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.

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

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

8. Literary Films Dramatic
Musical Artistic Sound Recording

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

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’

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”

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

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

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.