[Ip-health] Inside US Trade on Waxman report and GPhA statement on IPRs in FTAs

[Mike Palmedo]

WAXMAN, GENERIC PHARMACEUTICAL GROUP CRITICIZE FTA IPR PROVISIONS

Inside US Trade
June 17, 2005

The generic pharmaceutical industry and the ranking member of the House
Government Reform committee are taking advantage of the current
stalemate over a free trade agreement between the U.S., the Dominican
Republic and five Central American countries to criticize intellectual
property provisions the U.S. has negotiated in several of its free trade
agreements (FTA).

A spokesperson for the Generic Pharmaceutical Association (GPHA) said
the group =93felt the time was right=94 to draw attention to provisions tha=
t
they say extend the patent life of brand-name drugs, which limits access
to generic versions of these medicines in foreign countries.

Separately, an aide for Rep. Henry Waxman (D-CA) noted that the
representative has long been a critic of IPR provisions in FTAs and has
been particularly vocal in his opposition to provisions in CAFTA. The
IPR provisions in CAFTA are one of several reasons Waxman opposes the
agreement, the aide said.

Waxman released a report late last week that said IPR provisions in FTAs
violate U.S. obligations to uphold World Trade Organization rules
governing members=92 access to medicines in the name of public health.

Specifically, the June 9 report charged that the data exclusivity period
in recent FTAs go beyond those required in the U.S. and make it
difficult for generic drugs to secure marketing approval. The
Hatch-Waxman law sets a five year limit on data exclusivity, or the
period during which the Food and Drug Administration (FDA) is not
allowed to rely on patented drug companies=92 clinical trial data in
granting marketing approval for generic equivalents.

The language in recent FTAs, however, says data exclusivity should be
=93at least=94 five years. That language, the GPHA spokesperson said, leave=
s
open the possibility that a regulatory authority in a foreign country
could extend data exclusivity beyond five years.

In another example, both Waxman and GPHA criticize U.S.-negotiated
=93patent term restoration=94 provisions, which provide patent extensions i=
n
order to make up for delays in securing marketing approval for a
patented drug.

This goes beyond the U.S. standard, the spokesperson said, which under
the Hatch-Waxman law allows patent extensions of up to five years but
only for =93new chemical entities.=94 GPHA is calling for patent term
restoration provisions that fall in line with the Hatch-Waxman law.

In addition, Waxman and GPHA point out that provisions in recent trade
agreements =93force the drug regulators in the developing countries to
become patent enforcers even though they have no expertise in this area.=94

For example, CAFTA Article 15.10.2(a) requires regulatory authorities to
=93implement measures in its marketing approval process to prevent such
other persons from marketing a product covered by a patent.=94

U.S. law, however, does not require the FDA to consider other patents
when considering an application from a generic manufacturer. Instead,
the onus is placed on the patent holder to challenge a generic application.

GPHA laid out their arguments in a May 9 letter to U.S. Trade
Representative Rob Portman, in which the group warned that the FTA
provisions could impact the access to medicines in the U.S. as well as
other countries. A spokesperson for the group said the U.S. will
eventually be required to harmonize the various FTAs it has negotiated,
and GPHA is worried that the harmonization will alter U.S. standards to
come in line with those agreed to in the FTAs.