Invivoscribe FLT3 Method Patent Claims Upheld

SAN DIEGO, CA--(Marketwired - Jul 16, 2013) - Invivoscribe Technologies, Inc. ("Invivoscribe") has successfully defended the method claims at the core of international patents covering FLT3 internal tandem duplication (FLT3 ITD) mutation testing. The German Federal Patent Court on July 9, 2013 upheld in slightly amended form all of the original method claims of the German part of European Patent EP 959 132 B1 covering FLT3 ITD testing. The upheld claims still serve as basis for the German District Court's April 25, 2013 infringement judgment for Invivoscribe and against MLL Münchner Leukämielabor GmbH ("MLL").

MLL had petitioned the German Federal Patent Court to nullify in full patent EP 959 132 B1 - "Nucleic acid encoding a mutant receptor type protein kinase", a FLT3 testing patent owned by Takara Bio of Otsu, Japan, and licensed exclusively to Invivoscribe. The Court's five Judge panel rejected MLL's arguments that Invivoscribe's method claims amounted to improper patent control over testing for the FLT3 mutations involved, and that sequencing to identify specific internal tandem duplication mutations was required for the method claims to apply. After full briefing, expert input and lengthy oral argument, the Court ruled that the method patent claims were novel, inventive, and patent eligible and upheld the claims with only minor claim amendments. The court further held that detection of length mutations in the defined subregion of FLT3 was sufficient to fall under the scope of protection of the method claims of the FLT3 ITD patent and that sequencing is not required.

After review of data on MLL revenue during the period of infringement, and taking into account the major value of the patent, the Federal Patent Court set the value of the dispute at EUR 10M.

Dr. Jeffrey Miller, CSO & CEO of Invivoscribe, commented on the April and July court hearings: "These legal victories are a huge win for AML patients. FLT3 is the single most important biomarker for drugs targeting acute myeloid leukemia, and there are limited numbers of patients available to participate in clinical trials. Working with leaders in the pharmaceutical industry, we have made an enormous effort to harmonize FLT3 mutation testing. Timely, standardized testing will make it easier for patients to access and enroll in accelerated drug trials. This international effort, which is only possible with the protection provided by patents, will lead to more rapid development and approval of drugs that can help patients with acute myeloid leukemia." Miller, who attended the hearing in Munich added, "I was particularly impressed with the efforts made by the five Judge panel to understand the scientific and medical contexts of FLT3 ITD mutation testing."

Invivoscribe has a worldwide exclusive license to patents that cover methods for in vitro diagnostic testing for internal tandem duplication mutations in the juxtamembrane region of FLT3. The patents upheld in Germany mirror FLT3 testing method patents issued across Europe and in the United States and Japan. They apply whether testing is done by sequencing, by analysis of length, or by other methods. Institutions conducting such testing 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.

Invivoscribe was represented at the hearing by Vossius & Partner of Munich (lead Counsel Dr. Joachim Wachenfeld, German and European Patent Attorney; with Dr. Andreas M. Robinson, German Patent Attorney, Dr. Georg Andreas Rauh and Dr. Thure Schubert, attorneys-at-law), Andrew Simpson (Knobbe Martens Intellectual Property Law, California) and James Isaacs (in-house counsel).

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 acute myeloid leukemia in 2013 and 20,000 will die of this disease. FLT3 internal tandem duplication mutations (also termed FLT3-ITDs 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 World Health Organization 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. IVS 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 molecular tests enable doctors to determine and recommend the most successful method of treatment for their patients.

Invivoscribe manufactures all of its products at a centralized cGMP facility in San Diego, CA. Patents owned or exclusively licensed to Invivoscribe protect a majority of Invivoscribe's products. IVS 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 these testing needs. For more information, please visit http://www.labpmm.com.