The Agreement on Trade-Related Aspects of Intellectual Property Rights, also known as the TRIPS Agreement, introduced global standards for enforcing and protecting intellectual property rights for patents. This agreement, which was put in place in 1995, was expected to have the most impact on access to pharmaceutical medicines around the world.

WTO and the History of the TRIPS Agreement

The World Trade Organization (WTO) is an international entity which deals with trade rules between countries. Intellectual property rights are rights bestowed on individuals and companies for original creations. In 2006, the WTO had 148 member countries. By 2006, the organization's General Council made all documents public under GATT, the General Agreement on Tariffs and Trade. This move included all official TRIPS documents.

Countries that become members of the World Trade Organization agree to abide by 18 agreements which established the organization. As such, these countries cannot choose some agreements to follow and ignore others, save for a few non-obligatory agreements. All TRIPS Council administrators are also WTO members. The TRIPS Agreement is, to date, the most comprehensive intellectual property agreement.

The TRIPS Agreement covers almost every form of intellectual property, including:

  • Patents
  • Trade secrets
  • Copyrights
  • Geographical indications
  • Trademarks
  • Industrial designs
  • New plant variety exclusionary rights

Prior to TRIPS, there were no international conventions that specified patent standards. When negotiation began, more than 40 countries did not provide pharmaceutical patent protection.

Thanks to the TRIPS Agreement, all WTO members must adapt their laws to accommodate the minimum standard of intellectual property rights protection. In other words, all WTO countries must provide monopoly grants of limited duration for intellectual property and adhere to agreements laid out in the WTO Conventions, including the Paris Convention and Berne Convention. The TRIPS Agreement specifically refers to these two conventions in Articles 2.1 and 9.1. As such, the TRIPS Agreement is sometimes called the “Berne and Paris-Plus Agreement.”

It's important to note that the TRIPS Agreement provides a certain amount of flexibility for countries to accommodate their own intellectual property and patent systems. This flexibility allows them to modify certain regulations and formulate their own legislation with an eye toward making existing medications more affordable to the public.

TRIPS General Provisions

Each WTO member country has a basic obligation in how it treats intellectual property. Who benefits from treatment is defined in the Agreement with respect to WTO members.

Article 1.3 of the TRIPS Agreement defines people benefiting from IP protection as “natural or legal” persons with a close attachment to WTO members. Articles 3, 4, and 5 discuss rules on treating foreign nationals.

Obligations of the Agreement cover substantive standards of IP protection as well as matters which affect intellectual property:

  • Availability
  • Scope
  • Acquisition
  • Maintenance
  • Enforcement

One of the national treatment clauses prohibits discrimination between nationals and other WTO members to keep things fair.

Article 7 of the TRIPS Agreement is titled “Objectives.” This section pertains to the enforcement of IP rights and the mutual advantages producers and technology users share. Article 8, entitled “Principles,” discusses member rights for adopting public health measures and preventing IP rights abuse.

TRIPS: Key Provisions

There are some key and controversial provisions laid out in the TRIPS Agreement regarding patent protection. For instance, members must make all patent information available for all inventions in all technology fields without discrimination. Despite this rule, TRIPS never defines “invention.”

TRIPS outlines three exceptions that would allow countries to exclude patentable subject matter:

  • Inventions that are contrary to morality or are otherwise dangerous to human, plant, or animal life
  • Surgical, therapeutic, and diagnostic methods for human or animal treatment
  • Animals, plants, and other microorganisms or biological processes

The final clause has proven contentious because the term “sui generis” is used in describing plant varieties and whether they can be patented. Unfortunately, the term is not defined in the TRIPS Agreement, but it has enabled member countries to come up with their own protection schemes for plant life.

Because of this and other controversies, as many as 30 countries proposed a further discussion on the article, with proposals including:

  • Rewriting the article to exclude all patents for genetic material and organisms
  • Defining effective plant varieties
  • Extending rights for indigenous or traditional knowledge
  • Linking obligations for conservation and biodiversity use, including the required disclosure of any genetic materials used in a patent

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