[Ip-health] India, Novartis and EMR

[ds20@uow.edu.au]

India, Novartis and EMR=0D
Exclusive marketing rights (EMR) as discussed in the TRIPS=0D
Agreement Article 70(9) is to be read with Article 70(8)=0D
which says=0D
Where a Member does not make available as of the date of=0D
entry into force of the WTO Agreement patent protection for=0D
pharmaceutical and agricultural chemical products=0D
commensurate with its obligations under Article 27 that=0D
Member shall=0D
(a)=09Notwithstanding the provisions of Part VI, provide=0D
the date of entry into force of the WTO Agreement a means by=0D
which applications for patents for such inventions can be=0D
filed.=0D
(b)=09Apply to these applications , as of the date of=0D
application of this Agreement, the criteria for=0D
patentability as laid down in this Agreement as if those=0D
criteria were being applied on the date of filing in that=0D
Member or, where priority is available and claimed the=0D
priority date of the application, and=0D
(c)=09Provide patent protection in accordance with the=0D
Agreement as from the grant of the patent and for the=0D
remainder of the patent term, counted from the filing date=0D
in accordance with Article 33 of this Agreement, for those=0D
of these applications that meet the criteria for protection=0D
referred to in subparagraph (b).=0D
Paragraph (a) was an issue of dispute between the USA and=0D
India in India-Patent Protection for Pharmaceutical and=0D
Agricultural Chemical Products, Report of the Appellate=0D
Body, WTO Doc. WT/DS50/AB/R dated 19th December 1997, para=0D
56. The Appellate Body confirmed the Panel=E2=80=99s observation=0D
that, =E2=80=9C=E2=80=A6in order to prevent the loss of novelty of an=0D
invention=E2=80=A6filing and priority dates need to have a sound=0D
legal basis if the provisions of Article 70.8 are to fulfill=0D
their purpose.=E2=80=9D This =E2=80=98Sound Legal Basis=E2=80=99 was not re=
quired by=0D
the WTO Panel having Prof. Weiler as one of the panelists in=0D
WTO 1999: United States - Sections 301-310 of the Trade Act=0D
of 1974, WT/DS152 R dated 22 December 1999 where after=0D
determining that, the statutory language of Section 304=0D
constitute a prima facie violation of article 23.2(a) of the=0D
Dispute Settlement Understandings (para. 7.97), the WTO=0D
Panel observed that =E2=80=9Cthis threat had been removed by the=0D
aggregate effect of the SAA (Statement of Administrative=0D
Action) and the US statements before this Panel in a way=0D
that also removes the prima facie inconsistency  and fulfils=0D
the guarantees incumbent on the US under Article 23.=E2=80=9D=0D
However, coming to Article 70(8) and the Exclusive Marketing=0D
Rights given to Novartis for Gleevec, the important fact is=0D
that the patent was given to Gleevec in 1993. In 1997,=0D
apparently a fresh patent was again obtained by Novartis on=0D
the same medicines on the basis that the product was an=0D
improved version of its previous medicines. This type of=0D
scandal has been made acceptable in the USA through the=0D
formation of the Court of Appeals for Federal Circuit in=0D
1982 and in other Western Countries through such as the EC=0D
through the Patent Guidelines but the criteria of=0D
patentability in the TRIPS Agreement is entirely different=0D
from the criteria of patentability prevalent in the USA and=0D
the EC. The US Supreme Court=E2=80=99s decision regarding=0D
patentability criteria (something extra than ordinary=0D
improvement) in Cuno Engineering v. Automatic Devises Corp.=0D
314 U.S. 84 (1941) is regarded as a joke. By regarding the=0D
decision of the highest court as a joke, you essentially=0D
regard the whole institution as a joke. In the pronouncement=0D
(calling these decisions as judicial is difficult to digest)=0D
in 1998 in State Street (State Street Bank & Trust Co. v.=0D
Signature Financial Group, Inc. 149 F. 3d 13681998 U.S. App.=0D
LEXIS 16869, pp. 21-22) the US Court of Appeals dealing with=0D
patents even observed that since its inception,=0D
the =E2=80=9Cbusiness method=E2=80=9D exception has merely represented the=
=0D
application of some general but no longer applicable legal=0D
principle, perhaps arising out of the =E2=80=9Crequirement for=0D
invention=E2=80=9D- which was eliminated by Section 103. Since the=0D
1952 Patent Act, business methods have been, and should have=0D
been, subject to the same legal requirements for=0D
patentability as applied to any other process or methods=E2=80=9D=0D
i.e. there is no requirement for invention for something to=0D
become patentable. The TRIPS Agreement dos not permit a non-=0D
invention to be patentable. The US patent Act is in=0D
violation of the TRIPS Agreement as non-obviousness has been=0D
treated as equivalent to only inventiveness.=0D
The exclusive marketing rights given to Novartis for Gleevec=0D
is in violation of the patentability criteria as mentioned=0D
in the TRIPS Agreement as the 1997 patent appears to be=0D
nothing but a very insignificant improvement in the old=0D
chemical and does not qualify for fresh patenting in any=0D
country forget India.=0D
I think Hee Seob Nam should be in a position to explain=0D
these differences.=0D
Sometime back I had discussed, collateral damages of the=0D
monopoly and one of the main collateral damage I had=0D
mentioned was corruption apart from the capture of the=0D
regulatory agencies by the monopolists. In this case,=0D
allowing Exclusive Marketing Rights to Novartis appears to=0D
be a direct result of such action. Somebody senior either a=0D
bureaucrat or politician must have be involved. I shudder to=0D
think of extent of corruption with the increase in=0D
monopolist=E2=80=99s power in developing countries.=0D
Daya Shanker=0D
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