such testing where patents apply should contact Invivoscribe or its testing subsidiaries, Laboratory for Personalized Molecular Medicine (LabPMM LLC in the US; LabPMM GmbH in the EU), in order to assure compliance with patent law and avoid complications.
About FLT3 testing:
Acute myeloid leukemia, AML, is the most prevalent acute adult leukemia. Approximately 30,000 people in the United States and Europe will be diagnosed with AML in 2013 and 20,000 will die of this disease. FLT3 internal tandem duplication (FLT3-ITD) or FLT3 length mutations are present in approximately 25% of AML patients and represent the single most important prognostic indicator of outcome for patients with cytogenetically normal AML. Accordingly, FLT3-ITD mutation testing is an obligate standard of care in the diagnostic assessment of AML patients as determined by the WHO and leading cancer treatment centers worldwide.
About Invivoscribe Technologies, Inc.
Invivoscribe Technologies, Inc., a privately held company, is a world-leading provider of PCR and NGS-based molecular reagents, CE-marked IVDs, Analyte Specific Reagents, and RUO testing products and controls targeting the fields of hematology-oncology and hematopathology. Invivoscribe and its subsidiaries provide worldwide access to clinically validated, personalized molecular diagnostic products used to identify, classify and monitor leukemias, lymphomas and other lymphoproliferative diseases. Results from these tests enable doctors to optimize treatment for their patients.
Invivoscribe manufactures all of their products at their cGMP facility in San Diego, CA. Exclusive licensed patents protect a majority of Invivoscribe's products. Invivoscribe products are sold to more than 500 customers in over 50 countries directly from Invivoscribe (USA) and Invivoscribe SARL (France), as well as through a network of distributors worldwide. For more information, please visit http://www.invivoscribe.com
About LabPMM LLC and LabPMM GmbH
Invivoscribe's CLIA- and CAP-accredited laboratory, LabPMM LLC (San Diego, USA), and LabPMM GmbH (Planegg-Martinsried, Germany) are the only reference laboratories in the world (ex-Japan) holding licenses to perform mutation testing for both the FLT3 and NPM1 biomarkers, which are covered by two different sets of patents. LabPMM clinical reference laboratories, both in the US and in Germany, use cGMP products manufactured by Invivoscribe for testing. For more information, please visit http://www.labpmm.com