CSL Response to Patent Infringement Complaint


Melbourne, Australia — 10/07/2017

CSL Limited (ASX:CSL; USOTC:CSLLY) has become aware that Bioverativ has filed complaints in the U.S. District Court for the District of Delaware and with the International Trade Commission. Bioverativ alleges that the use of Idelvion®, a novel factor IX albumin fusion protein developed by CSL Behring, by patients and physicians constitutes patent infringement, and that by virtue of the US Food and Drug Administration (FDA) approved label for Idelvion®, CSL therefore infringes three Bioverativ patents.

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CSL is highly confident of its intellectual property position for Idelvion®, a product of over a decade of innovative research by CSL Behring and representative of a major advance for patients suffering hemophilia B, and will vigorously defend against the claim.

Idelvion® was approved by the FDA in March 2016 for use in children and adults with hemophilia B (congenital factor IX deficiency) for: on-demand control and prevention of bleeding episodes, perioperative management of bleeding and routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

CSL Behring is committed to making Idelvion® available to patients and believes that patients and physicians have the right, and should have the ability, to choose among a variety of treatment options for hemophilia B, including Idelvion®. As this is a litigation matter, specific details concerning the case cannot be further discussed.

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For further information, please contact:

Mark Dehring
Head of Investor Relations
CSL Limited
Telephone: +613 9389 3407
Email: mark.dehring@csl.com.au
Jemimah Pentland
Head of Communications, Asia Pacific
CSL Limited
Mobile +61 412 635 483
Email: jemimah.pentland@csl.com.au
© 2017 CSL Limited