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Roche Diagnostics Corp. v. Meso Scale Diagnostics, LLC

United States District Court, S.D. Indiana, Indianapolis Division

February 21, 2017



         This matter is before the Court on a Motion to Dismiss filed pursuant to Federal Rules of Civil Procedure 12(b)(2) and 12(b)(6) by Defendant Meso Scale Diagnostics, LLC (“Meso”) (Filing No. 23). Plaintiff Roche Diagnostics Corporation (“Roche Diagnostics”) initiated this lawsuit, seeking a declaratory judgment that it is not infringing any license rights of Meso in patented “ECL technology.” After many years of disputes among Meso, Roche Diagnostics, and Roche Diagnostics' affiliates concerning patent, license, and other contractual rights, Roche Diagnostics and its affiliates obtained a favorable judgment regarding some of the conflicts between the parties following a bench trial in a Delaware state court. After Roche Diagnostics received the favorable judgment, Meso asserted that it believed the Delaware litigation did not resolve some of the parties' disputes and that it retained the right to litigate claims that Roche Diagnostics infringed Meso's license rights in electrochemiluminescence (“ECL Technology”), a patented diagnostics detection technology. (Filing No. 1 at 1.) In response to Meso's contentions, Roche Diagnostics filed this declaratory judgment action to obtain a legal declaration that it does not infringe Meso's license rights in the patented ECL technology. Meso filed its Motion to Dismiss, asserting that this Court does not have personal jurisdiction over Meso and that Roche Diagnostics' Complaint fails to state a cognizable claim. For the following reasons, the Court GRANTS Meso's Motion to Dismiss.

         I. BACKGROUND

         The following facts are not necessarily objectively true, but as required when reviewing a motion to dismiss, the Court accepts as true all factual allegations in the Complaint and draws all inferences in favor of Roche Diagnostics. See Bielanski v. County of Kane, 550 F.3d 632, 633 (7th Cir. 2008); Avocent Huntsville Corp. v. Aten Int'l Co., 552 F.3d 1324, 1329 (Fed. Cir. 2008) (“the pleadings and affidavits are to be construed in the light most favorable to [Roche Diagnostics] . . . a district court must accept the uncontroverted allegations in the plaintiff's complaint as true and resolve any factual conflicts in the affidavits in the plaintiff's favor”).

         Roche Diagnostics is an Indiana corporation with its headquarters in Indianapolis, Indiana. It is an indirect subsidiary of Roche Holding AG (“Roche Holding”), which is a Swiss corporation and global healthcare organization that operates worldwide under two divisions-pharmaceuticals and diagnostics. Roche Holding conducts its diagnostics business through a number of its companies, including Roche Diagnostics. Pursuant to licenses granted to Roche Holding, Roche Diagnostics GmbH (a German company), and other Roche affiliates in 2003 and 2007, Roche Diagnostics markets and sells diagnostics products in the United States that use patented diagnostics detection technology known as ECL Technology (Filing No. 40-3; Filing No. 40-4). ECL Technology is used to detect diseases such as cancer, liver disease, and tuberculosis (Filing No. 32 at 2 ¶ 6). Roche Diagnostics' affiliate BioVeris Corporation (“BioVeris”) owns the patents to the ECL Technology (“BioVeris Patents”). For more than twenty years, the Roche affiliates have developed and marketed products using ECL Technology. They have built their diagnostics business into a world leader. Their diagnostics products, including those using ECL Technology, are sold through Roche Diagnostics in every state in the United States.

         Meso is a Delaware limited liability company based out of Rockville, Maryland. Meso was formed as a joint venture in 1995 between Meso affiliate Meso Scale Technologies, LLC (“MST”) and IGEN, Inc. (“IGEN”), a California corporation with its principal office in Maryland. The joint venture was formed to explore potential combinations of the ECL Technology with MST's multi-array and disposable electrode technologies. Pursuant to a 1995 license agreement, Meso has a limited exclusive license from BioVeris-originally granted from IGEN-to use the ECL Technology, including the BioVeris Patents, in connection with certain research-related technologies (Filing No. 35-1). This license agreement was amended in 2001 and 2004 (Filing No. 35-2; Filing No. 35-3).

         ECL Technology is the detection technology used by Roche Diagnostics in its line of immunoassay analyzers marketed and sold under the COBAS brand name. Immunoassays are diagnostic tests used to detect, monitor, and guide the treatment of disease and other conditions in human patients. ECL Technology uses electricity, chemistry, and light to detect and measure the presence of specific molecules in a test sample, for example molecules of a virus in a sample of blood or other bodily fluid.

         Roche Diagnostics' COBAS instruments employing ECL Technology utilize a detection component called a “flow cell” in which the ECL reaction takes place. The flow cell is reusable, contains one permanently installed electrode, and conducts one test at a time. All of Roche Diagnostics' ECL Technology products sold in the United States are FDA-approved for use in diagnostic testing of humans.

         In 1992, Boehringer Mannheim GmbH (“BMG”), a German company that a Roche Diagnostics affiliate later acquired, obtained an exclusive license to ECL Technology, including the BioVeris Patents. This license allowed for the development and commercialization of ECL Technology for use in the market fields of hospitals, blood banks, and clinical reference laboratories. BMG obtained the license from IGEN (Filing No. 40-2). IGEN had acquired the ECL Technology in the 1980s, including the patents describing the ECL Technology. BMG was acquired by a Roche Diagnostics affiliate in 1998.

         A dispute arose between IGEN and Roche Holding regarding the extent of the license granted in 1992 concerning the ECL Technology, and following litigation over the license, IGEN and Roche Holding entered into an additional license agreement in 2003. Under the 2003 agreement, Roche Holding received a non-exclusive license to develop, manufacture, and sell products using ECL Technology, including the BioVeris Patents, in a defined field that included all human testing for detection of disease, patient treatment, and monitoring purposes without limitation as to the setting. The field covered by this non-exclusive license specifically excluded use of ECL Technology in connection with multi-array assays and related technologies that were subject to Meso's 1995 limited license. Roche Diagnostics received a sublicense under this 2003 license agreement. As part of the agreement between IGEN and Roche Holding, IGEN was acquired by Roche Holding and much of IGEN's business, including the BioVeris Patents, was spun off to the newly-formed company BioVeris.

         Although Meso was not a party to the 2003 Roche Holding license agreement, it did expressly consent to the entire 2003 agreement, including IGEN's representations that IGEN held the rights being licensed to Roche Holding and Roche Holding's ability through the license granted to practice ECL Technology within the 2003 defined field.

         Because it wanted to expand its ECL Technology market, Roche Holding acquired BioVeris with its patents and other rights in the ECL Technology in 2007. BioVeris granted an expanded license to Roche Diagnostics GmbH to use the ECL Technology, including the BioVeris Patents, in market fields outside the 2003 defined field but excluding exclusive rights previously granted to third-parties by IGEN or BioVeris such as Meso. This license allowed Roche Diagnostics GmbH to sublicense its rights to its affiliates such as Plaintiff Roche Diagnostics.

         As noted above, Meso also has a limited license from IGEN-now from BioVeris-to practice ECL Technology. In 1995, Meso was formed as a joint venture between IGEN and Meso's affiliate MST. MST had been working with certain research technologies that allowed multiple tests to be performed in a single reading using disposable electrodes and a multi-well tray, also known as “multi-array” technology. The Meso joint venture was formed to research opportunities of combining the ECL Technology with MST's multi-array and disposable electrode technologies. To assist the joint venture, IGEN authorized Meso to use certain rights, including the BioVeris Patents, to pursue ECL Technology in connection with defined research technologies and a research program, which were defined based on the multi-array and disposable electrode technologies.

         Meso manufactures and sells ECL-based analyzers, multi-well trays, and reagents for use in scientific research, including early-stage drug discovery. Meso's commercially-sold products use multi-array, disposable electrode technologies. It does not offer any FDA-approved tests. Meso's multi-array, disposable electrode technologies differ from Roche Diagnostics' single-cell, permanent electrode technology. The two different technologies result in different instruments to be used in different markets. Roche Diagnostics cannot and does not use any multi-array, disposable electrode technologies in its ECL-based COBAS instruments.

         Over the course of many years, Meso, Roche Diagnostics, and the Roche affiliates have disputed the extent and reach of each other's rights to use ECL Technology under the license agreements granted to them by IGEN and later by BioVeris. Meso has repeatedly accused Roche Diagnostics and its affiliates of violating Meso's limited, exclusive rights.

         In 2010, Meso and MST sued Roche Diagnostics, Roche Diagnostics GmbH, Roche Holding, IGEN, BioVeris, and others in a Delaware state court for breach of the 2003 license agreement and Meso's consent thereto. Meso asserted claims for breach of contract, injunctive relief, and equitable relief. In its complaint in the Delaware suit, Meso alleged that the Roche entities were selling products using the ECL Technology outside the 2003 defined field and that they were in breach of the 2003 license agreement. Throughout the Delaware litigation, Meso asserted that its 1995 research license agreement with IGEN provided Meso with very broad exclusive rights in the ECL Technology. Because of those rights, IGEN could not grant any license to the Roche entities unless the Roche entities also obtained a license from Meso. Therefore, according to Meso, the consent provided by Meso also made Meso a licensor of the ECL Technology rights to the Roche entities, which gave Meso enforcement rights.

         Following a five-day bench trial in February 2013 and post-trial briefing and argument, on June 25, 2014, the Delaware court issued a 77-page memorandum opinion, which found in favor of the Roche entities and rejected Meso's claim to being a party to or having rights to enforce the 2003 license agreement between IGEN and Roche Holding. Following Meso's appeal of the decision, the Delaware Supreme Court summarily affirmed the judgment in favor of the Roche entities on June 18, 2015. Meso's petition for a writ of certiorari to the United States Supreme Court was denied.

         After the Delaware Supreme Court affirmed the lower court's decision, Meso through its litigation counsel notified F. Hoffman-La Roche Ltd. through its general counsel in Basel, Switzerland, that in Meso's view, the Delaware litigation did not resolve the dispute regarding the extent and reach of Meso's 1995 license covering the use of ECL Technology, including the BioVeris Patents. Meso asserted that it retained the right to litigate the issue of the patents and the license covering the patents and that the activities of the Roche entities infringed Meso's rights under the 1995 license agreement.

         Meso met with representatives of Roche Diagnostics in October 2015 at the offices of Roche Diagnostics' outside counsel in Milwaukee, Wisconsin. At the meeting, Meso's counsel asserted that Meso had complex patent rights arising out of its expansive research program and that Meso was entitled to assert those rights against the Roche entities' sales both outside and within the 2003 defined field. Following this meeting, Meso's counsel wrote again to Roche Diagnostics' general counsel in Switzerland, asking for another meeting to discuss the patent and license issue.

         Frustrated, and believing that further discussions would be unproductive, Roche Diagnostics initiated this litigation on October 22, 2015 (Filing No. 1). Asserting that it is bringing this action under the United States Patent Laws, 35 U.S.C. § 1 et seq., Roche Diagnostics seeks a declaratory judgment of non-infringement of Meso's license rights to use ECL Technology under the BioVeris Patents. Roche Diagnostics asserts that it is entitled to judgment from this Court that Roche Diagnostics does not violate any of Meso's limited exclusive license rights in the ECL Technology under any of the BioVeris Patents.

         Roche Diagnostics explains that there is an actual and justiciable controversy between Roche Diagnostics and Meso in that Meso has asserted in correspondence and in other communications that the Roche entities' use of ECL Technology infringes Meso's limited exclusive license rights under the BioVeris Patents and has threatened suit on that basis. Roche Diagnostics maintains that it has not and does not infringe the BioVeris Patents in violation of Meso's license rights in the ECL Technology.

         Roche Diagnostics further maintains that it does not challenge the validity of any of the BioVeris Patents nor does it dispute that some of its products are covered by some of the BioVeris Patents. Roche Diagnostics seeks confirmation that it has the right to practice ECL Technology with respect to the products it now sells pursuant to its licenses and that its ...

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