Pfizer 2009 Annual Report Download - page 92

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
In May 2009, Matrix Laboratories Limited (Matrix), a subsidiary of Mylan Inc. (Mylan), notified us that it had filed an abbreviated new
drug application with the FDA seeking approval to market a generic version of Lipitor. Matrix asserts the non-infringement of our
patent covering the crystalline form of atorvastatin, which (including the six-month pediatric exclusivity period) expires in 2017, and
the non-infringement of two formulation patents. Matrix is not challenging our enantiomer patent. In June 2009, we filed actions
against Matrix, Mylan and another Mylan subsidiary in the U.S. District Court for the District of Delaware and the U.S. District Court
for the Northern District of West Virginia asserting the infringement of the crystalline patent and two process patents that expire in
2016. In November 2009, our action in the Northern District of West Virginia was transferred to the District of Delaware and
consolidated with our pending action there.
In October 2009, Dr. Reddy’s Laboratories Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, Dr. Reddy’s) and KUDCO Ireland,
Ltd. and Kremers Urban LLC (collectively, KUDCO) notified us that they had filed abbreviated new drug applications with the FDA
seeking approval to market generic versions of Lipitor. They assert the invalidity and/or non-infringement of our patent covering the
crystalline form of atorvastatin and two other Lipitor patents. They are not challenging our enantiomer patent. In December 2009, we
filed actions against Dr. Reddy’s and KUDCO in the U.S. District Court for the District of Delaware asserting the infringement of our
crystalline patent.
Caduet (atorvastatin/amlodipine combination)
In August 2009, Sandoz Inc., a division of Novartis AG (Sandoz), notified us that it had filed an abbreviated new drug application
with the FDA seeking approval to market a generic version of Caduet. In that filing and in a declaratory judgment action brought by
Sandoz in October 2009 in the U.S. District Court for the District of Colorado, collectively, Sandoz asserts the invalidity of our patent
covering the atorvastatin/amlodipine combination, which expires in 2018, and the invalidity and non-infringement of three patents for
Lipitor, which (including the six-month pediatric exclusivity period) expire between 2013 and 2017. Sandoz is not challenging our
enantiomer patent for Lipitor. In October 2009, we filed suit against Sandoz in the U.S. District Court for the District of Delaware and
the U.S. District Court for the District of Colorado asserting the infringement of the atorvastatin/amlodipine combination patent.
In December 2009, 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 Caduet. Mylan asserts the invalidity of our patent covering the atorvastatin/
amlodipine combination and the non-infringement of three patents for Lipitor, which (including the six-month pediatric exclusivity
period) expire between 2013 and 2017. Mylan Pharmaceuticals, Inc. is not challenging our enantiomer patent for Lipitor. In February
2010, we filed suit against Mylan Pharmaceuticals, Inc. in the U.S. District Court for the District of Delaware asserting the
infringement of the atorvastatin/amlodipine combination patent.
Detrol (tolterodine)
In March 2004, we brought a patent infringement suit in the U.S. District Court for the District of New Jersey against Teva
Pharmaceuticals USA, Inc. (Teva USA), which had filed an abbreviated new drug application with the FDA seeking approval to
market a generic version of Detrol. In January 2007, Teva USA withdrew its challenge to our patent, and the patent infringement suit
was dismissed. Also in January 2007, Ivax Pharmaceuticals, Inc. (Ivax), a wholly owned subsidiary of Teva USA, amended its
previously filed abbreviated new drug application for tolterodine to challenge our basic patent for Detrol, and we brought a patent
infringement action against Ivax in the U.S. District Court for the District of New Jersey. The basic patent (including the six-month
pediatric exclusivity period) expires in September 2012. In January 2010, the court issued a decision in our favor, upholding the
basic patent. The court entered an order preventing the FDA from approving Ivax’s abbreviated new drug application for Detrol
before the expiration of the basic patent in September 2012. Ivax and Teva have filed a notice of appeal.
Detrol LA (tolterodine)
In October 2007 and January 2008, respectively, Teva USA and Impax Laboratories, Inc. notified us that they had filed abbreviated
new drug applications with the FDA challenging on various grounds four patents relating to Detrol LA, an extended-release
formulation of Detrol (tolterodine), and seeking approval to market their generic versions of Detrol LA. We filed suit against each of
them in the U.S. District Court for the Southern District of New York asserting the infringement of three of the patents relating to
Detrol LA., which (including the six-month pediatric exclusivity period) expire between 2012 (the basic patent) and 2020. Each of
these actions subsequently was transferred to the U.S. District Court for the District of New Jersey.
Vfend (voriconazole)
In October 2009, we settled a challenge by Matrix and Mylan to four of our patents relating to Vfend by entering into an agreement
granting Matrix and another subsidiary of Mylan the right to market voriconazole tablets in the U.S. beginning in the first quarter of
2011.
Lyrica (pregabalin)
In March and April 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. 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. In April 2009, we filed
an action against each of the generic manufacturers in the U.S. District Court for the District of Delaware asserting the infringement
and validity of our patents for Lyrica. In October 2009, all of these cases were consolidated in the District of Delaware.
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.
90 2009 Financial Report