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<nettime> Pfizer sues Philippines officials in their personal capacity

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From: James Love <>
Subject: [Random-bits] Pfizer suing Philippine's governmental officials in their personal capacity in order to stop parallel trade
Date: Fri, 31 Mar 2006 18:09:51 -0500

Judit Rius Sanjuan recently joined CPTech as a staff lawyer.  This is
her blog on Pfizer's recent decision to sue government officials in
the Philippines, in order to stop efforts to register cheaper
versions of a medicine for hypertension.   Jamie


Pfizer is suing Philippine's governmental officials in their personal
capacity in order to stop parallel trade
Judit Rius Sanjuan
March 31, 2006

Pfizer likes high prices -- even when the market is in a developing
country. And Pfizer is willing to sue to get high prices.

Now, Pfizer is suing a Philippine government-owned company (PITC,
Philippine International Trading Corporation), the Philippines FDA
(BFAD, Bureau of Food and Drugs) and two Philippine government
regulators (the BFAD director and one other staff person) in their
personal capacity. For what? For importing from India samples of a
drug that Pfizer sells in both the Philippines and India, and for
submitting the samples to the government drug regulatory agency.

Pfizer is doing this to delay parallel trade of one of its drugs.
Parallel trade is a term used to describe the practice of buying a
product in a country where prices are cheaper, and importing it into
a country where prices are higher. The Philippines permits parallel
trade, but only after patents expire.

The drug in this case is amlodipine besylate, which is marketed by
Pfizer in the United States under the trade name Norvasc. It is used
to treat hypertension, angina and myocardial ischemia. The drug is
sold in two dosage formats: 5 mg. and 10 mg. tablets, and typically
taken once a day.

Pfizer charges different prices in the Philippines than they do in
India. In the Philippines, the prices are $.87 per day for the 5 mg
version, and $1.46 per day for the 10 mg dose. In India, the prices
are $.12 and $.18 per day, for the same doses of the same drug made
by the same company.

Pfizer holds a Philippines patent on Norvasc, which expires in June

The Philippine government owned trading company says it will not to
sell the cheaper Indian version of the Pfizer product to the public
until the Pfizer patent expires in June 2007. Its only goal is to
begin the process of registering the imported version, so it can
promptly enter the market when the Pfizer controlled patent expires.

What is at stake legally is a new twist on the issue of "early
working" of a patent. In the United States, there was a 1983 dispute
between Roche and Bolar Pharmaceuticals. Bolar was in possession of
small quantities of a generic version of a sleeping pill marketed by
Roche as Dalmane. The Bolar Company wanted to register a generic
version, so it could promptly enter the market when the Roche patent
expired. Roche successfully sued Bolar and its officers and
importers, claiming the effort to register the generic product
violated the Roche patent. This had the effect of delaying entry by
generics for about 18 months. In 1984, the US Congress changed US
patent law to allow for the early working of a patent when preparing
a generic drug registration, effectively overturning this decision.
This is known as the "Bolar" provision, or "Bolar amendment."

Some countries have implemented similar statutory changes in their
laws (early Australia, Canada, Argentina, Israel), and recently the
European Union required its member states to implement similar
provisions. Some countries in Europe have done this through statutory
changes, while others already allow this through interpretations of
other exceptions in patent laws, including domestic experimental use

There is no express Bolar provision in the Philippines Intellectual
Property Code. The exception, however, has been part of Philippine
regulatory practice for several years, and it has never been
challenged before.

The Pfizer pricing of Norvasc in the Philippines:

The Pfizer prices for Norvasc vary by country. As noted above, in the
Philippines, the prices are from $.88 to $1.46 per day. For the vast
majority of people who live in the Philippines, this is not affordable.

The World Bank reports that the Philippines has a per capita income
of $1,170 per year. This is of course an average. Many earn much
less. About 20 percent of the population earns less than $400 per
year. A handful of Philippine residents earn more. The top 10 percent
have an average per capita income of $4,247.

The Pfizer price is targeted at only the wealthiest Philippine
residents -- probably no more than the top 5 percent of the
population. Like many developing countries with a highly skewed and
unequal income distribution, selling to the economic elite at high
prices is the profit maximizing strategy for Pfizer.

The government of the Philippines is trying to protect the 95 percent
of the population who cannot afford the high Pfizer price for Norvasc.

The lawsuit against the Philippine regulators is an appalling action
by Pfizer. Pfizer is reportly seeking more than 1.4 millions
Philippines pesos from the defendants. Pfizer is making it personal
by suing the government officials in their personal capacity;
therefore we are going to make it personal also. I will be writing
the Pfizer CEO, Mr. Henry A. McKinnell, asking him to take personal
responsibility for Pfizer's actions, and drop the lawsuit. I'll
report his response next week.

James Love, CPTech / / /
tel. +1.202.332.2670 / mobile +1.202.361.3040

"If everyone thinks the same: No one thinks."  Bill Walton

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