WTO | Intellectual property (TRIPS) - fact sheet - pharmaceuticals

September 2006

Contents
> Philosophy: striking a balance
> Obligations and exceptions
> What does “generic” mean?
> Developing countries

This fact sheet has been prepared by the Information and Media Relations Division of the WTO Secretariat to help public understanding. It is not an official interpretation of the WTO agreements or members’ positions

GENERAL back to top

Developing countries and economies in transition from central planning did not have to apply most provisions of the TRIPS Agreement until 1 January 2000. The provisions they did have to apply deal with non-discrimination. Article 65.2 and 65.3

Least-developed countries were given until 1 January 2006. Article 66.1. On 30 November 2005, members agreed to extend the deadline to 1 July 2013, or to the date a country is no longer “least-developed”, if that is earlier.

For pharmaceutical patents this is extended to 2016 under the Doha Declaration on TRIPS and Public Health.

Most new members who joined after the WTO was created in 1995 have agreed to apply the TRIPS Agreement as soon as they joined. Determined by each new member’s terms of accession

PHARMACEUTICALS AND AGRICULTURAL CHEMICALS back to top

Some developing countries delayed patent protection for pharmaceutical products (and agricultural chemicals) until 1 January 2005.

This was allowed under provisions that say a developing country that did not provide product patent protection in a particular area of technology when the TRIPS Agreement came into force (on 1 January 1995), has up to 10 years to introduce the protection. Article 65.4

However, for pharmaceuticals and agricultural chemicals, countries eligible to use this provision (i.e. countries that did not provide protection on 1 January 1995) had two obligations.

They had to allow inventors to file patent applications from 1 January 1995, even though the decision on whether or not to grant any patent itself need not be taken until the end of this period — Article 70.8. This is sometimes called the “mailbox” provision (a metaphorical “mailbox” is created to receive and store the applications). The date of filing is significant, which is why the mailbox provisions were set up. It is used for assessing whether the application meets the criteria for patenting, including novelty (“newness”).

And if the government allowed the relevant pharmaceutical or agricultural chemical product to be marketed during the transition period, it had to — subject to certain conditions — provide the patent applicant an exclusive marketing right for the product for five years, or until a decision on a product patent was taken, whichever was shorter. Article 70.9

Which countries used the extra transition period under Article 65.4, wholly or partially? The answer is not entirely straightforward. Thirteen WTO members — Argentina, Brazil, Cuba, Egypt, India, Kuwait, Morocco, Pakistan, Paraguay, Tunisia, Turkey, United Arab Emirates and Uruguay — notified “mailbox” systems to the TRIPS Council, indicating that at the time they did not grant patent protection to pharmaceutical products. It is possible that a few other members should have notified the WTO but did not do so.

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The TRIPS Agreement

Article 65
Transitional Arrangements

1.   Subject to the provisions of paragraphs 2, 3 and 4, no Member shall be obliged to apply the provisions of this Agreement before the expiry of a general period of one year following the date of entry into force of the WTO Agreement.

2.   A developing country Member is entitled to delay for a further period of four years the date of application, as defined in paragraph 1, of the provisions of this Agreement other than Articles 3, 4 and 5.

3.   Any other Member which is in the process of transformation from a centrally-planned into a market, free-enterprise economy and which is undertaking structural reform of its intellectual property system and facing special problems in the preparation and implementation of intellectual property laws and regulations, may also benefit from a period of delay as foreseen in paragraph 2.

4.   To the extent that a developing country Member is obliged by this Agreement to extend product patent protection to areas of technology not so protectable in its territory on the general date of application of this Agreement for that Member, as defined in paragraph 2, it may delay the application of the provisions on product patents of Section 5 of Part II to such areas of technology for an additional period of five years.

5.   A Member availing itself of a transitional period under paragraphs 1, 2, 3 or 4 shall ensure that any changes in its laws, regulations and practice made during that period do not result in a lesser degree of consistency with the provisions of this Agreement.

Article 66
Least-Developed Country Members

1.   In view of the special needs and requirements of least-developed country Members, their economic, financial and administrative constraints, and their need for flexibility to create a viable technological base, such Members shall not be required to apply the provisions of this Agreement, other than Articles 3, 4 and 5, for a period of 10 years from the date of application as defined under paragraph 1 of Article 65. The Council for TRIPS shall, upon duly motivated request by a least-developed country Member, accord extensions of this period.

[…]

Article 70
Protection of Existing Subject Matter

[…]
8.   Where a Member does not make available as of the date of entry into force of the WTO Agreement patent protection for pharmaceutical and agricultural chemical products commensurate with its obligations under Article 27, that Member shall:

(a)   notwithstanding the provisions of Part VI, provide as from the date of entry into force of the WTO Agreement a means by which applications for patents for such inventions can be filed;

(b)   apply to these applications, as of the date of application of this Agreement, the criteria for patentability as laid down in this Agreement as if those criteria were being applied on the date of filing in that Member or, where priority is available and claimed, the priority date of the application; and

(c)   provide patent protection in accordance with this Agreement as from the grant of the patent and for the remainder of the patent term, counted from the filing date in accordance with Article 33 of this Agreement, for those of these applications that meet the criteria for protection referred to in subparagraph (b).

9.   Where a product is the subject of a patent application in a Member in accordance with paragraph 8(a), exclusive marketing rights shall be granted, notwithstanding the provisions of Part VI, for a period of five years after obtaining marketing approval in that Member or until a product patent is granted or rejected in that Member, whichever period is shorter, provided that, subsequent to the entry into force of the WTO Agreement, a patent application has been filed and a patent granted for that product in another Member and marketing approval obtained in such other Member.