International Business
Assignment 1
Students’ name: Afnan Al Murad & Rola Bakeer
India — Patent Protection for
Pharmaceutical and Agricultural
Chemical Products
The case started in 2 July 1996 when the United States of America claimed that
India is violating the rights of patent protection for pharmaceutical and agricultural
chemical products. As a result, the dispute settlement board (DSB) established a meeting
on 20 November 1996 to solve the case. After conducting many studies the DSB reached
to a point that India has not complied with its obligations stated in article 70 that will be
clarified hereafter. India has failed to follow the applications for product patents for
pharmaceutical and agricultural chemical inventions also it is not in compliance with
marketing rights of the members of the World Trade Organization (WTO). Considering
that the United States is a member of the WTO, they have the right for a period of five
years marketing approval then the other members can be allowed to use it.
However, in 15 October 1997, India has appealed some issues of law and legal
interpretations developed by the Panel. At 22 April 1998, the DSB announced that they
had agreed on an implementation period of 15 months from the date of the adoption of
the reports so it expired on 16 April 1999. As a result, India took in consideration the
recommendation of the DSB and has gone through the implementation period. Then
again, in 14 January 1999, the US requested consultations with India regarding the
Patents rights case and the European Communities requested to join the consultations.
Finally, at 28 April 1999 the DSB had its meeting where India “presented its final status
report on implementation of this matter which disclosed the enactment of the relevant
legislation to implement the recommendations and rulings of the DSB”1.
After analyzing the case and studying each party’s situation, it is clear that India
has absolutely violated some of the WTO’s regulations. Articles 70.8 and 70.9 of the
TRIPS agreement measure the point of violation.
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International Business
Assignment 1
Students’ name: Afnan Al Murad & Rola Bakeer
Article 70.8 states that members of the WTO are forced to follow the obligations
of the patent protection for pharmaceutical and agricultural chemical products and
members shall do the following:
Once a country is a member of the WTO, it is necessary to start the
application of the patent rules and regulations and should be informed that
cases for patents for inventions can be filed.
Countries should apply to these applications starting from 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”2.
Countries must provide patent protection as from the date of granting the
patent and all over the patent period.
Additionally, article 70.9 states that once a product has been subject to
patentability and the patent agreement in a member of the WTO – of which follows the
70.8 article – a five year marketing exclusivity is attained. This can be granted only after
the member obtains a marketing approval or when product patent is accepted or
rejected, whichever earlier.
Another article that was referred to when settling the case is article 27. It states
that patents must be available for any invention that can be applicable industrially,
whether a product or service, in any field, wherever the invention takes place, and
whether products are imported or produced locally. Patents exclude from inventions
things that has a public need like protecting the “human, animal or plant life or health or
to avoid serious prejudice to the environment” 3. Also excluded from the patent are the
processes or methods used in the pharmaceutical field like kinds of treatment for human
and animal. Also excluded are “plants and animals other than micro-organisms, and
essentially biological processes for the production of plants or animals other than non-
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International Business
Assignment 1
Students’ name: Afnan Al Murad & Rola Bakeer
biological and microbiological processes”4. All countries that are part of the WTO
should enforce the rules of the WTO agreement.
Parties who were involved in solving the case include the DSB which is the
Dispute Settlements Board, the Appellate Body, and the third party which are the
European Union Countries.
However, the final decision of the World Trade Organization (WTO) was fair
enough since it gave India an appropriate period of time to execute the judgment. They
have 15 months to adjust their position and apply the law.
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