Patents and Design Act, 1970
Learning objectives
At the end of this lecture, the student will be able to:
• Discuss about the salient features of Indian Patent Act 1970
• Describe the changes made in the Patent act following GATT
agreement
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PATENTS ACT 1970
•At the time of independence, India’s pharma market was dominated
by MNCs that controlled a large share of market mainly through
imports
•Approx. 99% of all pharma products protected by patents were held
by foreign companies and domestic Indian prices were highest in the
world
•Due to lack of competition, drugs were sold at high prices in India
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PATENTS ACT 1970 contd..
•The Indian Pharma market remained import dependent through the
1960s until the Govt. initiated policies stressing self reliance through
local production
•The Govt. of India funded 5 state owned pharma companies
•To end the dominance of MNCs, the govt. enacted a series of policies
•Introduced the Patents act 1970
•The act scraped the product patent which was followed by foreign
countries
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PATENTS ACT 1970 contd..
•An MNC inventing a new drug could at best patent the process of
manufacturing it, provided it was new
•Only 1 method or process for a drug could be patented
•Post enactment of the Patents act, indigenous firms grew in size and
started producing drugs which were imported till then.
•By 1972, over 100 drugs were produced in India
•Firms like Ranbaxy and Cipla grew rapidly when compared to MNCs
like Glaxo, Pfizer, Sandoz, Boots, Smithkline and French
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PATENTS ACT 1970 contd..
•The favourable environment attracted entry of new firms
-Sun Pharma in 1983
-Dr. Reddy in 1984
-Aurobindo in 1986
-Morpen lab in 1984
-Orchid chemicals in 1992
•The Indian firms focused on Reverse Engineering oriented R&D
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PATENTS ACT 1970 contd..
•Advantages of this includes the shortening of the time lag
between introduction in the global market by the inventor
and marketing of the same drug in the Indian market
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Features of Patents Act 1970
•Included Product patent and Process patent
• PRODUCT PATENT is for all inventions except food,
pharmaceuticals, substances produced by chemical processes
and agrochemicals
•PROCESS PATENT is for food, pharmaceuticals, substances
produced by chemical processes and agrochemicals
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Features of Patents Act 1970
•This could help other competitors to find new, improved,
advanced and economical processes for producing the same
product
•It disallows monopoly
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Features of Patents Act 1970
•India provided patent protection only for 14 years
•In case of food, pharmaceuticals, chemicals and agrochemicals,
the patent period is only 5 yrs from the date of sealing or 7 yrs
from the date of filing whichever is earlier
(Note: Date of filing is the date on which complete specification
is submitted and date of sealing is the date when the patent is
sealed by the controller and the entry is made in the register of
Patents at the head office in Kolkata)
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Features of Patents Act 1970
•The act also provided for Compulsory Working Of A Patent
•The patented product had to be manufactured in India
•The patentee cannot hold a patent in India and import the
product from another country thereby compelling the Indian
customer to pay a higher price
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Features of Patents Act 1970
•The act also provided for Compulsory Licensing Of A Patent
•In case of non working of a patent (if a patent holder does not
commercialize the invention), the act provides that after 3 years
of sealing the patent, any other person can apply for compulsory
licensing on the grounds of public benefit
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Patent amendment 2005
• The WTO (comprising 123 nations) come into existence on 1st
Jan 1995,replacing GATT which had commenced in 1948.
• One of the agreements negotiated under WTO was TRIPS
•India being a member of WTO , automatically became a
signatory to TRIPS
•TRIPS provided a 3 stage frame for countries such as India which
did not grant product patent in pharmaceuticals
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Patent amendment 2005 contd…
• Provisions had to be applied by Jan 1, 1996
•Transition period of 4 years till Jan 1, 2000 to comply with other
obligations of TRIPS such as rights of the patentee, term of
patent, compulsory licensing etc.
•Additional period of 5 yrs till Jan1, 2005 for developing
countries like India to introduce full product patent protection in
all fields
•Least developed countries got a transition period of 10 years
from the date of application, till Jan 1, 2006
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Patent amendment 2005 contd…
• India amended its patent law on 22nd March 2005 and
reintroduced product patent for pharmaceuticals, food and
chemicals
• Reverse engineering or copying of patented drugs was made
illegal
•This encouraged many foreign pharma companies to invest in
the Indian market
•All Indian firms were forced to enhance R& D activities and
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Law and Regulations
• Patents Act, 1970
– Amended in
• 1999
• 2002
• 2005
• Patents Rules, 2003
– Amended in
• 2005
• 2006
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Legislative Measures -Patents
• From 1.1.1995
– Mail-Box for pharmaceutical and agrochemicals products
– Exclusive Marketing Rights
• From 1.1.2000
– Patent term increased to 20 years
– Definition of invention – inclusion of inventive step
– Reversal of burden of proof – on the infringer
– Mandatory compulsory licence provision for food, drugs and
chemicals removed
– Right of patentee (importation also included)
• From 1.1.2005
– Product patents for food, chemical and pharmaceutical
international commitments
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Patent Law 2005- Salient Features
• Both product and process patent provided
• Term of patent – 20 years
• Examination on request
• Both pre-grant and post-grant opposition
• Fast track mechanism for disposal of appeals
• Provision for protection of bio-diversity and traditional
knowledge
• Publication of applications after 18 months with facility for
early publication
• Substantially reduced time-lines
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Safeguards in the Patent Law
• Compulsory license to ensure availability of drugs at
reasonable prices
• Provision to deal with public health emergency
• Revocation of patent in public interest and also on security
considerations
Summary
• Patents act 1970 had both product and process patents
• The act was modified as a result of GATT
• India had to respect product patent in all fields
• Uniform patent duration of 20 yrs