Monday, October 12, 2015

Agricultural Data Exclusivity

Now that a draft text of the Transpacific Partnership ("TPP") trade agreement has been published on WikiLeaks for a few days, some of the provisions in the chapter on intellectual property rights are coming into sharper focus.  Section E ("Patents / Undisclosed Test or Other Data"), Subpart B ("Data Protection for Agricultural Chemical Products"), Article QQ.E.13 is remarkable.  It extends the sort of data exclusivity protection usually associated with biologics to "new agricultural chemical products".  Here is the text, sans footnotes:
1. If a Party requires, as a condition for granting marketing approval[] for a new agricultural chemical product, the submission of undisclosed test or other data concerning the safety and efficacy of the product[], the Party shall not permit third persons, without the consent of the person who previously submitted such information, to market the same or a similar[] product on the basis of that information or the marketing approval granted to the person who submitted such test or other data for at least ten years[] from the date of marketing approval of the new agricultural chemical product in the territory of the Party. 
2. If a Party permits, as a condition of granting marketing approval for a new agricultural chemical product, the submission of evidence of a prior marketing approval of the product in another territory, that Party shall not permit third persons, without the consent of the person who previously submitted undisclosed test or other data concerning the safety and efficacy of the product in support of that prior marketing approval, to market the same or a similar product based on that undisclosed test or other data, or other evidence of the prior marketing approval in the other territory, for at least ten years from the date of marketing approval of the new agricultural chemical product in the territory of the Party. 
3. For the purposes of this Article, a new agricultural chemical product is one that contains[] a chemical entity that has not been previously approved in the territory of the Party for use in an agricultural chemical product.
To owners of biologics, data exclusivity can be more valuable even than patent protection.  Owners of agricultural chemical products may soon enjoy a similar potent right throughout TPP territories.

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