Beruflich Dokumente
Kultur Dokumente
EPW
sales had reached $1 billion, and revenues 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 Myeloid Leukemia 2013). Such an article
could have been published several years
ago: this is hardly a new problem. But,
one hopes at this late stage that while
the key patents are still in force in several countries, and the original US patent having been extended from its expiry date of 28 May 2013 for 586 additional days, it might make a difference. It is
also worth noting that Druker reportedly 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
References
Brody, H (2007): Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry (Lanham:
Rowman & Littlefield).
Buchdunger, E and J Zimmermann (nd): The
Story of Gleevec, viewed on 2 June 2013,
http://www.innovation.org/index.cfm/Stories
ofInnovation/InnovatorStories/The_Story_
of_Gleevec
Druker, B, S Tamura, E Buchdunger, S Ohno,
G M Segal, S Fanning, J Zimmermann and
N B Lydon (1996): Effects of a Selective Inhibitor
of the Abl Tyrosine Kinase on the Growth of
Bcr-Abl Positive Cells, Nature Medicine, 2(5):
561-66.
Experts in Chronic Myeloid Leukemia (2013): The
Price of Drugs for Chronic Myeloid Leukemia
(CML) is a Reflection of the Unsustainable
Prices of Cancer Drugs: From the Perspective of
a 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 Revolution: How Smart Drugs and Other New
Therapies Are Renewing Our Hope and Changing the Face of Medicine (Hoboken: John Wiley
& Sons).
Nowell, P C and D A Hungerford (1960): A Minute
Chromosome in Human Chronic Granulocytic
Leukemia, Science, 132(3438): 1497.
Vasella, D and R Slater (2003): Magic Cancer Bullet:
How a Tiny Orange Pill Is Rewriting Medical
History (New York: HarperBusiness).
Smita M Patil
Varsha Ayyar
Rekha Raj
Anandhi S
Manisha Gupte
Swathy Margaret
Meena Gopal
vol xlviii no 32
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References
Arulanantham, David P (2004): The Paradox of
the BJPs Stance Towards External Economic
Liberalisation: Why a Hindu Nationalist Party
Furthered Globalisation in India, Asia Programme Working Paper, December, Royal
Institute of International Affairs, Chatham
House, London.
ICTSD (2005): Indian Parliament Approves Controversial Patent Bill, Bridges Weekly Trade
News Digest, 9(10), International Centre for
Trade and Sustainable Development, viewed
on 20 June 2013, http://ictsd.org/i/news/
bridges weekly/7294/
Khor, Martin (2013): A Victory for Patients Access
to Medicines, Global Trends Series, Third
World Network, 8 April, viewed on 20 June
2013, http://www.twnside.org.sg/title2/gtren
ds/2013/gtrends426.htm
Marcellin, Sherry S (2010): The Political Economy of
Pharmaceutical Patents: US Sectional Interests
and the African Group at the WTO (Farnham,
England: Ashgate Publishing).
Padma, T V (2007): Plagiarised Report on Patent
Laws Shames Indian Scientists, Nature Medicine,
13(4): 392.
Sen Gupta, Amit (2010): B K Keayla: A Personal
Reminiscence, Economic & Political Weekly,
45(51): 25-26.
Shukla, S P (2000): From GATT to WTO and Beyond, Working Papers No 195, United Nations
University/World Institute for Development
Economics Research, Helsinki, Finland.
45
Analysing the
Supreme Court Judgment
Anand Grover
46
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The Court found that as the crystalline 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 comparison could be made of the crystalline
form of imatinib mesylate with a known
substance with known efficacy as
required under Section 3(d). This was rejected 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 public, 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 science or men of commerce or consumers.
In examining the efficacy of the different forms of imatinib, that is imatinib
free base, non-crystalline form of imatinib 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 circumstances the Court queried how there
could be any enhanced efficacy in the
crystalline form of imatinib mesylate?
In this respect, Novartis filed two affidavits 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 bioavailability 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 noncrystalline 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 over
non-crystalline imatinib mesylate, which
Novartis had failed to do. Moreover, the
48
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12
13
14
15
vol xlviii no 32
References
Correa, Carlos M (2013): Is Section 3(d) Consistent
with TRIPS?, Economic & Political Weekly, 48(32).
NIHCM (2002): Changing Patterns of Pharmaceutical Innovation (Washington: National Institute
for 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 of
Indian Generic Manufacturers in Supplying Antiretroviral Medicines to Developing Countries,
Journal of the International AIDS Society, 13: 35.
49
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Another potential objection to Section 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 interpretations 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
IPAB considered 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 mesylate fails in both the tests of invention
and patentability as provided under
clauses (j), (ja) of Section 2(1) and Section 3(d) respectively (para 195).9
It has also been suggested that
Section 3(d) relates to the utility requirement for patentability: the limited integration 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
utility that mars patent regimes (Roderick
and Pollock 2012).
Whether Section 3(d) is part of the definition of invention (as explicitly stated by
the provision)10 or a patentability requirement (inventive step and/or utility), is not
essential for an assertion of the provisions
compatibility with Article 27.1 of the
TRIPS Agreement. 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 considered an invention for the purposes
of patent law. Like most patent laws in
the world, the TRIPS Agreement does not
define what an invention is. Hence, WTO
members can adopt different concepts,
august 10, 2013
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References
Burk, D and M Lemley (2003): Is Patent Law Technology-Specific?, 17 Berkeley Tech Law Journal,
(1155), 1155-1206.
Correa, C (2006): Guidelines for the Examination of
Pharmaceutical Patents: Developing a Public
Health Perspective (Geneva: WHO, ICTSD and
UNCTAD).
(2007): Trade Related Aspects of Intellectual
Property Rights (Volume VI of Commentaries on
the GATT/WTO Agreements) (Oxford: Oxford
University Press).
Purohit, R and P Venugopalan (2009): Polymorphism: An Overview, Resonance, September,
882-93, viewed on 8 July 2013, http://www.ias.
52
ac.in/resonance/September2009/p882-893.pdf
Roderick, P and A Pollock (2012): Indias Patent
Laws Under Pressure, The Lancet, 380(9846):
e2-e4, viewed on 8 July 2013, http://www.thelancet.com/journals/lancet/article/PIIS01406736(12)61513-X/fulltext
Sampat, B, K Shadlen and T Amin (2012): Challenges to Indias Pharmaceutical Patent Laws,
Science, (337): 414-15.
USTR (2013): 2013 Special 301 Report, United
States Trade Representative, viewed on 8 July
2013, http://www.ustr.gov/sites/default/files/
05012013%202013%20Special%20301%20Report.pdf
USDJAMP et al (2010): Brief for the United States
as Amicus Curiae in Support of Neither Party,
vol xlviii no 32
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Notes
1 In March 2000, the daily dose (400 mg) of fluconazole needed to treat cryptococcal meningitis cost $17.84, more than two times the daily
wage of an average employed South African
who earned just $7.69. In Thailand, however,
the daily dose of fluconazole costs just $1.20
(Doctors Without Borders 2000).
2 A common patenting practice in the pharmaceutical industry aimed at filing and then
obtaining separate (and sequential) patents relating to different aspects of the same medicine, such as different dosages, formulations,
fixed dose combinations and different forms of
the active ingredient, among others.
3 In September 1986, early clinical tests showed
that Azidothymidine (AZT), a drug first synthesised in 1964 to be used as chemotherapy
for leukemia, slowed down the progress of the
disease. In 1987, AZT became the first anti-HIV
drug 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%2F
PTO%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 on
30 June 2013, http://apps.who.int/medicinedocs/en/d/Js4913e/7.html
6 Under the 1970 Patents Act, India did not grant
product patents on medicines.
7 On 19 November 2003, the South African
National Department of Health announced an
Operational Plan for the rollout of ARV medicines in the public health system. UNAIDS/
WHO statistics from 2004 suggested that of the
approximately 5.3 million people living with
HIV/AIDS in the country, 7,50,000 were in
need of ARV treatment.
8 The TRIPS Agreement came into effect on 1
January 1995, setting out minimum standards
for the protection of intellectual property,
including patents on pharmaceuticals. Under
that agreement, since 2005 new drugs may be
subject to at least 20 years of patent protection
in all, apart from in the least-developed countries and a few non-World Trade Organization
members, such as Somalia.
References
Correa, Carlos M (2013): Is Section 3(d) Consistent with TRIPS?, Economic & Political Weekly,
48(32).
Doctors Without Borders (2000): One World, One
Price Means Death for People With AIDS in
Poor Countries, 13 March, viewed on 30 June
2013, http://www.doctorswithoutborders.org/
press/release.cfm?id=536
(2006): MSF Urges Novartis to Drop Case
Against Indian Government, 20 December,
viewed on 30 June 2013, http://www.doctorswithoutborders.org/press/release.cfm?id=37
15&cat=press-release
Dutfield, Graham (2013): Who Invented Glivec?
Does It Matter Anyway?, Economic & Political
Weekly, 48(32).
Ghose, Sagarika (2013): FTN: SC Ruling on
Novartis: 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-cancer-drugs-be-cheaply-available.html
Grover, Anand (2013): Analysing the Supreme
Court 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 Glivec
Patent Clarifies Limited Intellectual Property
Protection and Discourages Future Innovation
in India, 1 April, viewed on 30 June 2013,
http://www.novartis.com/newsroom/mediareleases/1689290.shtml
Menghaney, L (2013): R&D: What Novartis Says...
and Why Its Wrong, Livemint, 12 April, viewed
on 30 June 2013, http://www.livemint.com/
Opinion/ 3KaBPvulUVkRSoDh8xkVRJ/RDWhat-Novartis-says-and-why-its-wrong.html
Sengupta, Amit (2013): Two Decades of Struggle,
Economic & Political Weekly, 48(32).
Survey
August 27, 2011
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: circulation@epw.in
august 10, 2013
vol xlviii no 32
EPW
K M Gopakumar (kumargopakm@gmail.com)
is Legal Advisor and Senior Researcher with
the Third World Network.
Economic & Political Weekly
EPW
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vol xlviii no 32
Sharing the concern, the Parliamentary Standing Committee on Commerce in its report in
2008 recommended, The government should
clarify the usage of terms significantly and efficacy, which form parts of Section 3(d), to
clear the ambiguities involved in the interpretation of the said section (Parliamentary
Standing Committee on Commerce 2008).
A study by the National Intellectual Property
Organisation (NIPO) identifies at least 86
patents granted on known substances or combinations of substances bypassing Section 3(d)
(James 2010).
Ideally a country like India should curb the patenting of known substances by amending its
patent law to explicitly exclude patents for
known substances. The easiest way to do this
is by deleting the three-qualifications from
Section 3 (d). First, the word mere, second,
which does not result in the enhancement of
the known efficacy of that substance, third,
unless they differ significantly in properties
with regard to efficacy.
References
Chaudhuri, S, C Park and K M Gopakumar (2010):
Five Years Into The Product Patent Regime:
Indias Response, United Nations Development Programme, viewed on 3 July 2013,
http://www.undp.org/content/india/en/home/
knowledge-and-solutions/discussion-papers/
five_ years_into_ theproduct patentregimeindiasresponse.html
EAC (2013): Regional Intellectual Property Policy on
the Utilisation of Public Health-Related WTO-TRIPS
Flexibilities and the Approximation of National
Intellectual Property Legislation (Arusha: East
African Community), viewed on 3 July, http://
www.cehurd.org/wp-content/up loads/downloads/2013/05/EAC-TRIPS-Policy.pdf
James, T C (2010): Patent Protection and Innovation: Section 3(d) of the Patents Act and Indian
Pharmaceutical Industry (National Intellectual
Property Organization).
Livemint (2013): Health Ministry Recommends
Compulsory Licensing of Three Anti-Cancer
Drugs, 16 January, viewed on 3 July, http://
www.livemint.com/Companies/F3Rn5jCkKjCJNYzh tuQseO/Health-ministry-recommendscompulsory-licensing-of-three-ant.html
Parliamentary Standing Committee on Commerce
(2008): 88th Report on Patents and Trade Marks
Systems in India (New Delhi: Rajya Sabha),
viewed on 3 July 2013, http://164.100.47.5/
newcommittee/reports/EnglishCommittees/
Committee%20on%20Commerce/88th%20
Report.htm
Patent Office (2008): Draft Manual of Patent Practice
and Procedure (Mumbai: Controller General
of Patents, Designs & Trade Marks), viewed on
3 July 2013, http://ipindia.nic.in/ipr/patent/
DraftPatent_Manual_2008.pdf
Public Citizen (2013): Elli Lilly Investor State Dispute
Fact Sheet, Public Citizen, viewed on 3 July 2013,
http://www.citizen.org/documents/eli-lillyinvestor-state-factsheet.pdf
Sengupta, Amit (2013): Two Decades of Struggle,
Economic & Political Weekly, 48(32).
available at