[By NBC-1TV H. J Yook]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).