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THE
Philippine International Trading Corp. (PITC) on Tuesday
sought the cancellation of Pfizer’s patent over one of
its top-selling anti-hypertensive drugs, setting off the
country’s biggest intellectual property case against the
world’s biggest commercial company.
The PITC,
represented by the Office of the Government Corporate
Counsel (OGCC), filed the “interpartes” case with the
Intellectual Property Office of the Philippines (IP
Philippines), seeking cancellation of Pfizer’s (United
Kingdom) patent over Norvasc, alleging fraudulent claims
on the part of the firm.
The
company’s licensee in the country, Pfizer Philippines,
declined to comment on the case, saying it was not the
party which should be reacting, adding that it has yet
to be officially notified about the filing and details
of the case.
“We have
not seen the copy (case) and we are not aware of the
grounds (alleged),” said lawyer Millete Arnedo, Pfizer
Philippines’ public affairs and legal director.
The
petition asked the government’s IP regulator to cancel
Pfizer UK’s 18-year patent on “besylate salt of
amplodipine,” one of the components or ingredients of
Norvasc, alleging that such had not been invented by the
pharmaceutical firm. Drugs are patented over their
formulas.
“Amplodipine besylate is merely a variation of the
molecule amplodipine by combining it with salt besylate
instead of another salt. Significantly, the salt
besylate was already well known and recognized as a
pharmaceutically acceptable salt long before Pfizer
Ltd.’s patent application,” the PITC said.
“By
seeking a product that is neither new nor inventive,
Pfizer Ltd., in effect, would like to unconsciously and
unreasonably indefinitely extend, if not perpetually,
its exclusive rights over a product whose expiration has
long expired. Such unjustified patent will necessarily
disturb public order and is manifestly contrary to
morals,” it added.
Although
a patent has the maximum life or protection of 20 years,
Norvasc’s patent is only for 18 years and will expire on
June this year, as according to a Pfizer lawyer, it was
issued under the old IP law.
IP
Philippines director general Adrian Cristobal Jr. said
his agency will hear the case. “Petition to cancel falls
under the jurisdiction of the Bureau of Legal Affairs.
There will be hearing and summary proceeding in
accordance with the rules on cancellation of patents.”
Meanwhile, the PITC, Oxfam and other civic groups will
also seek the cancellation of the local patents of drugs
other than Norvasc that are considered essential
medicines but are overpriced when benchmarked with their
prices in other countries.
Norvasc,
which sells at P45/5-mg pill in the country, has an
equivalent price of only P12 in
Pakistan
and P25 in Thailand.
Teddie
Elson Rivera, officer-in-charge of PITC, said in a
press conference Tuesday they have created a technical
working group with representatives from concerned state
agencies, consumer and civil society groups, and other
stakeholders. The group will determine which drugs
should be offered at better price to Filipino consumers.
“We will
identify those that are expensive but are important to
the common people,” he said.
Among
those they are currently looking at, said Rivera, are
medicines for diabetes, hypertension, tuberculosis and
some antibiotics.
He cited
the antibad cholesterol drug Lipitor, also produced by
Pfizer, as an example of what they consider essential
but overpriced.
The
selling price locally of Lipitor, which is projected to
register over-the-counter sales of P1 billion this year,
is cheaper by about 50 percent in Pakistan, Rivera said.
Oxfam’s
Shalimar Vitan said they will challenge the legitimacy
of the patents granted to these medicines.
Salvacion Basiano of the Cut the Cost, Cut the Pain
Network (3CPNet) said the Philippine patents held by
these medicines should be canceled by the Intellectual
Property Office of the
Philippines
(IP Phils.) “to pave the way for the entry of cheaper
generics into the market.”
Rivera
said the PITC has advised Pfizer and other multinational
drug firms that the agency will only import cheaper
versions of their medicines if the price here is too
high to be accessed by ordinary Filipinos.
However,
Rivera said Pfizer particularly told them the company
will continue to hold on to its pricing because it is
protected by its patent.
Rivera
said Filipino patients will be saving hundreds of
millions of pesos if they are allowed access to the
cheaper imported Norvasc, which is estimated to sell
P1.5 billion locally this year.
Besides
this, at least 10 local drug makers are ready to supply
their own versions of Norvasc but could not do so at
this time because of the patent held by Pfizer for
amplodipine besylate.
Rivera
said PITC’s mission is to make essential medicines
accessible to Filipinos by promoting better competition
through importation and promotion of research and
development that will aid domestic makers.
In
filing its petition, the government through the PITC
took its cue from the US landmark case of Pfizer Inc. vs
Apotext Inc. a generic drug maker, where the US Appeals
Court ruled on March 22, 2007 against Pfizer’s patent on
Norvasc in the US.
Government Corporate Counsel Alberto Agra said the
company’s patent in the country is “nonexistent,” as it
has been “void from the very start.”
“It is
not new and noninventive,” he said. |