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Skinmedica, Inc v. Histogen Inc.; Histogen Aesthetics LLC

November 21, 2011

SKINMEDICA, INC.,
PLAINTIFF,
v.
HISTOGEN INC.; HISTOGEN AESTHETICS LLC; GAIL K. NAUGHTON,
DEFENDANTS.



The opinion of the court was delivered by: Honorable Janis L. Sammartino United States District Judge

ORDER: GRANTING DEFENDANTS' MOTION FOR PARTIAL SUMMARY JUDGMENT OF NONINFRINGEMENT (ECF No. 153) AND RELATED COUNTERCLAIMS

Presently before the Court is Defendant's motion for partial summary judgment of noninfringement. (ECF No. 153.) Plaintiff opposes the motion. Having considered the parties' arguments and the law, the Court GRANTS Defendant's motion for partial summary judgment.

BACKGROUND

I. Factual History

Plaintiff SkinMedica, Inc. ("SkinMedica") brought this patent infringement action against Defendants Histogen, Inc., Histogen Aesthetics LLC, and Gail K. Naughton (collectively, "Histogen"). SkinMedica and Histogen both develop and sell products for treating dermatologic conditions and diseases affecting skin appearance. The patents in suit are United States Patent Nos. 6,372, 494 (the '494 patent) and 7,188,746 (the '746 patent).

SkinMedica is a privately held company that sells its products primarily to dermatologists and plastic surgeons. Among SkinMedica's products is its TNS® (for Tissue Nutrient System) line of anti-aging products. The main ingredient in the TNS line of products is NouriCel®. NouriCel was originally developed by Advanced Tissue Science, Inc. ("ATS"). In 2002, ATS filed for bankruptcy. In 2003, through the ATS bankruptcy proceedings, SkinMedica claims to have acquired all of the assets, "including the trade secrets and know-how," related to NouriCel through an Asset Purchase Agreement ("APA"). SkinMedica contends that the APA included both the '494 and the '746 patents asserted in this lawsuit.

Defendant Gail Naughton was the co-founder, President, Chief Operating Officer, and Chief Scientific Officer at ATS. She was also the lead named inventor on the '494 and '746 patents. Naughton left ATS shortly after it filed for bankruptcy, and is now the Chief Executive Officer and Chairman of the Board of Directors for Histogen.

During her tenure at ATS, Naughton and her colleagues experimented with NouriCel, ultimately discovering that NouriCel could possibly stimulate hair growth. By September 2002, Naughton presented a confidential report on NouriCel's hair growth potential to ATS's Scientific Advisory Board ("the SAB Report"). In her official capacity as Vice Chairman of ATS, Naughton claims to have been authorized to discuss the contents of the SAB Report with outside parties, including a former ATS employee no longer under a confidentiality agreement, and competing pharmaceutical companies.

Beginning in 2004, Naughton and Histogen began filing patent applications for "conditioned medium" research similar to the NouriCel research Naughton performed at ATS. However, as of January 2009, the U.S. Patent and Trademark Office and the European Patent Office had rejected all of these claims in light of prior art.

II. The Patents in Suit

Generally, the '494 and '746 patents describe and encompass "novel conditioned cell culture medium compositions" derived from cells cultured in three-dimensions. See '494 Patent col. 4 ll.40-44; '746 Patent col.40 ll.7-18. Cell culture medium is the liquid solution used to 'culture,' or, 'grow' cells in vitro, and typically includes various raw materials-e.g., amino acids, vitamins, sugars, etc.-that the cells need to grow and expand in number." '494 Patent col.1 ll.21--26. "Once the culture medium is incubated with cells, it becomes a 'spent' or 'conditioned' medium." '494 Patent col.1 ll.30--32.

The '494 and '746 patents are specifically directed to conditioned medium derived from cells cultured in three-dimensions. Cells cultured in three dimensions "express an extracellular matrix of proteins, thus forming a living tissue." '494 Patent col.6 ll.54-56. Further, cells cultured in three dimensions secrete growth factors and other proteins in ratios higher than cells cultured in two-dimensional monolayers. '494 Patent col.5 ll.1-4, col.6 ll.9-17. Thus, conditioned medium derived from cells grown in three dimensions, such as NouriCel, is superior to conditioned medium derived from cells grown in two dimensions.

III. The Accused Products

In October 2008, SkinMedica became aware that Histogen planned to launch a line of skin care products based on a conditioned medium called ReGenicaTM that sounded similar to SkinMedica's NouriCel technology. These products include the ReGenica Facial Rejuvenation Complex, Regenica Advanced Rejuvenation Day Repair, and the ReGenica Advanced Rejuvenation Overnight Repair products, in addition to other unknown products directed for use as a promoter for hair growth (collectively, "the accused products").

The parties seem to agree on the method steps Histogen uses for cell culturing, although they disagree as to which of these steps is relevant to the issue of infringement. Histogen states it manufactures the accused products "by growing cells in monolayer in smooth surface roller bottles on microcarrier beads." (Def.'s Mem. ISO Motion 1, ECF No. 153.) These microcarriers are "microscopic beads" to which cells are attached and then later "mixed in vessels to a fluidized condition to maximize, and provide control of, mass transport characteristics." (Baumgartner Decl. ISO Def.'s Motion, Ex. 10.) Known as "bioreactor vessels," these vessels contains microcarrier beads and are kept continuously stirring as cells grow on the microcarrier beads. (Baumgartner Decl. ΒΆ 12.) Eventually, the cells secrete "sticky" extracellular matrix ("ECM") proteins that coat the beads and the surrounding surfaces. (Pl.'s Opp'n 8, ECF No. 171 (quoting Aug. 25, 2009 Naughton Dep., at 120:5-8.)) The sticky nature of this extracellular matrix leads to the formation of "clumps" or aggregates of beads. (Id.) After aggregates of beads begin to form, the cells continue to produce ECM, which forms bridges between beads, creating a three-dimensional structure. (Id.) Thus, SkinMedica summarizes that "cells which start out 'on' the beads in two dimensions then migrate ...


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