What is Evergreening?
• Evergreening is the practice whereby
pharmaceutical firms extend the patent life of a drug by obtaining additional
20-year patents for minor reformulations or other iterations of the drug,
without necessarily increasing the therapeutic efficacy for patients.
Benefits of Evergreening to patent holders
• Evergreening allows pharmaceutical companies
to obtain or extend monopoly protection for old drugs simply by making minor
modifications to existing formulations or dosages, or by identifying a new
therapeutic use for an existing medicine.
What is GLIVEC ?
• It is brand name of IMATINIB
• Novartis holds the patent right to produce
Imatinib
• It is used to treat many cancers including
chronic myeloid leukemia [ a type of blood cancer]
Who is Novartis?
• Novartis International AG is a Swiss
multinational pharmaceutical company based in Basel, Switzerland, ranking
number two in sales among the world-wide industry in 2010.
• Novartis is the third largest beneficiary of
registered patents in India, behind Roche and SanofiNovartis is the third
largest beneficiary of registered patents in India, behind Roche and Sanofi
What section 3[d] of Patents act says
• Section 3(d), as introduced in April 2005
into the Indian patent law, represents a unique requirement to be fulfilled for
patentability of certain types of pharmaceutical inventions. According to Section 3(d), in order for a new form
of a known substance to be patentable, it must show an enhanced efficacy with
respect to the known efficacy of the substance concerned.
What is TRIPS
• The Agreement on Trade Related Aspects of
Intellectual Property Rights (TRIPS) is an international agreement administered
by the World Trade Organization (WTO) that sets down minimum standards for many
forms of intellectual property (IP) regulation as applied to nationals of other
WTO Members
What TRIPS article says about Patent
• TRIPS Article 27.1 requires that “patents
shall be available for any inventions, whether products or processes, in all
fields of technology, provided that they are new, involve an inventive step and
are capable of industrial application.
Madras High court judgement on patent
evergreening issue
• Madras High Court had in 2007 held that the
appropriate route to challenge non-compliance with TRIPS is the WTO Dispute
Settlement Body and not the Indian courts.
Why the Glivec case has emerged ?
• Novartis is the producer of “Imatinib” and
got patent rights for 20 years. Now 20 years time period is over. Then Novartis
produced a new crystalline salt form of Imatinib mesylate. It claimed that it
is a new product and applied for patent right for another 20 years.
• But patents office rejected Novartis’s claim
then it moved to Intellectual Appellate tribunal board and it also rejected
then moved to supreme court it also rejected its claim.
Why patent office rejected Novartis’s claim ?
• In 2006, the Indian patent office ruled that
the new salt form did not deserve a new patent, since it did not meet the
provision of “increased efficacy” required under Sec. 3(d).
Controversial issue of “efficacy”
• Novartis argued that the salt form would have
higher levels of availability in the body of the patient, but the Madras High Court
clarified that “efficacy” means “therapeutic efficacy in healing a disease”
Who is IPAB ?
• IPAB stands for Intellectual Appellate
Tribunal Board
• It works under the ministry of commerce and
industry.
• IPAB also rejected the Novartis’s claim. The
IPAB had upheld the contention of the Indian Patent Office that the drug,
Glivec, is simply a new form of imatinib and hence not patentable as per
Section 3 (d) of Indian Patent Act.
• Then Novartis moved the case to supreme
court.
Supreme court judgement
• It is important to note that the Supreme
Court did indeed clarify that Section 3(d) does not bar patent protection for
all incremental inventions of chemical and pharmaceutical substances, provided
they pass the test of the expanded scope of Section 3(d).
Importance of Supreme court judgement
• In India, about 2,00,000 people suffer from
chronic myloid leukaemia and about 30,000 are added every year. After this
judgement, the prices of the drug will remain low, all these people would
benefit.
What needs to be done ?
• “On one hand we have a large number of
companies who have invested billions in research, in developing new molecules,
in new drug discoveries and in research. On the other hand, there is a social
obligation to provide affordable and cheap drugs and healthcare. We have to
strike the right balance”
What is compulsory license ?
• A compulsory license, also known as statutory
license or mandatory collective management, provides that the owner of a patent
or copyright licenses the use of their rights against payment either set by law
or determined through some form of arbitration. In essence, under a compulsory
license, an individual or company seeking to use another's intellectual
property can do so without seeking the rights holder's consent, and pays the
rights holder a set fee for the license.
• In March 2012, India granted its first
compulsory license ever. The license was granted to Indian generic drug
manufacturer Natco Pharma Ltd for Sorafenib tosylate, a cancer drug patented by
Bayer
Timeline of Issue
· 1997- Novartis filed a patent
application in India for its drug Glivec.
· 2005- India introduced the
Indian Patent Act to prevent the evergreening or patenting of new forms of
already known molecules.
· 2005- The patent controller in
Chennai denied Novartis the sought Patent.
· 2006- Novartis challenged the
Indian govt and four other Companies in Madras Court.
·
2007- The Madras court ruled
against Novartis’s Case.
·
2009- The Intellectual
Appellate Board rejected a fresh appeal.
·
2009- Novartis approached
Supreme Court of India
·
2013- Supreme Court Denied the
Patent
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Additional Reading !!!
What is the
Difference between Patents vs. Copyrights?
|
Patent
|
Copyrights
|
|
Inventor/Designer has complete rights over the idea in
whichever form it is used == right to exclude others from making, using,
offering for sale or selling
|
Copyrights on the other hand given for a work in particular form
like a book, an audio and only that exact reproduction, example cut and paste
of text falls under its ambit.
|
|
It requires compulsory registration.
|
Does not require a registration, once the work is created it is
a property of the author.
|
|
Patent rights are thus usually given for a brief period say 20
years.
|
The rights are given for the entire lifetime of the
author and extend for 50 years even after the death of the producer.
|
Copyright example:
·
a description of a machine could be
copyrighted, but this would only prevent others from copying the
description;
·
it would not prevent others from
writing a description of their own or from making and using the machine.
What is the Pranab Sen Task Force on Drug Pricing all about ?
§ In 2003 Supreme court passed an order that all essential drugs
should remain under price control..
§ Therefore, Government of India set up a Task Force under Dr.
Pronab Sen on drug pricing.
§ It submitted its final report in 2005.
