In a very interesting matter concerning the protection of regulatory data,
Syngenta, a Swiss
MNC argued before Justice
Ravindra Bhat of the Delhi High Court that Article 39.3 of TRIPS mandates data exclusivity.
This is sheer nonsense! Anyone with a fair understanding of Article 39.3 of TRIPS and its negotiating history would appreciate that it does not mandate "data exclusivity". But first the facts of
Syngenta India Ltd vs Union of India (W.P. (C) 8123/2008 ):Facts:Syngenta procured registration for its insecticide that was allegedly useful in tackling the
bollworm problem plaguing Indian cotton.
Jaishree comes along for a "me too" registration and submits essentially "bio-efficacy" data (asking the government to rely on data already submitted by
Syngenta).
Syngenta objects to this and takes the matter finally to court, stating that government rules provide for data exclusivity and the government cannot rely on
Syngenta's data to approve
Jaishree's generic version of the insecticide in question. The matter is a very technical and complex one and really turned on the fact that at the time that
Syngenta procured registration for its insecticide, the 'data exclusivity" rules by the government were not in force. In any case, since
Syngenta had "provisional registration" prior to final registration, its supposed data exclusivity period is 3 years from the date of the provisional registration--and this period had lapsed when
Jaishree's generic version came up for registration.
Back to
Syngenta's outlandish claim that Article 39.3 mandates data exclusivity:
Article 39.3 of TRIPSThe Article states as below:
"Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use."
In other words, the mandate above is that regulatory data be protected against "unfair commercial use". This does not however mean that the regulatory data submitted by an innovator cannot be relied upon by the government to approve a generic. It could mean (as I have
argued) that the government may use it to approve a generic version, but the generic manufacturer in question has to pay a certain sum of money to the innovator (a "compulsory licensing" scheme of sorts). It could also mean, as others have argued, that the data ought to be only protected against disclosure and fraudulent procurement by another third party.
A close look at the negotiating history of TRIPS would reveal why
Syngenta's argument that Art 39.3 mandates data exclusivity is inherently flawed. An earlier draft of Article 39.3 (the "Brussels draft") had clear "data exclusivity" language ( "the data shall not be relied upon for a reasonable time..") which was knocked off in the subsequent TRIPS text. And this clearly demonstrates that the TRIPS negotiators did not wish to impose a "data exclusivity" obligation, but wished to have a more flexible obligation. For more details of this negotiating history etc, see
here.
Reddy CommitteeMore worryingly perhaps, the petition also argued that the
Reddy Committee Report mandated "data exclusivity". Here is how Justice
Bhat captures the mistaken contentions of
Syngenta:
"The petitioner argues that .... a Statutory Authority (in this case the Committee) cannot rely on the data submitted by the Originator for approving the second and subsequent applications for the same insecticide. This protection and data exclusivity, however, would be for a limited period and not in perpetuity. The petitioner also alludes to a “
Reddy Committee” report, dated 31.05.2007 that endorses TRIPS’ recommendations concluding that the Act and the Rules should be amended.... "
While
Syngenta is right in stating that the
Reddy Committee opined that Indian law does not comply with Article 39.3, they are wrong in assuming that the
Reddy Committee recommended "data exclusivity" as the only way to comply with Article 39.3. Preventing data from "unfair commercial use" is not the same thing as preventing "reliance" on the data (which is essentially what data exclusivity is all about).
Far from endorsing a "data exclusivity" mandate under Article 39.3, the
Reddy Committee Report
clearly mentions that such exclusivity is not needed for pharmaceutical data at the moment. However, they propose amendments to the Drugs and Cosmetics Act to ensure that no data wrongfully leaks out of the Drug Controller's office and falls into the hand of competitors. These proposals are yet to be implemented in India. Round 2 of amendments to the Drugs and Cosmetics Act, setting up the Central Drug Authority (
CDA) and dealing with clinical trial regulation etc is on the anvil; and one expects that some of the
Reddy recommendations would be implemented through these amendments. (
ps: the first set of amendments to the
DCA deals with
"spurious drugs" and came into force recently).
Interestingly although the
Reddy Committee does not recommend "
data exclusivity" for pharmaceuticals (at least for the time being), they do so for
agro-chemicals and traditional medicines. And since the
Syngenta case is really about the approval of an originator pesticide (and its generic version),
Syngenta is correct in their view that the
Reddy committee recommends data exclusivity at least for
agro-chemicals. However, the
Reddy committee does not do this out of a fear of the Article 39.3 mandate. Rather, they are of the view that there is broad industry consensus in favour of exclusivity in so far as
agro-chemicals were concerned.
Data Exclusivity Through Government RulesWhat is even more interesting in this case is that without an amendment to the Insecticides Act, the government introduces data exclusivity through a mere "rule". Justice
Bhat takes them to task noting that this is an 'essential legislative function" that cannot be subsumed within rule making powers of the government. However, since the
vires of these rules was not directly challenged in the litigation, he did not dwell further on this aspect.
However, in keeping with his reputation as a "costly" judge, he imposed a cost of Rs 3.75
lakhs on
Sygenta (75,000 per hearing) to be paid to
Jaishree, the generic
manfacturer for bringing a "speculative" action and inviting "the court to make a policy declaration, which could not have been made under any circumstances." Also the
pendency of the court proceedings delayed the entry of
Jaishree into the market and this had to be compensated.
Its interesting that the last few months have seen two similar cases by
patentees who attempt to delay generic entry by bringing highly untenable legal claims. The first was the B
ayer vs Cipla matter, where Bayer attempted to introduce a patent drug linkage mechanism through the backdoor. And now this agrochemical case involving
Syngenta.
But perhaps, it is even more interesting that Justice
Ravindra Bhat, the presiding judge in both these cases is clearly not amused by these attempts to use courts to create legislative policy through the backdoor and expresses his displeasure by imposing costs!
On August 11, 2009, a Division Bench of the Delhi High Court upheld Justice
Bhat's order, but it watered down the costs imposed on
Syngenta to about Rs 1
lakh.
ps: Thanks to
Prashant for bringing this interesting case to my attention.