Pfizer 2011 Annual Report Download - page 100

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
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.
Avinza (morphine sulfate)
King Pharmaceuticals, Inc. (King) and Elan Pharma International LTD (EPI) brought a patent-infringement action in the U.S. District
Court for the District of New Jersey against Sandoz in July 2009 as the result of its abbreviated new drug application with the FDA
seeking approval to market a generic version of Avinza. Sandoz is challenging a formulation patent for Avinza, which is owned by
EPI, that expires in 2017.
EpiPen
King brought patent-infringement actions against Sandoz in the U.S District Court for the District of New Jersey in July 2010 and
against Teva Pharmaceutical Industries and Intelliject, Inc. (Intelliject) in the U.S. District Court for the District of Delaware in August
2009 and January 2011, respectively, as the result of their abbreviated new drug applications with the FDA seeking approval to
market epinephrine injectable products. The two actions in Delaware subsequently were consolidated. Sandoz and Teva
Pharmaceutical Industries are challenging and Intelliject challenged two patents, which expire in 2025, covering the next generation
autoinjector for use with epinephrine that is sold under the EpiPen brand name. In February 2012, the action against Intelliject was
settled. Under the settlement agreement, Intelliject may launch its epinephrine injectable product no earlier than November 15,
2012, subject to final approval by the FDA.
Embeda (morphine sulfate/naltrexone hydrochloride extended-release capsules)
In August 2011, Watson Laboratories Inc.—Florida (Watson Florida) notified us that it had filed an abbreviated new drug application
with the FDA seeking approval to market a generic version of Embeda extended-release capsules. Watson Florida asserts the
invalidity and non-infringement of three formulation patents that expire in 2027. In October 2011, we filed an action against Watson
Florida in the U.S. District Court for the District of Delaware asserting the infringement of, and defending against the allegations of
the invalidity of, the three formulation patents.
Torisel (temsirolimus)
In November 2011, Sandoz and Accord Healthcare, Inc. USA and certain of its affiliates (collectively, Accord) notified us that they
had filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Torisel. Sandoz and
Accord assert the invalidity and non-infringement of two patents for Torisel, including the basic patent, which expires in 2014. In
December 2011, we filed suit against Sandoz and Accord in the U.S. District Court for the District of Delaware asserting the
infringement of, and defending against the allegation of the invalidity of, the basic patent.
ACTION IN WHICH WE ARE THE DEFENDANT AND A RELATED ACTION
ReFacto AF 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 AF and Xyntha products infringe two Novartis patents.
Novartis’s 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 August 2010, Novartis granted Wyeth and its subsidiary a covenant not to
sue on the third patent and withdrew that patent from its pending action.
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. In February 2010,
the District of Delaware declined to invalidate those two Novartis patents. In March 2010, the Wyeth subsidiary appealed the
decision to the U.S. Court of Appeals for the Federal Circuit. In August 2011, the Federal Circuit affirmed the District Court’s
decision. In November 2011, the Federal Circuit denied the Wyeth subsidiary’s petition for a rehearing. The Federal Circuit’s
decision does not address the defenses that Wyeth and its subsidiary are asserting in the action referred to in the previous
paragraph.
B. Product Litigation
Like other pharmaceutical companies, we are defendants in numerous cases, including but not limited to those discussed below,
related to our pharmaceutical and other products. Plaintiffs in these cases seek damages and other relief on various grounds for
alleged personal injury and economic loss.
Asbestos
•Quigley
Quigley Company, Inc. (Quigley), a wholly owned subsidiary, was acquired by Pfizer in 1968 and sold products containing small
amounts of asbestos until the early 1970s. In September 2004, Pfizer and Quigley took steps that were intended to resolve all
pending and future claims against Pfizer and Quigley in which the claimants allege personal injury from exposure to Quigley
products containing asbestos, silica or mixed dust. We recorded a charge of $369 million pre-tax ($229 million after-tax) in the third
quarter of 2004 in connection with these matters.
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