[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.  Anand Grover, =
appearing for the Cancer Patients Aid Association, continued with his argum=
ent that unless a treaty provides for rights to private individuals in dome=
stic courts, no declaration can be given by a domestic court for an alleged=
 violation of an international treaty.


Then he pointed out the factors in Articles 1, 7, 8, and 27 of TRIPS which =
have to be considered and which allow for flexibility in enacting TRIPS.  H=
e also pointed to 4bis of the Paris Convention, which provides for independ=
ence of patent determinations, which was incorporated by reference into TRI=
PS.


He then discussed the WTO case involving the Canadian Bolar provision, in w=
hich the WTO dispute panel held that Article 27 does not prohibit bona fide=
 exceptions to patentability for problems that exist only in certain produc=
t areas.  He also pointed out that the WTO held that the fact that the legi=
slation in question was targeted towards a specific area of technology did =
not render the statute in violation of the antidiscrimination provision in =
article 27 as long as the statute was broadly applicable in scope. He then =
argued that 3d was enacted to deal with the specific problem of evergreenin=
g, and that because it was facially neutral and applicable to all fields of=
 technology, it was perfectly valid under Article 27 and the WTO=92s interp=
retation of its requirements.


He then pointed out that Parliament, when amending the Patents Act in 2005,=
 was bound to consider not only its obligations under TRIPS, but it=92s con=
stitutional and international human rights obligations to protect and promo=
te the right to health.  In this context, he referred to Article 21 of the =
Indian Constitution, which guarantees the right to life, and subsequent jud=
gments that had held that the right to health is incorporated into the fund=
amental right to life.  He also pointed to numerous international human rig=
hts conventions, as well as the Protection of Human Rights Act, which place=
d upon Parliament the duty to achieve the highest attainable standard of he=
alth for its citizens.  Therefore, read in light of these competing interes=
ts, section 3d could be read as a perfectly valid balance between India=92s=
 TRIPS obligations and its obligation to protect the health of its people.


In discussing the objects and purposes of enacting section 3(d), he asserte=
d that one of the primary purposes was to prevent evergreening.  He argued =
that the problem of evergreening was a globally recognised problem.  He cit=
ed the recent Canadian Supreme Court case, Apotex v. Astra Zeneca, which ha=
d restricted the ability of patent holding pharmaceutical companies to prev=
ent generic competition by adding =93bells and whistles=94 to already exist=
ing products.  He then pointed to a study by the US Federal Trade Commissio=
n, which had studied the outcome of patent litigation between patent holdin=
g companies and their generic competitors.  The study had found that in the=
 vast majority of cases, it had been determined that the patent was ultimat=
ely found to be either invalid or not infringed.  He submitted that this wa=
s an indication that many patents on derivates of known products served ver=
y little purpose other than to delay the entry of affordable generic compet=
ition.


He then introduced Indian caselaw to show that it was permissible to look i=
nto Parliamentary debates to ascertain the objectives of a law.  He then po=
inted to the statements by Commerce Minister Kamal Nath in Parliament, whic=
h indicated that section 3(d) was being enacted to combat evergreening.  Th=
erefore, in light of the problem that Parliament was seeking to solve, sect=
ion 3(d) was a perfectly valid exercise with a rational relation to the obj=
ective of the statute.  Therefore, there existed a rational nexus, and sect=
ion 3(d) was not in violation of Article 14.


He then addressed Novartis=92 contention that because =93efficacy=94 and =
=93significant=94 were left undefined by Parliament, it was thus vague, arb=
itrary and invalid.  He pointed to several authorities, which expressly hel=
d that in cases where legislation had to deal with a myriad of factual circ=
umstances, the use of general, undefined expressions was perfectly appropri=
ate, and was commonplace in the law.


Next, he read closely the requirements of Article 27 of TRIPS, and contende=
d that the exclusions specifically enumerated in paras 2 and 3 of Article 2=
7 were not necessarily an exhaustive list of valid exclusions.  He pointed =
out that the prohibition of a =93new use of a known substance=94, which Nov=
artis itself had admitted was perfectly valid, could not be found under Art=
icle 27.2 or 27.3.  Additionally, he listed many countries that excluded va=
rious categories form patentability, including business methods, forms of p=
resentation, computer programs, and aesthetic creations.  Thus, he conclude=
d that paras 2 and 3 of Article 27 do not form an exhaustive list, that the=
re was no generally accepted international practice on such matters, and th=
at therefore section 3(d) was equally valid.


Finally, he pointed out that it was a requirement under Indian law to clear=
ly and unambiguously state in the substantive writ petition the facts upon =
which the constitutional challenge under Article 14 was based.  Because Nov=
artis failed to do so, its challenge on Article 14 was defective.


Mr. Thyagarajan, appearing for the Indian Pharmaceutical Alliance, pointed =
to two other uses of the word =93efficacy=94 in other Indian statutes, and =
observed that these words were not defined in these statutes either.  There=
fore, he concluded, Novartis=92 complaint that =93efficacy=94 was vague bec=
ause it lacked a definition was misplaced.


Mr. Vijayan, appearing for Sun Pharma, argued that because section 3(d) doe=
s not discriminate on the basis of nationality, it does not violate Article=
 14.  He argued that the dispute settlement mechanisms under the WTO were e=
xclusive, and thus Novartis could not seek a remedy in the Indian courts.


Lastly, Mr. Bharat Raman, appearing for Natco Pharma, characterised the dis=
pute as involving five questions:  1. Whether section 3(d) was TRIPS compli=
ant; 2. If not TRIPS compliant, then could the law be struck down? 3.  What=
 was the rationale and justification for section 3(d)?  4.  Is section 3(d)=
 vague or ambiguous?  5.  Even if ambiguous, could it be struck down as vio=
lative of Article 14?


On the first issue, he adopted the arguments of Grover and Lakshmikumaran. =
 Referring to the UNCTAD handbook on TRIPS, he pointed out that implementin=
g legislation was presumed to be TRIPS compliant, and that the discretion t=
o adopt measures to protect human health were in-built.


On the second issue, he again asserted that the WTO dispute panel was the s=
ole and exclusive forum for determining TRIPS compliance, and questioned wh=
y Novartis was pursuing the current action in an Indian court.  He wondered=
 whether Novartis had failed in persuading Switzerland to take India to the=
 WTO dispute panel.  If Novartis=92 own home country would refuse to questi=
on the validity of India=92s implementation of TRIPS, then he said that it =
would be doubly inappropriate for an Indian court to hold section 3(d) as i=
ncompatible with TRIPS.


He then pointed to further authority to support the contention that in the =
case of a conflict between domestic and international law, domestic law wil=
l prevail, and therefore the law could not be struck down.


On the third issue, Bharat claimed that section 3(d) was nothing more than =
a statutory recognition of the doctrine of equivalents, and was aimed at en=
couraging innovation while preventing evergreening.  The doctrine of equiva=
lents states that where a product is technically non-infringing, but nevert=
heless serves a similar purpose in a similar manner as that of a patented p=
roduct, courts nonetheless may hold under the doctrine of equivalents that =
the product infringes the patent.  Section 3(d), he argued, implicitly reco=
gnised this doctrine, and stated that a patent could be granted for similar=
 products that were significantly different.


He argued that Novartis used section 3(d) as an anchor during the examinati=
on phase, and even argued in terms of enhancement of efficacy, and only cha=
llenged section 3(d) when it was not granted a patent by the patent control=
ler.

He then cited to the Philippines bill, which reproduced, almost verbatim, t=
he provision of section 3(d), claiming that imitation was the sincerest for=
m of flattery.  Unlike the Philippines bill, which was limited to drugs and=
 medicines, he pointed out that section 3(d) was applicable to all fields o=
f technology.


On the fourth issue, he questioned whether the terms =93efficacy=94 and =93=
significant enhancement=94 were vague and arbitrary.  He claimed that the c=
oncepts were not unknown in patent law, and many applicants, including Nova=
rtis, had compared the efficacy of its product to those already existing to=
 justify its grounds for being granted a patent.  He then stated that it wo=
uld not be possible for Parliament to define every word used in every statu=
te.  He pointed to several differing concepts in the Patents Act that could=
 feasibly be open to more than one interpretation but were left undefined b=
y Parliament.  He claimed that it was precisely the duty of the Court to gi=
ve meaning and effect to broad terms used in a statute by ascertaining to t=
he best of its abilities the object and purpose behind the legislation, and=
 to adopt an interpretation that would best fulfil those purposes.


He pointed out that the term =93efficacy=94 was not an unknown term, even t=
o Novartis.  During the patent examination stage, Novartis had submitted an=
 affidavit which claimed that its product =93differed significantly in prop=
erties with respect to efficacy=94 from an earlier product.


Finally, on the fifth issue, he claimed that even if the undefined terms in=
 section 3(d) were in fact vague or ambiguous, it would not provide a basis=
 for striking down the statute.  Rather, he asserted that it was the duty o=
f the Court to construe the vague terms in harmony with the aims and object=
s of the statue to give meaning to them.


In solidarity,


The Lawyers Collective HIV/AIDS Team,

Anand
Chan
Julie
Ramya


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