[Ip-health] Philippines: U.S. Norvasc ruling supports IP reform

[Benjamin Krohmal]

http://www.asianjournal.com/?c=193&a=19148
March 27th, 2007

Last week, the US Court of Appeals for the Federal Circuit
invalidated the patent of Pfizer, a major drug multinational, over
amlodipine besylate, a hypertension drug under the brand name "Norvasc."

A three-judge panel unanimously invalidated the patent of amlodipine
besylate, referred to as the "303 patent," issued in 1989, because
Pfizer already had a previous patent, the "909 patent," issued in
1982 already disclosing amlodipine, but combined with a different
salt, maleate. Since patents lapse after 25 years, the ruling
effectively places amlodipine besylate in the public domain, meaning
any company can manufacture it under its generic name.

Pfizer had sought to extend the life of the patent by using a new
combination, but the court found that "the superior property of
amlopidine mixed with the salt besylate, compared to the previous
amlodipine maleate, was not unexpected, thus, rendering the invention
as 'obvious.'"

This development was welcomed by Sen. Mar Roxas, who said the US
court's decision is consistent with his proposed amendments to the
Intellectual Property Code, or SB 2263, also known as the "Cheaper
Medicines Bill."

"The US Federal Circuit's decision to invalidate the patent of
Norvasc for 'obviousness' also upholds one key principle in our bill,
which is on the 'inventiveness' or 'newness' of medicine patents," he
said.

Existing loopholes in the Intellectual Property Code had allowed
multinational firms to have an extended hold over the patents of
medicines -- the so-called "ever-greening of patents" -- denying
generics manufacturers the opportunity to develop cheaper versions,
said the senator.

* * *

ROXAS explained that for a product to deserve a new patent, it must
involve an "inventive step," which means that the invention is "not
obvious" or not known to any person skilled in an art -- in the case
of medicines, a chemist -- during the date of application for the
patent.

"This means that if the so-called invention just results from the
mere discovery of a new use, form or property of a known substance --
but its efficacy is still the same -- there is no "inventive step,"
he said.

Among the "Roxas Amendments" in SB 2263 is a new provision specifying
that "there is no inventive step if the invention results from the
mere discovery of a new form or new property of a known substance
which does not result in the enhancement of the known efficacy of
that substance, or, the mere discovery of any new use for a known
substance or a known process unless such known process results in a
new product that employs at least one new reactant."

The amendments are compliant with the Agreement on Trade-Related
Aspects of Intellectual Property Rights (TRIPS) of the World Trade
Organization.

The Senate has passed the bill on third reading. The House of
Representatives is expected to pass its counterpart, House Bill 6035,
when session resumes on June 4.

This piece of legislation has been the subject of much controversy,
including one episode in which Rep. Teodoro Locsin of Makati City
ordered drug industry lobbyists out of the session hall for allegedly
exerting undue pressure on him and other legislators to delay passage
of the "Cheap Medicines Bill."

Studies have shown that drug prices in the Philippines -- even for
drugs manufactured by the same drug multinationals under the same
brand names -- are as much as 10 times more expensive than in other
countries, primarily India and Thailand.



Benjamin Krohmal
Coordinator - Project on Medical Innovation
Knowledge Ecology International
Tel: +1-202-332-2670 ex. 14
Fax: +1-202-332-2673
ben.krohmal@keionline.org