the glivec precedent

7/24/2019 The Glivec Precedent

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Special Issue on The GlivecPrecedent, Economic and

Political Weekly, Vol.

XLVIII No.32, pages 4157.


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THE GLIVEC PRECEDENT

Economic & PoliticalWeekly EPW august 10, 2013 vol xlviii no 32 41

Who Invented Glivec?Does It Matter Anyway?

Graham Dutfield

This article looks at Glivecs

journey from its invention to

its patenting and sale while

questioning the concept of credit

for inventions in science and

technology.

In 2003, the then Novartis Chief

Executive Officer Daniel Vasella pub-

lished a book (Vasella and Slater

2003) in praise of Glivec detailing his

firms major role in delivering this un-

commonly effective life-saving medi-

cine. But, who was really responsible? In

the original USpatent,1one single per-

son is named as the inventor: Jrg Zim-

mermann of Ciba Geigy (later Novartis).

In the later USpatent on the beta crystal-

line form, held in India to be unpatentable,

Zimmermann is joined by two Novartis

colleagues.2However, contrary to what

this might suggest, chronic myeloid

leukaemia (CML) patients would never

have received a product called Glivec if

they had had to rely solely on Novartis.

Credit in science and technology is a

devilishly tricky matter to be objective

about. Effort, dedication, inspiration, vision,

ambition, intuition, counter-intuition, ad-

vanced technical knowledge in one or moredisciplines, skill, serendipity, networking

abilities, and sheer bloody-mindedness,

all help make a creative achievement

possible. But, assessing what contributions

and which people are not just important,

but indispensable, can be a tough task.

The various Glivec stories bring to-

gether a whole cast of actors and locations

over broad geographical and chronologi-

cal distances (Brody 2007: 13-18; Keating

and Cambrosio 2012; Mukherjee 2010:

430-43; Nathan 2007: 180-85). Medicines

have histories and Glivec is no exception,

being the final destination of a long and

winding historical learning trail; one

that begins in 1960 with a foundational

discovery by two US-based scientists of a

chromosomal defect, which they suggested

had a causal relationship with chronic

granulocytic leukemia (Nowell and

Hungerford 1960: 1497).

Glivec: To Whose Credit?

Which stories are most complete and

accurate depends largely on what Glivec

is. Glivec, the synthetic small molecule,

a pyrimidine derivative generically known

as imatinib, is one thing. If Zimmermann

was the first and only person to make

this molecule, he is rightly the inventor of

it as long as we are unconcerned about

scientific credit and merely need to

identify one or a few individuals closelyassociated with its first manufacture.

But, Glivec is much more than this or

that pyrimidine derivative in this or that

structural form. It is a pharmaceutical

product of a type known as a tyrosine

kinase inhibitor; one that is extraordi-

narily effective in the treatment of CML,

and that was made to a specification

well worked out by others. Potentially,

an almost infinite variety of different

molecules can be made in the laboratory.

But, to identify a class of chemicals to be

made for a specific purpose, make them,

analyse them, select a few for testing, test

them in various ways, select the best one,

optimise it, and finally get it approved for

sale, requires the contribution of many

more people than a synthetic chemist

working in a lab, however talented.

One way to look fairly at credit is to

ask which people were the sine qua non,

those without whom there would have

been no Glivec. The importance of theindividual coming up with the actual

chemical cannot be underestimated, but

the inventor named on the patent can

also be seen in such cases as the one who

added the finishing touches, inching the

idea forward over the novelty, inventive

step and industrial applicability thresh-

olds. Legally, it is immaterial whether

this persons effort or intellectual input

was proportionately significant compared

to anybody elses, and this may not

necessarily be seen as unfair.

None of the numerous scientists who

contributed has publicly challenged

Zimmermanns sole inventorship. Zimmer-

mann did spend more than two years in

developing the right molecule and then

preparing it in a form that could be taken

orally. Designing the last piece of the

jigsaw was no quick and easy task (Buch-

dunger and Zimmermann ND).

Competing claims could be made for

Nicholas Lydon or Alex Matter of CibaGeigys programme on kinase inhibitors.

But, if one really can single out the

Graham Dutfield ([email protected])

teaches International Governance at the

School of Law, University of Leeds, UK.


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august 10, 2013 vol xlv ii i no 32 EPW Economic & PoliticalWeekly42

irreplaceable person without whom

there would have been neither an inven-

tion nor a pharmaceutical product called

Glivec, then it would probably be Brian

Druker, initially of the Dana-Farber Can-

cer Institute, and thereafter at the Ore-

gon Health Sciences University.

From Brian Druker to Novartis

Druker was not just lead author of the

article that announced Glivec to the

world under the name of CPG57148

(Druker et al 1996). He was relentless in

his determination to find a treatment

for CML and to make it available to as

many patients as possible. This com-

mitment to do all that was necessary to

cure leukaemia patients led him to

collaborate with Lydon and Ciba Geigy

to harness the companys biochemical

capacity in kinase inhibition to his

search for a molecule that was able

specifically to block the action of a sin-

gle aberrant enzyme common to the

cells of CMLsufferers. His role did not

end when the molecule was discovered

and, largely under his direction, shown

to work.

In an interview with author-medical

scientist Siddhartha Mukherjee (2010:

436), Druker described his incrediblypersistent efforts to talk a reluctant

Novartis, concerned about the small

number of patients and, therefore, the

lack of a market for the drug, into

producing enough for clinical trials.

Ironically, the specificity of Glivec that

made it such an outstanding drug did

not favour it as a commercial product

from Novartiss perspective: it kept the

patient base small.

In the event, Novartis went ahead

with Glivec, which turned out to be to

its considerable advantage. In May 2001,

in unusually quick time, the USFood and

Drug Administration approved Glivec.

Novartis subsequently set a global

patient-per-month price of $2,400. Even

with patient assistance for poorer peo-

ple, which enabled some to get it for

free, the drug proved to be highly profit-

able. Besides, such programmes, bene-

ficial as they obviously are to some

patients, are an excellent way to dis-courage generic market entry where

there are no patents. By 2003, annual

sales had reached $1 billion, and reve-

nues have risen considerably since then.

True to his convictions, Druker was

one of over 100 physicians who recently

publicly criticised the high prices of

drugs for CML(Experts in Chronic Mye-

loid Leukemia 2013). Such an article

could have been published several yearsago: this is hardly a new problem. But,

one hopes at this late stage that while

the key patents are still in force in sev-

eral countries, and the original USpat-

ent having been extended from its expi-

ry date of 28 May 2013 for 586 addition-

al days, it might make a difference. It is

also worth noting that Druker report-

edly welcomed the Indian Supreme

Court decision.

Brian Drukers name may not be on

any of the patents. But, it would be

hard to name any other individual to

whom leukaemia patients should be

more grateful.

Notes

1 US Patent no 5521184, Pyrimidine Derivativesand Processes for the Preparation Thereof,28 May 1996.

2 US States Patent no 6894051, Crystal Modi-fication of a N-phenyl-2-Pyrimidineamine

Derivative, Processes for Its Manufacture andIts Use, 17 May 2005.

References

Brody, H (2007):Hooked: Ethics, the Medical Profes-sion and the Pharmaceutical Industr y (Lanham:Rowman & Littlefield).

Buchdunger, E and J Zimmermann (nd): The

Story of Gleevec, viewed on 2 June 2013,http://www.innovation.org/index.cfm/StoriesofInnovation/InnovatorStories/The_Story_of_Gleevec

Druker, B, S Tamura, E Buchdunger, S Ohno,G M Segal, S Fanning, J Zimmermann andN B Lydon (1996): Effects of a Selective Inhibitorof the Abl Tyrosine Kinase on the Growth ofBcr-Abl Positive Cells, Nature Medicine , 2(5):561-66.

Experts in Chronic Myeloid Leukemia (2013): ThePrice of Drugs for Chronic Myeloid Leukemia(CML) is a Reflection of the UnsustainablePrices of Cancer Drugs: From the Perspective ofa Large Group of CML Experts,Blood, 121(22):4439-42.

Keating, P and A Cambrosio (2012):Cancer on Trial:Oncology as a New Style of Practice

(Chicago:University of Chicago Press).

Mukherjee, S (2010): The Emperor of All Maladies:A Biography of Cancer (New York: Scribner).

Nathan, D G (2007): The Cancer Treatment Revolu-tion: How Smart Drugs and Other NewTherapies Are Renewing Our Hope and Chang-ing the Face of Medicine (Hoboken: John Wiley& Sons).

Nowell, P C and D A Hungerford (1960): A MinuteChromosome in Human Chronic GranulocyticLeukemia, Science, 132(3438): 1497.

Vasella, D and R Slater (2003):Magic Cancer Bullet:How a Tiny Orange Pill Is Rewrit ing MedicalHistory (New York: HarperBusiness).

REVIEW OF WOMENS STUDIES

May 4, 2013

Intersections of Gender and Caste Sharmila Rege, J Devika, Kalpana Kannabiran,

Mary E John, Padmini Swaminathan, Samita Sen

Revitalising Dalit Feminism: Towards

Reflexive, Anti-Caste Agency of Mang

and Mahar Women in Maharashtra Smita M Patil

Caste and Gender in a Mumbai Resettlement Site Varsha AyyarDalit Women as Political Agents: A Kerala Experience Rekha Raj

The Mathammas: Gender, Caste and the Politics

of Intersectionality in Rural Tamil Nadu Anandhi S

The Concept of Honour: Caste Ideology

and Patriarchy in Rural Maharashtra Manisha Gupte

Cultural Gandhism: Casting Out the Dalit Woman Swathy Margaret

Ruptures and Reproduction in Caste/Gender/Labour Meena Gopal

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Two Decades of Struggle

Amit Sengupta

The Supreme Court judgment in

the Novartis case is important as

it vindicates the entire process

leading to health safeguards

being incorporated in the Indian

Patents Act. The article discusses

this process, from the General

Agreement on Tariffs and Trade

and popular mobilisation in

India to the enactment of and

amendments to the Act, in thebackdrop of the judgment.

The judgment by the Supreme Court

of India, denying the claim of apatent on the anti-leukaemia drug

Glivec (imatinib) by the Swiss multi-

national Novartis, is important at many

levels. In this article we discuss, in the

backdrop of the judgment, the long and

protracted course leading to the enact-

ment of the Indian Patents Act of 2005.

The Uruguay Round

In 1986, a new round of negotiations was

initiated under the General Agreement

on Tariffs and Trade (GATT), otherwise

known as the Uruguay Round of negoti-

ations. In the Uruguay Round, developed

countries introduced a number of issues

on the agenda which were hitherto

not considered trade issues related to

intellectual property (IP) rights, invest-

ment and services.

Initially, developing countries led by

India and Brazil were able to stall the

introduction of these new issues (Shukla

2000: 14-15), while the UScontinued topress for their inclusion. The latters

position was dictated by the state of the US

economy. Having lost its competitive edge

in the manufacturing sector and with its

own agricultural exports threatened by

state-subsidised agricultural exports from

Europe, the USwas keen to open up the

services sector especially for financial

services. At the same time, the UShad an

interest in protecting its IP-dependent

industries where it still had an advantage,

specifically in pharmaceuticals, software

and audiovisual media (ibid: 20-21).

India had a clear interest in not

agreeing to these new demands. Indias

pharmaceutical sector had flourished in

the wake of its 1970 Patents Act, which did

not allow product patents on medicines

and agro-chemicals. India only allowed

process patents on pharmaceuticals, and

had leveraged on this to develop capacity

in process technologies.

By the beginning of 1989, the resistanceby developing countries was broken down.

Enormous pressure exerted by the US

resulted in the two main hold-outs

changing their position. India went to

the extent of replacing Indias chief

negotiator at GATT, S P Shukla, because

of his strong opposition to the inclusion

of IP issues in the negotiating agenda

(Marcellin 2010: 87).

The significance of the negotiations wasnot clear to most popular movements and

civil society groups in different parts of

the world. A key to the development of

the resistance in India was the formation

of the National Working Group on Patent

Laws (NWGPL). In spite of its relatively

small numbers, the NWGPLwas hugely

influential in shaping opposition to the

Trade-Related Aspects of Intellectual

Property Rights (TRIPS) Agreement, right

from the late 1980s. It was composed of

a group of former civil servants, lawyers,

scientists, representatives of the domestic

pharmaceutical industry and represent-

atives of trade unions in the pharma-

ceutical industry.1

The NWGPL, itself not a mass movement,

became a catalyst for advocacy and

mobilisation. It was the principal source of

evidence-based arguments against the

proposed regime on IP. Strong support

from the domestic industry found reso-

nance among a wide range of politicalactors. Over the next decade, the NWGPL

organised the Forum of Parliamentarians,

which had representation from virtually the

entire political spectrum. Several political

and social movements, non-governmental

organisations and mass organisations in

India formed alliances against the GATT

negotiations. Many subsequent develop-

ments had their roots in the popular mo-

bilisations between 1990 and 2005.

Tortuous Path

The path towards the final formulation

of Indias Patents Act was also increas-

ingly informed by, from 1991, the formal

introduction of neo-liberal reforms. From

an earlier position that India was forced

to concede to in the GATTnegotiations,

there was now an attempt to argue that

strong IP protection would promote

domestic interests. However, popular

sentiment continued to be hostile.

The TRIPSAgreement provided a three-stage time framework for developing

countries: introduction of a mailbox

Amit Sengupta ([email protected])

is co-convenor of Jan Swasthya Abhiyan

(Peoples Health Movement, India) and is alsoassociated with the All India Peoples Science

Network.


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facility and Exclusive Marketing Rights

(EMRs) from 1995; provisions on rights

related to term of patent protection,

compulsory licensing, reversal of burden

of proof, etc, by 2000; and introduction

of product patent protection in all fields

from 1 January 2005.

The political instability in India, post-1996, meant that further discussions on

amendments to Indias 1970 Act resumed

only in 1998 after the installation of the

Bharatiya Janata Party (BJP)-led National

Democratic Alliance (NDA) government.

Indian Parliament enacted two legislations

through the Patents (Amendment) Act of

1999 and 2002, which addressed the first

two requirements of the TRIPSAgreement.

After assuming office, the NDAgovern-

ment was clearly subsumed by the neo-

liberal logic while engaging with public

policy on a range of issues.2 The NDA

government then circulated the draft

Third Patents (Amendment) Bill in 2003,

but it could not be discussed because of

the change of government in 2004.

In 2004, there was a clear consensus

between the two principal parties in India

the Congress and the BJP and the

United Progressive Alliance (UPA) govern-

ment circulated an almost unchanged

version of the NDAs Third Patents

(Amendment) Bill draft. In the then

political spectrum only the left parties

(along with some regional parties) stood

firmly against the draft Bill. But towards

the end of 2004, the BJPstarted voicing

opposition to the draft Bill. While this is in

the realm of speculation, BJPs volte-face

had little to do with any opposition to thesubstance of the Bill (given that this was

identical to the Bill they had circulated)

and more to do with an intent to embarrass

the UPA government. With support for

the bill now unsure, the UPAgovernment

decided to beat the 31 December 2004

deadline by promulgating an ordinance

on 26 December 2004 (The Patents

(Amendment) Ordinance 2004).

Patents Ordinance of 2004

The Ordinance, if ratified by Parliament,

would have made it impossible for Indian

companies to continue producing cheaper

versions of new drugs. In early 2005, with

the BJPengaged in a bitter tussle with the

Congress in Bihar and Jharkhand over

formation of ministries, it became clear

that the Ordinance would be defeated in

Parliament and the Congress was now

forced to seek the lefts support.

In the consequent negotiations between

the left and the government, the left

largely depended on advice provided by

people associated with the NWGPL. These

negotiations also allowed other interest-

ed parties to suggest new language. At

the end, several important amendments

were made to the 2004 Ordinance

(ICTSD2005), including the insertion of

Section 3(d), which has been the subjectof much discussion after its use by the

Supreme Court to strike down the

appeal by Novartis.

The negotiations were held in the back-

drop of protests across the country, as

well as in different parts of the world

all demanding that the pharmacy of the

South should not be jeopardised. By 2005,

the global Access to Medicines campaign

was a powerful force and organisations

such as Mdecins Sans Frontires (MSF)

and others were able to organise support

across the globe. Protest letters were

sent to the prime minister, including one

where the co-signatories included Jim

Yong Kim, the present World Bank chief

(then director, Department of HIV/AIDS,

World Health Organization) (Khor 2013).

Important Amendments

While there has been considerable

focus on Section 3(d) of the amended

Act, many important amendments

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to the 2004 Ordinance were adopted,

including:

(1) Restrictions on Patentability: The

amendments clarified that an inventive

step means a feature of an invention that

involves technical advances as compared

to the existing knowledge or having eco-nomic significance or both. It incorpo-

rated a new definition for new invention:

any invention or technology which has not been

anticipated by publication in any document

or used in the country or elsewhere in the world

before the date of filing of patent application

with complete specification, i e, the subject

matter has not fallen in public domain or that

it does not form part of the state of the art.

It also provided a definition forpharma-

ceutical substanceas beinga new entity

involving one or more inventive steps.

(2) Restoration of Pre-grant Opposition

to Patents: The amendments restored

all the original grounds in the previous

Act for opposing grant of a patent and

also provided that: the Controller shall,

if requested by such person for being

heard, hear him. The time for filing

such opposition was extended from

three to six months.

(3) Export to Countries Without Manu-facturing Ability: The amendments

clarified that a country could import

from India if it by notification or other-

wise allowed importation of the patent-

ed pharmaceutical product from India.

(4) Continued Manufacture of Drugs

with Applications in Mailbox: The

amendments clarified that Indian com-

panies that were already producing drugs

that were the subjects of mailbox applica-

tions could continue to produce them

after payment of a royalty, even if the

drug was subsequently granted a patent.

(5) Time Period for Considering Com-

pulsory Licence Application: Concerns

that the process of granting compulsory

licences could take too long were ad-

dressed by specifying that the reasonable

time period before the Patents Controller

considers issuance of a compulsory licence

when such a licence is denied by thepatent holder shall not ordinarily exceed

six months.

(6) Export by Indian Companies of

Patented Drugs: The amendments pro-

vided that when patented drugs are

produced under compulsory licence in

India the licensee may also export the

patented product.

Several of the amendments are being

used today by different groups to try tosafeguard access. In particular, the pre-

grant opposition provisions have been

used extensively by domestic companies

and civil society groups, and combined

with restrictions on patentability, the

provisions have allowed many important

drugs to be kept off patents. Further,

a number of drugs introduced in the

transition phase (1995-2005) were not

patented as the amended Act allowed

generic companies to manufacture and

sell drugs introduced in this period.

The language for Section 3(d) was

provided by the Indian Drug Manufac-

turers Association (IDMA). The left parties

had asked for a more stringent definition

of patentability by limiting grant of patents

for pharmaceutical substances to new

chemical entities or to new medical

entities involving one or more inventive

steps. Section 3(d) was a compromise

and the government had agreed to refer

the matter to an expert panel.Subsequently, the government consti-

tuted a Technical Expert Group under

the chairmanship of R A Mashelkar,

former director general, Council of

Scientific and Industrial Research. The

Group, in its report in 2007, opined that

restriction of patents to new chemical

entities would be incompatible with the

TRIPSAgreement. Evidence surfaced that

parts of the report had been plagiarised

from a study by the UK-based Intellectual

Property Institute, funded by Interpat,

an association of 29 drug companies

including Novartis (Padma 2007: 392).

The report was withdrawn and press

reports indicated that Mashelkar had

resigned from the committee (ibid). Yet,

the same committee resubmitted a new

version with the same conclusions in

2009. These recommendations were ex-

peditiously accepted by the government.

Vindication of Struggle

The Supreme Court judgment in the

Novartis case, thus, needs to be read not

just as an instance of the application of

one section (Section 3(d)) of the Indian

Patents Act. The judgment is important

as it vindicates the entire process that

led to health safeguards being incorpo-

rated in the Indian Act.

The judgment, in fact, refers clearly to

this process by noting (in para 26):3

to understand the import of the

amend-

ments in clauses (j) and (ja) of section 2(1)

and the amendments in section 3 it is

neces-

sary to find out the concerns of Parliament,

based on the history of the patent law in

the

country, when it made such basic changes in

the Patents Act. What were the issues the

legislature was trying to address? What was

the mischief Parliament wanted to check

and

what were the objects it intended to

achieve through these amendments?

The judgment is a vindication not

just of a legislative process, but of popu-

lar resistance and mobilisation in

India and across the world that chal-

lenged corporate power. Small victories

such as this become inspirations for

larger battles.

Notes

1 For more informat ion about the formation ofthe NWGPL, see Sen Gupta (2010).

2 See, for example, Arulanantham (2004).

3 Text of final judgment is available at: http://ju-

dis.nic.in/supremecourt/imgs1.aspx? filename=40212 (viewed on 20 June 2013).

References

Arulanantham, David P (2004): The Paradox ofthe BJPs Stance Towards External EconomicLiberalisation: Why a Hindu Nationalist PartyFurthered Globalisation in India, Asia Pro-gramme Working Paper, December, RoyalInstitute of International Affairs, ChathamHouse, London.

ICTSD (2005): Indian Parliament Approves Con-troversial Patent Bill, Bridges Weekly Trade

News Digest, 9(10), International Centre forTrade and Sustainable Development, viewedon 20 June 2013, http://ictsd.org/i/news/

bridges weekly/7294/Khor, Martin (2013): A Victory for Patients Access

to Medicines, Global Trends Series, ThirdWorld Network, 8 April, viewed on 20 June2013, http://www.twnside.org.sg/title2/gtrends/2013/gtrends426.htm

Marcel lin, Sherr y S (2010):The Political Economy ofPharmaceutical Patents: US Sectional Interestsand the African Group at the WTO(Farnham,England: Ashgate Publishing).

Padma, T V (2007): Plagiarised Report on PatentLaws Shames Indian Scientists,Nature Medicine,13(4): 392.

Sen Gupta, Amit (2010): B K Keayla: A PersonalReminiscence, Economic & Political Weekly,45(51): 25-26.

Shukla, S P (2000): From GATT to WTO and Be-yond, Working Papers No 195, United NationsUniversity/World Institute for DevelopmentEconomics Research, Helsinki, Finland.


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Chennai Patent Controller, and was kept

in the mailbox.

Hit by Section 3(d)

After 1 January 2005, the mailbox facility

was opened. Five pre-grant oppositions

were filed, one by the Cancer Patients Aid

Association (CPAA), and four by Indiangeneric companies.9Novartis contended

that the claimed invention was novel,

inventive and industrially applicable. The

oppositionists contended otherwise. They

also argued that the claimed invention

was hit by Section 3(d) of the Patents Act.

In this respect, Novartis had filed ad-

ditional affidavits ostensibly to show

that on account of the alleged increased

bioavailability (30%) of the crystalline

form imatinib mesylate, there was a sig-

nificant increase in the efficacy in the

claimed invention.10While there was no

dispute as to the claimed inventions

industrial applicability, the Patent Con-

troller concluded that the claimed in-

vention was neither novel nor inventive

and was also hit by Section 3(d), thus,

rejecting the application.

Against this order, Novartis filed ap-

peals before the Madras High Court.

These were later transferred to the Intel-

lectual Property Appellate Board (IPAB).Both, NovartisAGand Novartis India also

challenged the validity of Section 3(d) on

the grounds that it did not comply with

the TRIPSAgreement and the term effi-

cacy was vague and, therefore, in viola-

tion of Article 14 of the Constitution. The

Madras High Court dismissed both the

Writ Petitions on both the grounds. It also

held that Section 3(d) had been enacted,

amongst others reasons, to protect public

health, observing,

We have borne in mind the object which the

amending Act wanted to achieve namely, to

prevent evergreening; to provide easy access

to the citizens of the country to life saving

drugs and to discharge their constitutional

obligation of providing good health care to

its citizens.11

Importantly, Novartis did not challenge

the order of the Madras High Court.

In the appeals, the IPABreversed the

Patent Controller order on two grounds,

and held that the claimed invention was

novel and inventive. However, it agreedwith the Patent Controller that it was hit

by Section 3(d) and rejected the patent

application. It was against this order

that Novartis filed the Special Leave

Petition in the Supreme Court.

In the Supreme Court, the maintain-

ability of Novartiss appeal was dropped

and it was heard on merits.

On MeritsNovartis had patented imatinib, which

was exemplified in Example 21 of the

Zimmerman patent. Novartis argued

that the claimed invention involved a

twofold step over Zimmerman, firstly

from imatinib to imatinib mesylate, the

salt form, and secondly to the crystal-

line form of imatinib mesylate.

On the interpretation of Section 2(1)(j)

and (ja) and Section 3, the Court, speak-

ing through Justice Aftab Alam, held that

if they are read together, even though a

product or a process may satisfy the test

of invention under 2(1)(j) and (ja), it

may still be held not patentable under

Section 3 of the Act.

On Novelty

The Court noted that the salt form was

actually claimed in the Zimmerman ap-

plication itself. Moreover, the acid addi-

tion salt forms could be made in a cus-

tomary manner or in the manner knownper se. That apart, Novartis itself had

made a Patent Term Extension Application

in the US in the Zimmerman patent, in

respect of the mesylate form. This was

granted for a period of 586 days on the

basis that the Zimmerman patent covered

the mesylate form. Also, Novartis had

sought an injunction against Natco in

the UKfrom marketing the mesylate form.

Therefore, the Court observed, that

there was no room for doubt that imat-

inib mesylate, marketed as Glivec, was

submitted for drug approval and was

covered by the Zimmerman patent.

The Court also observed that the

properties of imatinib, namely the in-

hibition of tyrosine kinase activity, were

also found in the pharmaceutically

acceptable salt forms, particularly not-

ing that the authors of Cancer Research

had concluded that in respect of proper-

ties no significant difference in results

could be seen between the two forms ofCGP 57148.12 Similar findings were

recorded in an article in the journal,

Nature. The Court, therefore, concluded

that it was unable to see how Imatinib

Mesylate can be said to be a new product,

and was in fact covered by the

Zimmerman patent.

In order to get over this hurdle,

Novartis admitted that though imatinib

mesylate may have been claimed andtherefore covered under the Zimmerman

patent, it was not disclosed, as there was

no enabling disclosure in the Zimmerman

patent. Novartis relied on the decision of

the US court of Customs and Patent

Appeals inHogan.13The Court found that

Hogan was rendered in very specific

circumstances and later decisions of the

US courts had narrowed that down to

Hogans impact. Additionally, on the basis

that the artificial distinction between

coverage and disclosure negated the fun-

damental rule underlying patents, the

argument was rejected.

The Crystalline Form:

Interpreting 3(d)

For the purposes of argument the Court

accepted that the crystalline form im-

atinib mesylate was new and not obvi-

ous.14Of course, the crucial question be-

fore the Court was, whether in view of

Section 3(d) as amended, Novartis couldbe granted a patent on the claimed in-

vention of the crystalline form of imat-

inib mesylate.

The Court observed that in order to

correctly understand the present law it

would be necessary to briefly delve into the

legislative history of the law of patents in

the country. It noted the parliamentary

debate during the final amendments to

the Patents Act in 2005, with concerns

about evergreening in pharmaceutical

patents. It recalled that Section 3(d) is

directed at these practices.

In interpreting the new provisions,

the Court held that the Act provided for

the duality of the concepts of invention

and patentability. Not all inventions

under the Act were patentable, as is

illustrated by Sections 3 and 4. The Court

rejected the submission by Novartis that

Section 3(d) was trifling change. It held

that different standards are set by the

Act for medicines and other chemicalsubstances and that Section 3(d) had

been enacted to prevent evergreening.


9/20



The Court found that as the crystal-

line form imatinib mesylate was a new

form of imatinib mesylate, Section 3(d)

would apply.

However, Novartis argued that neither

imatinib nor imatinib mesylate had

known efficacy. Therefore, no compari-

son could be made of the crystallineform of imatinib mesylate with a known

substance with known efficacy as

required under Section 3(d). This was re-

jected by the Court on the grounds that it

is well established by the Supreme Court

itself, as interpreted in Monsanto,15 that

the expression publicly known was

held not to mean that it was widely used

to the knowledge of the consumer pub-

lic, but that it is sufficient if it is known

to the persons who are engaged in the

pursuit of knowledge of the patented

product or process either as men of sci-

ence or men of commerce or consumers.

In examining the efficacy of the dif-

ferent forms of imatinib, that is imatinib

free base, non-crystalline form of imat-

inib mesylate, and the crystalline form

of imatinib mesylate, the Court noted that

it was Novartiss own case that all the

properties possessed by the imatinib free

base were possessed by the crystalline

form of imatinib mesylate. In the circum-stances the Court queried how there

could be any enhanced efficacy in the

crystalline form of imatinib mesylate?

In this respect, Novartis filed two affi-

davits to satisfy the requirements of

Section 3(d) for consideration.

One of these affidavits stated that on

conducting experiments it was found

that there was a 30% increase in bio-

availability in the crystalline form of

imatinib mesylate as compared to the

imatinib free base. The Court noted that it

was Novartiss own case that the product

immediately preceding the crystalline

form imatinib mesylate is the non-

crystalline form of imatinib mesylate.

The non-crystalline form of imatinib

mesylate was thus known. The Court

found that the comparison with imatinib

free base was inappropriate.

The Court therefore held that Novartis

was bound to show enhanced efficacy

of crystalline imatinib mesylate overnon-crystalline imatinib mesylate, which

Novartis had failed to do. Moreover, the

Court opined that the bioavailability

of the crystalline imatinib mesylate

would be on account of the salt form,

that is the non-crystalline form of

imatinib mesylate.

Efficacy Is Therapeutic Efficacy

The Court held that the term efficacy in3(d) has to be understood as the ability

to produce the desired or intended

effect. This would differ in the context

of the product, its function, utility or the

purpose under consideration. In the con-

text of medicines that claim to cure a

disease, it has to be therapeutic efficacy.

Considering the context of 3(d), the

Court held that, with respect to medi-

cines, it had to be construed strictly and

narrowly in line with language used in

the Explanation to 3(d), namely, differ

significantly in properties with regard to

efficacy, therefore, that not all advan-

tageous or beneficial properties are rele-

vant, but only such properties that di-

rectly relate to efficacy, which in case of

medicineis its therapeutic efficacy.

Thus, holding that the physico-

chemical properties of the crystalline

form of imatinib mesylate contended by

Novartis to be properties with regard

to efficacy, namely more beneficialflow properties, better thermodynamic

stability, and lower hygroscopicity, may

be otherwise beneficial but cannot be

taken into account for the purpose

of the test of Section 3(d) of the Act.

These properties have nothing to do

with therapeutic efficacy.

That left bioavailability and its role in

efficacy. There were two rival contentions

here. The CPAAargued that in the pharma-

ceutical field, drug action is explained

by pharmacokinetics (effect of the body

on the drug) and pharmacodynamics

(effect of the drug on the body). Efficacy

is the capacity of a drug to produce an

effect, an aspect of pharmacodynamics.

The generation of response from the

drug receptor complex is governed by a

property described as efficacy. Bioavail-

ability, on the other hand, is a pharma-

cokinetic property. It is the term used to

indicate the extent to which a dose of

drug reaches its site of action or a bio-logical fluid from which the drug has

access to its site of action.

Shamnad Basheer, intervenor-cum-

amicus, argued that safety or significantly

reduced toxicity should also be taken

into consideration to judge enhanced

therapeutic efficacy of a pharmaceutical

product in terms of Section 3(d).

While the Court left these submissions

untouched, it held that bioavailability byitself may or may not result in its efficacy

being affected. In terms of Section 3(d),

it must be claimed and established by re-

search data with in vivo animal models,

which Novartis had not done. Therefore,

the claimed invention,crystalline form

of imatinib mesylate, failed the test of

Section 3(d). Thus, Novartiss appeal

came to be dismissed, and the others by

the CPAAand Natco allowed.

The Novartis decision has enormous

significance. It clarifies the meaning of

efficacy in Section 3(d), stating that mere

advantages are insufficient. The applicant

has to show with in vivo animal models

how therapeutic efficacy is significantly

enhanced. Crucially, the relentless lobby-

ing by western pharma MNCsto whittle

down Section 3(d) has been repelled.

Notes

1 The unfinished agenda is now being pursuedthrough the free trade agreements.

2 These deliberations included the Tek Chandand Ayyangar Committees and various Parlia-mentary Committees.

3 Earl ier Parliament had refused to introducethis, as a result of which India was taken to theTRIPS Disputes Council where India lost. Indiathen appealed again. It lost again. Parliamenthad no choice but to introduce the interimregime of EMR to avoid trade sanctions.

4 In 1999 the Patent Act was amended to providepatent protection for foods and medicines. The2002 amendments were made to amend Sec-tion 2(1)(j) relating to invention, add 2(1)(ac)relating to industrial application and 2(1)(ja)relating to inventive step, as also Section 83relating to general principles. In 2005 apart

from amending Section 3(d), amendmentswere carried to Section 2(1)(ja) and the provisionof pre-grant opposition under Section 25(1). Asa result of all the amendments India has beenable to use TRIPS flexibilities to the maximum.This includes patentability criteria, pre-grant,post-opposition, revocation procedures, counterclaim in infringement suits to set aside the grantof the patent, provisions for compulsory licences,government use, etc.

5 The World Health Organization (WHO) andthe UNAIDS, amongst others, had appealed toIndian Parliamentarians to keep in mind thatIndia was the pharmacy of the poor in the de-

veloping world while making the final amend-ment (see Sengupta 2013).

6 The Doha Declaration of 11 December 2001

issued by the Inter Ministerial Conference ofthe WTO recognised the gravity of publichealth problems and that the TRIPS Agreementhas to be interpreted to protect public health.


10/20



7 Interestingly the letter from the WHO wassigned by the present president of the WorldBank Jim Young Kim.

8 Thus, in India the MNCs have, with the localindustry formed the US-India Business Coali-tion, which has issued documents aboutthe need to delete Section 3(d) from thePatents Act.

9 Under the Indian Patents Act any person can filea pre-grant opposition on the grounds indicated

in Section 25(1). Post-grant opposition can befiled only by a person interested.

10 The study was conducted on rats, but the com-parison was with the base form of imatinib and

not with the mesylate form of imatinib, whichwas also known at that time.

11 Madras High Court Writ Petition No 24759 and24760 of 2006, at para 19.

12 Referring to the imatinib base and the mesylatesalt form of imatinib.

13 Application of John Paul Hogan and Robert LBanks, 1977 (559 F.2d 595).

14 The Court did go into the issue of novelty ornon-obviousness of the crystalline form imat-

inib mesylate. It dealt with the issue of the ap-plicability of Section 3(d).

15 Monsanto Company vs Coramandal IndagProducts (P) Ltd, 1986 (1 SCC 642).

References

Correa, Carlos M (2013): Is Section 3(d) Consistentwith TRIPS?,Economic & Political Weekly, 48(32).

NIHCM (2002): Changing Patterns of Pharmaceuti-cal Innovation(Washington: National Institutefor Health Care Management).

Sengupta (2013): Two Decades of Struggle,Economic & Political Weekly, 48(32).

Waning, Brenda, Ellen Diedrichsen and Suerie Moon

(2010): A Lifeline to Treatment: The Role ofIndian Generic Manufacturers in Supplying Anti-retroviral Medicines to Developing Countries,

Journal of the International AIDS Society, 13: 35.


11/20



Is Section 3(d) Consistent

with TRIPS?

Carlos M Correa

This article looks at how

inventions are assessed by various

policy regimes in the world and

analyses the Indian regulations

in this light. A well-formulated

and scientific legislation to apply

the inventive step standard could

avoid most of the complications

caused by Section 3(d) of theIndian Patents Act, which is

compatible with the Trade-Related

Aspects of Intellectual Property

Rights Agreement, but about

which questions can still be raised.

Novartis challenged the consistency

of Section 3(d) with regard to

the Agreement on Trade-Related

Aspects of Intellectual Property Rights

(TRIPS) before the Madras High Court.

The high court refused to entertain this

argument. Interestingly, the Swiss gov-

ernment did not initiate a case in the

World Trade Organization (WTO) in sup-

port of Novartiss argument regarding

the alleged violation of TRIPS. However,the Supreme Court decision has not

foreclosed the possibility of such com-

plaints and an analysis of the subject is

still relevant.

On the one hand, the United States

Trade Representative (USTR) which

has regularly cited Section 3(d) as

one of the reasons to keep India on its

list of countries whose intellectual

property rights regimes are of concern

to the US (Sampat et al 2012: 414)1

stated (USTR2013: 38) that the Indian

Supreme Court decision

appears to confirm that Indias law creates a

special, additional criterion for select tech-

nologies, like pharmaceuticals, which could

preclude issuance of a patent even if the ap-

plicant demonstrates that the invention is

new, involves an inventive step, and is capa-

ble of industrial application.

This statement suggests the possible

incompatibility of Section 3(d) with two

aspects of Article 27.1 of the TRIPS

Agreement: (a) the non-discriminationclause,2and (b) the obligation to grant

a patent when the three patentability

criteria specified in that article (novelty,

inventive step/non-obviousness, industrial

applicability/utility) are met, without im-

posing additional substantive conditions.

On the other hand, other countries,

such as the Philippines, have adopted

measures similar to Section 3(d) or apply

policies that limit the patentability of

certain categories of pharmaceutical

products. For instance, in Argentina's 2013

Trade Policy Review a series of specific

questions were raised regarding recently

adopted guidelines on the patentability

of pharmaceutical products and proc-

esses3that suggested possible inconsist-

encies with Article 27.1 of the TRIPS

Agreement. Some of those questions

(posed by Japan, the European Union)

specifically addressed the patentabilityof crystalline forms, the subject matter

of Novartis s patent application in India.

Does It Discriminate?

The obligation not to discriminate con-

tained in Article 27.1 applies both to the

availability and enjoyment of patent

rights, meaning that neither the acquisi-

tion of patent rights nor the means

for enforcement can be subject to dis-

crimination. Although the provision is

broad in this respect, it is only applica-

ble when discrimination takes place on

the basis of one of the following grounds

(1) the place of invention, (2) the field

of technology, and (3) whether prod-

ucts are imported or locally produced

(Correa 2007).

Arguments about the possible incon-

sistency of Section 3(d) with the TRIPS

Agreement allude to the second ground

the field of technology.

A possible conflict with the non-discrimination clause was unsuccessfully

claimed by the European Commission (EC)

Carlos M Correa ([email protected]) teaches at

the University of Buenos Aires and is Advisoron Intellectual Property and Trade, South

Centre, Geneva.


12/20



in its complaint against Canada relating

to the Bolar exception (WTO2000).The

panel rightly made a distinction between

discrimination and differentiation.4

Section 3(d) is not discriminatory

under the terms of Article 27.1 of TRIPS.

First, it does not apply only to pharma-

ceutical products, but to any chemicalproduct. It may be applied, for instance, to

examine the patentability of an isomer of

an agrochemical product. Second, even if

(for the sake of argument) Section 3(d)

applied only to inventions in the pharma-

ceutical field, it would be justified by the

need to take the specific characteristics

of such products into account in the

examination process. Indeed, special

considerations regarding the type of

claims (compositions, salts, polymorphs,

etc) are unavoidable whether explicitly

contained or not in laws or other regula-

tions, to assess the patentability of any

claimed product in that field. The same

applies to other technological fields, such

as biotechnology and computer software.5

There are, in fact, many examples of

guidelines and legal provisions that

specifically address the case of pharma-

ceutical inventions in national laws and

policies, including in developed countries.

Thus, several patent offices have adoptedspecific criteria to examine chemical

and/or pharmaceutical patents, without

objection from any WTO member. For

example, the Japanese Examination

Guidelines for Patent and Utility Model

contains a specific chapter on Medicinal

Inventions (PartVII, Chapter 3).

Moreover, some national laws contain

provisions specifically related to phar-

maceuticals which have never been chal-

lenged under the WTO rules: the French

industrial property law provides for the

grant of compulsory licences on patents

relating to medicines (Article L613-16);

the Australian USFree Trade Agreement

Implementation Bill 20046 introduced

anAU$10 million penalty for drug patent

litigation in bad faith; under USlegislation

(35 USCSection 156) and in accordance

with the free trade agreements (FTAs)

signed by the USwith a number of coun-

tries,7 special provisions apply for the

extension of the term of pharmaceuticalpatents to compensate for delays in the

marketing approval of medicines.

Another potential objection to Sec-

tion 3(d) under Article 27.1 of the TRIPS

Agreement, as suggested in the USTR

2013 Report quoted above, is that it

imposes an additional standard to obtain

a pharmaceutical patent, not provided

for and in violation to the first sentence

of Article 27.1.There have been different interpreta-

tions in the context of the Novartis

case regarding what type of standard

Section 3(d) actually establishes.

The Intellectual Property Appellate

Board (IPAB) competent to hear appeals

from the decisions of the Indian patent

office characterised the efficacy test

imposed by that provision as an enhanced

inventive step requirement. While the

IPABconsidered that Novartiss crystalline

form met the ordinary inventive step

standard, it argued that it failed to meet

the stricter inventive step standard

demanded by Section 3(d).8

Invention and Patentability

In the view of the Indian Supreme Court

the crystalline form of imatinib me-

sylate fails in both the tests of invention

and patentability as provided under

clauses (j), (ja) of Section 2(1) and Sec-

tion 3(d) respectively (para 195).9It has also been suggested that

Section 3(d) relates to the utility require-

ment for patentability: the limited inte-

gration of efficacy considerations, more

traditionally seen in drug-marketing laws,

is a sound and long-overdue attempt to

rectify the low level of proof of real

util ity that mars patent regimes (Roderick

and Pollock 2012).

Whether Section 3(d) is part of the defi-

nition of invention (as explicitly stated by

the provision)10or a patentability require-

ment (inventive step and/or utility), is not

essential for an assertion of the provisions

compatibility with Article 27.1 of the

TRIPSAgreement. Such compatibility can

be sustained under both interpretations.

In effect, an important flexibility that

WTO members enjoy under the TRIPS

Agreement is to define what is to be con-

sidered an invention for the purposes

of patent law. Like most patent laws in

the world, the TRIPSAgreement does notdefine what an invention is. Hence, WTO

members can adopt different concepts,

in accordance with their legal traditions

and national policies, as long as this is

made in good faith and in accordance

with the interpretative criteria codified

by the Vienna Convention on the Law of

the Treaties (Articles 31 and 32).

As a result of the policy space left by

the TRIPSAgreement, national laws candistinguish between inventions that

are patentable and other matters that

are not, as many laws actually do.11

The TRIPSAgreement permits diverse

approaches regarding the interpretation

of the obligation to patent any inven-

tions. As noted in a World Intellectual

Property Organization (WIPO) study, [A]t

the national/regional level, the exclusions

from patentable subject matter provided

for in national/regional legislation vary

significantly (WIPOSecretariat 2009: 3).

One example is the different treatment

conferred under various national regimes

to substances found in nature such

as genes.12

If Section 3(d) were deemed to define

a patentability requirement (as held by

the IPAB) then similar considerations

would apply. While Article 27.1 obliges

WTOmembers to grant patents where the

specified standards are met, it does not

define them. This important flexibilityallowed, for instance, the USto maintain

until recently and defend the TRIPScom-

patibility of a novelty standard (35 USC

Section 102(a)) that combined local and

universal novelty depending on whether

the disclosure of the invention had taken

place within or outside the territory of

the US. The US held at the Council for

TRIPSthat in the TRIPSAgreement there

was no prescription as to how WTO

members define what inventions are to

be considered new within their domestic

systems and, hence, that its legislation

was perfectly consistent with the provi-

sions of the TRIPSAgreement.13

In particular, the TRIPS Agreement

does not define the standard of non-

obviousness or inventive step: it does

not limit the WTO members right to

choose whether to apply more or less

rigorous criteria to grant a patent. Al-

though under most patent laws those

concepts require an enquiry as t0 whetherthe claimed invention is evident or obvi-

ous to a person with skills in the relevant


13/20



technical field, there is in fact no uni-

formity in the way the standard is

defined and applied.

Given this important flexibility under

the TRIPSAgreement, WTOmembers can

adopt patentability criteria that avoid

the evergreening of pharmaceutical

patents, that is, the grant of patents onminor developments whose protection is

sought to delay or block generic com-

petition. Preventing evergreening was the

very purpose of Section 3(d) as extensively

elaborated on by the Indian Supreme

Court in the commented decision.14The

rejected Novartis patent application, as

noted, referred to a crystalline form or

polymorph of imatinib mesylate, not

to the drug itself (imatinib), or its

particular salt (mesylate).

Several polymorphs may exist for the

same chemical compound. A polymorph

is not actually invented; it is a property

inherent to such a compound which is

found in the process of crystallising a

given substance (depending on solvent,

heating, stirring, and other conditions)

or as the result of the transformation

(without human intervention) of the ar-

rangements of the molecules in thesolid-

state structure.15Hence, it may be argued

that a polymorph is not an invention, butrather the outcome of a discovery.

If, however, a polymorph would be

deemed an invention, it would not meet a

rigorous inventive step/non-obviousness

standard since, for a person working in

the pharmaceutical industry, the need

to try and obtain different polymorphs

and to choose the most suited for pro-

duction is obvious. For a person with

basic knowledge in organic chemistry, it

is well known, in effect, that one poly-

morph may be more stable and have

better properties than others for manu-

facturing a particular drug (Purohit and

Venugopalan 2009: 890-91).Hence, even

if a particular polymorph showed a

significant enhancement of the drugs

therapeutic effect, a patent office may

consider it as not patentable.

This suggests that the same decision

to reject a patent application regarding

a crystalline form may be reached

even in the absence of a provision likeSection 3(d). The guidelines for the

examination of pharmaceutical patents,

published by the International Centre

for Trade and Sustainable Development

(ICTSD), World Health Organization

(WHO), United Nations Conference on

Trade and Development (UNCTAD) and

United Nations Development Programme

(UNDP), for instance, recommended patent

offices to refuse patent applications onparticular polymorphs (Correa 2006: 11).

In line with this recommendation, but

with a more rigorous approach, the Joint

Resolution adopted by the Argentine

government in 2012 establishes that, as a

rule, a new crystalline form of a known

substance is not patentable.

This Joint Resolution illustrates that

an outcome similar to that emerging from

the Novartis decision can be obtained

through the application by patent offices,

in a rigorous manner, of the conventional

inventive step/non-obviousness require-

ment. In many instances, patents on

polymorphs have been held invalid or

not infringed; even in the US it has

become more difficult to get a patent

granted on a polymorph and to defend it

if challenged in courts (Vure 2011).

Conclusions

Section 3(d) is not discriminatory in

terms of Article 27.1 of the TRIPSAgree-ment. It does creates neither additional

nor different requirements of patentability

other than those specified in said article.

With the adoption of Section 3(d) India

has made use of the flexibility allowed to

WTOmembers to determine what is the

eligible subject matter for the purposes

of the national patent law. WTO mem-

bers also have policy space to define the

specific contours of the patentability

standards, as the TRIPSAgreement does

enumerate them, but does not provide

specific rules governing their definition

and application.

Section 3(d) is not only compatible

with the TRIPSAgreement. As interpreted

in the Novartis decision commented

above, it also enshrines the right policy

approach in dealing with pharmaceutical

patents: protection should be granted

when genuine inventions are claimed,

but rejected when patent applicants just

aim at creating barriers for generic com-petition through the patenting of a broad

range of minor, often trivial developments.

While some countries may be rightly

encouraged by the outcome of the Novartis

case to adopt a provision similar to

Section 3(d) through legislative reform,

regulations or patent offices guidelines,

it is worth noting that an equivalent result

may be obtained through a rigorous and

scientific application of the inventivestep standard.

Notes

1 On occasion of Indias Trade Policy Review(2011) at WTO, the US questioned whether theGovernment of India considered the require-ment under Section 3(d) to be in line withTRIPS Article 27(1). Indias reply indicated thatthe provisions of Section 3(d) of the Patents

Act, 1970 are fully compliant with Article 27(1)of the TRIPS Agreement read with Article 8 ofthe said Agreement.

2 Article 27.1: patents shall be available andpatent rights enjoyable without discrimination

as to the place of invention, the field of techno-logy and whether products are imported orlocally produced.

3 Joint Resolution of the Ministry of Industry(118/2012), Ministry of Health (546/2012) andInstituto Nacional de la Propiedad Industrial(107/2012).

4 See WTO (2000), para 92. It is worth notingthat the TRIPS Agreement does differentiatethe treatment given to semiconductor technol-ogies (Article 31(c)). There is also specifictreatment for the textile sector in the area ofindustrial designs (Article 25.2).

5 For instance, the US patent office and courts ap-ply differently the non-obviousness and disclo-sure standards to biotechnological and softwareinventions (Burk and Lemley 2003).

6 Amendment (2), The Senate, The Parliament ofthe Commonwealth of Australia (codified as newSection 26C of the Therapeutic Goods Act 1989).

7 See Singapore FTA, Article 16.8.4(a); Chile FTA,Article 17.10.2(a); Morocco FTA, Article 15.10.3;Bahrain FTA, Article 14.8.6(b)(i); CAFTA,

Article 15.9.6(b).

8 See the IPAB decision of 26 June 2009, p 189.

9 The Court, however, emphasised that in which-ever way Section 3(d) may be viewed, whetheras setting up the standards of patentability oras an extension of the definition of invention,it must be held that on the basis of the materialsbrought before this Court, the subject product,that is, the beta crystalline form of ImatinibMesylate, fails the test of Section 3(d), too, ofthe Act (para 190).

10 Section 3 (chapeau): What are not inventions.The following are not inventions within themeaning of this Act.

11 See, for instance, Article 52(2) of the EuropeanPatent Convention.

12 The controversy regarding the patentability ofhuman genes in the US is illustrative of the

various views on the matter found even at thenational level (USDJAMP et a l 2010).

13 See WTO document IP/Q3/USA/1, 1 May 1998.

14 See, e g, para 100-102.15 For instance, in the case of ritonavir (an anti-

retroviral), after 18 months of its launch itsmanufacturing company Abbott observed anunexpected occurrence. The final product did notshow dissolution and the drug was precipitating.

After considerable investigations it was revealedthat this was because of a new thermodynamicallymore stable and less soluble polymorph Form-II(Purohit and Venugopalan 2009: 890-91).


14/20



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Vure, P (2011): Polymorph Patents: How StrongThey Are Really?, International Journal of

Intellectual Property Management, 4(4): 297-306.

WIPO Secretariat (2009): Exclusions from PatentableSubject Matter and Exceptions and Limitations

to the Rights, SCP/13/3,F, viewed on 8 July 2013,http://www.wipo.int/edocs/mdocs/scp/en/scp_13/scp_13_3.pdf

WTO (2000): Canada Patent Protection for Phar-maceutical Products, Report of the WTO Panel,WT/DS114/R.


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Drop the CaseCampaigning against Novartis

Leena Menghaney

Evergreening and the issues this

practice of abusive patenting

raised were first highlighted

in the late 1990s with the HIV

epidemic, when medicines were

priced way out of reach. The

Supreme Courts rejection of

Novartiss patent has set in placean important safeguard to ensure

production of affordable generic

medicines from India.

That patents on medicines can

make the difference between life

and death for millions, first hit

home with the AIDS pandemic, when

medicines to treat HIVwere priced way

out of reach of patients and governments

in developing countries.1In 1999, in the

wake of Mdecins Sans Frontires (MSF)

being awarded the Nobel Peace Prize,

MSFlaunched the Access Campaign. At thetime patented HIV treatment cost more

than $10,000 per patient per year. One

of the first tasks of the Access Campaign

was to challenge the high costs of exist-

ing drugs such as those to treat HIV/

AIDS and working to bring prices down

for its medical projects in South Africa

and Thailand.

Evergreening and AIDS Treatment

Evergreening and the issues this practice

of abusive patenting raised were first

highlighted in the late 1990s, when the

HIVepidemic was devastating communi-

ties particularly those in Africa and

the barriers to providing treatment

seemed insurmountable.2

Zidovudine (AZT) (previously Azidothy-

midine), one of the first antiretrovirals

(ARVs) to treat HIV, was a known cancer

product,3but GlaxoSmithKline (GSK) was

granted a patent for its use to treat HIV,4

making it one of the first examples ofan evergreened drug used to treat HIV.

Similarly, GSK filed a secondary patent

in 1997 on a formulation containing

lamivudine andAZT, which was granted

in several countries, including South

Africa.5 Access to these ARVs then be-

came difficult and expensive because of

these patents.

The answer to a sustainable supply of

affordable HIVmedicines lay in India,

where policies that fostered production

of and access to affordable generics had

taken hold in the absence of product

patents (Sengupta 2013).6The countrys

generic producers took up the challenge

in 2001 to develop genericARVs, which

they sold for just $1 per day, a fraction of

the price that multinational pharma-

ceutical companies were then charging.

With Indian producers able to manu-facture and export fixed dose combina-

tions ofARVs, the World Health Organi-

zation (WHO) launched the Treat 3 Million

by 2005 initiative in 2003. The same year,

an HIVtreatment programme was set up

in South Africa the country with the

highest burden of HIV/AIDS7 through

the public health system, with India

following in 2004.

Indias Patents Act: What Future?

In 2005, as the deadline for India to fully

implement the Trade-Related Aspects

of Intellectual Property Rights (TRIPS)

Agreement8approached, the country was

obliged to introduce product patents for

medicines. Until then, generic producers

had supplied medicines without fear of

facing protracted and expensive patent

infringement suits. Thousands of patent

applications on medicines had been

filed since 1995 in anticipation of the

amendments in Indias patent regime,and a large number including those

for HIV, tuberculosis (TB) and cancer

Leena Menghaney ([email protected]) is Campaign Coordinator (India) for the

Mdecines San Frontires Access Campaign.


16/20



could be considered as evergreening

patent claims.

As a result, a single medicine had many

secondary patent applications pending

in the Indian patent office covering one

or more specific features, including

formulation (e g, heat stable tablets

and capsules, syrups, etc), combinations(e g, a fixed-dose combination when dif-

ferent HIV medicines are combined in

the same pill), and derivatives (salts,

prodrugs, crystals and polymorphs).

Concerned about the impact on access

to medicines, MSF, UNAIDS, WHO and

even the French Prime Minister Jacques

Chirac, stepped in to warn the Indian

government to find the right balance

between protecting production and access

to affordable generics, and coming into

compliance with TRIPS.

In the midst of civil society protests,

big pharma lobbying, and international

media attention, Parliament passed the

new Patents Act in March 2005 to allow

for pharmaceutical product patents

something the country had not done

since 1970. Although not perfect,9 the

law crucially allowed for any party to

oppose a patent before it is granted (Sec-

tion 25), and the scope of patentability

under Section 3(d) was restricted toavoid evergreening, the practice of

granting multiple secondary patents on

an existing medicine.

Novartis vs Union of India

A Novartis patent application on the

anti-cancer drug imatinib mesylate10

was one of the first to be examined,

opposed and rejected by an Indian

patent office on grounds that it claims

covered a new form of a known sub-

stance Section 3(d) of the new law

and lack of an inventive step. Angered

by this decision, Novartis went to court

in May 2006 alleging, among other

things, that Indias Section 3(d) was

contrary to the TRIPS Agreement and

was unconstitutional.

The patent rejection order obtained

after Cancer Patients Aid Association

and others filed a pre-grant opposition

set an important precedent for the exa-

mination of patent applications on HIVmedicines. More importantly, Section 3(d)

had already demonstrated its importance

in upholding the rejection of the patent

on imatinib.

If Novartis succeeded in weakening

the interpretation of Section 3(d) in

order to obtain a patent on imatinib

mesylate, this would defeat its purpose

in forestalling the practice of evergreen-

ing. The Indian Patent Office would haveto apply the same standards of patent-

ability on existing patent applications

covering HIVmedicines and their differ-

ent forms, meaning HIVmedicines could

be easily patented and generic compa-

nies could face expensive infringement

suits. This could ultimately result in hav-

ing a chilling effect on the availability of

affordable generic medicines.

The Campaign

In December 2006, MSFs Access Cam-

paign, in partnership with Oxfam and

Delhi Network of Positive People (DNP+),

launched a petition appealing to people

to urge Novartis to Drop The Case in

order to protect the pharmacy of the

developing world (Doctors Without

Borders 2006).

The campaigners faced the daunting

task of educating ordinary people about

access to medicines, pharmaceutical

patents and the impact of the case on theseissues. The message needed to be simple

this case was a direct attack on the safe-

guards in Indias patent law and risked

dismantling Indias capacity to produce

quality, affordable generic medicines.

The launch of the campaign turned

what otherwise promised to be a complex

patent dispute followed by just a few

technical organisations and patient groups

into a global outcry against the greedy

practices of pharmaceutical companies.

The petition received a groundswell of

support from MSF field workers, HIV

organisations, and ordinary people from

around the world, resulting in close to

half a million signatures by August 2007

when Novartis lost its case at the Madras

High Court fuelled by protests before

Novartis s offices worldwide.

In the wake of two failed appeals,

Novartis took its final bid for a patent

and now a challenge on the interpreta-

tion and application of Section 3(d) tothe countrys Supreme Court. If this

challenge were successful, it could take

much of the substance out of the public

health provision, allowing evergreen-

ing, and, as Correas (2013) accompany-

ing article explains, narrowing the flexi-

bility in TRIPS.

MSF relaunched the Drop The Case

campaign, this time rebranded as Stop

Novartis, in February 2012. While theinitial campaign took the form of a peti-

tion, the Stop Novartis campaign took

advantage of the global reach of Twitter.

The social media platform was used to ask

people to target the company directly,

through the companys @Novartis pro-

file and the hashtag of #STOPNovartis.

The new campaign almost immediately

goaded Novartis into responding, with a

series of tweets defending the companys

record and documents that attempted to

set the record straight on its actions

from its own perspective.

Novartis: What They Had to Say

Over a period of seven years, civil society

and MSF received thousands of media

queries from journalists who had picked

up on the campaign. Public statements

from Novartis covered the most com-

mon misconceptions on the subject of

pharmaceutical patents.

These included Novartiss statementthat as imatinib mesylate had been

granted a patent in 40 countries, includ-

ing Switzerland and the US, India should

simply follow suit. In using this tactic,

Novartis conveniently glossed over the

fact that countries have at their disposal

TRIPS flexibilities to adopt different

standards in designing their patent sys-

tems to best suit their own needs a

point well elaborated in Correa (2013).

Accordingly, it is crucial that developing

countries, in particular, make a careful

decision in what should be allowed a

patent and what should not.

MSF was clear in its response: India

must stand firm, applying a patentability

standard that weeded out evergreened

patent claims. Its generic production of

medicines saved millions of lives.

Novartis also tried predictably to

justify its patent claims in India by

stating its research and development

(R&D) costs needed to be recoupedthrough the drugs high cost (Ghose 2013).

The company which claims patent


17/20



rights in 40 countries, reaping huge

profits in return deliberately under-

played the significant contribution made

by the public sector and philanthropic

sources in the US11 meaning it actually

spent just a fraction of the total R&Dcost

(Love 2013).

Throughout the court challenges andin the wake of the Supreme Courts

decision, which Grovers (2013) article

discusses, Novartis was quick to raise

fears about the future of innovation in

India if patents were rejected by the

patent office (Novartis 2013). This was a

lazy argument, in that the case was not

about India refusing to grant patents on

new medicines, but stemmed from

whether a salt form of an existing drug

deserved a patent in India. It further

opened the debate on the current sys-

tem, that despite patent protection, the

diseases and health issues of developing

countries are neglected by companies

(Menghaney 2013).

What Worked?

The Supreme Court decision on 1 April

was the final act in a legal battle that

stretched back to 2004. The verdict,

when read with the law, sets a high

standard for the various tests in the pat-ent legislation, particularly the efficacy

test of Section 3(d) and the inventive

step requirement. In the future, this will

lead to fewer patents on new forms of

known medicines, an important safe-

guard to ensure production of affordable

generic medicines from India.

While the campaign ultimately failed

to convince Novartis to Drop The Case, it

effectively forged alliances in civil society

in creating an international debate on

the abusive practice of evergreening pat-

ents. This groundswell of support and

the local and international outcry on the

daring tactics pharmaceutical companies

will stoop to in order to secure profit, set

the tone of the campaign and formed the

backdrop to the legal case.

Ultimately, the campaign showed that

there is no reason for developing countries

to have a system that blindly hands out

patents when clear measures to protect

peoples access to medicines and preventabusive patenting practices by the pharma-

ceutical industry can be taken.

Notes

1 In March 2000, the daily dose (400 mg) of flu-conazole needed to treat cryptococcal menin-gitis cost $17.84, more than two t imes the daily

wage of an average employed South Africanwho earned just $7.69. In Thai land, however,the daily dose of fluconazole costs just $1.20(Doctors Without Borders 2000).

2 A common patenting practice in the pharma-

ceutical industry aimed at filing and thenobtaining separate (and sequential) patents re-lating to different aspects of the same medi-cine, such as different dosages, formulations,fixed dose combinations and different forms ofthe active ingredient, among others.

3 In September 1986, early clinical tests showedthat Azidothymidine (AZT), a drug first syn-thesised in 1964 to be used as chemotherapyfor leukemia, slowed down the progress of thedisease. In 1987, AZT became the first anti-HIVdrug to be approved by the US FDA.

4 US4724232, Glaxo Wellcome, February 1988,viewed on 30 June 2013, http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r= 1&f=G&l= 50& s1=

47 24 32.PN. &OS=PN/ 4724232& RS= PN/4724232

5 ZA9709726, Glaxo Wellcome, 1997, viewed on30 June 2013, http://apps.who.int/medicine-docs/en/d/Js4913e/7.html

6 Under the 1970 Patents Act, India did not grantproduct patents on medicines.

7 On 19 November 2003, the South AfricanNational Department of Health announced anOperational Plan for the rollout of ARV medi-cines in the public health system. UNAIDS/WHO statistics from 2004 suggested that of theapproximately 5.3 million people living withHIV/AIDS in the country, 7,50,000 were inneed of ARV treatment.

8 The TRIPS Agreement came into effect on 1

January 1995, setting out minimum standardsfor the protection of intellectual property,including patents on pharmaceuticals. Underthat agreement, since 2005 new drugs may besubject to at least 20 years of patent protect ionin all, apart from in the least-developed coun-tries and a few non-World Trade Organizationmembers, such as Somalia.

9 See Gopakumars (2013) accompanying article.

10 Marketed as Glivec.

11 See Dutfields (2013) article for a discussion.

References

Correa, Carlos M (2013): Is Section 3(d) Consist-ent with TRIPS?,Economic & Political Weekly,48(32).

Doctors Without Borders (2000): One World, OnePrice Means Death for People With AIDS inPoor Countries, 13 March, viewed on 30 June2013, http://www.doctorswithoutborders.org/press/release.cfm?id=536

(2006): MSF Urges Novartis to Drop CaseAgainst Indian Government, 20 December,viewed on 30 June 2013, http://www.doctor-swithoutborders.org/press/release.cfm?id=3715&cat=press-release

Dutfield, Graham (2013): Who Invented Glivec?Does It Matter Anyway?,Economic & Polit icalWeekly, 48(32).

Ghose, Sagarika (2013): FTN: SC Ruling onNovartis: Should Cancer Drugs be Cheaply

Available?, IBN Live, 2 April, viewed on

30 June 2013, http://ibnlive.in.com/videos/382785/ftn-sc-ruling-on-novartis-should-can-cer-drugs-be-cheaply-available.html

Grover, Anand (2013): Analysing the SupremeCourt Judgment,Economic & Political Weekly,48(32).

Love, James (2013): R&D Costs for Gleevec,Knowledge Ecology International, 3 April,

viewed on 30 June 2013, http://lists.keionline.org/pipermail/ip-health_lists.keionline.org/2013-April/003005.html

Novartis (2013): Supreme Court Denial of GlivecPatent Clarifies Limited Intellectual PropertyProtection and Discourages Future Innovationin India, 1 April, viewed on 30 June 2013,http://www.novartis.com/newsroom/media-releases/1689290.shtml

Menghaney, L (2013): R&D: What Novartis Says...and Why Its Wrong,Livemint, 12 April, viewedon 30 June 2013, http://www.livemint.com/Opinion/ 3KaBPvulUVkRSoDh8xkVRJ/RD-What-Novartis-says-and-why-its-wrong.html

Sengupta, Amit (2013): Two Decades of Struggle,Economic & Political Weekly, 48(32).

SurveyAugust 27, 2011

Experimental Economics: A Survey

by

Sujoy Chakravarty, Daniel Friedman, Gautam Gupta, Neeraj Hatekar, Santanu Mitra, Shyam Sunder

Over the past few decades, experimental methods have given economists access to new sources

of data and enlarged the set of economic propositions that can be validated. This field has

grown exponentially in the past few decades, but is still relatively new to the average Indian

academic. The objective of this survey is to familiarise the Indian audience with some aspects

of experimental economics.

For copies write to:

Circulation Manager,

Economic and Political Weekly,

320-321, A to Z Industrial Estate,

Ganpatrao Kadam Marg, Lower Parel,

Mumbai 400 013.email: [email protected]


18/20



The Need to Curb Patentson Known Substances

K M Gopakumar

Despite a progressive judgment

by the Supreme Court of India

on Section 3(d) of the Indian

Patents Act, the processes of

legislation and implementation

are not equipped to uphold the

spirit of the Novartis judgment.

This article explains the various

loopholes that plague the system

of patents in India, and suggests

possible solutions.

Legally speaking, the most impor-

tant implication of the judgment is

that the Supreme Court has bro-

ught a great degree of clarity with re-

gard to the interpretatio

the glivec precedent

Documents