[Ip-health] Pfizer's original press release from Philippines litigation

[James Love]

http://www.pfizer.com.ph/corporate/news/main.php?page=3Drelease&ID=3D95


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Press Release - March 07
Pfizer Sues PITC, BFAD for Patent Infringement

Pfizer recently filed a case against the Philippine International
Trading Corporation (PITC) and the Bureau of Food and Drugs (BFAD)
for dealing with an anti-hypertensive medicine that is still under
patent.

Pfizer's position is that the agencies=92 dealing with Norvasc
(amlodipine besylate) supposedly sourced from India, without the
authority of the patent owner, violates the law. The complaint
further states that BFAD and its officers induced the violation of
Pfizer=92s patent rights by granting registration approval to PITC.

The case Pfizer filed versus PITC and BFAD is not only a trade issue,
but a public health concern as well. Products that enter the
Philippines through parallel importation may carry health risks
associated with counterfeits. Counterfeit medicines may be
manufactured in unregulated settings that do not adhere to the
rigorous standards of Good Manufacturing Practice (GMP). They may be
contaminated, stored improperly, outdated, may not work as claimed or
may contain potentially dangerous ingredients. There is no way to
ensure that these products adhere to an effective batch tracking and
product recall mechanism. Further, there is no Post Marketing
Surveillance (PMS) or Adverse Event Reporting system that can
indicate possible side-effects not detected in earlier clinical trials.

Pfizer=92s finding is that none of PITC's source had been identified by
Pfizer India as one of its authorized distributor or sub-distributor.
According to the World Health Organization, about 30-40% of medicines
in the Indian market have been found to be counterfeit. Further,
there is no reason to import medicines from India that treat high
blood pressure since there are many available treatment options in
the Philippine market today.

Respecting patent rights ensures that Pfizer will be able to sustain
its mission to innovate and bring new and better lifesaving medicines
to more patients. Pfizer is also concerned for the safety of
Filipinos since importing medicines from unreliable sources may put
patients' health at risk.

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---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org /
tel. +1.202.332.2670 / mobile +1.202.361.3040

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