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Business, Government and Society: Pre-Market Structures Facilitating Business

The document discusses the development of the cancer drug Glivec/imatinib by Novartis for treating chronic myeloid leukemia. It provides details on the scientists and institutions involved in inventing and developing the drug. It then summarizes the legal battle between Novartis and the Indian government over a patent for the beta crystalline form of imatinib, which India rejected on the grounds that it did not show significant improvement in efficacy. The document places this case in the context of negotiations over intellectual property rights in global trade agreements and debates around balancing pharmaceutical patents and access to affordable medicines.

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manmeet kaur
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38 views

Business, Government and Society: Pre-Market Structures Facilitating Business

The document discusses the development of the cancer drug Glivec/imatinib by Novartis for treating chronic myeloid leukemia. It provides details on the scientists and institutions involved in inventing and developing the drug. It then summarizes the legal battle between Novartis and the Indian government over a patent for the beta crystalline form of imatinib, which India rejected on the grounds that it did not show significant improvement in efficacy. The document places this case in the context of negotiations over intellectual property rights in global trade agreements and debates around balancing pharmaceutical patents and access to affordable medicines.

Uploaded by

manmeet kaur
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Business, Government and Society

Pre-Market structures facilitating


business

Session 2
Basic Facts:
What is Glivec and who made it?
• Glivec (imatinib mesylate)--produced by Novartis--prescribed for
Chronic Myeloid Leukemia.
• Imatinib--invented in the late 1990s by biochemist Nicholas,
Elisabeth Buchdunger and Jürg Zimmermann at Ciba-Geigy (which
later became Novartis).
• Its use to treat CML driven by oncologist Brian Druker of Oregon
Health & Science University (OHSU).
• Other major contributions to imatinib development:
– Carlo Gambacorti-Passerini, Italy,
– John Goldman, UK
– Charles Sawyers of Memorial Sloan-Kettering Cancer Center.
• Druker led the clinical trials confirming its efficacy in CML.
Timeline: The Patent
• 1992: Swiss patent application filed on imanitib
• 1993: patents in EU, the US, and other countries .filed
• 1996: US and EU issued patents listing Jürg Zimmermann as the inventor.
• 1997: Novartis filed a new patent application in Switzerland on the beta
crystalline
– This is the actual form of the drug sold as Glivec;
• 1998: Novartis filed international patent applications claiming priority to
the 1997 filing.
• 1998: Patent application filed by Novartis in India.
– Novartis fought a seven-year battle, case went to the Indian Supreme Court.
• 2005: US patent granted.
Glivec Case in a Nutshell
• Novartis filed an application for Glivec, in the beta crystalline
form of the salt.
• The Supreme Court affirmed India’s pharmaceutical patenting
is stricter than the US or the EU.
– Patent applicant must show new form is different from old form
& the modification results in an improvement in the treatment.
• The Supreme Court upheld the Indian patent office's rejection
of the patent.
• Novartis threatened to stop supplying India with new
medicines.
Invention: One Man Show or Team Work?
• For Glivec, no one challenged Zimmerman’s sole
inventorship.
• But did he do it alone?
– Legally, the law does not look at whose contribution/effort
towards the product was more or less.
• Innovation rests on the shoulder of giants
• Can we point to anyone person?
– Numerous scientists contributed to the making of Glivec
– Zimmerman and Buchdunger spent >2 years in developing the
right molecule
– Brian Drucker was the lead author of article on Glivec and
worked to find a treatment for CML
• Teams have multiple layers
Glivec Case in India: Brief History
• The TRIPS 2005 Agreement set mandatory minimum rules for
20 year patents for products and processes
– The agreement did not stipulate what ‘new’ or ‘inventive’
– This gave flexibility to developing nations.
• Earlier patent law in India no product patents only process
patents
– Generic medicines.
– India net exporter of medicine by 1988.
• India complied with the TRIPS--introduced Exclusive Market
Rights (ERM) regime
• Parliament careful that Right to Health not be compromised by
the ‘Evergreening’
– Resulted in the famous Section 3 (d) of the patent law
Section 3 (d)
• Section 3(d) of the Indian Patents Act, 1970:
“the mere discovery of a new form of a known substance which does not
result in the enhancement of the known 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 known
process results in a new product or employs at least one new reactant.”
• Novartis challenged section 3(d)
• 5 pre-grant oppositions filed by Cancer Patients Aid
Association (CPAA) and 4 by Indian Generic Companies.
Two sides of the Argument
Indian SC Novartis
• Accepted that the beta crystalline • Novartis contented the invention
form imatinib mesylate was new was novel, inventive and
and not obvious. industrially applicable.
• Noted that 30% increase in • Alleged 30% increase in bio-
bioavailability was in comparison
to the free-base form of imatinib availability in the beta crystalline
which was already known, form mesylate.
therefore this comparison was • Significant increase in efficacy.
inappropriate.
• In the context of Section 3(d):
“…not all advantageous or beneficial
properties that directly relate to
efficacy, which in case of
medicine…is its therapeutic efficacy.”
How Novartis Reacted?
• Stated that imatinib mesylate had been granted patent in 40
different countries and India should do the same.

• Justified its patent claims by stating R&D costs need to be


recovered through the drug’s high cost.

• Tried to raise fears about the future of innovation in India if


patents were rejected.
Global Context: Negotiations at WTO
• In 1986: Uruguay round under the GATT.
• The developed countries introduced issues not entirely to
trade such as IPR, investment and services.
• Initially, the developing countries lead by India and Brazil able
to stall the introduction of these new issues.
• USA continued to press for inclusion
– Economy in a bad shape
– Losing competitive edge in manufacturing
– Agricultural exports threatened by state-subsidised agricultural from
Europe.
– Protecting IP-dependent industries where it still had an advantage –
Pharmaceuticals, software and audio-visual media.
So Where is This Coming From?
Global Context: Negotiations at WTO

• India had a clear interest in not agreeing to these new demands


– Indian Patent Act, 1970 did not allow patents on medicines and agro-
chemicals; the Indian pharma sector had flourished.
• By the beginning of 1989, the resistance by developing
countries was broken down.
• The significance of the negotiations was not clear to most
popular movements and civil societies in different parts of the
world.
Are Patents on Medicines Ethical?
• Evergreening and the practice of abusive patenting were first
highlighted in 1990s with the HIV epidemic, when medicines
were priced way out of reach.
• First example: ‘Zidovudine’ (AZT)-- a cancer drug, but GSK
granted a patent for it as a antiretroviral.
• GSK in 1977 granted secondary patent in several countries
making the access to this drug difficult and expensive for
patients.
Are Patents on Medicines Ethical?
• India managed sustainable supply of affordable HIV
medication through generics manufacture.
• 1995: In anticipation of change in patent laws many patents
filed for TB, cancer, HIV drugs.
– Resulted in many secondary patent applications pending in the
Indian Patent office
• MSF, UNAIDS, WHO and French President warned India to
strike a balance between the TRIPS obligation and protecting
the access to affordable medicines.

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