Lexapro - Forest has two U.S. patents listed with the FDA that they claim cover Lexapro, the ’712 patent and the ’941 patent. We filed an
ANDA in which we certified to the noninfringement and/or invalidity of both patents. On July 10, 2006, Forest sued us on the ’712 patent
in federal court in Detroit, Michigan. On February 23, 2007, the court partially stayed discovery pending a decision in the U.S. Court of
Appeals for the Federal Circuit in a related case in federal court in Delaware. The Delaware case involved Forest’s assertion of the ’712
patent against Ivax Pharmaceuticals. On December 3, 2007, after the appellate court affirmed the Delaware district court’s finding that the
’712 patent was valid and infringed by Ivax, the Detroit judge issued a ruling allowing discovery to proceed in our case. Accordingly,
discovery is now ongoing.
We also filed a separate case challenging the ’941 patent on the grounds of noninfringement. On April 23, 2007, Forest granted us a
covenant not to sue on the ‘941 patent and, based upon that covenant, the Detroit court dismissed the case for lack of a controversy. For
strategic reasons, we appealed. On April 1, 2008, the Federal Circuit reversed, finding that the covenant not to sue did not moot the
controversy between the parties and that we could therefore proceed with our lawsuit. Forest subsequently filed a motion for en banc
review of the decision, which was denied on June 24, 2008. Forest has indicated its intention to file a petition for a writ of certiorari to
challenge this decision with the Supreme Court.
Prandin – Novo Nordisk filed suit against us in Michigan for patent infringement. FDA granted tentative approval on August 13, 2007.
The parties are in discovery. We anticipate receiving final approval in mid-March 2009. No trial date has been set.
Ultracet - Ortho originally filed suit in Michigan for patent infringement. We certified to noninfringement and obtained summary
judgment of noninfringement. This decision was recently affirmed by the Federal Circuit. Our generic version of Ultracet is presently on
the market. Ortho subsequently filed for a reissue patent, and again sued for patent infringement in New Jersey. We certified to invalidity
of the reissue patent and filed another motion for summary judgment. On April 18, 2008, the United States District Court of New Jersey
granted our motion for summary judgment that the claims of the reissue patent are invalid. Final judgment has been granted and Ortho-
McNeil has filed a notice that it intends to appeal Judge Cavanaugh’s decision.
Clarinex - Schering filed suit in both New Jersey and Michigan for patent infringement against us and Sun. Sun certified to
noninfringement and invalidity. We filed a motion to dismiss for lack of subject matter jurisdiction because Sun is the ANDA filer, not
us. Schering also filed suit against several other ANDA filers. Each of these proceedings has been consolidated in New Jersey for
pretrial proceedings. Fact discovery is ongoing. No trial date has been set.
Product Litigation
