Well it looks as though all good things, including
IP Scorecards must come to an end. Pfizer and Ranbaxy have
decided to (mostly) settle the global lipitor patent battle.
Lipitor Scorecard has been updated, so go and have a look
at the latest results - across 23 countries.
For those keen on a little pharmaceutical patent blood
sport, don't despair, the battle wages on in five
European counries: Finland, Spain, Portugal, Denmark and
Here's the press release from Pfizer:
Pfizer and Ranbaxy Settle Lipitor Patent Litigation
Ranbaxy to Receive License in U.S. on November 30, 2011;
NEW YORK-- (BUSINESS WIRE)--Pfizer Inc announced today
that it has entered into an agreement with generics
manufacturer Ranbaxy Laboratories Ltd. of India and certain of
its affiliates to settle substantially all their patent
litigation worldwide involving Lipitor, the world's
most-prescribed cholesterol-lowering medicine. Under the terms
of the agreement, Ranbaxy will have a license to sell generic
versions of Lipitor and Caduet in the United States effective
November 30, 2011. Caduet is a medicine that combines the
active ingredients of Lipitor and Norvasc and treats both high
blood pressure and high cholesterol.
The settlement provides shareholders of Pfizer and Ranbaxy,
as well as patients, with substantial certainty regarding the
potential date – November 30, 2011 – for
entry of a generic version of Lipitor in the United States. In
addition, the agreement provides a license for Ranbaxy to sell
generic versions of Lipitor on varying dates in seven
additional countries: Canada, Belgium, Netherlands, Germany,
Sweden, Italy and Australia. Pfizer and Ranbaxy have also
resolved their disputes regarding Lipitor in Malaysia, Brunei,
Peru and Vietnam.
The lawsuits between Pfizer and Ranbaxy regarding Lipitor
and Caduet will be dismissed in the specified countries, and
Ranbaxy will no longer contest the validity of Pfizer's
patents in the specified countries, including the United
States, according to the agreement. The settlement also
resolves all patent litigation with Ranbaxy relating to
Accupril in the United States and Viagra in Ecuador.
"This agreement is a win-win-win because it is
pro-patient, pro-competition and pro-intellectual
property," said Ian Read, president of Worldwide
Pharmaceutical Operations for Pfizer. "The agreement
provides patients with access to a generic product much earlier
than if Ranbaxy were unsuccessful in obtaining approval for its
product and overcoming the relevant patents. It provides
substantial certainty regarding the timing of the entry of a
generic version of Lipitor. Finally, the agreement clearly
reaffirms the value and importance of intellectual property and
this country's well-balanced system of creating
incentives to develop innovative medicines while at the same
time establishing a strong generic drug business."
"Without patents and rigorous defense of intellectual
property rights, innovators would face significant challenges
that could inhibit the discovery of new medicines," Mr.
The settlement provides Ranbaxy with licenses to all the
patents it needs to make the generic product and enables
Ranbaxy to manufacture and launch a generic version of Lipitor
prior to the expiration of the crystalline and amorphous
The Lipitor patents involved in this agreement are the basic
compound patent, which expires in the United States in 2010;
the enantiomer patent, which expires in the United States in
2011; as well as various process and crystalline form patents,
which expire in 2016 and 2017; and the combination patent for
Caduet, which expires in 2018.
The settlement complies with all applicable laws, and does
not contain any of the practices – such as
"reverse payments" – that have been
identified as of concern recently by the U.S. Federal Trade
Pfizer has been defending Lipitor patent challenges by
Ranbaxy throughout the world since 2003. The agreement pertains
solely to Ranbaxy and its affiliates and does not cover legal
challenges to the Lipitor patents involving other generic
manufacturers. However, Ranbaxy was the first generic
challenger to the listed Lipitor patents and, as such, holds
the rights to 180 days of marketing exclusivity in the United
The patent infringement litigation between Pfizer and
Ranbaxy relating to Lipitor will continue in five other
European countries -- Finland, Spain, Portugal, Denmark and
Romania. Court cases involving the enantiomer patents are
pending in Spain and Portugal, while an infringement action on
the commercial process patent is pending in Finland. Patent
cases involving the enantiomer patent are pending in Denmark
The content of this article is intended to provide a
general guide to the subject matter. Specialist advice should
be sought about your specific circumstances.
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