Pfizer 2011 Annual Report Download - page 98

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Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
Caduet (atorvastatin/amlodipine combination)
In December 2011, our previously reported patent-infringement action related to Caduet against Sandoz, Inc., a division of Novartis
AG (Sandoz), in the U.S. District Court for the District of Delaware was voluntarily dismissed by us.
Caduet began to face generic competition in the U.S. in November 2011.
Viagra (sildenafil)
In March 2010, we brought a patent-infringement action in the U.S. District Court for the Eastern District of Virginia against Teva
Pharmaceuticals USA, Inc. (Teva USA) and Teva Pharmaceutical Industries Ltd. (Teva Pharmaceutical Industries), which had filed
an abbreviated new drug application with the FDA seeking approval to market a generic version of Viagra. Teva USA and Teva
Pharmaceutical Industries assert the invalidity and non-infringement of the Viagra use patent, which expires in 2019, but have not
challenged the basic patent, which expires in 2012. In August 2011, the court ruled that our Viagra use patent is valid and infringed,
thereby preventing Teva USA and Teva Pharmaceutical Industries from receiving approval for a generic version of Viagra before
October 2019. In September 2011, Teva USA and Teva Pharmaceutical Industries appealed the decision to the U.S. Court of
Appeals for the Federal Circuit.
In October 2010, we filed a patent-infringement action with respect to Viagra in the U.S. District Court for the Southern District of
New York against Apotex Inc. and Apotex Corp., Mylan Pharmaceuticals Inc. and Mylan Inc., Actavis, Inc. and Amneal
Pharmaceuticals LLC. These generic manufacturers have filed abbreviated new drug applications with the FDA seeking approval to
market their generic versions of Viagra. They assert the invalidity and non-infringement of the Viagra use patent, but have not
challenged the basic patent.
In May and June 2011, respectively, Watson Laboratories Inc. (Watson) and Hetero Labs Limited (Hetero) notified us that they had
filed abbreviated new drug applications with the FDA seeking approval to market their generic versions of Viagra. Each asserts the
invalidity and non-infringement of the Viagra use patent. Neither has challenged the basic patent. In June and July 2011,
respectively, we filed actions against Watson and Hetero in the U.S. District Court for the Southern District of New York asserting
the validity and infringement of the use patent.
Sutent (sunitinib malate)
In May 2010, Mylan Pharmaceuticals Inc. notified us that it had filed an abbreviated new drug application with the FDA seeking
approval to market a generic version of Sutent and challenging on various grounds the Sutent basic patent, which expires in 2021,
and two other patents, which expire in 2020 and 2021. In June 2010, we filed suit against Mylan Pharmaceuticals Inc. in the U.S.
District Court for the District of Delaware asserting the infringement of those three patents.
Detrol and Detrol LA (tolterodine)
In January 2008, Impax Laboratories, Inc. (Impax) notified us that it had filed an abbreviated new drug application with the FDA
seeking approval to market a generic version of Detrol LA. Impax is challenging on various grounds the basic patent, which
(including the six-month pediatric exclusivity period) expires in 2012, and three formulation patents, which (including the six-month
pediatric exclusivity period) expire in 2020. We filed an action against Impax in the U.S. District Court for the Southern District of
New York asserting the infringement of the basic patent and two of the formulation patents. This action subsequently was
transferred to the U.S. District Court for the District of New Jersey.
In March 2008 and May 2010, respectively, Sandoz and Mylan Pharmaceuticals Inc. notified us that they had filed abbreviated new
drug applications with the FDA seeking approval to market generic versions of Detrol LA. They assert the invalidity and/or
non-infringement of three formulation patents for Detrol LA. They have not challenged the basic patent. In June 2010, we filed
actions against Sandoz and Mylan Pharmaceuticals Inc. in the U.S. District Court for the District of New Jersey asserting the
infringement of two of the formulation patents.
In April 2011, Impax notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a
generic version of Detrol. Impax asserts the non-infringement of the basic patent, which (including the six-month pediatric exclusivity
period) expires in 2012. In June 2011, we filed an action against Impax in the U.S. District Court for the District of New Jersey
asserting infringement of the basic patent.
In June 2011, Torrent Pharmaceuticals Ltd. (Torrent) notified us that it had filed an abbreviated new drug application with the FDA
seeking approval to market a generic version of Detrol LA. Torrent asserted the invalidity and non-infringement of three formulation
patents. Torrent did not challenge the basic patent. In July 2011, we filed an action against Torrent in the U.S. District Court for the
District of New Jersey asserting the validity and infringement of the challenged patents. In February 2012, this action was settled on
terms that are not material to Pfizer.
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 and, in the case of one generic manufacturer, Lyrica oral
solution. 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 November 2010, Novel Laboratories, Inc. (Novel) notified us that it had filed an abbreviated new drug application with the FDA
seeking approval to market a generic version of Lyrica oral solution and asserting the invalidity and/or infringement of our three
patents for Lyrica referred to above. In January 2011, we filed an action against Novel in the U.S. District Court for the District of
Delaware asserting the validity and infringement of all three patents.
2011 Financial Report 97