Genmab Announces that the patents asserted against DARZALEX® in the United States have been declared invalid by summary judgment.
- Patents asserted against Janssen Biotech, Inc. & Genmab in the United States have been declared invalid by summary judgment
Copenhagen, Denmark; January 26, 2019 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that the U.S. District Court of Delaware has declared the three U.S. patents (Nos. 8,263,746, 9,200,061, and 9,758,590), asserted by MorphoSys AG against Genmab and Genmab’s collaboration partner Janssen Biotech, Inc. (Janssen) are invalid by summary judgment. The patent infringement lawsuit was initiated by MorphoSys against Genmab and Janssen in April 2016 asserting that activities with DARZALEX (daratumumab) in the United States infringe its U.S. patents, and the case has been pending before the U.S. District Court of Delaware. The summary judgment order declared all three patents invalid due to lack of enablement. As a result of this decision, the jury trial scheduled for February 2019 will not take place. MorphoSys has the opportunity to appeal the district court decision to the U.S. Court of Appeals for the Federal Circuit (CAFC). In addition, during the case a further claim by Janssen and Genmab was included in the case that the three MorphoSys patents were unenforceable due to inequitable conduct by MorphoSys. That issue remains to be decided.
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications and other blood cancers. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody® platform for generation of bispecific antibodies, the HexaBody® platform, which creates effector function enhanced antibodies and the HexElect™ platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; E: email@example.com
This Company Announcement contains forward looking statements. The words “believe”, “expect”, “anticipate”, “intend” and “plan” and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab’s most recent financial reports, which are available on www.genmab.com. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody™; HexElect™; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.
Company Announcement no. 05
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Kalvebod Brygge 43
1560 Copenhagen V