Increasingly global markets have rewarded biopharmaceutical companies with operations outside the United States and Europe
with ample opportunities to expand successfully into new marketplaces around the world. At the same time, innovative companies
in the biotechnology and pharmaceutical industries depend heavily on the protection of their intellectual property. In today's
international markets, biopharmaceutical companies still face rampant piracy and counterfeiting of patented products. Since
the establishment of the World Trade Organization (WTO) in 1995, important progress has been made in achieving better international
harmonization of patent laws; however, many challenges for innovative biopharmaceutical companies remain, and new obstacles
continue to emerge.
Paul Sharer, J.D.
Through the United States Trade Representative (USTR) and in close consultation with the biopharmaceutical industry, the US
government has worked consistently for stronger and more harmonized international patent protections for innovative industries,
both at the global level as well as in regional and bilateral negotiations with US trading partners. Various domestic trade
laws are tools at the disposal of the US government to protect US patents from infringement. This article highlights the efforts
in international patent harmonization and explores some of the ever-changing challenges that face the US biopharmaceutical
MULTILATERAL AND BILATERAL TRADE AGREEMENTS
WTO TRIPS Agreement: Overview
The WTO agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is the most comprehensive multilateral
agreement on intellectual property to date.1 The TRIPS agreement was negotiated during the Uruguay Round trade negotiations and became effective on January 1, 1995. This
agreement motivated WTO members to implement and enforce patent rights, including those for biopharmaceutical products and
processes. Most WTO members were immediately bound by the standards stipulated by the TRIPS agreement, although the deadline
for implementing its provisions was extended to 2000 for some developing countries, and was recently extended from 2006 to
2016 for least-developed nations.
TRIPS attempts to strike a balance between the long-term objective of providing incentives for future inventions and creations,
and the short-term objective of allowing people to use existing inventions and creations. The agreement covers a wide range
of intellectual property rights, from copyrights and related rights, trademarks, integrated circuit designs, geographical
indications, and trade secrets to patents. The preamble of the agreement lays out its general goals as reducing distortions
and impediments to international trade, promoting effective and adequate protection of intellectual property rights, and ensuring
that measures and procedures to enforce intellectual property rights do not themselves become barriers to international trade.
Certain general provisions of the agreement apply to all forms of intellectual property rights, from copyrights to patents.
These include the fundamental rules of international trade on nationals, and on most-favored-nation treatment of foreign nationals,
contained in Articles 3 and 4, respectively. The national-treatment clause generally forbids discrimination between a member's
own nationals and the nationals of other TRIPS members, with respect to the protection and enforcement of intellectual property
rights. The most-favored-nation clause forbids discrimination between nationals of other TRIPS members, thereby affording
all foreign nationals operating in a member state the same level of protection. An additional important general provision,
Article 6, makes it clear that exhaustion of intellectual property rights is outside the scope of the TRIPS agreement.2
The substantive patent provisions of the TRIPS agreement first and foremost require member countries to make patents available
for any inventions, whether product or process, in all fields of technology, provided that the inventions are new, involve
an inventive step, and are capable of industrial application. As stipulated in Article 27, patents must also be available
without discrimination as to the place of invention, the field of technology, and whether products are imported or locally
produced. This important core provision presented a major step forward in international patent protection for the pharmaceutical
industry in particular, as many nations had excluded pharmaceuticals and biopharmaceuticals from all patent protection prior
to binding themselves to the standards of the TRIPS agreement. Countries where patent protection for pharmaceuticals was only
recently introduced as a result of the TRIPS agreement include Argentina, Brazil, Guatemala, India, Morocco, and Turkey.