Pfizer 2012 Annual Report Download - page 102

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
2012 Financial Report 101
abbreviated new drug application with the U.S. Food and Drug Administration (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 (including the six-
month pediatric exclusivity period resulting from the Company’s conduct of clinical studies to evaluate Revatio in the treatment of pediatric
patients with pulmonary arterial hypertension; Viagra and Revatio have the same active ingredient, sildenafil) expires in 2020. 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 FDA approval for a generic version of Viagra and from marketing its generic product in the U.S. before 2020. 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.
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. 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.
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 were consolidated in the District of Delaware. In July 2012,
the court held that all three patents are valid and infringed, thereby preventing the generic manufacturers from obtaining final FDA approval for
their generic versions of Lyrica and from marketing those products in the U.S. prior to the expiration of the three patents. In August 2012, the
generic manufacturers appealed the decision to the U.S. Court of Appeals for the Federal Circuit.
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 non-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.
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.
In December 2012, Wockhardt Limited (Wockhardt) 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 non-infringement of the basic patent. In January
2013, we filed an action against Wockhardt in the U.S. District Court for the District of Delaware asserting the validity and infringement of the
basic patent.
In February 2013, the Canadian Federal Court denied our application to prevent approval of a generic version of Lyrica in Canada, a decision
that is not subject to appeal, and shortly thereafter generic versions of Lyrica became available in Canada.
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