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CS Professional · Intellectual Property Rights - Law and Practice · Protection of Trade Secrets

Zenith Agro submits undisclosed test data to an Indian regulator to obtain marketing approval for a new agricultural chemical; generating the data involved considerable effort. Under TRIPS Article 39(3), what must the member country do?

TRIPS Article 39(3) requires members to protect undisclosed test data, submitted for approval of new chemical entities and involving considerable effort, against unfair commercial use and disclosure. Exceptions apply where disclosure is necessary to protect the public or where safeguards against unfair commercial use exist.

  1. APublish the data immediately so rivals can rely on it
  2. BProtect the data against unfair commercial use, and against disclosure except where necessary to protect the public or where steps ensure protection against unfair commercial useCorrect
  3. CGrant the applicant a patent over the data for twenty years
  4. DGrant a compulsory licence of the data to any applicant

Explanation

Article 39(3) obliges members, where approval requires submission of undisclosed test data involving considerable effort for new chemical entities, to protect it against unfair commercial use and against disclosure, except where necessary to protect the public or where steps ensure protection against unfair commercial use. It does not mandate a patent or publication.

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