Summary
As stated in the 25 Mar 2009 press release by Teva (NasdaqGS:TEVA), the FDA recently denied Teva's Citizen Petition (CP) which was previously filed 26 Sep 2008. Teva is now fully-engaged in its dual efforts to protect its American COPAXONE sales. These dual efforts are (1) at the FDA: through petition practice, Teva seeks to have the FDA undertake specific action which in effect would either delay or prevent FDA review or approval of the now pending Novartis-Momenta Abbreviated New Drug Application No. 90-128 for generic COPAXONE; and (2) at the United States District Court for the Southern District of New York (USDC/SDNY): in Case No. 1:08-cv-07611-BSJ-JCF, Teva as Plaintiff has sued Novartis (NYSE:NVS) and Momenta (NasdaqGM:MNTA) for patent infringement of multiple FDA Orange Book patents [7 patents are listed in the FDA Orange Book 5981589 6054430 6342476 6362161 6620847 6939539 7199098].
Analysis
As always in Patent FDA Disputes for Life Sciences, the details are both important and complex. As background, COPAXONE (glatiramer acetate for injection) is (1) FDA-approved as of 20 Dec 1996 for reduction of the frequency of relapses in patients with Relapsing-Remitting Multiple Sclerosis (RRMS); and (2) very important to Teva - with 2008 American sales of more than $1.3 Billion. For these COPAXONE disputes, Teva is positioned as the Innovator Company (think "Big Pharma") seeking to protect its flagship product COPAXONE, a FDA Orange Book Reference Listed Drug (RLD) versus the would-be generic competitors of Novartis (acting though Sandoz, its generic pharmaceutical business) in collaboration with Momenta Pharmaceuticals (a Cambridge, MA biotechnology company).
With respect to the FDA determination to deny Teva's Citizen Petition (CP), as noted in the press release itself, the FDA decision by itself does not imply one way or the other way the manner in which the FDA will respond to the now pending Novartis-Momenta ANDA. It does indicate, however, that the FDA has interpretated a specific provision of FDA Law [namely, 21 USC 355(q) Petitions and Civil Actions Regarding Approval of Certain Applications] to (1) require final FDA action relative to Teva's CP within 180 days of the CP's 26 Sep 2008 date of filing; and (2) not require final FDA action relative to the Novartis-Momenta ANDA within the 180 days window. Patent litigation filings indicate that the Novartis-Momenta ANDA was filed in Dec 2007.
With respect to the now ongoing Paragraph (IV) patent infringement litigation in Manhattan, certain details are now available. The lawsuit parties are (1) on the one side, Plaintiffs = Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industry Ltd., Teva Neuroscience, Inc., and Yeda Research And Development Co. Ltd.; and (2) on the other side, Defendants = Sandoz Inc., Sandoz Intl. GmbH, Novartis AG, and Momenta Pharmaceuticals, Inc. The original Plaintiffs' Complaint for Patent Infringement, filed 28 Aug 2008, asserts 4 patents [7199098 6939539 6054430 6620847] (the "patents-in-suit") as being infringed by the generic COPAXONE ANDA. Plaintiffs are suing Defendants for Patent Infringement (Counts I-VIII) together with charges of Misappropiation Of Trade Secrets (Count IX) and Unfair Competition (Count X).
