Biotech/Pharma Docket

    By Suresh Pillai --

Federal Court Approves Eloxatin® Settlement Agreement

The U.S. District Court for the District of New Jersey has signed off on Sanofi-Aventis' settlement agreement with Sun Pharmaceutical Industries Ltd. despite the fact that Sanofi failed to exchange all relevant signature pages.  The agreement ends the litigation over a generic version of Eloxatin®, a colon cancer drug manufactured and marketed by Sanofi (see "Biotech/Pharma Docket," July 14, 2009).  Sanofi originally filed suit against Sun, Sandoz, Actavis Inc., and Par Pharmaceutical Inc., among other generic manufacturers, in June 2007, accusing them of infringing Sanofi's patent covering Eloxatin®, U.S. Patent No. 5,338,874 (see "Court Report," July 30, 2007).  During the course of litigation, Sanofi and Sun began negotiating for a settlement and reached a final agreement in May 2009.  On June 16, Sanofi summarily verified to Sun that Sun had fully executed and signed Sun's portions of the agreement and that Sanofi had obtained almost all of the signatures required for the settlement.  Sanofi also stated that it would send out the final completed document to Sun on June 17.  However, on June 17, having concluded that the parties used a different method for the formulation of the drug's active ingredient, the District Court granted motions for summary judgment of non-infringement for Sandoz, Mayne Pharma, Teva Pharmaceutical Industries, Ltd., and Hospira, Inc.

Following the Court's ruling, Sanofi refused to turn over a signed copy of the settlement, stating that the Court's ruling had diminished the value of any such settlement agreement.  In its most recent ruling, however, the Court ruled that because the essential terms of the agreement were set forth in both the letter of intent and the term sheets, the agreement was enforceable regardless of whether all required signatures had been obtained.  The Court also concluded that both parties, prior to the Court's ruling on June 17, had considered the settlement complete, with no further revisions required.

Lupin Acquisition Ends Oscient Infringement Suit

In the wake of Lupin Ltd.'s acquisition of U.S. rights to Oscient Pharmaceuticals Corp.'s cholesterol drug Antara®, the U.S. District Court for the District of Maryland has accepted two stipulations dismissing with prejudice all claims and counterclaims in the lawsuit involving Oscient, Ethypharm SA, and Lupin.  Oscient and Ethypharm originally filed suit in January 2009 following Lupin's filing of an ANDA seeking approval to manufacture and market a generic version of Antara® (see "Court Report," January 18, 2009).  In the suit, Oscient (the exclusive licensee of the patent) and Ethypharm (the patentee) alleged that Lupin's ANDA filing infringed U.S. Patent No. 7,101,574, the patent covering pharmaceutical compositions of Antara®.  However, during the course of the litigation, Oscient filed for Chapter 11 bankruptcy protection.  Lupin subsequently purchased the rights to the patent pursuant to bankruptcy court procedures.  Lupin's purchase of the patent-in-suit rendered moot the initial case or controversy.

Court Bifurcates Infringement and Antitrust Determinations in Amrix Dispute

The U.S. District Court for the District of Delaware has denied Mylan Inc., in its patent dispute with Cephalon Inc., the opportunity to raise either antitrust counterclaims or a patent misuse defense until the completion of the infringement trial.  Cephalon originally filed suit in November 2008 following Barr Pharmaceuticals' and Mylan's submissions of ANDAs seeking approval to manufacture and market generic versions of Cephalon's drug Amrix® (see "Court Report," November 30, 2008).  In its complaint, Cephalon alleged that both Barr and Mylan had infringed U.S. Patent No. 7,387,793, Cephalon's patent covering Amrix®.

In its answer, Mylan alleged that its generic did not infringe Cephalon's patent, that the patent was invalid, and that Cephalon had failed to make a good faith effort to investigate Mylan's drug formulation prior to filing the suit.  Mylan also alleged that Cephalon's filing was a preemptive measure aimed to monopolize the marketing and manufacture of Amrix®, thereby violating federal antitrust laws.

In its ruling, the District Court determined that because the evidence presented in support of the counterclaims was irrelevant in the determination of the issues of infringement and validity, judgment on the counterclaims would be stayed until the completion of the infringement trial in order to prevent jury distraction.

Supreme Court Refuses to Hear Mylan's Appeal over Takeda's Attorneys' Fees

The U.S. Supreme Court has refused to grant certiorari to review a Federal Circuit decision affirming a lower court decision that the case of Mylan Laboratories Inc. v. Takeda Pharmaceutical Inc. was exceptional and warranted the award of attorneys' fees.  Takeda filed suit against Mylan and Alphapharm, a Mylan subsidiary, alleging that Mylan had infringed Takeda's patent covering the diabetes treatment Actos® by filing ANDAs with Paragraph IV certifications.  In March 2006, the U.S. District Court for the Southern District of New York issued its ruling that Mylan and Alphapharm, had infringed Takeda's patent.  During the trial, Mylan had originally alleged that patent was invalid on grounds of obviousness.  Following discovery, however, Mylan alleged that Takeda had committed inequitable conduct before the USPTO.  The shifting arguments led the lower court to conclude that Mylan had acted in bad faith, and the lower court summarily awarded Takeda $16.8 million in attorneys' fees, the largest amount ever granted under Section 285 in Hatch-Waxman patent litigation.

The Federal Circuit concluded that both Alphapharm and Mylan had committed misconduct by claiming in their Paragraph IV certifications that the patents were invalid.  The Federal Circuit affirmed the lower court's finding that Mylan's ANDA certification letter was submitted in bad faith (see Patent Docs report).

Settlement Announced in Flomax® Dispute

Impax Laboratories Inc. has announced a settlement in its ongoing patent dispute with Astellas Pharma Inc. and Boehringer Ingelheim Pharmaceuticals Inc. over generic versions of Astellas' and Boehringer Ingelheim's blockbuster drug Flomax®, which is used to treat symptoms associated with enlarged prostates.  Astellas and Boehringer Ingelheim filed their infringement suit in July 2008 after Impax filed an ANDA seeking to manufacture and market a generic version of Flomax® (see "Court Report," July 27, 2008).  The ANDA included a Paragraph IV certification that Impax' generic did not infringe any valid or enforceable claim of U.S. Patent No. 4,703,063, the patent covering Flomax®.

As part of the terms of the settlement, Impax will be allowed to market and manufacture a generic version of the drug as of March 2, 2010, prior to the expiration of pediatric exclusivity.  The U.S. District Court for the Northern District of California has signed off on a consent order closing the case in the wake of the settlement agreement.  Under the terms of the consent order, Impax has admitted that the '063 patent is enforceable and valid.  Impax has also agreed not to dispute these admissions in any other related litigation proceedings.  In addition, Impax admitted that the manufacture, use, sale or distribution of its generic Flomax® product prior to the patent's expiration date would infringe the patent.