[Ip-health] (no subject)

[James Packard Love]

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We are all impressed by the efforts by India NGOs and the very
informative reporting on this case.  Jamie

On Feb 23, 2007, at 2:56 PM, chan park wrote:

> --
> [ 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 argument that unless a treaty provides for
> rights to private individuals in domestic 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.  He also pointed to 4bis of the Paris
> Convention, which provides for independence of patent
> determinations, which was incorporated by reference into TRIPS.
>
>
> He then discussed the WTO case involving the Canadian Bolar
> provision, in which the WTO dispute panel held that Article 27 does
> not prohibit bona fide exceptions to patentability for problems
> that exist only in certain product areas.  He also pointed out that
> the WTO held that the fact that the legislation 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
> evergreening, 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 interpretation 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 constitutional and international human rights
> obligations to protect and promote the right to health.  In this
> context, he referred to Article 21 of the Indian Constitution,
> which guarantees the right to life, and subsequent judgments that
> had held that the right to health is incorporated into the
> fundamental right to life.  He also pointed to numerous
> international human rights conventions, as well as the Protection
> of Human Rights Act, which placed upon Parliament the duty to
> achieve the highest attainable standard of health for its
> citizens.  Therefore, read in light of these competing interests,
> 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
> asserted that one of the primary purposes was to prevent
> evergreening.  He argued that the problem of evergreening was a
> globally recognised problem.  He cited the recent Canadian Supreme
> Court case, Apotex v. Astra Zeneca, which had restricted the
> ability of patent holding pharmaceutical companies to prevent
> generic competition by adding =93bells and whistles=94 to already
> existing products.  He then pointed to a study by the US Federal
> Trade Commission, which had studied the outcome of patent
> litigation between patent holding companies and their generic
> competitors.  The study had found that in the vast majority of
> cases, it had been determined that the patent was ultimately found
> to be either invalid or not infringed.  He submitted that this was
> an indication that many patents on derivates of known products
> served very little purpose other than to delay the entry of
> affordable generic competition.
>
>
> He then introduced Indian caselaw to show that it was permissible
> to look into Parliamentary debates to ascertain the objectives of a
> law.  He then pointed to the statements by Commerce Minister Kamal
> Nath in Parliament, which indicated that section 3(d) was being
> enacted to combat evergreening.  Therefore, in light of the problem
> that Parliament was seeking to solve, section 3(d) was a perfectly
> valid exercise with a rational relation to the objective of the
> statute.  Therefore, there existed a rational nexus, and section 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,
> arbitrary and invalid.  He pointed to several authorities, which
> expressly held that in cases where legislation had to deal with a
> myriad of factual circumstances, the use of general, undefined
> expressions was perfectly appropriate, and was commonplace in the law.
>
>
> Next, he read closely the requirements of Article 27 of TRIPS, and
> contended that the exclusions specifically enumerated in paras 2
> and 3 of Article 27 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 Novartis itself had admitted was
> perfectly valid, could not be found under Article 27.2 or 27.3.
> Additionally, he listed many countries that excluded various
> categories form patentability, including business methods, forms of
> presentation, computer programs, and aesthetic creations.  Thus, he
> concluded that paras 2 and 3 of Article 27 do not form an
> exhaustive list, that there was no generally accepted international
> practice on such matters, and that therefore section 3(d) was
> equally valid.
>
>
> Finally, he pointed out that it was a requirement under Indian law
> to clearly and unambiguously state in the substantive writ petition
> the facts upon which the constitutional challenge under Article 14
> was based.  Because Novartis 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.  Therefore, he concluded, Novartis=92 complaint that
> =93efficacy=94 was vague because it lacked a definition was misplaced.
>
>
> Mr. Vijayan, appearing for Sun Pharma, argued that because section 3
> (d) does not discriminate on the basis of nationality, it does not
> violate Article 14.  He argued that the dispute settlement
> mechanisms under the WTO were exclusive, and thus Novartis could
> not seek a remedy in the Indian courts.
>
>
> Lastly, Mr. Bharat Raman, appearing for Natco Pharma, characterised
> the dispute as involving five questions:  1. Whether section 3(d)
> was TRIPS compliant; 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 violative 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 implementing legislation was presumed to be TRIPS
> compliant, and that the discretion to adopt measures to protect
> human health were in-built.
>
>
> On the second issue, he again asserted that the WTO dispute panel
> was the sole and exclusive forum for determining TRIPS compliance,
> and questioned why 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 question 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
> incompatible 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 will 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 encouraging innovation while preventing
> evergreening.  The doctrine of equivalents states that where a
> product is technically non-infringing, but nevertheless serves a
> similar purpose in a similar manner as that of a patented product,
> courts nonetheless may hold under the doctrine of equivalents that
> the product infringes the patent.  Section 3(d), he argued,
> implicitly recognised 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
> examination phase, and even argued in terms of enhancement of
> efficacy, and only challenged section 3(d) when it was not granted
> a patent by the patent controller.
>
> He then cited to the Philippines bill, which reproduced, almost
> verbatim, the provision of section 3(d), claiming that imitation
> was the sincerest form 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 of technology.
>
>
> On the fourth issue, he questioned whether the terms =93efficacy=94 and
> =93significant enhancement=94 were vague and arbitrary.  He claimed
> that the concepts were not unknown in patent law, and many
> applicants, including Novartis, 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 would not be possible for
> Parliament to define every word used in every statute.  He pointed
> to several differing concepts in the Patents Act that could
> feasibly be open to more than one interpretation but were left
> undefined by Parliament.  He claimed that it was precisely the duty
> of the Court to give meaning and effect to broad terms used in a
> statute by ascertaining to the 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 to Novartis.  During the patent examination stage, Novartis
> had submitted an affidavit which claimed that its product =93differed
> significantly in properties 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 of the Court to construe the vague terms in
> harmony with the aims and objects of the statue to give meaning to
> them.
>
>
> In solidarity,
>
>
> The Lawyers Collective HIV/AIDS Team,
>
> Anand
> Chan
> Julie
> Ramya
>
>
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----------------------------------------------
James Packard Love
Knowledge Ecology International
http://www.keionline.org
james.love@keionline.org
Washington, DC +1.202.332.2670

"If everyone thinks the same: No one thinks." Bill Walton"