[Ip-health] Inside US trade: PHRMA opposes Pending Filipino Patent Law

[Judit Rius Sanjuan]

PHRMA OPPOSES PENDING FILIPINO PATENT LAW AS UNDERCUTTING RESEARCH

The Pharmaceutical Research and Manufacturers of America (PhRMA) is
fighting against pending patent legislation in the Philippines, which it
charges would reduce incentives for research and could endanger the
reputation
of brand-name medicines. PhRMA last week raised its complaints in a
meeting with Adrian Cristobal, Director General of the Intellectual
Property Office of the Philippines, but has also raised the issue to the
United States Trade Representative.

In the meeting with Cristobal, PhRMA complained about a number of the
proposed changes, including one regarding =93new indications=94 of existing
drugs, according to a PhRMA spokesperson.
=93New indications=94 refers to the practice of issuing a second patent if =
a
new use for a chemical compound is discovered. In the U.S., for
instance, a drug company can patent a chemical compound used to treat
asthma, and then later obtain second patent if the same compound is
found to treat high blood pressure, the PhRMA spokesperson said. This
practice encourages continued research into existing medicines, the
spokesperson said.
In contrast, the proposed Filipino legislation allows for patents on
only the original chemical compound.

Cristobal was hesitant to comment on the specifics of the proposed
legislation in the meeting, but stated that patent law changes are
legislative decisions, the PhRMA spokesperson said. But in an interview
with Inside U.S. Trade, Cristobal said it would still be possible to
obtain a second-use patent under the proposed legislation, though under
more stringent requirements than exist now.
According to Cristobal, USTR is not opposing the pending law per se, but
is consulting with the Philippines to ensure that it includes safeguards
against possible patent infringement.
He also said that he has worked to ensure that the proposed Senate
version of the bill is consistent with the flexibilities for addressing
public health needs in the Agreement on Trade-Related Aspects of
Intellectual Property
Rights (TRIPS).

The Director General said he did not think the Filipino Congress would
approve the patent law changes before the end of the year.
The pending patent bill is being developed to lower the price of
medicines in the Philippines. Senate Bill No. 2139, which would amend
the Intellectual Property Code of the Philippines, is currently on its
third draft in the
Senate. A similar bill also exists in the Filipino House, although that
bill is still in its first draft.

PhRMA also objects to language in the new legislation that allows for
the parallel importation of medicines from third countries, something
currently prohibited by the United States and the Philippines.
If passed, the Filipino legislation would allow the Philippines to
import from a third country any patented drug available on the world
market. This would allow the Philippines to shop around for the best
price and lower the
price of medicines available in its market.

PhRMA objects to parallel importation because there is no assurance that
a drug imported from a third country into the Philippines has been
stored properly or that its quality has been otherwise maintained,
according to the spokesman. There is not even no assurance that a drug
sold to the Philippines is the one that was originally exported from the
United States, the spokesperson said.

Under the current direct export scheme, the manufacturer knows to what
distributor he is selling to in the Philippines and what rules and
regulations that distributor is following. Compliance with these rules
can be inspected,
and non-compliance can be remedied by switching distributors, the
spokesperson said. This is important for maintaining the reputation for
quality and safety so important to the sales of brand name drugs, the
spokesperson
said.

While the U.S. currently prohibits parallel importation, many countries
in Asia do allow it, including Japan, Cambodia, Thailand, Vietnam, and
Indonesia, as well as the European Union. In addition, there have been some
calls in the U.S. Congress for limited parallel importation of medicines
from Canada.

The proposed Filipino legislation also calls for the institution of
provisions similar to the =93Bolar amendment=94 in the United States that
would facilitate generic competition in the Philippines by allowing
testing and regulatory
approval of generic versions of a drug before the patent of the
brand-name drug expires.

Separately, the Cristobal received a commitment from Jon Dudas, Under
Secretary of Commerce for Intellectual Property, to enter into
negotiations for a bilateral cooperation agreement. Details of the
agreement are still to be negotiated, and Christobal said he did not
know when U.S. and Filipino representatives would next meet.

Cristobal said he hopes the bilateral deal would help him receive
training and technical assistance in the examination of patents for
biotechnology for Filipino patent examiners. He also said he hopes the
Philippines will receive assistance in information technology,
especially with regards to improving the programs and software in the
Philippines for filing trademarks online.

Cristobal also hopes to implement a version of the Bayh-Dole Act in the
Philippines. This act would allow for publicly funded universities to
commercialize patent technologies under certain conditions for their own
profit, he
explained, which could help bolster the resources of Filipino universities.

--
Judit Rius Sanjuan
judit.rius at cptech.org
www.cptech.org

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