[Ip-health] US proposed TPP IP provisions are dangerous to access to medicines

Baker, Brook b.baker at neu.edu
Mon Mar 14 08:06:58 PDT 2011

Even though the US's proposed patent and data provisions in its TPP text has multiple place-savers, there are substantial dangers to access-to-medicines reflected in hard text already proposed.

The provision on liberalizing patentability, Art. 8.1, is the most troubling as it builds on earlier US FTAs that have mandated patents on "new uses."  TPP Art. 8.1 goes further not only by requiring patentability of new uses, but of new forms and new methods of use as well.  

The "new forms" language will cover variations on existing chemical entities, variations in formulation, method of delivery, dosage, combinations, etc., but only so long as the new form satisfies the basic, minimum standards of patentability in the first sentence of subsection 1. However, the new language specifically repudiates the language adopted by India in 3(d) and the few other copycat provisions that have been adopted, language that requires a showing of significant impact on efficacy (interpreted by India to mean more than mere bioavailability, stability, etc.).  My interpretation is that the US is trying to stop India-style provisions in their track, keep hammering away in India on modifying 3(d), and perhaps even issue a future WTO challenge.

The new methods of use language, referenced in Art. 8.1, undermines stringent jurisdictions' interpretation of the "industrial application."  Methods of use liberalization would allow patenting of what many consider to be merely an "idea" - that for which a particular product is useful. This liberalization of industrial application towards what the US defines as "utility" is further amplified in Art. 8.12, which requires Parties to find that a claimed invention is industrially applicable if it has a "specific, substantial, and credible utility," even if that utility is abstract. 

In addition to substantially liberalizing standards of patentability, the US proposal also eliminates flexibilities that countries have under TRIPS to exclude certain subject matter.  Proposed Art. 2 eliminates flexibility to exclude patentability for plants and animals, and for diagnostic, therapeutic, and surgical methods of treatment.

Art. 8.7  disallows pre-grant opposition procedures such as those that have been used successfully on multiple occasions in India. 

Art. 1.4 requires countries to ratify the flawed Art. 31bis outlining labyrinth procedures for export of predominate portions of medicines produced pursuant to compulsory licenses to countries with insufficient manufacturing capacitxy; and Art. 1.5 requires eventual adoption of the Patent Law Treaty.

My quick read of the enforcement section is that the US is mostly focused on trademark and copyrights.  I don't see third party liability implicating patent-related activities anywhere.


Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
(w) 617-373-3217
(c) 617-259-0760
(f) 617-373-5056
b.baker at neu.edu

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