[Ip-health] Removal of "new forms" patent protection in most recent TPP Draft

Jamie Love james.love at keionline.org
Wed Aug 5 10:25:28 PDT 2015

This debate now shifts to this language.

Article QQ.E.10:​[US/AU/MX/SG propose; [76] CL/MY/VN/PE/BN/NZ/CA oppose:
Each Party shall provide that a claimed invention is [US/AU/SG propose:
useful] [MX propose: industrially applicable] if it has a specific [MX
propose: and], substantial, [MX oppose: and credible] utility.]

On Wed, Aug 5, 2015 at 11:31 AM, Baker, Brook <b.baker at neu.edu> wrote:

> After a long campaign by right-to-health activists and TPP partners, it
> appears that the U.S. has finally dropped its efforts in TPP negotiations
> to require patent coverage for new forms of known products that lack
> evidence of enhanced efficacy.  The most recent previous leaked draft TPP
> patent chapter contained Article QQ.E.1.2 which stated that a "patent may
> not be denied solely on the absence of enhanced efficacy of a known product
> where the applicant has set forth distinguishing features."  This provision
> - or any equivalent - is now absent from the draft text leaked by KEI
> yesterday.
> The deleted provision had been  proposed as a direct challenge a patent
> exclusion/standard-of-inventiveness used by India in section 3d of its
> Amended Patents Act to prevent ever greening of patent monopolies by minor
> changes to the chemical form of a known substance or by a mere new dosage,
> new formulation, or new combination of known substances in the absence of
> evidence of a significant therapeutic effect.  This anti-evergreening
> standard is gaining traction in state practice elsewhere having been
> adopted by several other countries and under discussion in others.
> The universal opposition to the U.S. "new form" proposal by other TPP
> partners, rich and poor, bodes well for the defense of India's section 3d
> against ideological attacks by the U.S. and for further adoption of
> comparable provisions in law reform efforts in Brazil, South Africa, and
> elsewhere.  Instead of being able to force a pro Big-Pharma, eased
> patentability criterion down the throats of TPP partners, the U.S. has
> become so isolated on this issue that it has actually dropped the demand.
> This retreat also bodes well for future progress on stricter standards of
> patentability even in the U.S. where the vast majority of pharmaceutical
> patents are granted on minor variations to known medicines with little, no,
> or even less therapeutic benefit - all in pursuit of longer
> profit-maximizing pharmaceutical monopolies.
> 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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James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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