Pfizer 2013 Annual Report Download - page 107

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Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
106
2013 Financial Report
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,
one of which expired in October 2013 and the other of which expires in 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. In August 2012, the generic
manufacturers appealed the decision to the U.S. Court of Appeals for the Federal Circuit. In February 2014, the Federal Circuit affirmed the
decision of the District Court with respect to the validity and enforcement of one claim of the basic patent and determined, on the ground of
mootness, that it did not have to render a decision on any other issues raised on appeal, including with respect to the other patent that expires
in 2018. As a result, the generic manufacturers cannot obtain FDA approval for their generic versions of Lyrica or market those products in the
U.S. prior to the expiration of the basic patent in 2018, subject to the possible filing by any of the generic manufacturers of a motion requesting
a rehearing by the Federal Circuit or a petition for certiorari requesting a review by the U.S. Supreme Court.
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 expired in October 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 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 the first paragraph of this section. 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.
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 addition, 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 December 2011 and January
2013, we filed actions against Alembic and Wockhardt, respectively, in the U.S. District Court for the District of Delaware asserting the validity
and infringement of the basic patent.
Each of Novel, Alembic and Wockhardt has agreed to a stay of the respective actions described above and to be bound by any final judgment
of infringement and validity of the patents at issue in the consolidated action discussed above in the first paragraph of this section.
EpiPen
King Pharmaceuticals, Inc. (King), which we acquired in 2011 and is a wholly owned subsidiary, brought a patent-infringement action against
Sandoz, Inc., a division of Novartis AG (Sandoz), in the U.S. District Court for the District of New Jersey in July 2010 as the result of its
abbreviated new drug application with the FDA seeking approval to market an epinephrine injectable product. Sandoz is challenging patents,
which expire in 2025, covering the next-generation autoinjector for use with epinephrine that is sold under the EpiPen brand name.
Embeda (morphine sulfate/naltrexone hydrochloride extended-release capsules)
In August 2011, Watson Laboratories Inc. - Florida (Watson Florida) notified us that it had filed an abbreviated new drug application with the
FDA seeking approval to market a generic version of Embeda extended-release capsules. Watson Florida asserts the invalidity and non-
infringement of three formulation patents that expire in 2027. In October 2011, we filed an action against Watson Florida in the U.S. District
Court for the District of Delaware asserting the infringement of, and defending against the allegations of the invalidity of, the three formulation
patents.