Pfizer 2010 Annual Report Download - page 102

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
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 has not challenged 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
February 2010, our action and Sandoz’s action in the District of Colorado were transferred to the District of Delaware and
consolidated with our pending action there.
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 Pharmaceuticals Inc. asserted 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. did not challenge 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. In January 2011, we settled this action. Under the settlement
agreement, Mylan Pharmaceuticals Inc. will have certain rights to launch a generic atorvastatin/amlodipine combination product in
the U.S. beginning on November 30, 2011; other terms of the settlement agreement are confidential and not material to the
Company.
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 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 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.
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 (tolterodine)
In March 2004, we brought a patent-infringement suit in the U.S. District Court for the District of New Jersey against 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 USA have appealed the District Court’s decision to the U.S. Court of Appeals for the Federal Circuit.
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 seeking approval to market generic versions of Detrol LA, an extended-release formulation of
Detrol (tolterodine). They are 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 actions against them 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. These actions subsequently were 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.
100 2010 Financial Report