Pfizer 2010 Annual Report Download - page 103

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
Lyrica (pregabalin)
Beginning in March 2009, several generic manufacturers notified us that they had filed abbreviated new drug applications with the
FDA seeking approval to market generic versions of Lyrica capsules. Each of the generic manufacturers is challenging one or more
of three patents for Lyrica: the basic patent, which expires in 2018, and two other patents, which expire in 2013 and 2018. Each of
the generic manufacturers asserts the invalidity and/or the non-infringement of the patents subject to challenge. Beginning in April
2009, we filed actions against these generic manufacturers in the U.S. District Court for the District of Delaware asserting the
infringement and validity of our patents for Lyrica. All of these cases have been consolidated in the District of Delaware.
In August and November 2010, respectively, Lupin Limited (Lupin) and Novel Laboratories, Inc. (Novel) notified us that they had
filed abbreviated new drug applications with the FDA seeking approval to market generic versions of Lyrica oral solution 20 mg/mL
and asserting the invalidity and/or infringement of our three patents for Lyrica referred to above. In October 2010 and January 2011,
respectively, we filed actions against Lupin and Novel in the U.S. District Court for the District of Delaware asserting the validity and
infringement of all three patents.
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.
Chantix (varenicline)
In July 2010, we received notices from Apotex Inc. and Apotex Corp. and from Mylan Pharmaceuticals Inc. that they had filed
abbreviated new drug applications with the FDA seeking approval to market generic versions of Chantix. They assert the invalidity of
our patent covering the tartrate salt of varenicline and the non-infringement of our crystalline form patent, both of which expire in
2022. They have not challenged the basic patent, which expires in 2020. In August 2010, we filed actions against Apotex Inc. and
Apotex Corp. and against Mylan Pharmaceuticals Inc. in the U.S. District Court for the Southern District of New York asserting the
infringement of both of the challenged patents. In December 2010, both of these actions were voluntarily dismissed by us without
prejudice.
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 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. This action was dismissed voluntarily in November 2010 upon the expiration of the basic patent. We co-promote Aricept
with Eisai in the U.S., but we were 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.
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 assert the non-infringement of our patent
covering the crystalline form of eletriptan, which expires in 2017. They have not challenged 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.
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 20 mg and 40 mg 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
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