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 US didn`t want patents in ACTA, and will probably use the option to exclude
them from the scope. If the reasons for this were substantial, the US wouldn`t
want the elsewhere either.
Yet the US wants them in the TTP. Any know reason for this difference?
It is just that ACTA raised too much heat?
vriendelijke groet,
cordialmente,
Ante
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.
