Pfizer 2011 Annual Report Download - page 99

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
Apotex Inc. notified us, in May and June 2011, respectively, that it had filed abbreviated new drug applications with the FDA seeking
approval to market generic versions of Lyrica oral solution and Lyrica capsules. Apotex Inc. asserts the invalidity and
non-infringement of the basic patent, as well as the seizure patent that expires in 2013. In July 2011, we filed an action against
Apotex Inc. in the U.S. District Court for the District of Delaware asserting the validity and infringement of the challenged patents in
connection with both of the abbreviated new drug applications.
In October 2011, Alembic Pharmaceuticals Limited (Alembic) notified us that it had filed an abbreviated new drug application with
the FDA seeking approval to market a generic version of Lyrica capsules and asserting the invalidity of the basic patent. In
December 2011, we filed an action against Alembic in the U.S. District Court for the District of Delaware asserting the validity and
infringement of the basic patent.
We also have filed patent-infringement actions in Canada against certain generic manufacturers who are seeking approval to market
generic versions of Lyrica capsules in that country.
Zyvox (linezolid)
In December 2009, Teva Parenteral Medicines Inc. (Teva Parenteral) notified us that it had filed an abbreviated new drug
application with the FDA seeking approval to market a generic version of Zyvox. Teva Parenteral asserts the invalidity and
non-infringement of the basic Zyvox patent, which (including the six-month pediatric exclusivity period) expires in 2015, and another
patent that expires in 2021. In January 2010, we filed suit against Teva Parenteral in the U.S. District Court for the District of
Delaware asserting the infringement of the basic patent.
Relpax (eletriptan)
In June 2010, we received notices from Apotex Inc. and Apotex Corp. and from Teva USA that they had filed abbreviated new drug
applications with the FDA seeking approval to market generic versions of Relpax. They asserted the non-infringement of our patent
covering the crystalline form of eletriptan, which expires in 2017. They did not challenge the basic patent, which expires in 2016. In
July 2010, we filed actions against Apotex Inc. and Apotex Corp. and against Teva USA in the U.S. District Court for the Southern
District of New York asserting the infringement of the crystalline patent. In July 2011, the action against Teva USA was settled on
terms that are not material to Pfizer. In October 2011, the action against Apotex Inc. and Apotex Corp. was voluntarily dismissed by
the parties without prejudice.
Protonix (pantoprazole sodium)
Wyeth has a 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 expired in January 2011.
Following their respective filings of abbreviated new drug applications with the FDA, Teva USA and Teva Pharmaceutical 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 20mg and 40mg delayed-
release tablets. Wyeth and Nycomed filed actions against those generic manufacturers 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 Pharmaceutical 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 compensation for damages resulting from Teva USA’s,
Teva Pharmaceutical Industries’ and Sun’s at-risk launches.
In April 2010, the jury in the pending patent-infringement action upheld the validity of the basic patent for Protonix. In July 2010, the
court upheld the jury verdict, but it did not issue a judgment against Teva USA, Teva Pharmaceutical Industries or Sun because of
their other claims relating to the patent that still are pending. Wyeth and Nycomed will continue to pursue all available legal remedies
against those generic manufacturers, including compensation for damages resulting from their at-risk launches.
Separately, 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.
Rapamune (sirolimus)
In March 2010, Watson and Ranbaxy Laboratories Limited (Ranbaxy) notified us that they had filed abbreviated new drug
applications with the FDA seeking approval to market generic versions of Rapamune. Watson and Ranbaxy assert the invalidity and
non-infringement of a method-of-use patent which (including the six-month pediatric exclusivity period) expires in 2014 and a solid-
dosage formulation patent which (including the six-month pediatric exclusivity period) expires in 2018. In April 2010, we filed actions
against Watson and Ranbaxy in the U.S. District Court for the District of Delaware and against Watson in the U.S. District Court for
the Southern District of Florida asserting the infringement of the method-of-use patent. In June 2010, our action in the Southern
District of Florida was transferred to the District of Delaware and consolidated with our pending action there.
98 2011 Financial Report