(SAN FRANCISCO) July 15, 2008 – Heller Ehrman LLP announced that clients Allergan, Inc. and Roche Palo Alto LLC prevailed in a long-running patent dispute with Apotex, Inc., a Canadian generic drug manufacturer.  On Wednesday, July 9, the U.S. Court of Appeals for the Federal Circuit upheld a decision by the U.S. District Court for the Northern District of California to grant summary judgment to Roche and Allergan.  The latest ruling follows seven years of litigation between the parties over a patent connected to prescription anti-inflammatory eye medicine.

Allergan is the distributor of ACULAR® and ACULAR®LS, which are covered by a patent owned by Roche (formerly Syntex (U.S.A.) LLC).  The dispute with Apotex over Roche’s patent began in 2001, when Allergan and Roche filed a patent infringement lawsuit against Apotex over Apotex’s application to the FDA to make a generic version of ACULAR®, the number-one prescribed anti-inflammatory eye medicine in the U.S.

After a bench trial in 2003, Heller Ehrman achieved a win on behalf of Allergan and Roche before the Northern District of California.  Apotex appealed.  The Federal Circuit reversed and remanded a portion of the district court’s findings in May 2005.  After a February 2006 remand hearing, however, the district court ruled again in favor of Allergan and Roche, taking into consideration all of the Federal Circuit’s directives.  As a result, Apotex was barred from receiving FDA approval for its generic ACULAR® product before the patent expires in 2009.

Apotex appealed to the Federal Circuit again, but after hearing oral arguments in April 2007, the Federal Circuit handed Heller Ehrman and the firm’s clients another favorable outcome by affirming the district court’s remand decision, without opinion.  Apotex filed a petition for certiorari with the U.S. Supreme Court, but that petition was denied.

In 2005, Apotex filed another application with the FDA, this time seeking approval for a generic form of ACULAR®LS.  As it had done in its generic ACULAR® application, Apotex asserted Roche’s patent was invalid and not infringed.  Roche and Allergan responded by filing another patent infringement lawsuit in the Northern District in May 2005.  On behalf of Roche and Allergan, Heller Ehrman filed a motion for summary judgment that Apotex infringed the patent at issue and that Apotex’s validity and unenforceability defenses should be barred as a result of the initial litigation involving ACULAR® based on doctrines of issue and claim preclusion.

Apotex asserted that its ACULAR®LS formulation escapes infringement under the reverse doctrine of equivalents and that the issue and claim preclusion doctrines did not apply because the generic ACULAR® and ACULAR®LS formulations were distinct, and the change in law exception, in view of KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007), precluded application of those doctrines.

On September 11, 2007, the district court granted Roche’s motion for summary judgment, holding that Apotex failed to make the showing needed under the reverse doctrine of equivalents analysis.  The court also held that, with the exception of obviousness, Apotex’s invalidity and unenforceablity arguments were prevented by issue preclusion because invalidity had already been raised in previous litigation.  As to the validity challenge based on obviousness, the court ruled that such a challenge was prevented by claim preclusion.  It was thus unnecessary for the court to decide whether KSR constituted a change in law justifying an exception to issue preclusion.

On appeal, the Federal Circuit affirmed the Northern District’s finding that the patent held by Roche is valid and infringed by Apotex.  The Federal Circuit found no error in the district court’s dismissal of Apotex’s reverse doctrine of equivalents argument and agreed that Apotex was precluded from bringing additional validity claims because of the prior infringement case concerning the same patent.  The Federal Circuit’s opinion is available online at: http://www.cafc.uscourts.gov/opinions/08-1021.pdf.

Heller Ehrman’s team, which has represented Allergan and Roche throughout the Apotex dispute, is led by Alexander L. Brainerd and Christine Saunders Haskett.  Both lawyers are shareholders in the firm’s San Francisco office. Also assisting in the matter were San Francisco associates Sam Ernst and Nate Shafroth.  The lawyers on the team are all members of Heller Ehrman’s Intellectual Property Litigation Practice, which consists of more than 80 IP litigators.  The firm’s IP clients include industry leaders such as Genentech, Symantec, Allergan, Texas Instruments, Merck KGaA, Yahoo!, Innogenetics, CA, Varian, Palm, Depomed, Apple, ALZA, and SAP.  Since 2003, Heller Ehrman’s IP Litigation Practice has been successful in 17 consecutive trials.

In early July, IP Law & Business released its annual Patent Litigation Survey, which ranked Heller Ehrman among the most active law firms handling patent cases and appeals.  Heller Ehrman was ranked 15^th overall, based on the 40 cases it handled before district courts. The firm ranked 5^th – moving up nine places over 2007’s No. 14 ranking – based on the number of actions filed in district court on behalf of plaintiffs.  The firm’s Appeals & Strategy practice earned a No. 8 ranking, based on the number of matters the firm has handled before U.S. Court of Appeals for the Federal Circuit.  To compile its rankings, IP Law & Business contacted more than 300 law firms, asking for a list of patent cases filed during calendar year 2007 in which they represented clients in federal district courts and in appeals at the Federal Circuit.

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