This presentation include brief about various intellectual property rights in India like patent, copyright, trademarks etc. It also include a detailed case discussion of Novartis anticancer drug Glivec i.e imatinib mesylate which is a patent case.
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Intellectual property litigations: A case study of Anticancer drug Glivec in India
1. Dr. Shahid A Saache
Dept. of Pharmacology
BJGMC, Pune
PG Guide- Dr. S. A. Divhare
2. Intellectual property is an intangible creation of
human mind, usually expressed or translated
into a tangible form that is assigned certain
rights of property.
3. The US. Constitution authorizes Congress to protect
patents (Art. 1, Sec. 8, clause 8):
“Congress shall have the power to promote the
progress of science and useful arts, by securing for
limited times to Inventors the exclusive right to their
discoveries"
4. No mention of IP but just the word "property"
Article 19 - Freedom to acquire, hold and dispose off
property
Article 31 - Protection from deprivation of property
Article 32 - Property could be possessed or acquired
for public purpose only by law and only on payment
of compensation
5.
6. Functional & Technical
Inventions
Patents Act, 1970
Amended
in 1999 & 2005
Purely
Artistic works
Copyright Act,
1957
Amended in1982,
1984, 1992,
1994 & 1999
A symbol, logo, word, sound,
color, design, etc.
Trademark
Act, 1999
Amended in 1994,
1996 & 2000
7. The term original in the copyright law means that the
work originated with the author
There is no requirement for novelty or uniqueness
as there is in patent law
Copyright law protects the expression of an idea
not the idea itself
9. Ideas
Facts
Recipes
Works lacking originality
(e.g. The phone book)
Names, titles or short
phrases
10. Register a copyright by completing a simple
application form, along with appropriate fee
Need not send a copy of your work
It may appear with the same title, but if each work
has been created independently, each will have its
own copyright protection
11. Copyright lasts for-
Author’s lifetime + 50 years from the end of calendar
year in which the author dies
50 years for films & sound recordings
25 years for typographical arrangements of a
published edition
Copyright protection always expires on December 31
of the last calendar year of protection
12. Word “Patent”- “litterae patentes” meaning an open
letter
Covered under the Act called the Patents Act, 1970
[Amended by Patents Act, 2005]
Invention patentable if...
New (novel)
Useful
Not obvious
Pertains to patentable subject matter
13. Term of the patent is 20 years from the date of filling
for all types of inventions
The date of patent is the date of filing the application
for patent
The term of the patent is counted from this date
14. The Government fee for filing a patent application in
India is Rs.1600/- for individuals and Rs.8,000/- for
legal entities
No fee for 1st and 2nd year
Renewal fee, on yearly basis, is required to be paid
for 3rd to 20th for keeping the patent in force.
Patent lapses if renewal fee is not paid within the
prescribed period
15. The object: The object of patent law is to encourage
scientific research, new technology, industrial progress
Inventive step: The fundamental principle of Patent law
is that a patent is granted only for an invention which
must have novelty & utility
Useful: should be useful to the community
Improvement: In order to be patentable, it must satisfy
the test of invention or an inventive step
16.
17. It is covered under the Act called the Trade Marks Act,
1999 --- came into effect on Sept 15, 2003
It replaced the Trade and Merchandise Marks Act, 1958
™ Intent to use application filed for product
SM Intent to use application filed for services
® Registered trademark
18. Application for search
Application for registration
Examination of trademark
Advertisement of trademark
Filing of opposition
Certificate issued
19. • Trademark is valid for 10 years from the date of
application which may be renewed for further period
of 10 years on payment of prescribed fees.
• Service mark Rights are reserved exclusively for
owners for 17 year & it can also be renewed.
• The Govt. fees
20. The case of
Novartis
Anticancer drug
Glivec in India
Novartis International AG is swiss MNC based
in Basel, Switzerland is 3rd largest beneficiary
of registered patents in India.
21. Generic pharmaceutical manufacturers dominate the
Indian pharmaceutical market, accounting for up to
90% of product sales
Given its capacity to produce large quantities of
drugs at cheap, affordable prices, India is known to
many as the “Pharmacy of the Developing World”
India now supplies 80% of the 6 million people
receiving treatment for HIV/AIDS in the developing
world today
22. For well over 30 years, the Indian government did not
allow product patents for pharmaceutical inventions,
paving the way for Indian generics companies to
“freely produce medicines created by foreign
drug companies at a fraction of the cost”.
23. • In 1995, India became a member of WTO & was
compelled to revise its patent laws following a 10-year
transition period.
• India’s adjusted laws had to comply with the TRIPS
Agreement i.e. WTO’s minimum standards for
intellectual property protection.
24. Process patents, on the other hand, were recognized
as they were seen as an incentive for domestic
manufacturers to develop “cheaper methods of
making expensive patented products”, and a way for
the Indian government to keep drug prices low
India’s domestic patent provisions have been
contested by the international research-based
pharmaceutical industry
provisions in its domestic law that ban
‘EVERGREENING’
25.
26.
27.
28. Criteria for ‘Compulsory licensing’ a clause permissible
under the TRIPS Agreement, which under extenuating
circumstances, permits a country to “force a firm to
license a patented drug to a generic company”
29.
30. Filing of patent by Novartis:
Novartis filed an application at Chennai patent office
in 1997 to grant a patent on Glivec
At that time India did not yet grant patents on
medicines
In Nov. 10, 2003 Novartis able to get EMR (Exclusive
Marketing Rights) for a period of 5 years based on
previous provision of Indian patent act
31. Granting EMR was a TRIPS obligation for countries
like India which do not give patent on
pharmaceutical products
After 2005 , Indian Patent Office began to review
pharma product patent applications EMR are either
given patent or are rejected
If rejected EMR rights also ends
EMR works like a patent monopoly which prevents
other pharma companies to manufacture of sell
generic products of Imatinib Mesylate
32. Cancer patient aid association (CPAA) has filed an
opposition on behalf of cancer patients in the
Chennai patent office
Pre grant opposition of Glivec
1. Claims show that patent is granted not on the
compound in its free form but also for the salt form
of Imatinib Mesylate
2. There is no inventive step, specifications do not
show any inventive step in making salt from free
base of Imatinib Mesylate & the process described
is too obvious for the person skilled in art
33. 1. Crystal salt form does not allow to invention
2. Patent application does not claim any therapeutic
efficacy- sec 3(d)
3. At the time of filing the patent application in 1998
Switzerland is not recognized as convention country
in India
34. Moreover to these grounds Glivec costs
Rs.1,20,000 per patient per month which is not
affordable in comparison to cost of generic
medicines which is Rs. 8000 per month per person
This is beneficial for public health in developing
countries like India
Also India is the main market of medicine for
developing countries, so low cost medicines are
needed
Issuing of patent will effect such requirements
35. In January 2006, the Patent Controller in Chennai,
refused to grant Novartis a patent, agreeing, amongst
others, with the contentions of the CPAA and generic
companies that the subject application
lacked novelty, was obvious, was not
patentable under section 3(d)
36. “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”
37. In June 2006, Novartis AG & its Indian subsidiary,
Novartis India, filed a series of writ petitions against
the Government of India, CPAA and 4 Indian generic
manufacturers before the Madras High Court
In April 2007 the Government of India notified the
IPAB to hear appeals relating to patents
Consequently, Novartis’ appeals were transferred to
the IPAB- a specialist tribunal on matters relating to
intellectual property
38. In August 2007, Madras High Court issued its
decision rejecting Novartis’ writ petitions challenging
the validity of section 3(d)
Novartis’ primary contention in its challenge to the
constitutional validity of section 3(d) was that the
use of the term “efficacy” in section 3(d) is vague
and ambiguous, and therefore violates the equality
provision (Article 14) of the Indian Constitution
39. During the arguments, while conceding that the
meaning of the term “efficacy” is known, Novartis
contended that because there was no clarity as to
what constituted “enhancement of efficacy” and
“significant enhancement of efficacy” as required by
section 3(d), the law was vague and lent itself to
arbitrary decisions by the Patent Controller
40. The Government of India, CPAA and generic companies
argued that section 3(d) is not in violation of the
equality provision of the Indian Constitution as the
concept of efficacy is well-known to persons in the
pharmaceutical industry and it is impossible to lay
down a “one size fits all” standard to determine what
constitutes a significant enhancement of efficacy
41. Dismissing the petition, the Madras High Court held
that section 3(d) was not vague or arbitrary and
therefore did not violate the Indian Constitution
The term “efficacy” was known in the
pharmaceutical field to mean “therapeutic efficacy”
Madras HC states- “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 this country to life saving
drugs and to discharge their Constitutional obligation
of providing good health care to it’s citizens.”
42. Commenced before the IPAB:
After a series of litigation in which Novartis contested
the constitution of the IPAB, Novartis’ appeal
challenging the patent controller’s order was finally
heard by a specially constituted bench of the IPAB
In its decision issued in june 2009, the IPAB
overturned the patent controller’s findings on
novelty and inventive step and held that the beta-crystalline
form of imatinib mesylate was new and
involved an inventive step
43. However, the IPAB held that Novartis’ alleged
invention did not satisfy the test of section 3(d) in as
much as Novartis did not provide data to show that
the beta-crystalline form of imatinib mesylate
exhibited significantly enhanced therapeutic efficacy
over imatinib mesylate, the known substance
In the appeals, the IPAB reversed the Patent
Controller order on two grounds, and held that the
claimed invention was novel and inventive
44. However, it agreed with the Patent Controller that it
was hit by Section 3(d) & rejected the patent
application
Subsequently in 2009, Novartis appealed directly
before the Supreme Court through a special leave
petition under Article 136 of the Indian constitution
45.
46. Chief contentions of Novartis were as follows
1. Company had met the required criteria of novelty &
inventive step
2. Compound in its β-crystalline form had enhanced
efficacy over other variants of the same compound
such as imatinib or imatinib mesylate and thereby
all requirements of the section 3(d) of the Indian
patents act, 1970 stands fulfilled
3. Sufficient research was carried out to selectively
prepare beta crystalline form of imatinib mesylate &
it was worthy of being granted patent rights
47. The contentions made by the Additional Solicitor
General of India are as follows
β-crystalline form of the compound is neither novel
nor non-obvious owing to publications about it in the
‘Cancer Research and Nature’ in 1996, and various
other disclosures in Zimmerman patents & by FDA
Requirement of efficacy as stated in section 3(d) of
the Act should be held to be interpreted on lines of
therapeutic efficacy and not merely one of physical
efficacy
48. Taking into consideration the contentions of the
parties, the Supreme court held that Novartis failed
to meet the requirement of novelty
And also thereby failing to qualify for the test of
invention as provided for under in section 2(1)(j) and
section 2(1)(ja) of the Patents Act, 1970 as a result of
the various publications and disclosures already
made about the beta crystalline form of the
compound, Imatinib Mesylate
49. Section 2(1)(j) in The Patents Act, 1970
“Invention" means a new product or process
involving an inventive step & capable of industrial
application
“Inventive step" means a feature of an invention
that involves technical advance as compared to the
existing knowledge or having economic significance
or both and that makes the invention not obvious to
a person skilled in the art
50. Further the court decided to interpret efficacy as laid
down in section 3(d) of the Act of lines of therapeutic
efficacy and not merely physical efficacy
Though physical efficacy of imatinib mesylate in beta
crystalline form is enhanced in comparison to other
forms, but since there was no substantive and
conclusive material and evidence to prove that beta
crystalline form of imatinib mesylate will produce an
enhanced or superior therapeutic efficacy, Novartis
failed to meet the requirements under section 3(d)
of the act
51. On these grounds Supreme court also rejected the
patent application on April 2013
52.
53.
54. 1997: Novartis filed a patent application in India for its drug Glivec.
2005: India introduced the Indian Patent Act preventing frivolous patents.
January 2006: The Patent Controller in Chennai denied Novartis a patent.
May 2006: Novartis challenged the Indian government and four other companies in
the Madras High Court.
August 2007: The Madras High Court ruled against Novartis's case.
June 2009: The Intellectual Property Appellate Board rejected a fresh appeal.
August 2009: Novartis approached the Supreme Court of India.
Notes de l'éditeur
The Indian Copyright Act, 1957 governs the system of copyrights in India.
It is a right which Grants protection to the unique expression of Ideas
Fair Use
Gives permission to use copyrighted materials if certain criteria are met
Protects freedom of speech
Promotes public benefits like education
Never assume that your use falls under the fair-use exception!
A patent describes an invention for which the inventor claims the exclusive right
It extends to the whole of India
Is A Patent Granted In One Country Enforceable In Other Countries?
No, there is nothing like a global patent or a world patent
Patent rights are essentially territorial in nature
Granting a patent in one country of the Union does not force other countries to grant the patent for the same invention.
The refusal of the patent in one country does not mean that it will be terminated in all the countries
The previous Act, i.e. Act of 1911
A symbol, logo, word, sound, color, design, or other device that is used to identify a business or a product in commerce.
It extends to the whole of India
The fee for filling of application to register a trademark is Rs 4000/- for expedite examination it is Rs.20000/-
It produces Glivec (imatinib mesylate) is used to treat CML & GIST
It is patented in 35 countries across the world
India’s pharmaceutical industry- 3rd largest in world in terms of volume & 14th in terms of its value
With China, Brazil and Russia, it led a group of seventeen high-growth pharmaceuticals markets also called “Pharmerging countries”
By 2020, pharmaceutical sales in India are predicted to grow over 6 times than what they were in 2010
as it has become a leading supplier of generic medicines to many developing countries
India also stands as “the second leading provider of medicines distributed by UNICEF in the developing world”.
Thus, January 1st, 2005 saw the “implementation of substantially enhanced patent protection for pharmaceuticals” in India, in that drug products were now able to become patentable
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
1.Reasonable requirement of public have not satisfied
2.Patented drug is not at affordable price to public
3.Patented invention is not worked in territory of india
The history of Novartis patent case goes back to 1993 when it patented the molecule imatinib.
The patent rejection meant that generic companies could manufacture and market their generic versions of the drug in India, and make available the generic imatinib mesylate priced at less than one-tenth of Novartis’ price
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 substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy
(Natco, Cipla, Hetero and Ranbaxy)
These writ petitions challenged the decision of the Patent Controller to refuse to grant Novartis a patent for the beta-crystalline form of its anticancer drug, imatinib mesylate, as well as the validity of section 3(d) that provided one of several grounds for rejecting its patent application
The Madras High Court refused to examine whether section 3(d) was in compliance with the TRIPS Agreement
Novartis AG did not challenge the judgment of the Madras High Court upholding the constitutional validity of section 3(d).
comprising Justice Negi (Chairperson) and Dr PC Chakraborty (Technical Member) in November and December 2008.
Supreme Court decided the matter de novo looking into matters of both fact and law