[Ip-health] IP-Watch: Pfizer Fights IP Flexibilities In The Philippines

[Thiru Balasubramaniam]

     Pfizer Fights IP Flexibilities In The Philippines



30/4/2006

posted by Tove Iren S. Gerhardsen @ 5:12 pm

The world=92s largest pharmaceutical company, Pfizer, is suing the
Philippine government for having imported and registered - but not
marketed - a product that is still under patent. At the same time,
industry is said to be lobbying against a bill under consideration in
the Philippines that would introduce more flexibilities into the
country=92s intellectual property law, according to sources.

Philippine sources fear that if Pfizer wins the case, it may continue
using this strategy to hinder the entering of cheaper generic versions
of other medicines into the Philippine market immediately upon patent
expiry.

The product in question, Pfizer=92s Norvasc (amlodipine besylate) for high
blood pressure, does not have any cheaper versions available in the
Philippines, while it is being sold for nearly half the price in
Indonesia and Thailand, according to an internal working paper of an
alliance which will address this issue along with other access to
medicines issues in the Philippines, a Philippine lawyer said. The
Philippine price for the equivalent product in India, Amlogard, is 650
percent higher (for 5mg), according to the paper.

On 1 March 2006, Pfizer (Pfizer, Ltd. UK and Pfizer, Inc. Philippines)
filed a case against the government-owned Philippine International
Trading Corporation (PITC), the Bureau of Food and Drugs (BFAD) and two
of the employees at the BFAD for having imported samples of Norvasc from
India, sources say.

BFAD Director Leticia Barbara Gutierrez and Emilio Polig, BFAD officer
in charge of the legal, information and compliance division, have been
asked to pay damages to Pfizer, the Philippine lawyer said.

Some 200 tablets were imported and submitted to the BFAD for
registration, according to the paper. BFAD granted the products approval
in the form of a parallel import drug registration, and a government
source said the country=92s rules required this registration even though
it is not intended to be sold in the market until after patent expiry.
The PITC has =93repeatedly informed Pfizer in writing that it will not
market its amlodipine besylate product until after the Pfizer patent
expires,=94 the paper said.

But Pfizer argued that this infringed its patent on Norvasc, which runs
until 13 June 2007.

The Philippines has implemented the World Trade Organization Agreement
on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which
allows countries flexibilities from the agreement such as parallel
importation. The Philippines does not have a clear policy agreement and
=93no general law that governs parallel imports,=94 according to a
government source. But there are a number of bills pending on the issue,
and parallel import of pharmaceuticals from countries such as India is
allowed in the Philippines under the Administrative Order 85 (series
2000) issued by the Department of Health, he said.

Parallel importation is purchase of a patented drug from an approved
source in an exporting country where it is sold more cheaply, without
seeking the consent of the patent holder, as defined by a recent World
Health Organization report. The TRIPS agreement, reinforced by the 2001
Doha Declaration, leaves it to national governments to decide for
themselves when a patent may be exhausted, such as with parallel imports.

This practice of early registration is in many IP regulations referred
to as the =93Bolar provision,=94 and allows a company to import samples of =
a
product and develop and test it in order to prepare for an early
registration while the product is still under patent. This ensures that
the product can hit the market immediately upon patent expiry.

The Bolar provision is found in Argentina, Canada, the United States and
some European countries, but it is not explicitly expressed in the
Philippine law, the paper said. But the Consumer Project on Technology
<http://www.cptech.org/ip/health/c/phil/> (CPTech) said that this =93has
been part of Philippine regulatory practice for several years, and it
has never been challenged before.=94

As a result of the lawsuit, Pfizer is now demanding that the
registration granted to the PITC be revoked, according to the paper. But
it said that without early registration it would take at least 18 months
after the patent has expired before a cheaper version could be marketed.
This is the time it takes BFAD to handle a drug registration application
from a company such as PITC, it said, adding that this would effectively
extend Pfizer=92s monopoly.

The PITC has filed a countersuit against Pfizer, according to the US
publication Salon.

Pfizer=92s Reaction

A Pfizer spokesperson told /Intellectual Property Watch/ that the case
had been filed =93following several attempts to remedy the situation with
the government and the PITC.=94

The spokesperson said the move was a matter of protecting its patent for
amlodipine besylate until it expires in June 2007. =93There was no legal
assurance provided to Pfizer that our patent would not be infringed by
the importation of an unauthorized amlodipine besylate product,=94 the
spokesperson said, adding that the company was also concerned about
patient safety as it was unknown from which manufacturing source the
product would be imported to the Philippines.

The company also disagreed that this case involves parallel importation.
=93Pfizer doesn=92t consider this a parallel importation issue because we
don=92t believe the product in question is from a Pfizer-authorised
source,=94 the spokesperson said.

Pfizer sued two individuals as well, according to the spokesperson,
because, =93The two government representatives are named in the suit in
their respective official capacities as director of the BFAD and officer
in charge of the legal, information and compliance division of the
BFAD,=94 the spokesperson said.

It was perhaps not a good week for Pfizer, as company CEO Henry
McKinnell personally met with resistance for his recent salary hike and
reported $83 million retirement arrangement, as well as for the
Philippine case. Stanford alumni and graduate students in the United
States have initiated a signatory campaign to =93kick McKinnell off a
Stanford advisory board over Pfizer=92s bullying of Philippine government
drug regulators,=94 according to CPTech=92s Judit Rius, one of the
initiators of the campaign.

There were also protests at Pfizer=92s annual shareholder meeting on 27
April regarding executives=92 pay packages, according to reports.
According to one report, McKinnell has called for a review of the
Philippines case.

The case was filed in the Republic of the Philippines Regional Trial
Court, Makati City Branch, Pfizer said, which added that at the moment
=93the parties are working to resolve the issue as expeditiously as
possible.=94

The Philippine source said that the hearing that was scheduled for 25
April was reset as the judge was on leave. But he said that this was
=93the usual thing=94 in the Philippine courts.

Pfizer Influencing News Coverage of the Case?

CPTech said that Pfizer also has attempted to =93block negative articles
in the newspapers=94 through a =93multiple print ads campaign.=94 The activ=
ist
group argues that this has led to critical coverage only by columnists
and tabloid newspapers where Pfizer has not yet run its ads.

A Philippine source told /Intellectual Property Watch/ that just prior
to a scheduled 25 April hearing of the case, =93groups working on the
issue made a press release and circulated it to national media
organisations and not one bit of it came out,=94 despite it being a high
profile news issue.

An editor at /The Manila Times/ told /Intellectual Property Watch/ that
there had been a =93very wide coverage=94 of the issue in the Philippine
media. Most newspapers have been =93sort of siding with the general good,=
=94
but, he said, there may be some that ran the Pfizer ads that have sided
with the company.

The editor held the view that it would be good for a poor country such
as the Philippines to have more generic medicines available. He said The
Manila Times had not been pressured by Pfizer not to run articles on the
issue, and had published editorials as well as critical articles.

As for the case, he said that Pfizer does not want anyone in the
Philippines to do anything until the patent has expired, but the PITC
has never said it wanted to manufacture but to prepare itself for when
the patent would expire. He said that the price if Norvasc was very high
in the Philippines as the product was available only from Pfizer.

Pfizer said that =93there is no advertising campaign underway as a result
of this lawsuit. In fact, direct-to-consumer advertising is not
permitted in the Philippines.=94 The spokesperson also said that Pfizer
was =93absolutely not=94 attempting to block negative news coverage of the
issue.

Flexibilities Bill Awaiting Action

CPTech says that the pharmaceutical industry in the Philippines,
including Pfizer and the business group called the Pharmaceutical and
Healthcare Association of the Philippines, is lobbying against the bill
that would change Philippine IP law.

Senate bill 2139, introduced by Senator Mar Roxas, would introduce
flexibilities enjoyed under TRIPS into the intellectual property law in
the Philippines, CPTech says.

This would help lower the cost of medicines, according to a 22 March
press release from 3CPNet, a coalition of non-governmental
organisations. =93The bill has already had several hearings and the
committee report will be filed soon,=94 the release said.

The bill was introduced on 13 October 2005 and referred to a Senate
Committee on Trade and Commerce and the Senate Committee on Health on 24
October 2005. The committees are supposed to carry out consultations
with stakeholders, one informed source said.

The 3CPNet cited a speech by Roxas in which he said that more and more
Philippine families had problems paying their medicine bills, and the
intellectual property code should be amended to =93promote fair and
healthy competition in the pharmaceutical industry.=94

=93We need to level the playing field on drug importation and
manufacturing for our people=92s benefit,=94 Roxas said.

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