[Ip-health] Novartis' Challenge to India's Patent Act, section 3d

[B.Baker@neu.edu]

I've just finished reading the Novartis pleading and offer the following
short analysis.

TRIPS enforcement must ordinarily be undertaken through WTO complaint and
dispute resolution procedures initiated by a WTO member (not a disgruntled
company).  However, some countries have legal regimes whereby properly
executed treaties because enforceable and justiciable claims in national
courts without any further implementing legislation.  (This also would be
the end result of investor clauses in FTAs.)

Thankfully, India is a country where treaties are not self-executing, as
Novartis reluctantly admits in its pleading.  Nonetheless, Novartis
essentially tries to get around the non-self-executing clause in the Indian
constitution by arguing that:  (1) courts are obligated to interpret Indian
law so as to harmonize it with binding international law if at all possible
and (2) section 3d is unconstitutionally arbitrary and irrational because
(a) it upsets "established expectations," (b) it is inconsistent with the
stated intent of the three Patent Act Amendments to comply with TRIPS, and
(c) because it is internally inconsistent with the basic definition of an
invention in the Patent Act.  Of course, the underlying TRIPS argument that
Novartis is making is that section 3d does not satisfy the minimum
standards of patentability (novelty, inventive step, and industrial
applicability) in TRIPS Article 27 and that section 3d thereby violates
India's implementation obligations under TRIPS Article 1.1.  This long,
rambling, and poorly drafted pleading also appears to make an argument that
section 3d represents a prohibited form of discrimination against a field
of technology (para. 8T), but that claim is not expanded anywhere else in
the pleading.

It's easy to understand why Indian lawyers believe that the case will be
thrown out on for lack of justiciability.  Hopefully, the same will also be
true on the substance based on strong counter-arguments (1) that it is
permissible to differentiate between field of technology and (2) that
countries have flexibility under Article 1 and under the broadly
interpretable meanings of novelty and inventive step to limit
pharmaceutical product patents in the way India has.

Professor Brook K. Baker, Health GAP