The “GLIVEC” Patent Saga - atrip

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SHAMNAD BASHEER


THE “GLIVEC” PATENT
SAGA: A 3
-
D PERSPECTIVE ON IND
IAN
PATENT POLICY AND TR
IPS COMPLIANCE



This work is dedicated by a humble native of Flatland

In the hope that

Even as he was initiated into the mysteries of Three Dimensions

Having been
previously conversant with only two

So the citizens of that celestial region

May aspire yet higher and higher

To the secrets of four or five or even six dimensions

Thereby contributing to the enlargement of the “imagination”
1





I
NTRODUCTION


Indian pat
ent law recently landed itself in the eye of a “TRIPS”
2

storm on
account of the rejection of a patent application covering Novartis’s famed
anticancer drug, Glivec.
3

The rejection stemmed,
inter
-
alia

from a unique section
in the Indian patent regime (sect
ion 3(d))
4

that prohibits the patenting of new
forms of existing pharmaceutical substances that do not demonstrate
significantly enhanced “efficacy.”



Not only did Novartis appeal the patent office decision, but in a rather
controversial move, it challeng
ed the TRIPS compatibility and constitutionality of
section 3(d). The Madras High Court recently ruled that section 3(d) was
constitutional.
5

More importantly, it also stated that it did not have jurisdiction to
rule on the TRIPS issue. As one can apprecia
te, this does not settle the TRIPS
issue but only shifts the jurisdictional venue. With the sword of Damocles
hanging over India, it is an opportune moment to examine section 3(d), it’s
contours and context and the broader implications for Indian intellect
ual property
policy and TRIPS.



1

Edwin A Abbott,
Flatland: A Romance of Many Dimensio
ns

(Dover Publications, 2007)

2

The Agreement on Trade Related Aspects of Intellectual Property Rights (
15 April 1994)
LT/UR/A
-
1C/IP/1

<http://www.wto.org/english/docs_e/legal_e/27
-
trips.pdf>.

3

Novartis AG vs Natco Pharma and Others,
Indian Patent Office,

Application No.1602/NAS/1998
(
25 January 2005) <http://lists.essential.org/pipermail/ip
-
health/2006
-
March/009200.html>.

4

Patents Act, 1970, § 3(d), amended by Patents (Amendment) Act, 2005.

5

Novartis AG & Anr. v. Union of India & Othrs
. (Mad HC) 2007

<http://www.lawyerscollective.org/%5Eamtc/current_issues/Judgement.pdf>.



Apart from discussing the various aspects of the dispute, this paper argues that
section 3(d) represents the “third dimension” in international intellectual property
debates. The regular two
-
dimensional view hardwired into
the WTO/TRIPS
framework and represented in most of the literature speaks of a developed vs
developing country schism

a schism that blinded
policy debates
for a great
number of years. Given the proliferation of “technologically proficient developing
countri
es”
6

such as India, China and Brazil that are not yet fully “developed”, but
have clearly transcended the “developing country” status in some respects, this
schism needs some rethinking.


On the one hand, a rapidly growing economy and strength in technolog
y sectors
such as software and pharmaceuticals invest India with some “developed”
country characteristics.
7

On the other, the fact that
its Human Development
Index (HDI) ranks as one of the lowest in the world
8

and that
26% of its people
live below poverty

line
9

keep it from fully transcending it’s “developing country”
status.


This paper argues that when viewed

through a three
-
dimensional (3
-
D) lens,
section 3(d) emerges as a provision premised on India’s status as a
“technologically proficient” developin
g country.
With a view to

incentivising
incremental pharmaceutical innovation by domestic pharmaceutical companies,
patent protection is provided to pharmaceutical inventions. However, owing to
fears of ever
-
greening and
extended
monopolies, such patent pr
otection is
limited to new chemical entities and their derivatives that provide substantially
enhanced “efficacy”. Of course, the true mettle of section 3(d) will emerge only
after the government defines what “efficacy” really
entails
.


Section 3(d) is si
gnificant for Indian patent policy in other ways too. For one,
section 3(d) represents the congruence of three distinct interests that vie for
predominance in Indian pharmaceutical patent policy. The interests of multi
-
national companies (MNC), the interes
ts of the domestic industry and the


6

The term “technologically proficient” developing country appears to have been first used by
Professor John Barton. See John Barton
“Catch
-
up Strategies for Technologically Profici
ent
Developing Nations”
, Simposio Nacional
de Pesquisa de Administracao em Ciencia e Tecnologia,
Rio de Janeiro (1991).

7

See
generally,
Annual report of the Planning Commission of India

(2006)
<
http://planningcommission.nic.
in/reports/genrep/ar0607_eng.p
d>
.

8

India ranks 126 (out of 177) in the recent Human Development Index.
The HDI provides a
composite measure of three dimensions of human development: living a long and healthy life
(measured by life expectancy), being educated (measured by

adult literac
y and enrolment at the
primary, secondary and tertiary level) and having a decent standard of living (measured by
purchasing power parity, PPP, income)
See
Human Development Report

(2006)
<http://hdr.undp.org/hdr2006/statistics/countries/country_fact_sheet
s/cty_fs_IND.html>
.

9

Press Note 2006, Ministry
of Statistics and Programme Implementation,
<
http://www.mospi.nic.in/mospi_social_pr.htm> (13 Feb 2006).

interests of consumers. Unfortunately, till recently, a regular two
-
dimensional
view of patent policy in India saw the balancing of pharmaceutical patent policy
as one between MNC’s on the one hand, and of consumers/dome
stic producers
on the other. In other words, there was conflation of consumer interest with
those of domestic producers, who provide affordable generic versions of drugs.


Here again, this paper stresses that it is essential for the reader to wear a 3
-
D
l
ens and see these interests as distinct. A regular 2
-
D

view and a conflation of
interests would suggest that the “efficacy” threshold be defined as high as
possible. This would significantly limit the grant of patents, and provide cheaper
drugs for consume
rs. However, a high threshold would harm the interests of
domestic majors such as Ranbaxy and Dr Reddy’s, who are now extensively
involved with incremental innovation. The ex post effects of a patent in the form
of high prices etc can be addressed via meas
ures such as price control,
compulsory licensing etc. However, it is not wise to peg patentability criteria at
arbitrary levels to achieve these purposes, particularly when such an action will
adversely impact the innovation incentives of Indian pharmaceut
ical companies.
In short, the term “efficacy” is a very useful policy lever
10

and one ought to ply
with it very carefully.


Lastly, this paper argues that section 3(d), a section that does not find a parallel
in any other patent regime in the world, repres
ents a new phase in India’s TRIPS
implementation efforts. The earlier phases were marked with hostility towards
TRIPS.
11

The current phase, which includes enactments of provisions like 3(d),
represent an “innovative” exploitation of TRIPS flexibilities by I
ndia to further
national interest.


T
HE GLIVEC PATENT SAGA


Like all corporate sagas, the story of Novartis begins with two individuals, who
surprisingly never figure in the “patent” narratives that we hear about.


In 1960, Peter Nowell and David Hunger
-
Fo
rd, two medical doctors from the
United States discovered a genetic mutation in patients with chronic myeloid
leukemia (CML),

a form of cancer. Their discovery launched the search for a
compound that could block the single enzyme that causes the disease.
In 1990,
scientists at Novartis closed in on the target and, in 1993, the company filed a
patent for a free base called “Imatinib”.
12

Imatinib was then further researched


10

Two prominent
intellectual property
scholars
propos
e that
courts
ought to
apply patent “policy
lever
s”
to tailor patent protection to suit
specific

industries. See
Dan L. Burk & Mark A. Lemley,
Policy Levers in Patent Law
, 89 V
A
. L. Rev

1575, 1630 (2003).

11


See generally,

Daniel Gervais,
Intellectual Property, Trade & Development: The State of Play
,
74
Fordham L. Rev. 505 (2005).

12

US Patent Number
5521184
(issued May 28, 1996).

upon and improved
--
a beta crystalline version of

one of the salts of Imatinib
(imatini
b m
esylate) was found to work well and within no time, the world had
Glivec,
13

an effective treatment for CML.

14



The patent dispute tha
t sets the tone for this paper centers around the beta
crystalline form of imatinib m
esylate referred to above

in more t
echnical terms,
this substance is a particular
polymorphic

form of
the
methane
sulfonic acid
addition salt of imatinib m
esylate. Till date, 35 patents covering this salt have
been granted to Novartis in various countries.
15

However, owing to the
unavailabili
ty of drug patents in India until 1 January 2005,
16

Novartis claimed
this polymorph in a mailbox applicat
ion, that was to be opened on
January
1,
2005 and examined
17
.
This mailbox application, filed on July 17
,

1998 covered

the ‘beta crystalline form of ima
tinib m
a
esylate’.
18


Pursuant to the 2005 amendments
to India’s patent regime
19

which introduced
product patents for pharmaceuticals, this application was opened and examined.
It was
immediately
opposed
by
generic drug companies that had already been
manufac
turing this drug and the Indian Cance
r Patients Aid Association
on
several grounds including:

i)

lack of novelty/anticipation

ii)

the claimed salt did not have any added “efficacy” under Section 3(d),

iii)

obviousness and

iv)

wrongful priority

Agreeing with the above ar
guments, the
Assistant Controller of Patents

rejected
the patent application.
20

Aggrieved by this rejection, Novartis AG, along with
its


13

Glivec is sold as “Gleevec” in the US.

14

Glivec is also useful in treating
Gastro
-
Intestinal Stromal Tumours (GIST),
a very rare cancer
affecting the digestive tract or nearby

structures within the abdomen.
<http://www.gistsupport.org/treatments/current
-
treatments/gleevec.php>.

15

Novartis AG and Anr vs Union of India and Ors
, WP
No. 24759 of 2006, High Court of
Judicature at Madras (May 17, 2006) (on file with author).

16

Under
Art 65 of TRIPS, India had 10 years from the date of coming into force of TRIPS to
implement product patent protection in pharmaceuticals.

17

India’s patent regime was amended 1999 to provide that applications claiming pharmaceutical
inventions would be acc
epted and put away in a mailbox, to be examined in 2005

these
applications are commonly referred to as ‘mailbox applications’. This amendment was in
pursuance of Article 70.9 of TRIPS and a WTO dispute filed by the United States against India for
a failure

to comply with this TRIPS provision.
See

WTO Appellate Body,
India: Patent Protection
For
Pharmaceutical And Agricultural Chemical Products
, WT/DS50/AB/R

(Dec. 19, 1997),
<
http://docsonline.wto.org/imrd/directdoc.asp?DDFDocuments/t/WT/DS/50ABR.WPF
>
.

18


Cr
ystal Modification of A N
-
Phenyl
-
2
-
Pyrimidineamine derivative, processes for its manufacture
and use”, Application No.1602/MAS/98 (July 17, 1998).

19

The Patents (Amendment) Act, 2005 was published as law in the Gazette of India on
April 5,
2005
.

20
Novarti
s
AG vs Natco Pharma and Others,
Indian Patent Office

(
supra

n 3
).

Indian subsidiary, Novartis India
,

filed

two writ petitions in the Madras High
Court. These petitions not only sought a
reversal of the Asst Controller’s order,
but also a declaration that Section 3(d) was unconstitutional and in violation of
India’s obligations under TRIPS.
21


Pursuant to a government notification,
22

the High Court transferred the first
petition to the Intel
lectual Property Appellate Board (IPAB)


a specialist tribunal
set up to deal with appeals from the various intellectual property offices across
the country.
23



Before we assess the TRIPS challenge, let us dwell briefly on the merits of the
dispute that i
s before the IPAB

i.e. whether the beta crystalline form is
patentable or not.
For the purpose of this paper, I limit my discussion to section
3(d)
.


SECTION 3(D)
: THE STRUCTURE AND CONTEXT


Section 3(d) reads as below:


d)
the mere discovery of a new for
m of a known substance which does
not result in increased efficacy of that substance

or the mere discovery of
any new property or new use for a known substance or of the mere use of a
known process, machine or apparatus unless such process results in a new

product or employs at least one new reactant.

Explanation: For the purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of isomers, complexes,
combinations and other derivatives of known subs
tance shall be considered to be
the same substance,
unless they differ significantly in properties with
regard to efficacy.



In essence, section 3(d) aims to prevent a phenomenon commonly referred to as
“ever
-
greening”
:
under one definition
, this

occurs w
hen a manufacturer
supposedly ‘stockpiles’ patent protection by obtaining separate 20
-
year patents


21

Novartis AG vs Union of India
,
WP
(
supra

n 15
).

22

The notification under the Patents (Amendment) Act (section 117G), provided that all pending
appeals in the High Court shall be transferred

to the newly constituted Appellate Board.
Notifications No.12/15/2006
-
IPR
-
III) dated 2/4/2007 issued by the Ministry of Commerce &
Industry

<
http://ipindia.nic.in/ipr/patent/gazetteofindia_apr2007.pdf>.

23

See < http://www.ipab.tn.nic.in/> for more details

on the IPAB.
The IPAB is currently
embroiled in a controversy around the appointment of one of its members, Chandrasekharan,
who had been Controller of Patents when the patent office rejected Novartis’ application.

on multiple attributes to a single product.
24

According to a report of the US
National Institute of Healthcare and Medicines (NIHCM):
25


Drug manufacturers pat
ent a wide range of inventions connected
with incremental modifications of their products, including minor
features such as inert ingredients and the form, colour and scoring of
tablets.


In an attempt to stave off the possibility of ever
-
greening, section

3(d) stipulates
that
only those pharmaceutical derivatives that demonstrate significantly
enhanced “efficacy” are patentable.
26



The underlying assumption is that derivatives, such as salt forms, polymorphs
,
isomers

etc that are structurally similar to kn
own pharmaceutical substance
s are
likely to
be functionally equivalent as well
--
and if this is not the case and the new
form of an existing substance works better than the old form, it is up
-
to the
patent applicant to demonstrate this and claim a patent.



To this extent, section 3(d) draws a distinction between “evergreening” and
incremental innovation.
27

By making derivates with added efficacy patentable,
section 3(d) encourage
s

sequential developments of existing products or
technologies that help bring i
n improved products to the market, capable of
addressing unmet public health needs.


In order to appreciate

whether Novartis’ invention is

more “efficacious” than an
earlier known form, let’s look at

what the “invention” entails
.
The invention
represents
a transition from the discovery of a free base to a useful drug. The
various steps in this transition can be encapsulated as under:


i)

Synthesizing the Imatinib free base, a compound that was patented in
the US, EU and several other countries.
28

However, thi
s could not be


24

‘See
Patentee Attorneys Challenge Asse
rtions re FTA Patent Practices

(Press Release dated 4
August 2004) <http://www.ipta.com.au/forms&notices/FTA_Release.doc> (5 July 2005) (last
visited Aug. 30 2007).

25

Nat. Institute For Health Care Management
Changing Patterns of Pharmaceutical Innovation
,

May

2002

<

http://www.nihcm.org/~nihcmor/pdf/innovations.pdf>.

26

During the Parliamentary debates,
Sri Kamal Nath, Minister of Commerce and Industry, in
response to concerns by other Parliamentarians stressed that section 3(d) was introduced to
prevent “e
vergreening”. Interestingly, Suresh Kurup, a Parliamentarian, specifically cited the
ongoing case of Glivec to demonstrate the ill effects of ever
-
greening. See
Lok Sabha Debates

(22 March 2005) <http://164.100.24.230/Webdata/datalshom001/dailydeb/22032005
.htm>

27

Classifying all ‘incremental innovations’ as tantamount to ‘evergreening’ is misguided. See
Shamnad

Basheer
Limiting the Scope of Pharmaceutical Patents and Micro
-
organisms: A TRIPS
compatibility Review
, (Intellectual Property Institute, London, 2
005.)

28

U.S. Patent No.
5,521,184
(issued May 28, 1996). See also corresponding
European Patent No.
0564409.

patented in India, owing to the fact that in 1993, India did not provide
product patents for pharmaceutical substances.
29


ii)

The conversion of t
he free base to a salt form
--

i
matinib

m
esylate by
adding methanesulfonic acid.

iii)

The obtaining o
f t
he beta crystalline form of imatinib m
esylate, a
polymorphic form that is allegedly the most stable form of the salt. A
patent application was filed for this and it is this application that is the
subject matter of dispute.
30

iv)

The making of Glivec, a drug th
at is based upon the above beta
crystalline form of imatinib mesylate.



Novarits claims that Gl
ivec (beta crystalline form of imatinib m
esylate) is more
effective than the Imatinib free base, since it displays better bio
-
availability
properties i.e. it i
s abso
rbed more easily into the blood.
31

To this effect, it
submitted evidence before the
Assistant
Controller demonstrating an increase in
bio
-
availability of upto 30%.
He disagreed that this was sufficient to constitute
“increased efficacy”:
32


As per the
affidavit the technical expert has conducted studies to
compare the relative bioavailability of the free base with that of beta
crystalline form of imatinib mesylate and has said that the difference
in bioavailability is only 30% and also the difference in

bioavailability
may be due to the difference in their solubility in water. The present
patent specification does not bring out any improvement in the
efficacy of the beta crystal form over the known substances
--

rather
it states the base can be used equal
ly in the treatment of diseases of
in the preparation of pharmacological agents wherever the beta
crystal is used. Even the affidavit submitted on behalf of the
Applicant does not prove any significant enhancement of known
efficacy.


As can be seen from th
e above, the decision of the patent office is not very
illuminating and the patent controller did not give any detailed reasons as to why
he thought the beta crystalline form lacked “efficacy”. What does the term
“efficacy” mean? Does it connote
only
“ther
apeutic efficacy”? Or will it also
include bioavailability? And importantly, what will constitute a “significant
enhancement in efficacy” under the Explanation

to section 3(d)
? Will

a 30%
increase in bio
-
availability suffice?



29

Supra

n 16.

30

Supra

note 18.

31

Gauri Kamath,
Interview with Paul Herring, Head of Corporate Research, Novartis AG
, BUS.
WORLD, Feb. 19, 2007 <

w
ww.businessworldindia.com/feb1907/indepth04.asp>
.


32

Novartis AG vs Natco Pharma
, Indian Patent Office (
supra

note 3)
.



It is hoped that a final res
olution of this dispute at the IPAB as well as the
governments’ recent move to draft guidelines for determining “efficacy” in the
patent manual will yield some clues in this regard.
33


SECTION 3(D):
TRIPS COMP
ATIBILITY


As mentioned in the introduction, Nov
artis challenged both the TRIPS
compatibility and constitutionality of section 3(d). The Madras High Court ruled
that section 3(d) was constitutional.
34



More importantly, it also stated that it does not have jurisdiction to rule on the
TRIPS issue. Rather
, the proper forum to bring this before would be the WTO.
35

As one can appreciate, this does not settle the TRIPS issue but only shifts the
jurisdictional venue. Assuming the matter were to come before the WTO,
it is
very unlikely that a panel will rule aga
inst India.
36


Article 27 of TRIPS stipulates that ‘patents shall be available for any inventions…
provided that they are
new, involve an inventive step and are capable of
industrial application
.’
However, none of the terms used in this Article have been
de
fined.
This leaves some flexibility in the hands of member states to define
patentability criteria in a manner that suits their specific national interests.
37



Historically, member states have refined patentability criteria in the context of
specific field
s of technology, taking into account the unique concerns posed by
such technologies. Illustratively, in 2001, the United States Patent and
Trademark Office (USPTO) revised its utility guidelines to cater specifically to
biotechnology inventions.
38

It is als
o pertinent to note a German provision


33

Gireesh Chandra Prasad,
Novartis warns India of losing R&D biz to China
,
E
CON
.

T
IMES
,

A
UG
.

7,
2007 <http://economictimes.indiatimes.co
m/articleshow/msid
-
2261510,prtpage
-
1.cms>

34

Novartis AG v. Union of India & Othrs
, Mad HC
(
supra

note 5

at para 19
)
.

The court based it’s
decision on the fact that
since section 3(d) did not confer “uncanalised” discretionary power on
the patent controlle
r, it was not vague or arbitrary. Therefore, it could not be struck down under
the “equality” clause enshrined in Article 14 of the Constitution.

35

Id

at
para

8.

36

It is interesting to note that the Swiss government recently indicated that it was not willi
ng to
take up cudgels on behalf of Novartis.
Business Standard
Reporter,
Swiss Govt. not to take
Novartis case to the WTO,
Business Standard

Aug 8, 2007
<
http://www.business
-
standard.com/common/storypage_c.php?leftnm=10&autono=293771>.

37

See
Commission on
Intellectual Property Rights

Integrating Intellectual Property Rights and
Development Policy

114 (2002) <http://www.iprcommission.org>.

38

USPTO ‘Guidelines for Examination of Applications for Compliance with Utility Requirements’,
66 (4) Fed Reg 1092 (5 J
anuary 2001)
<http://www.uspto.gov/web/offices/com/sol/notices/utilexmguide.pdf>. Such a requirement is,
to some extent, also being applied by the EPO (EPO Opposition Decision revoking EP0630405
(
ICOS Corporation
) 20 June 2001 (Unreported)).

brought in to ensure that the patent monopoly on a gene sequence is limited to
the specific function disclosed and not to all functions.
39


In much the
same way as the above provision
s
, Section 3(d) may be construed
as

a refinement of patentability criteria to cater to “evergreening”
--
a specific
problem inherent in pharmaceutical innovations.
40

More specifically, the
‘enhanced efficacy’ criterion can be seen as refinement of ‘non obviousness’
principles

i.e. most forms o
f existing pharmaceutical substances are deemed
obvious, unless they demonstrate increased ‘efficacy’.
41


In short, patentability criteria have not been defined under TRIPS, a deeming
provision such as section 3(d) can be made and sustained, provided it is
not
entirely arbitrary. This section aims to weed out frivolous patents by creating a
credible “efficacy” barrier. It is very difficult to see how a WTO panel might strike
this down as being in contravention of TRIPS. Of course, if the term “efficacy” is
c
onstrued in so narrow a manner that the Indian patent regime effectively
protects only New Chemical Entities, this may tantamount to a TRIPS violation.


This is something that the government wished to avoid, as can be seen from the
debates surrounding the

Mashelkar Committee Report, which found that a
blanket denial of patents to all pharmaceutical incremental innovations was likely
to contravene TRIPS.
42



SECTION 3 (D): A 3
-
D PERSPECTIVE


The above sections help contextualise section 3(d). At a broader l
evel,
I wish to
highlight
the importance of appreciating India’s patent policy in the context of its
current status as a “technologically proficient” developing country. To this extent,


39

An amendme
nt approved by the German Parliament in 2004 limits patent protection on human
gene sequences to ‘disclosed functions’ at the time of the patent application i.e. a patent on a
human DNA sequence used for a specific function would not cover a second functio
n discovered
later by another researcher using the same DNA sequence. See N Stafford ‘
German Biopatent
Law Passed’

<http://www.bintegrating omedcentral.com/news/20041209/01> (24 December
2004)
.

40

supra
note 24
-
26

41

See
Shamnad Basheer, IPI
,
supra

note 27
.


42

The government constituted a technical committee, with Dr Mashelkar, a reputed scientist, as
Chairman to determine whether restricting the grant of patents for pharmaceutical substance to
only new chemical entities
(NCEs) would be in compliance with TR
IPS.
See
D
R
.

R.

A.

Mashelkar et
al., Report of The Technical Expert Group on Patent Issues

(2007)

<
http://ipindia.nic.in/ipr/patent/mashelkar_committee_report.doc
>
.

The Mashelkar Committee
Report was however withdrawn due to certain ‘technical inaccuracies

in the report’ namely the
fact that certain sections of the report had been reproduced from a paper prepared by Basheer
(
supra

note 27
), without proper acknowledgement of the same.
See generally
Pallava Bagla,
‘Plagiarism’ in his panel’s report, Mashelkar

tells Govt. to withdraw it
, Indian Express
,

F
EB

22,

2007

available at <http://www.indianexpress.com/story/23941.html>
.

the readers are cautioned against
an antiquated 2
-
D view of internatio
nal IP
debates

a view premised on the developed vs developing country schism.
43

At
the risk of oversimplification, the broad notion is this:


Developed countries need maximalist IP regimes, as they are highly innovative
and strong IP regimes provide the req
uisite incentives in this regard. Developing
countries require minimalist IP regimes, as they are hardly innovative and
are
often
net importers of technology. This is borne out in part by the Ayyangar
Committee Report, a report which, in large part, formed

the basis for the 1970
Indian Patents Act.
44

The report stressed the virtues of a relatively “weaker”
patent system and stated:
45



It does not need much argument to establish that if the scope of
patentable inventions were widened, the persons to benefit w
ould
be mostly inventors in the highly advanced industrial countries
and for the use of these inventions which are not subject to
patents in any country of the world other than in the United
Kingdom, the industries in India would have to pay a tax in the
s
hape of royalty.


The consequences of the developed vs developing country schism reverberate in
several channels of domestic and international IP making and is in fact hardwired
into the very fabric of the WTO and TRIPS.
46


Unfortunately, this black and wh
ite categorisation that has come to inform most
intellectual property
debates does not hold tight in the context of emerging
economies such as India, China and Brazil.
47





43

A number of recent papers play into this regular 2 dimensional schism. Illustratively, see Luigi
Palombi,
TRIPS, Bilateralism and Pat
ents: How They are Failing Both the Developed and the
Developing World and What to do About It,

1
Elect. J. Inf. Innov. Health
71

(2007)

<
http://cgkd.anu.edu.au/menus/PDFs/Palombi%20(RECIIS)%20eng.pdf>.

44

N.

R.

Ayyangar,
Report on the Revision of the Pate
nts Law

(1959).


45

Id
p. 22
.

46

There are no WTO definitions of "developed" and "developing" countries. Members announce
for themselves whether they are "developed" or "developing" countries. However, other
members can challenge the decision of a member to
make use of provisions available to
developing countries. See
WTO Web Page on Development

<http://www.wto.org/english/tratop_
e/devel_e/d1who_e.htm>.
We therefore use these terms in the same way in which most of the
existing literature on intellectual prop
erty and development uses them. Il
lustratively, see Luigi
Palombi

(
supra

n
ote

43
)
. See also
Chenxi Jiao,
The Negative Effect of Pharmaceutical Patents on
South African Industry
, Cardozo Public Law, Policy and Ethics Journal, Spring 2007, 655 at 657
who sta
tes:
“Although it might seem as though patent protection would lead to industrial growth,
this Note will argue that patent protection has favored developed economies and stifled the
growth of local industry in developing countries
”.

47

Supra

n
ote

6.


In fact, the developing vs developed country classification is coming to be criticize
d in
other areas of the WTO as well. Professor Picker demonstrates the anachronicity of
such a classification, citing Russia as an example:
48


Certainly there are other scenarios where countries may fall between
the developed and the developing world, thus
making development
policy less pointed or efficient or effective…..This demonstrates that
the WTO definitions of development are arbitrary and that
classification of countries in this way does not take into account their
individuality.


India is neither ‘
developed’ nor ‘developing’. It is what I would prefer to label as
a ‘technologically proficient’ developing country.
49

On the one hand, it is keen
on
incentivising innovation in sectors, where it is “technologically proficient”
. Yet 26
per cent

of it’s peo
ple live below poverty line and it has significant “public health”
concerns

to this extent, it
continues to remain a
“deve
loping”

country
.
50

The
age
-
old intellectual property rules that were premised on a neat distinction
between developed versus developing

countries do not fit India
anymore.
51

This
calls for ‘new’

norms
,
driving India
to
‘innovate’ in its intellectual property polic
y.


Section 3(d) is one such innovative norm that attempts to strike a balance
betw
een two conflicting priorities: On the one h
and,
drastic levels of poverty and
resulting problems associated with drug pricing and affordability warrant a
reduction in the scope of patent grants. On the other hand, India’s industrial and


48

See

Colin Picker,
Neither here nor there


Countries that fall between the Developed and the
Developing World in the WTO
, 36 Geo. Wash. Int’l L. Rev. 147

(2002)

AT
149.


49

Some scholars use the term “innovative developing country” (IDC). See CM Morel et al
Hea
lth
Innovation Networks to Help Developing Countries Address Neglected Diseases
,
Science

15 July
2005:
Vol. 309. no. 5733, pp. 401


404, who state:
Some developing countries, however, are
more

scientifically advanced than others and are starting to reap

b
enefits from decades of
investments in education, health research

infrastructure, and manufacturing capacity. We refer to
these

as innovative developing countries (IDCs)
.

Unfortunately, this does not appear to be an
entirely accurate classification given t
hat India, though “technologically proficient” in certain
technology sectors such as software and pharmaceuticals has not yet witnessed any significant
levels of “innovation” in these sectors. See
Innovation in India
, National Knowledge Commission,
Delhi 2
007 <http://knowledgecommission.gov.in/downloads/documents/NKC_Innovation.pdf>.

50

Supra

note 9
.

51

One might argue that at different times in history, other countries went through similar phases.
Japan is an excellent example of a country that might have b
een categorized as a
“technologically proficient” developing country in the 1970’s/80’s. However, what makes India,
China, Brazil and other emerging economies of today different is that these are the first distinct
set of “technologically adept” developing

country cases to emerge in a post TRIPS environment.
To this extent, this group challenges accepted norms of a developed vs developing schism, on
which the international IP regime as elucidated in arenas such as TRIPS is premised.


innovation imperatives warrant the grant of incentives in the
form of patents to
domestic majors such as Ranbaxy,
Dr. Reddy’s and CIPLA
.
52



Section 3(d) therefore provides that patents shall be granted only to new
chemical entities and to pharmaceutical derivatives that represent “genuine”
incremental inventions by b
eing more “efficacious” than existing substances.


In this way, section 3(d)
makes a break from the regular two

dimensional view
of intellectual property policy premised on the developed vs developing country
schism.
A continuation of policies based on th
e regular 2
-
D perspective might
have seen the introduction of a blanket provision excluding incremental
inventions altogether. Fortunately, the government avoided such a measure. In
the wake of pressure from the Left Parties to introduce such a blanket exc
lusion,
the government referred this issue to an expert committee.
53

Some may
therefore argue that the non
-
introduction of such a provision stemmed more
from a fear of TRIPS, rather than being driven by well thought out innovation
policy goals.


A study of

the political context surrounding the introduction of the 2005 Patents
Amendment Act would suggest that the government was driven
more
by national
policy imperatives. The constitution of a committee to review the proposed
measure for TRIPS compliance was
nothing more than an effort to stave off
any
delays in
effectuating
the 2005 Amendments
.
54

In other words, TRIPS was only
an excuse by the government to further domestic industry interests and assuage
the concerns of those that sought to limit incremental p
atents altogether.
55




52

Illustratively, Ranba
xy and Dr Reddy’s, the two largest pharmaceutical companies in India are
amongst the
top
3 Indian patentees in the US. Most of the
ir

current applications are for
incremental inventions and processes. See Mashelkar Committee Report
(
supra

note

42
)
.
However,

when looked at from an international perspective, the numbers are still relatively small.
Ranbaxy has only about 79 US patents till date (from 1975
-
2006), whereas Dr Reddy’s has 53.
See
U
SPTO
D
ATABASE
,

<
http://www.uspto.gov/patft/
>. But with more R&D spen
ding in the coming
years, these numbers are bound to grow See Gautam Kumara, Palash Mitra, Chandrika Parschira,
Indian Pharma 2015: Unlocking the potential of the Indian Pharmaceuticals Market
, Mckinsey &
Co. (2007).

53

Supra

note 42
.

54

It is pertinent to n
ote in this regard that, during the course of Parliamentary debates, Shri
Kharabela Swain, a member of Parliament, opined that patents ought to be given for incremental
innovations as Indian scientists did not have the know
-
how or capital to come up with n
ew
chemical entities, but do have the know how to make improvements. See
Lok Sabha Debates,
(
supra

note 26
)
.


55

See Shamnad Basheer, “
The Mashelkar Committee Report on Patents: Placing it in Context”

SpicyIP

<
http://spicyipindia.blogspot.com/2007/01/mashel
kar
-
committee
-
report
-
on
-
patents_28.html
>

(Jan 28, 2007) for an overview of the political context surrounding the
constitution of the Mashelkar Committee.

As discussed in an earlier section, Section 3(d) has no statutory parallel
anywhere else in the world. It’s “innovativeness” lies in the fact that it deploys a
drug regulatory term “efficacy” to lay down an almost bright line rule for
determining the patentability of pharmaceutical inventions. Of course, the
“brightness” of the line would depend on how the term “efficacy” is defined.


It is interesting to note in this regard that the term “efficacy” and the explanation
to section 3(d)
is derived, in large part, from a drug regulatory directive. Article
10(2)(b) of Directive 2004/27/EC
56

defines a ‘generic medicinal product’ as:


a medicinal product which has the same qualitative and
quantitative composition in active substances and the s
ame
pharmaceutical form as the reference medicinal product, and
whose bioequivalence with the reference medicinal product has
been demonstrated by appropriate bioavailability studies.
The
different salts, esters, ethers, isomers, mixtures of isomers,
compl
exes or derivatives of an active substance shall be
considered to be the same active substance, unless they
differ significantly in properties with regard to safety
and/or efficacy
. In such cases, additional information providing
proof of the safety and/or

efficacy of the various salts, esters or
derivatives of an authorised active substance must be supplied by
the applicant. (emphasis by author).


T
ransposing a provision that operates within the context of a drug regulatory
regime to a patent regime may no
t work optimally. For one, it makes it likely that
the term “efficacy” would be construed in a ‘drug regulatory’
sense

consequently, the requirement would be a difficult one for most patent
applicants to satisfy. Pharmaceutical companies generally file pat
ent applications
at the initial stage of discovery of a drug; it is only much later in the
development process that clinical studies are conducted to gather information
pertaining to the therapeutic efficacy of the drug. Requiring information on
‘efficacy’

at the stage of filing a patent application is therefore an onerous
requirement.
57


On the other end of the spectrum, defining efficacy too loosely may result in
even trivial increments gaining patent protection, further exacerbating the


56

‘Directive 2004/27/EC of the European Parliament and of the Council of 31

March 2004
amending Direct
ive 2001/83/EC on the Community Code Relating to Medicinal Products for
Human Use’, (
2004) 0.J. (L

136)

34.

57


The task of proving efficacy is much more difficult, expensive, and time
-
consuming than the
task of proving safety
.”The Independent Institute,
Hi
story of FDA Regulation: 1902
-
Present
<
http://www.fdareview.org/history.shtml>.

problem of ever
-
gr
eening

the very problem sought to be eviscerated by section
3(d).


EXPLICATING EFFICACY: CREATING MORE “EFFICACIOUS” NORMS


The Madras High Court judgment relied on a medical dictionary definition to hold
that the term "efficacy" in section 3(d) meant "the
rapeutic" efficacy. Under such
a definition, the
kind of
derivatives that qualify for protection are likely to be
severely limited.
For instance,
increased "bio
-
availability" (which is what Novartis
claims for its beta crystalline form)
may
not count as "t
herapeutic" efficacy.
Further,
salt forms that provide more stability and enable the drug to remain on
the shelf for longer or be transported to various parts of rural India without
refrigeration

will not be patentable
.
58

But should this be the case? If the

intention
behind section 3(d) is to provide incentives to new forms of pharmaceutical
substances that come with genuine advantages, then ought not drugs with
significant increased bio
-
availability and stability to qualify?


In this context, it is importa
nt to distinguish the interests of consumers from
those of domestic pharmaceutical producers. Of course, were one to see
intellectual property policy through a long
-
term dynamic innovation lens, one will
appreciate that even consumers will benefit from mor
e innovation

if there is no
drug, there is no question of access to the drug.

Unfortunately, most public
health groups and civil society activists
resort to a myopic
“pricing”
lens i.e. beat
the price down to the lowest possible level, without regard for a
nything else
.
Illustratively, the Drug Action Forum
, Karnataka

is now calling on Novartis to
withdraw its case, when the issue of whether it has a patentable polymorph or
not is yet to be decided by the IPAB.
59


Till recently, a regular two
-
dimensional view

of patent policy in India saw the
balancing of pharmaceutical patent policy as one between MNC’s on the one
hand, and of consumers/domestic producers on the other.
60

In other words,
there was a conflation of consumer interest with those of domestic produce
rs,
who provide cheap affordable versions of drugs.



58

In particular, see the recent
pre
-
grant opposition filed by I
-
MAK against Abbot’s
application
claiming “Aluvia”, a “heat stable” f
orm of an anti
-
retroviral drug, consisting o
f
Lopinavir and
Ritonavir
.
The advantages of this new combination include increased
solubility in water and
better
bioavailability and stability


translating to a
lower pill burden and
the ability to store
without refrigeration
.

See <

http://www.i
-
mak.org
/lopinavirritonavir/
>.

59

See Amrita Nair
-
Ghaswalla

NGO takes Novartis battle online

(29 August 2007)
<http://timesofindia.indiatimes.com/Business/India_Business/NGO_takes_Novartis_battle_online/
articleshow/2318139.cms>.

60

The Ayyangar Report, which forme
d the basis for the 1970 Patent Regime, was premised, in
large part, on the notion that Indian
pharmaceutical patent policy ought to be a balance between
MNC’s on the one hand, and of consumers/domestic producers on the other
. See Ayyangar
Committee Report

(
supra

n
ote

44
).


As noted in the introduction, a 3
-
D lens comes in handy here as well, in that it
enables one to see these interests as distinct.
61

Consumer groups wish to peg
th
e “efficacy” standard
as high as possible
in order to ensure that there are very
few pharmaceutical patent grants. Illustratively,
in their pre
-
grant opposition filed
against the application at the patent office,
the CPAA recommended that
“efficacy”
be interpreted in a drug regulatory manner.
62



M
ore
interestingly, in a submission made to the Mashelkar Committee, the
Affordable Medicines Treatment Campaign (AMTC) support
ed

the introduction of
a clause that would have restricted patentability to only new chemical entities

(NCE’s)

in other words, it
advocated a total ban on any kind of incremental
pharmaceutical patenting
.
63


Therefore, groups such as
AMTC
are likely to support the elevation of efficacy
standards to extremely high levels

and perhaps even to a level close enough to
approximat
e a law tha
t effectively grant

patent protection to only new chemical
entities.
64


On the other hand, multinational pharmaceuticals wish to peg th
e “efficacy”
standard
as low as possible. In fact, Novartis would prefer that section 3(d) not
exist at all. Which is esse
ntially why it challenged section 3(d) as violating TRIPS,
and the constitution of India.


A regular 2 dimensional view and a conflation of interests would suggest that the
views of consumer groups be preferred, since they tally with the views of
indigeno
us pharmaceutical producers: therefore the “efficacy” threshold should
be defined as high as possible. This would significantly limit the scope of grant of
pharmaceutical patents, and provide cheaper drugs for consumers. However, a
third dimensional perspe
ctive
is likely to
reveal that a high threshold will harm
the interests of domestic producers such as Ranbaxy and Dr Reddy’s, who are
now extensively involved with incremental innovation,
such as new
heat stable
forms, drug delivery systems, extended relea
se capsules etc.
65

Illustratively,
under a restrictive efficacy standard, Ranbaxy’s incremental innovation which


61

The clearest indication that these interests are divergent can be gleaned from the fact that
domestic producers oppose price controls, as vehemently as the multinational pharmaceutical
industry. See
Pharma I
ndustry Opposes Price Contro
l Mechanism
, The Hindu Business Line, Jan
11, 2007 <http://www.thehindubusinessline.com/2007/01/11/stories/2007011106660100.htm>
.
In contrast, consumers and associations are likely to favour extensive price controls.

62

Copy of pre
-
grant opposition filed by

CPAA
(
on file with author
)
.

63

Mashelkar Committee Report (
supra

note
42)
.

64

Such a result is likely to contravene
TRIPS.

See Mashelkar Committee Report

(
supra

note 42)
.
See also Shamnad Basheer
,
IPI
(
supra

note 27)

65

See Mashelkar Committee Report (
supra

note

42
)

enabled Bayer’s famed anti anthrax drug, Cipro to be taken just once a day, will
not gain patent protection
66
.


Given India’s status a technolog
ically proficient country, India ought not to adopt
an excessively restrictive efficacy standard. i.e. if the intention is to incentivise
incremental invention, then one ought to encourage all kinds of incremental
inventions and not just inventions limited

to “therapeutic efficacy”. The ex post
effects of a patent in the form of high prices etc can be addressed via measures
such as price control, compulsory licensing etc.
67

However, it is not wise to peg
patentability criteria at arbitrary levels to achieve
these purposes,
68

particularly
when such an action will adversely impact the innovation incentives of Indian
pharmaceutical companies. Given the recent opportunities for R&D collaboration
with multinational pharmaceutical companies, the levels of patent pro
tection
ought to be at a fairly reasonable level to induce such investment.
69



Perhaps India could draw from other jurisdictions such as the United States,
where the patentability of a pharmaceutical derivative such as a new salt form or
polymorph hinges t
o some extent on whether or not such derivative
demonstrates "unexpected or surprising
results
".
70

Under this standard,
“unexpected
results
” would include not just "therapeutic" efficacy, but any other
significant advantage as well, such as enhanced bioavai
lability, heat stability,
humidity resistance etc.


An excellent example in this regard is Wockhardt Ltd, which developed humidity
resistant salt forms and isomers of known antimicrobial substances. The original
compounds had been patented by Otsuka Pharm
aceutical Company as potential
antimicrobial agents against bacteria that were resistant to conventional
antibiotics. When compared with these original compounds, the salts developed
by Wockhardt
and later patented in the US
had better solubility character
istics
and greater stability in the presence of high humidity climates.
71

Such


66

The invention, sold as Cipro
-
OD, enabled a patient to take the medicine just once a day (OD)
as was successfully licensed to Bayer AG.

Padmashree Gehl Sampath,
Economic Aspects of
Access to Medicines After 2005: Product Patent Protection and Em
erging Firm Strategies in the
Indian Pharmaceutical Industry

43

<
http://www.who.int/intellectualproperty/studies/PadmashreeGehlSampthFinal.pdf>
.

67

Shamnad Basheer,
India’s New Patent Regime: Aiding Access or Abetting Genericide

8
International Journal of B
iotechnology 5 (2006).

68

Protecting only therapeutic efficacy, and not other advantages would be seen as arbitrary. And
it is also likely that such a measure could be seen as contravening the mandate under Article 27
to grant patents to all “inventions” an
d to not discriminate between fields of t
echnology. See
Shamnad Basheer, IPI

(
supra

note 27)
.

69

McKinsey Report
(
supra

n
ote

52
).


70

Illustratively, see
Pfizer v. Apotex
,
480 F.3d 1348 (2007).

This “unexpected property” standard
is to mirrored to some exten
t in the decisions of the European Patent Office (EPO) as well.

71

See Follow
-
on Innovation and Intellectual Property, Submission to the WHO’s CIPIH by WIPO (20
May 2005) <http://www.who.int/intellectualproperty/submissions/en/> 13
-
14.

incremental innovations are of tremendous value in a country like India and the
Indian patent regime ought to incentivise such innovations.


I
t is important

to note an important
distinction between the US standard and
section 3(d).
“Unexpected properties” as drawn out by US case law is only a
secondary consideration in assessing non
-
obviousness. In other words, one gets
to this stage only when the primary enquiry on inventive step

cannot be
answered concl
usively i.e. was it “obvious” to a skilled person
to
combine the
prior art to get to the
specific polymorphic
form?


In most cases, a structurally similar form would lead to a prima facie finding of
obviousness. A showing of unex
pected or surprising results (“secondary
considerations”) helps in dislodging such an assumption.
72



Illustratively, in
Pfizer vs Apotex
, t
he Federal Circuit stated that Pfizer failed to
prove that the properties of amlodipine besylate over the prior art w
ould have
been unexpected to the skilled artisan, and that even if Pfizer made such a
showing,
“this secondary consideration does not overcome the strong showing of
obviousness in this case.”

73


Section 3(d) is clearly distinct

in that it elevates the “une
xpected property”
norm to a primary enquiry

to be asked at the stage of determining patent
eligibility. To this extent, it is a creative deployment of patentability principles
and represents a new phase in TRIPS implementation efforts by India,
characteris
ed by a strategic use of TRIPS flexibilities.

For a great number of
years,
TRIPS implementation efforts in India
has been
characterised by
some
level of
hostility. The best example is the failure by India to implement the
mailbox and exclusive marketing ri
ghts provisions
, despite a good seven years
passing by
.
74



Although
section 3 (d) appears
to have been introduced without much
deliberation in Parliament, it still encapsulates a conscious attempt to balance
innovation imperatives of domestic pharmaceutica
l companies with public health
concerns. This explains why the government did not agree as readily to another
proposed clause from the Left Parties that would have denied patentability to all
incremental innovations. Rather, in a move meant to prevent the
Left Parties
from further “stalling” the progress of the Patent Amendments, the government


72

See
In re Soni
, 54
F.3d 746, 750 (Fed. Cir. 1995), where the court noted that “[t]he principle
applies most often to the less predictable fields, such as chemistry, where minor changes in a
product or process may yield substantially different results”.

73

Pfizer vs

Apotex
(
s
upra

n 70

at 1371
)
.


74

Supra

note
17
.

See also Anita Ramanna
Interest Groups and Patent R
eform in India
,
Indira
Gandhi Institute of Development Research, Mumbai Working Papers

(2003)
<
http://econ
papers.repec.org/paper/indigiwpp/2003
-
006.htm
>.

deployed the excuse of “TRIPS compliance” and referred this to an expert
committee.
75




Section 3(d) creates something close to a bright line rule for determining th
e
patentability of pharmaceutical derivatives. In a country with a relatively
unsophisticated patent office that is examining pharmaceutical product claims for
the first time, the advantage of such a bright line rule cannot be stressed
enough. However, sec
tion 3(d) is still shrouded in

considerable uncertainty and
the government must now work towards guidelines to help
“brighten”
the line.



Even assuming that we determine

the precise contours of
“efficacy”, how do

we
go
about deciding as to
what level of

efficacy


would suffice

to make something
patentable
? The Explanation to section 3(d) mandates stipulates that there
should be a “si
gnificant difference in properties

with regard to efficacy”? Will a
10% increase in efficacy amount to a significant differe
nce in property”? Or will it
have to be higher? This is a complex issue for which there is no ready answer. A
quantitative increase of 5% in “stability” may cause one substance to improve so
much that it can finally be converted to a drug form, whereas wit
h another drug,
it would hardly amount to much.
76


Unlike defining efficacy (which could either be restrictively defined as
“therapeutic efficacy” or broadened to include any kind of “advantageous
property”), it is not possible to lay down a definitive gui
deline or a bright line rule
for determining when something amounts to a “significant” difference in efficacy.
Therefore
it is best to leave this to be decided on a case
-
by
-
case basis.


The term “efficacy” is a very useful policy lever and India ought to
ply with it
very carefully. This becomes ever more pertinent, now that now that there are
more cases at the patent office that hinge on section 3(d)
77

and several countries
that are seeking to emulate section 3(d).
78




75

Mashelkar Committee Report

(
supra

note 42
).


76

See
In re Carabateas
,
357 F.2d 998, 1001 (C.C.P.A. 1966)
, where the prior art suggested at
most a four to eight
-
fold increase in activity level, whereas the ap
plicant’s compound exhibited a
nineteen
-
fold increase. Therefore it was held “unexpected”. Compare with
Ortho
-
McNeil Pharm.,
Inc. v. Mylan Labs., Inc.,

348 F. Supp. 2d 713, 749 (N.D. W. Va. 2004)
,
where the court found
that a mere two
-
fold increase was une
xpected, even in light of a prior art showing that some
increase might be expected. For a discussion of these cases, see Jonathan J Darrow
The
Patentability of Enantiomers: Implications for the Pharmaceutical Industry
2007 Stan. Tech. L.
Rev. <http://stlr
.stanford.edu/pdf/darrow
-
patentability.pdf>

77

S
upra

note
58
.


78

Gireesh Chandra Prasad,
Copycats Popping Patent Law P
ill
,
E
CON
.

T
IMES
,

A
UG
.

13,

2007

<http://economictimes.indiatimes.com/News/News_By_Industry/Healthcare__Biotech/Pharmaceu
ticals/Copycats
_p
opping_patent_law_pill/articleshow/2276358.cms>
.


C
ONCLUSION


To reiterate the thesis of

this paper, section 3(d) represent India’s attempts at
innovatively striking a balance between innovation and public health, given its
status as a “technologically proficient” developing economy and it’s need to work
within the broad framework of TRIPS.


To this extent, section 3(d) is best appreciated through a 3
-
D lens
---
a lens that
helps us move beyond the antiquated developed vs developing country
classification.


However, it is not clear what the term “efficacy” in section 3(d) entails. Section
3(d)

needs to be refined further to make it work more “efficaciously” and to help
India spearhead the emergence of truly innovative patent norms, characteristic
of a new breed of “technologically proficient countries. This would lend more
certainty to the law
and attract more investment in R&D. It will also create more
bright line rules that are tremendously helpful in countries like India with less
sophisticated patent of
fices. However, in so far as a

quantitative determination of
a “significant difference” in

efficacy is concerned, bright line rules may not help,
since diffe
rent percentages have different

implications
, depending on the kind of
derivatives that are
used and the context in which they are so used
. This should
therefore be decided on a case
-

by
-

c
ase basis.


To this end, one ought to appreciate that the term “efficacy” is a useful policy
lever and has to be plied with carefully. If pegged too high, it could hurt the
innovation imperatives. If pegged too low, it could exacerbate ever
-
greening. In
th
is regard, it is important that we not conflate the interests of domestic majors
and consumers and peg the level as high as possible

to possibly approximate a
position where effectively
only new chemical entities will

be granted patent
protection. A clear
pair of 3
-
D lens w
ill
help us see these interests as distinct and
thereby enable us to peg the level at a more reasonable level, than would have
been the case, had we continued to be blinded by this conflation.



When I could find voice, I shrieked aloud
in agony, "Either this is madness or it is
Hell." "It is neither," calmly replied the voice of the Sphere, "it is Knowledge; it is
Three Dimensions: open your eye once again and try to look steadily."
79



79

Edwin A Abbott,
Flatland: A Romance of Many Dimensions

(Dover Publications, 2007).