Pfizer 2007 Annual Report Download - page 72

70 2007 Financial Report
Notes to Consolidated Financial Statements
Pfizer Inc and Subsidiary Companies
granted and will be upheld on reexamination. This process could
take a few years to complete.
U.S. – enantiomer patent: In January 2007, we filed a reissue
application with the Patent Office seeking to correct a technical
defect in our patent covering the enantiomer form of atorvastatin.
The enantiomer patent, including the six-month pediatric
exclusivity period, expires in June 2011. In August 2007, the
Patent Office issued its initial official action, which determined that
the technical defect had been corrected but rejected the
enantiomer patent on other grounds. In October 2007, we
submitted our response to the Patent Office. We continue to
believe that we have strong arguments for securing the reissued
patent. This process also could take a few years to complete.
Separately, in April 2007, Teva Pharmaceuticals USA, Inc. (Teva)
notified us that it had filed an abbreviated new drug application
with the FDA seeking approval to market a generic version of
Lipitor. Teva asserts the invalidity of our enantiomer patent and
the non-infringement of certain later-expiring patents, but does
not challenge our basic patent. In June 2007, we filed suit against
Teva in the U.S. District Court for the District of Delaware asserting
the validity and infringement of the enantiomer patent.
In addition, in October 2007, Cobalt Pharmaceuticals, Inc. (Cobalt)
notified us that it had filed an application with the FDA seeking
approval to market a product containing atorvastatin sodium, a
salt that is different from atorvastatin calcium, which is used in
Lipitor. The notice states that Cobalt is challenging our enantiomer
patent and certain later-expiring patents, but not our basic
patent. In December 2007, we filed suit against Cobalt in the U.S.
District Court for the District of Delaware asserting the validity and
infringement of the enantiomer patent.
Canada – enantiomer patent: In January 2007, the Canadian
Federal Court in Toronto denied our application to prevent
approval of Ranbaxy’s generic atorvastatin product based on our
enantiomer patent, which expires in July 2010. In February 2007,
we appealed that decision to the Federal Court of Appeal of
Canada. The appeal was heard in May 2007, and we are awaiting
the decision. We also are seeking to prevent approval of Apotex
Inc.’s (Apotex’s) generic atorvastatin product based on our
enantiomer patent. A trial was held on this matter in October 2007
in the Canadian Federal Court in Toronto and, on January 2,
2008, the court denied our application. On January 3, 2008, we
appealed the decision to the Federal Court of Appeal of Canada.
Canada – certain other patents: In September 2007, in a case
against Ranbaxy, the Canadian Federal Court in Toronto issued a
decision concerning two other patents. First, the court ruled that
our patent covering a crystalline form of atorvastatin would be
infringed by Ranbaxy’s process for making its proposed generic
atorvastatin product. The court granted our application for an
order preventing Ranbaxy from launching its product until the
expiration of the patent in July 2016. In October 2007, Ranbaxy
appealed this decision to the Federal Court of Appeal of Canada.
This decision does not apply to any other generic manufacturer,
including Apotex, which is challenging the same patent and
other crystalline patents in another proceeding. Second, the
Canadian Federal Court in Toronto denied our application for a
prohibition order against Ranbaxy in connection with another
patent covering a process for making amorphous atorvastatin,
which also expires in July 2016.
Caduet (atorvastatin/amlodipine combination)
In January 2007, Ranbaxy notified us that it had filed an
abbreviated new drug application with the FDA seeking approval
to market a generic version of Caduet and asserting the invalidity
of our patents relating to atorvastatin and of our patent covering
the atorvastatin/amlodipine combination, which expires in 2018.
In March 2007, we filed suit against Ranbaxy in the U.S. District
Court for the District of Delaware asserting the validity and/or
infringement of the subject patents. In November 2007, the
court granted our motion to dismiss Ranbaxy’s challenge to the
validity of the atorvastatin (Lipitor) basic patent. The case
continues with respect to our assertion of infringement of the
patent covering the atorvastatin/amlodipine combination and,
at such time as the atorvastatin enantiomer patent is reissued in
corrected form, Ranbaxy’s challenge regarding the validity of one
claim of that patent.
Norvasc (amlodipine)
In 2006, the Federal Court of Appeal of Canada upheld the
validity of our Norvasc patent in Canada in an action involving the
generic manufacturer Ratiopharm. The Supreme Court of Canada
denied Ratiopharm’s petition to appeal this decision. We also have
filed legal challenges against certain other generic manufacturers
who are seeking to market their own amlodipine products in
Canada. In February 2008, a trial was held in the Federal Court of
Canada in Toronto in our challenge against Cobalt, and we are
awaiting the decision. Our Norvasc patent in Canada expires in
August 2010.
Celebrex (celecoxib)
In January 2004, Teva notified us that it had filed an abbreviated
new drug application with the FDA seeking approval to market
a product containing celecoxib and asserting the non-
infringement and invalidity of our patents relating to celecoxib.
In February 2004, we filed suit against Teva in the U.S. District
Court for the District of New Jersey asserting infringement of our
patents relating to celecoxib. In March 2007, the court held that
all three of the patents in dispute are valid and infringed and,
in April 2007, it issued an injunction prohibiting Teva from
marketing its generic celecoxib product before 2015. In April 2007,
Teva appealed the decision to the U.S. Court of Appeals for the
Federal Circuit. The appeal was heard in January 2008, and we
are awaiting the decision.
Neurontin (gabapentin)
In August 2005, the U.S. District Court for the District of New Jersey
held that the generic gabapentin (Neurontin) products of a
number of generic manufacturers did not infringe our gabapentin
low-lactam patent, which expires in 2017, and it granted summary
judgment in their favor. Several generic manufacturers launched
their gabapentin products in 2004 and 2005. In September 2007,
the U.S. Court of Appeals for the Federal Circuit reversed the
District Court’s summary judgment decision and remanded the case
to the District Court for trial on the patent-infringement issue. If
successful at trial, we intend to seek compensation from the
generic manufacturers for damages resulting from their at-risk
launches of generic gabapentin.