Pfizer 2009 Annual Report Download - page 93

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
Aricept (donepezil hydrochloride)
In October 2005, Teva USA notified Eisai Co., Ltd. (Eisai) that Teva USA had filed an abbreviated new drug application with the
FDA challenging on various grounds Eisai’s basic patent for Aricept, which expires in November 2010, and seeking approval to
market a generic version of Aricept. In December 2005, Eisai filed suit against Teva USA in the U.S. District Court for the District of
New Jersey asserting infringement of that patent. While Teva USA has received final approval from the FDA for its generic product,
it is subject to a preliminary injunction prohibiting the marketing of its product pending the outcome of Eisai’s patent infringement
action. We co-promote Aricept with Eisai in the U.S. but are not a party to Eisai’s patent infringement action.
Neurontin (gabapentin)
In August 2005, the U.S. District Court for the District of New Jersey held that the generic gabapentin (Neurontin) products of a
number of generic manufacturers did not infringe our gabapentin low-lactam patent, which expires in 2017, and it granted summary
judgment in their favor. Several generic manufacturers launched their gabapentin products in 2004 and 2005. In September 2007,
the U.S. Court of Appeals for the Federal Circuit reversed the District Court’s summary judgment decision and remanded the case to
the District Court for trial on the patent infringement issue. If successful at trial, we intend to seek compensation from the generic
manufacturers for damages resulting from their at-risk launches of generic gabapentin.
Protonix (pantoprazole sodium)
Wyeth has an exclusive license to market Protonix in the U.S. from Nycomed GmbH (Nycomed), which owns the patents relating to
Protonix. The basic patent (including the six-month pediatric exclusivity period) for Protonix expires in January 2011.
Following their respective filings of abbreviated new drug applications with the FDA, Teva USA and Teva Pharmaceutical Industries,
Ltd. (Teva Industries), Sun Pharmaceutical Advanced Research Centre Ltd. and Sun Pharmaceutical Industries Ltd. (collectively,
Sun) and KUDCO Ireland, Ltd. (KUDCO Ireland) received final FDA approval to market their generic versions of Protonix 20 mg and
40 mg delayed release tablets. Wyeth and Nycomed filed actions against Teva USA and Teva Industries, Sun and KUDCO Ireland
in the U.S. District Court for the District of New Jersey, which subsequently were consolidated into a single proceeding, alleging
infringement of the basic patent and seeking declaratory and injunctive relief. Following the court’s denial of a preliminary injunction
sought by Wyeth and Nycomed, Teva USA and Teva Industries and Sun launched their generic versions of Protonix tablets at risk in
December 2007 and January 2008, respectively. Wyeth launched its own generic version of Protonix tablets in January 2008, and
Wyeth and Nycomed filed amended complaints in the pending patent infringement action seeking to recover lost profits and other
damages resulting from Teva USA’s and Teva Industries’ and Sun’s at-risk launches. To Wyeth’s knowledge, KUDCO Ireland has
not launched its generic product to date.
In July 2009, Apotex notified Wyeth that it had filed an abbreviated new drug application with the FDA seeking approval to market a
generic version of Protonix 20 mg and 40 mg delayed release tablets and asserting the invalidity of the basic patent for Protonix. In
August 2009, Wyeth and Nycomed filed suit against Apotex in the U.S. District Court for the Northern District of Illinois alleging
infringement of the basic patent.
Wyeth and Nycomed are defendants in purported class actions brought by direct and indirect purchasers of Protonix in the U.S.
District Court for the District of New Jersey. Plaintiffs seek damages, on behalf of the respective putative classes, for the alleged
violation of antitrust laws in connection with the procurement and enforcement of the patents for Protonix. These purported class
actions have been stayed pending resolution of the underlying patent litigation in the U.S. District Court for the District of New
Jersey.
Effexor XR (venlafaxine HCl (extended release capsules))
In 2005, Wyeth entered into a settlement of patent litigation against Teva USA and Teva Industries pursuant to which they are
permitted to launch generic versions of Effexor XR (extended release capsules) in the U.S. beginning on July 1, 2010, subject to
possible earlier launch based on specified market conditions or developments regarding the applicable patent rights, including the
outcome of other generic challenges to such patent rights. Since the settlement with Teva USA and Teva Industries, Wyeth has
settled patent suits against certain other generic companies that generally grant licenses permitting the generic companies to launch
generic versions of Effexor XR (extended release capsules) in the U.S. on or after June 1, 2011, subject to possible earlier launch in
limited circumstances but in no event earlier than January 1, 2011. Wyeth has patent infringement actions pending against several
other generic companies that have filed abbreviated new drug applications with the FDA seeking approval to market generic
versions of Effexor XR (extended release capsules) in the U.S.
ReFacto and Xyntha
In February 2008, Novartis Vaccines and Diagnostics, Inc. (Novartis) filed suit against Wyeth and a subsidiary of Wyeth in the U.S.
District Court for the Eastern District of Texas alleging that Wyeth’s ReFacto and Xyntha products infringe two Novartis patents.
Novartis’ complaint seeks damages, including treble damages, for alleged willful infringement. Wyeth and its subsidiary assert,
among other things, the invalidity and non-infringement of the Novartis patents. In November 2009, Novartis added a third patent to
its infringement claim against Wyeth and its subsidiary.
In May 2008, a subsidiary of Wyeth filed suit in the U.S. District Court for the District of Delaware against Novartis seeking
a declaration that the two Novartis patents initially asserted against Wyeth and its subsidiary in the action referred to in the
preceding paragraph are invalid on the ground that the Wyeth subsidiary was the first to invent the subject matter.
Tygacil (tigecycline)
In October 2009, Sandoz notified Wyeth that it had filed an abbreviated new drug application with the FDA seeking approval to
market a generic version of Tygacil. Sandoz asserts the invalidity and non-infringement of two of Wyeth’s patents relating to Tygacil,
including the basic patent, which expires in 2016. In December 2009, Wyeth filed suit against Sandoz in the U.S. District Court for
the District of Delaware asserting infringement of the basic patent.
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