Genentech and Biogen Idec Refused a Re-hearing of U.S.

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News Desk 2018
Genentech and Biogen Idec Refused a Re-hearing of U.S. Court of Appeals Decision in the Arzerra Patent Infringement Case

Company Announcement

  • Genentech and Biogen Idec refused re-hearing in Arzerra patent infringement case

Copenhagen, Denmark; July 15, 2013 – Genmab A/S (OMX: GEN) announced today that the U.S. Court of Appeals for the Federal Circuit has declined the request for re-hearing. The court upheld its judgment in favor of GlaxoSmithKline (GSK) in the patent infringement case involving Arzerra® brought against GSK by Genentech and Biogen Idec.

The lawsuit is now over unless Genentech and Biogen Idec are granted further review by the Supreme Court.

Genentech and Biogen Idec originally filed the lawsuit in 2010 in the U.S. District Court for the Southern District of California claiming that Arzerra infringed U.S. Patent No. 7,682,612 covering methods of treating Chronic Lymphocytic Leukemia (CLL) with CD20 antibodies. GSK denied infringement and claimed the patent was invalid and unenforceable. An initial judgement by the court in favor of GSK in December 2011 was subsequently appealed by Genentech and Biogen Idec. In April 2013 the US court of appeals upheld the original decision by the US district court in favor of GSK. In May 2013, Genentech and Biogen Idec filed a request for re-hearing en banc (i.e. before all judges of the court) of the decision from the US court of appeals stating that it was against court precedent.

Arzerra is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.  

About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer.  Founded in 1999, the company’s first marketed antibody, ofatumumab (Arzerra ® ), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development.  Genmab’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates.  Partnering of innovative product candidates and technologies is a key focus of Genmab’s strategy and the company has alliances with top tier pharmaceutical and biotechnology companies.  For more information visit www.genmab.com .

Contact:           Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.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 in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab ® ; the Y-shaped Genmab logo ® ; the DuoBody™ logo; HuMax ® ; HuMax-CD20 ® ; DuoBody ® , HexaBody TM and UniBody ® . Arzerra ® is a trademark of GlaxoSmithKline.

Company Announcement no. 31 CVR no. 2102 3884

Genmab A/S Bredgade 34E 1260 Copenhagen K Denmark

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