Biotech/Pharma Docket

    By Suresh Pillai --

Bavarian Nordic Suit over TroVax® Survives Motion to Dismiss

Last week, the U.S. District Court for the Southern District of California refused to dismiss an amended complaint filed by Bavarian Nordic A/S alleging that Oxford Biomedica infringes Bavarian Nordic's U.S. Patent Nos. 6,761,893, 6,913,752, 7,335,364, and 7,459,270 with respect to Oxford Biomedica's experimental cancer vaccine TroVax® (see "Court Report," July 6, 2008).

In its attempt to have the suit dismissed, Oxford claimed that Bavarian Nordic's action was premature, as TroVax® was still in the development phase.  However, Bavarian Nordic argued that Oxford should be denied safe harbor because Oxford had already commercialized the TroVax® vaccine and entered into a $700 millon contract with Sanofi.  The District Court agreed with Bavarian Nordic's arguments, ruling that Bavarian Nordic may continue its suit against Oxford.

Settlement Reached in Coreg® Patent Suit

Teva Pharmaceuticals Industries Ltd. announced the settlement of its patent infringement suit with Zydus Pharmaceuticals Inc. and Cadila Healthcare Ltd. concerning the process of making the key ingredient in Coreg®, a beta blocker used to treat high blood pressure.  Teva launched lawsuits against Zydus and Cadila in 2007 asserting infringement of patents covering the preparation of carvedilol, Coreg's® active ingredient (see "Court Report," July 1, 2007).  Coreg® is currently sold by GlaxoSmithKline PLC.  The patents-in-suit, U.S. Patent Nos. 7,056,942, 6,710,184, 6,699,997, and 7,126,008, had all been assigned to Teva.  In October, Teva learned that Zydus had submitted a new drug master file to the FDA that disclosed a new process for the manufacture of carvedilol.

After filing suit, Teva reviewed the FDA filing and withdrew the infringement suit as it pertained to the '184 and '942 patents.  Teva also provided Zydus with a covenant not to sue regarding the two patents.  The U.S. District Court for the District of New Jersey signed off on the dismissal last week.  Details of the settlement have not been released.


Patent Co-owned by U.S. Not Immunized from Infringement or Validity Determinations

Last week, the U.S. District Court for the Northern District of Illinois ruled that KGK Synergize Inc. could not avoid a determination of validity and infringement on the basis that the co-owner of the patent-in-suit is the United States government.  SourceOne Global Partners LLC, a former licensee of KGK, sued KGK in December 2008 after KGK sent a cease and desist letter ordering SourceOne to halt manufacturing and marketing of a cholesterol-reducing nutritional supplement.  In 2003, KGK and SourceOne entered into a licensing agreement providing SourceOne with the right to manufacture, distribute, and sell Sytrinol, a nutritional supplement used to lower cholesterol.

As part of its lawsuit, SourceOne sought a declaratory judgment of noninfringement or invalidity of a patent co-owned by the United States government (U.S. Patent No. 6,987,125) as well as two other patents not co-owned by the government.  KGK argued that, because the United States was a co-owner of one of the patents-in-suit, the suits were immune from suit, thereby depriving the District Court of subject matter jurisdiction.  In the alternative, KGK argued that the government was a required party for the suit due to its co-ownership of the '125 patent.

The District Court, however, disagreed with KGK's interpretation, holding that the government's co-ownership and inability to be joined as a defendant did not divest the Court of subject matter jurisdiction.  Furthermore, the District Court concluded that SourceOne had standing to bring suit.  In his ruling, Magistrate Judge Schenkier stated that he would not allow KGK to "retreat behind the government's cloak of immunity and prevent the infringement or validity of the '125 patent from ever being tested in court."

Comments

[R.A. Guthrie]

Last week, the U.S. District Court for the Northern District of Illinois ruled that KGK Synergize Inc. could not avoid a determination of validity and infringement on the basis that the co-owner of the patent-in-suit is the United States government.

Quote: KGK in fact welcomes the opportunity of a full Jury trial in order to vindicate its position and patent rights.Far too often infringement cases are settled in secretive agreements that do not fully expose the infringing party.