Pfizer 2013 Annual Report Download - page 108

Notes to Consolidated Financial Statements
Pfizer Inc. and Subsidiary Companies
2013 Financial Report 107
Torisel (temsirolimus)
In December 2011, we brought a patent-infringement action in the U.S. District Court for the District of Delaware against Sandoz as a result of
its abbreviated new drug application with the FDA seeking approval to market a generic version of Torisel before the expiration of the basic
patent in 2014. In May 2012, we brought an action in the same court against Sandoz for infringement of a formulation patent that expires in
2026. In September 2012, our actions against Sandoz were consolidated in the District of Delaware. In December 2013, this action was
settled on terms that are not material to Pfizer.
Pristiq (desvenlafaxine)
Beginning in May 2012, several generic manufacturers notified us that they had filed abbreviated new drug applications with the FDA seeking
approval to market generic versions of Pristiq. Each of the generic manufacturers asserts the invalidity, unenforceability and/or non-
infringement of two patents for Pristiq that expire in 2022 and in 2027. Beginning in June 2012, we filed actions against these generic
manufacturers in the U.S. District Court for the District of Delaware asserting the validity, enforceability and infringement of those patents. All
of these actions have been consolidated in the District of Delaware.
Zyvox (linezolid)
In February 2013, Apotex Inc. and Apotex Corp. notified us that they had filed an abbreviated new drug application with the FDA seeking
approval to market a generic version of Zyvox. They asserted invalidity of the basic Zyvox patent, which (including the six-month pediatric
exclusivity period) expires in 2015. In March 2013, we filed an action against Apotex Inc. and Apotex Corp. in the U.S. District Court for the
Northern District of Illinois for infringement of the basic patent. In December 2013, this action was settled on terms that are not material to
Pfizer.
Celebrex (celecoxib)
In March 2013, the U.S. Patent and Trademark Office granted us a reissue patent covering methods of treating osteoarthritis and other
approved conditions with celecoxib, the active ingredient in Celebrex. The reissue patent, including the six-month pediatric exclusivity period,
expires in December 2015. On the date that the reissue patent was granted, we filed suit in the U.S. District Court for the Eastern District of
Virginia, asserting the infringement of the reissue patent, against Teva USA, Mylan Pharmaceuticals Inc., Watson, Lupin Pharmaceuticals
USA, Inc., Apotex Corp. and Apotex Inc. Each of those generic companies had previously filed an abbreviated new drug application with the
FDA seeking approval to market a generic version of celecoxib beginning in May 2014, upon the expiration of the basic patent (including the
six-month pediatric exclusivity period) for celecoxib.
Toviaz (fesoterodine)
We have an exclusive, worldwide license to market Toviaz from UCB Pharma GmbH, which owns the patents relating to Toviaz.
Beginning in May 2013, several generic manufacturers notified us that they had filed abbreviated new drug applications with the FDA seeking
approval to market generic versions of Toviaz and asserting the invalidity, unenforceability and/or non-infringement of all of our patents for
Toviaz that are listed in the Orange Book. Beginning in June 2013, we filed actions against all of those generic manufacturers in the U.S.
District Court for the District of Delaware asserting the infringement of five of our patents for Toviaz: three composition-of-matter patents and a
method-of-use patent that expire in 2019, and a patent covering salts of fesoterodine that expires in 2022.
Tygacil (tigecycline)
In September 2013, Apotex Inc. notified us that it had filed an abbreviated new drug application with the FDA seeking approval to market a generic
version of Tygacil. Apotex Inc. asserts the non-infringement of a polymorph patent for Tygacil that expires in 2030, but has not challenged the
basic patent, which expires in 2016. In September 2013, we filed suit against Apotex Inc. in the U.S. District Court for the District of Delaware
asserting the infringement of the polymorph patent.
Lipitor (atorvastatin)
In an action initially brought against us by a generic company, the Beijing High Court upheld the validity of our patent in China covering the
crystalline form of atorvastatin in Lipitor. The crystalline patent expires in July 2016 and is the only patent covering Lipitor in China. In January
2014, the China Supreme People’s Court (SPC) notified us that it will conduct a retrial regarding certain issues related to the validity of the
crystalline patent. If there were an adverse decision by the SPC, we would expect additional generic competition for Lipitor in China, and the
price for Lipitor in China may be subject to a government-imposed price reduction larger than might otherwise occur.
A2. Legal Proceedings––Product Litigation
Like other pharmaceutical companies, we are defendants in numerous cases, including but not limited to those discussed below, related to our
pharmaceutical and other products. Plaintiffs in these cases seek damages and other relief on various grounds for alleged personal injury and
economic loss.
Asbestos
Between 1967 and 1982, Warner-Lambert owned American Optical Corporation, which manufactured and sold respiratory protective devices
and asbestos safety clothing. In connection with the sale of American Optical in 1982, Warner-Lambert agreed to indemnify the purchaser for
certain liabilities, including certain asbestos-related and other claims. As of December 31, 2013, approximately 66,000 claims naming
American Optical and numerous other defendants were pending in various federal and state courts seeking damages for alleged personal
injury from exposure to asbestos and other allegedly hazardous materials. Warner-Lambert is actively engaged in the defense of, and will
continue to explore various means to resolve, these claims.
Warner-Lambert and American Optical brought suit in state court in New Jersey against the insurance carriers that provided coverage for the
asbestos and other allegedly hazardous materials claims related to American Optical. A majority of the carriers subsequently agreed to pay for
a portion of the costs of defending and resolving those claims. The litigation continued against the carriers who disputed coverage or how