[Ip-health] (no subject)

[chan park]

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[ Picked text/plain from multipart/alternative ]
The Novartis matter resumed today in the Madras High Court.  Under the Orde=
r of the Chief Justice of the Madras High Court, the appeal of the Patent C=
ontroller=92s order will be heard by the same bench of Justices Balasubrama=
niam and Prabha Sridevan.


Mr. Soli Sorabjee, counsel for Novartis, commenced his rejoinder arguments =
relating to Novartis=92 claim that Section 3d is violative of Art. 14 of th=
e Constitution.  He contended that the manner in which the amendment to 3d =
was introduced, and the fact that India had undertaken a solemn obligation =
to comply with the TRIPS agreement, introduced an element of irrationality =
into the legislation, and therefore violated Art. 14.  He further repeated =
his contention that India=92s refusal to comply with TRIPS would lead to an=
 erosion of India=92s credibility internationally.


At this point, Justice Prabha Sridevan interjected and said that she unders=
tood the respondents=92 arguments to say that whether 3d was TRIPS complian=
t or not was simply not a matter for judicial determination because TRIPS i=
s not part of domestic law.


Sorabjee responded by claiming that the court had to look at the background=
 surrounding the legislation. He claimed that the legislative history showe=
d that Commerce Minister Kamal Nath disagreed with the TRIPS-compliance of =
3d, and that while there was uncertainty in the government as to whether 3d=
 was TRIPS compatible, Parliament went ahead and enacted 3d anyway.


Then he argued that the fact that =93efficacy=94 and =93significant enhance=
ment=94 lacked any guidelines made it vague and arbitrary.  Responding to t=
he contention that a simple lack of definition did not render a statute inv=
alid, he claimed that while other instances of broad undefined terms had ac=
quired a well-understood judicial understanding, this was not the case with=
 =93efficacy=94 and =93significant enhancement,=94 and thus made it vulnera=
ble to varying interpretations that differ from individual to individual.


He pointed to a litany of Indian caselaw to advance the argument that where=
 Parliament delegates unguided powers to the executive brance without layin=
g down any clear legislative policy in the legislation itself, such delegat=
ion could be struck down by the courts as an excessive delegation of power.


At this point, Justice Balasubramaniam interjected and said that it was the=
 case of the Respondents that =93efficacy=94 was a concept known to those i=
n the pharmaceutical field, including Novartis, and that the explanation on=
ly related to a requirement of significant increase in efficacy.  Respondin=
g to this, Sorabjee admitted that the meaning of =93efficacy=94 is known an=
d that what was problematic was that section 3(d) did not explain what cons=
tituted a =93significant enhancement.=94


At this, Justice Prabha Sridevan observed that it appeared that Novartis=92=
 grievance lay in the fact that section 3(d) did not provide a specific per=
centage for what constitutes =93significant enhancement.=94  She said that =
it could be case that for a headache medicine, a 30% enhancement in efficac=
y may not amount to an increase in efficacy but that it could be amount to =
a significant increase in efficacy for an anti-cancer drug. She said that i=
t would be incorrect to lay down the a specific percentage and that section=
 3(d) gave  leeway to the Patent Controller to allow patentability of new f=
orms of known substances. To this, Sorabjee replied that Novartis was not c=
laiming that a rigid standard be defined.


Sorabjee argued that section 3(d) created an irrational legal fiction of de=
eming new forms of known substances to be the same substance. He said that =
he would refer to authorities to cite instances in which irrational legal f=
ictions had been struck down.  Sorabjee said that after creating such an ir=
rational fiction, an attempt was made to provide an escape route by introdu=
cing the requirement of significant increase in efficacy. He said that it w=
as important to have guidelines which were flexible.


Justice Balasubramaiam asked how Parliament could possibly anticipate all d=
erivatives of known substances and list them.  Responding to this, Sorabjee=
 claimed that it was an irrational legal =93fiction=94 to deem different su=
bstance to be the same substance.  He argued that this legal =93fiction=94 =
was arbitrary, and that this arbitrariness was not cured by allowing only c=
ertain new forms to be patented.


Admitting that Parliament could not lay down a rigid standard to determine =
what constituted an increase in efficacy, he argued that neither could Parl=
iament leave section 3(d) without providing any guidance to the Patent Cont=
roller. He reiterated that a determination of what constituted a significan=
t increase in efficacy would be a value judgment and that there was no guid=
eline in section 3(d) that would guide the Patent Controller in arriving at=
 this judgment.


To show how arbitrary 3(d) could be, he pointed to the affidavit filed by t=
he Patent Controller, where he stated that a 30% increase in bioavailabilit=
y =93may or may not be statistically significant.=94  He argued that if eve=
n the patent controller did not know what constituted significance, then 3(=
d) surely was vague and ambiguous.


Mr. Shanti Bhushan, also appearing for Novartis, commenced his argument tha=
t 3(d) was incompatible with TRIPS.  He claimed that the EU Directive, from=
 which the language of 3(d) was borrowed, related to the drug regulatory re=
view process, and such concepts, as applied to patentability criteria, woul=
d result in an absurdity.  He claimed that the drug regulatory approval pro=
cess generally took place years after a drug was patented, and that the cli=
nical trials necessary to establish efficacy could not possibly be presente=
d as evidence to satisfy the requirements of 3d during the patent examinati=
on stage.


At this point, Justices Balasubramaniam and Prabha Sridevan both interjecte=
d, observing that while this may be true in some circumstances, it was the =
case that Novartis actually knew and had data relating to the efficacy of i=
matinib mesylate during the patent examination stage.  Mr. Bhushan admitted=
 that this was the case, but this was only so because of the lag of several=
 years between the filing of the application in the =93mailbox=94 and the e=
xamination of the application in 2005.  Justice Prabha Sridevan observed th=
at whatever the reason for the lag, if Novartis did in fact have clinical t=
rial data relating to imatinib mesylate=92s efficacy, on what basis could N=
ovartis claim that 3d imposed an unreasonable requirement?


Justice Prabha Sridevan also asked what the difference was between =93inven=
tion=94 and =93discovery.=94  She asked whether or not it was the case that=
 only inventions needed to be patented, and discoveries did not need to be =
patented.  Viewed in this light, she asked whether 3(d) is not a valid excl=
usion of all discoveries of new forms except for those with an increase in =
efficacy.  To this, Mr. Bhushan replied that all =93discoveries=94 become p=
atentable =93inventions=94 if such =93discoveries=94 involve an inventive s=
tep.


Bhushan then continued with his argument that because section 3(d) imposes =
requirements above and beyond the basic requirements of novelty, inventive =
step and industrial application, it was in contravention to Art. 27 of TRIP=
S.  He contended that Articles 7 and 8 provided for flexibilities only with=
 respect to compulsory licensing, which India took advantage of in section =
84, et seq of the Patents Act.  He further argued that Article 27 only cont=
emplates exclusions from patentability as laid out in Articles 65(4), 70(8)=
, and subsections (2) and (3) of Article 27, and that no further exclusions=
 are allowed under TRIPS.  Justice Prabha Sridevan asked whether it was his=
 contention that the exclusions contemplated under 27(2) and (3) formed an =
exhaustive list of valid exclusions from patentability, to which Bhushan re=
plied in the affirmative.


At the conclusion of the day=92s proceedings, Sorabjee indicated that he ca=
me to learn of the fact that the Additional Solicitor General, VT Gopalan, =
intended on filing some additional documents, one of which was the letter w=
ritten by Henry Waxman to Novartis asking it to reconsider its position on =
the case.  Sorabjee asked that the documents be filed today, so that Novart=
is could examine it and initiate contempt of court proceedings against Cong=
ressman Waxman.


To this, Grover responded that Novartis should examine its own website on w=
hich they were posting comments on the merits of the case, which also amoun=
ted to contempt of court.


Bhushan will complete his arguments relating to TRIPS tomorrow, at which po=
int the Respondents will have the opportunity to respond to some of the new=
 arguments that Novartis presented during its rejoinder.  We will keep you =
posted.


In solidarity,


The Lawyers Collective HIV/AIDS Unit Team


Anand
Chan
Julie
Asha


All of the updates from this case can be found at our website,

www.lawyerscollective.org



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