Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that it won a key ruling from the United States District Court for the Southern District of California in the patent lawsuit that SkinMedica, Inc. filed against Histogen in 2009. In this hearing, known as a “Markman hearing”, both sides presented evidence and arguments to the court on how they requested that the disputed terms be interpreted.
In the ruling issued on May 24, 2011, the court addressed the meaning of disputed terms in United States Patent Nos. 6,372,494 (titled “Method of making conditioned cell culture medium compositions”) and 7,118,746 (titled “Conditioned cell culture medium compositions and methods of use”). The court interpreted the terms in both of the patents-in-suit as excluding cells grown on microcarrier beads. Histogen grows cells in suspension on microcarrier beads to produce its products, which the federal court has confirmed is outside the scope of the claims of the patents in the lawsuit.
With this result, Histogen has prevailed on the key claim interpretation relevant to the lawsuit filed by SkinMedica. This important ruling should lead to the trial court’s dismissal of the patent infringement allegations against Histogen.
“The Order supports what we have believed since Histogen’s inception, which is that Histogen’s methods and products are unique, and that our technology for culturing cells on microcarrier beads is free from any patent rights that SkinMedica may have,” said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. “It will allow us to raise the additional capital to continue the development of our lead therapeutic products, and will re-start partnership discussions, all of which have been slowed by this litigation since January 2009.”
The federal court in San Diego issued the order in case 09-CV-122 JLS (NLS) following a two day evidentiary hearing on February 15-16, 2011, where the court determined the meaning of disputed claim terms in the patents being asserted in the case. A copy of the Markman Order is available upon request.
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, including low oxygen and suspension, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families – a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix. For more information, please visit http://www.histogen.com.