1. Patent evergreening refers to obtaining multiple patents on minor variations of an existing product to extend monopolies and delay generic competition. This practice is common in the pharmaceutical industry. 2. Section 3(d) of the Indian Patents Act prevents evergreening by not granting patents for new forms of known substances that do not enhance efficacy. This aims to ensure availability of affordable medicines. 3. Indian patent law has provisions to prohibit indefinite patent rights and recognizes need for low-cost drugs, showing its balancing of patent holder and public interests.

1. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
EVERGREENING OF PATENTS
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
P.ILANANGAI
IP CONSULTANT
EMAIL
info@altacit.com PATENT DEPARTMENT
WEBSITE
www.altacit.com

2. INTRODUCTION
CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
• Patent is an exclusive right given to the right holder
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
to reap benefits out of his invention.
BANGALORE
Suite 920, Level 9,
• Internationally, it is the TRIPS Agreement that
Raheja Towers,
26-27, M G Road, regulates the law relating to Copyrights, Patents,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400 Trademarks and other forms of IPR.
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
• The grant of a patent is based on the premise of full
Coimbatore - 641018.
Tel: +91 - 422 – 6552921 disclosure by the patentee the best method of
performing the invention so that the others are able
to use the invention after the expiry of patent rights.
However, sometimes, this patent protection is
sought to be extended indefinitely by the patentee
EMAIL
info@altacit.com through the practice of ‘Evergreening‘.
WEBSITE
www.altacit.com
• contd…

3. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
• As research and development of novel drugs
within pharmaceutical multinationals has
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
slowed down, they have focused their energies
on patenting minor tweaks to existing drugs in
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
order to extend monopolies, whenever
Tel: +91 - 80 - 6546 2400
COIMBATORE
possible.
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

4. PATENT EVERGREENING
CHENNAI
3rd Floor, ‘Creative Enclave’,
• “Patent evergreening” generally refers to the
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
strategy of obtaining multiple patents that cover
Tel: +91 - 44 - 2498 4821 different aspects of the same product, typically by
BANGALORE
Suite 920, Level 9,
obtaining patents on improved versions of existing
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
products.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road, • Although the patent system allows improvement
patents to be obtained in any industry, evergreening
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
is said to be most common in the pharmaceutical
industry.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

5. HOW EVERGREENING CAME INTO EXISTENCE?
CHENNAI
• Evergreening has been in practice since the passage
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004. of the Waxman-Hatch legislation (Drug price
Tel: +91 - 44 - 2498 4821
competition and Patent term restoration act) in 1984,
BANGALORE
Suite 920, Level 9,
Raheja Towers,
in which the pioneer drug can receive an extension
26-27, M G Road,
Bangalore - 560 001. term equal to one-half the time of the investigational
new drug (IND) period, running from the start of the
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
human clinical trial to the time till the new drug
Coimbatore - 641018.
Tel: +91 - 422 – 6552921 application (NDA) is submitted.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

6. HOW DOES IT AFFECT?
CHENNAI
3rd Floor, ‘Creative Enclave’,
• Extending the patent period seizes the generic drug
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
manufacturing. Once the generic drugs are being produced, the
Tel: +91 - 44 - 2498 4821
price of the drug can drop by as much as 90%.
BANGALORE
Suite 920, Level 9, • When the original patent is due to expire, the drug companies
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
often claim large numbers of complex and often highly
Tel: +91 - 80 - 6546 2400 speculative patents by evergreening. When the generic drug
COIMBATORE
BB1, Park Avenue,
manufacturers intend to market copies at the expiry of the
# 48, Race Course Road,
Coimbatore - 641018. original patent, the original patent holders can then threaten
Tel: +91 - 422 – 6552921
these potential generic competitors with breaching their now
"evergreened" patents and seek a court order preventing their
marketing approval.
• The ultimate consequence could be elderly and poor patients
paying several times the present price for drugs.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

7. HOW TO AVERT EVERGREENING?
CHENNAI
3rd Floor, ‘Creative Enclave’,
• Not granting patents on the basis of trivial and
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
insignificant changes in the original pharmaceutical
patented product;
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
• Ensuring that generic manufactures can manufacture
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400 the patented pharmaceutical product soon after the
COIMBATORE
BB1, Park Avenue,
term of patent expires, by making use of Bolar
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
provision.
• “Bolar” provision under Section 107 A (a) of the
Indian Patents Act that permitted a drug manufacturer
to experiment with any patented drug for generating
data that could then be submitted to a drug control
EMAIL
info@altacit.com
authority.
WEBSITE
www.altacit.com

8. INDIAN PATENTS ACT AND EVERGREENING
CHENNAI
3rd Floor, ‘Creative Enclave’,
• Patent law in India came into being in 1852 and aimed at
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
giving preference to foreign pharmaceutical companies.
Tel: +91 - 44 - 2498 4821
• Indian Patent Act 1970 was enacted and was aimed at
BANGALORE
Suite 920, Level 9,
Raheja Towers,
providing medicines at affordable prices to the masses.
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
• Provision was made only for the process patent.
COIMBATORE • India stopped granting drug patents in the 1970s, and only
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
resumed granting drug patents in 2005 as part of a World
Tel: +91 - 422 – 6552921
Trade Organisation agreement.
• The government introduced amendments in Indian Patent
Act (Amendment) Bill 2005.
• Provision was made to discourage continuation of Patent
EMAIL Right beyond the period of patent by preventing the grant
info@altacit.com of frivolous patents and ever-greening.
WEBSITE
www.altacit.com • contd..

9. CHENNAI
3rd Floor, ‘Creative Enclave’, • ‘Evergreening’ results in infinite monopoly or a
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
lifetime of artificially high-priced medicines, as only
Tel: +91 - 44 - 2498 4821
one manufacturer is allowed to supply the drug in the
BANGALORE
Suite 920, Level 9,
Raheja Towers,
market during the existence of patent right. As a result
26-27, M G Road,
Bangalore - 560 001. of this trend, the need to have affordable medicines
Tel: +91 - 80 - 6546 2400
COIMBATORE
intensified in 2005, when India amended its patent
BB1, Park Avenue,
# 48, Race Course Road, laws to comply with the TRIPs agreement.
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
• Indian patent law has provision which prohibits a new
form of a known substance from receiving a patent
unless it significantly improves the medicine’s
"efficacy". The provision was ostensibly aimed at
EMAIL preventing "evergreening".
info@altacit.com
WEBSITE
www.altacit.com

10. CHENNAI
3rd Floor, ‘Creative Enclave’, • To prevent the grant of patents to trivial and insignificant
148-150, Luz Church Road,
Mylapore, pharmaceutical inventions, the following provisions have been
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821 introduced under the Indian Patents (Amendment) Act, 2005:
BANGALORE
Suite 920, Level 9,
• Section 2 (1) (l) deals with “new invention”, which means any
Raheja Towers,
26-27, M G Road, invention or technology which has not been anticipated by
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400 publication in any document or used in the country or elsewhere
COIMBATORE in the world before the date of filing of the application with
BB1, Park Avenue,
# 48, Race Course Road, complete specification.
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
• Section 2 (1) (ja) defines “inventive step” which means those
features of invention that involve technical advancement as
compared to existing knowledge, or that have economic
significance or both and which make the invention not obvious to
a person skilled in the art.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

11. CHENNAI
3rd Floor, ‘Creative Enclave’, • Section 3(d) of the Indian Patent Act, 1970, states that the mere
148-150, Luz Church Road, discovery of a new form of a known substance, which does not
Mylapore,
Chennai - 600 004. result in the enhancement of the known efficacy of that substance or
Tel: +91 - 44 - 2498 4821
the mere discovery of any new property or new use for a known
BANGALORE
Suite 920, Level 9, substance or of the mere use of a known process, unless such known
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
process results in a new product or employs at least one new
Tel: +91 - 80 - 6546 2400 reactant, is not an invention within the meaning of the Patents Act.
COIMBATORE
BB1, Park Avenue,
• Explanation: For the purposes of this clause, salts, esters, ethers,
# 48, Race Course Road,
Coimbatore - 641018. polymorphs, metabolized, pure form, particle size, isomers, mixtures
Tel: +91 - 422 – 6552921
of isomers, complexes, combination and other derivatives of know
substances shall be consider to be the same substances, unless they
defer significantly in properties with regard to efficacy.
• Section 3(d) is aimed at preventing pharmaceutical companies from
obtaining patents on minor variations of existing patented
EMAIL medicines; this effectively prevents trivial patenting or mere
info@altacit.com workshop improvement of already patented drugs in India. Section 3
WEBSITE (d) also prevents new use of known substances.
www.altacit.com

12. ILLUSTRATIONS
CHENNAI
3rd Floor, ‘Creative Enclave’, • Sildenafil Citrate was originally discovered as a cardio vascular
148-150, Luz Church Road,
Mylapore,
agent and patented by Pfizer. Later, its second medical use in
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821 treating impotence was also found. Even though second medical use
BANGALORE
patents are allowed in UK, it was refused by EPO owing to
Suite 920, Level 9,
Raheja Towers, obviousness determined by articles published in journals. In India,
26-27, M G Road,
Bangalore - 560 001. second medical use is prevented by Section 3 (d).
Tel: +91 - 80 - 6546 2400
• Griseofulvin is an effective agent for fungal infections of skin to be
COIMBATORE
BB1, Park Avenue,
# 48, Race Course Road,
applied locally. Later, it was found that if the dimensions of the
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
particles of the drug were reduced, it could be used orally. This
change in physical form of Griseofulvin is patentable as it shows
increased ‘functional’ efficacy.
• The Patent Office recently struck down the attempts of evergreening
by multinationals and rejected a series of applications on the
grounds that they were mere modifications or extensions of known
EMAIL substances. These include Pfizer's Caduet (cholesterol and
info@altacit.com
hypertension), GlaxoSmithKline's rosiglitazone salt (diabetes),
WEBSITE
www.altacit.com
Gilead Science's Tamiflu (bird flu) and Hepsera (Hepatitis B).

13. CHENNAI
3rd Floor, ‘Creative Enclave’, • The Indian position on evergreening is best
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
exemplified by the Novartis-Glivec case which has
Tel: +91 - 44 - 2498 4821
been the centre of debates in patent circles.
BANGALORE
Suite 920, Level 9,
Raheja Towers,
• Pharmaceutical giant Swiss drug maker Novartis first
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
file a suit against Indian companies producing generic
COIMBATORE version of cancer drug imatinib, which was marketed
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
as Glivec (or Gleevec in the US) after second
Tel: +91 - 422 – 6552921
amendment of Indian patent Act 1970, claiming
generic producers of the drug violates it’s (Novartis’s)
patent rights.
• The company was granted interim relief and was
EMAIL granted one of first exclusive marketing rights. For
info@altacit.com
WEBSITE
Glivec in November 2003, the price increased from
www.altacit.com $230 to $2,740.

14. CHENNAI
3rd Floor, ‘Creative Enclave’, • Novartis was refused a patent for Glivec on the basis that the beta
148-150, Luz Church Road,
crystalline from did not provide a significant enough “enhancement
Mylapore,
Chennai - 600 004.
of efficacy” of the original imatinib molecule.
Tel: +91 - 44 - 2498 4821
• Novartis responded with a writ to the High Court appealing against
BANGALORE
Suite 920, Level 9, the ruling. It argued that Section 3(d) of the Indian Patent Act was
Raheja Towers,
26-27, M G Road,
“unconstitutional as it is vague, arbitrary and violative of Article 14
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
of the constitution (right to equality)”, and alleged that it contravened
COIMBATORE
India’s obligations under the TRIPS Agreement.
BB1, Park Avenue,
# 48, Race Course Road, • India differentiated genuine innovation from evergreening by using
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
the “enhancement of efficacy” concept. The High Court suggested
only that efficacy can be defined as the ability of a drug to produce a
desired therapeutic effect.
• The whole process of developing the Mesylate salt of Imatinib and
the beta crystal form of Imatinib Mesylate and to make it viable in
the form of a pill, took many years of efforts involved. This was
EMAIL more than a mere incremental improvement and thus cannot be
info@altacit.com interpreted as “ever greening”.
WEBSITE
www.altacit.com

15. CHENNAI
3rd Floor, ‘Creative Enclave’, • Novartis maintains that Glivec boosts bioavailability (i.e.
148-150, Luz Church Road,
Mylapore,
the degree to which the drug is absorbed by the patient) by
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
30 percent over the original form of imatinib, which
BANGALORE
should constitute an enhancement of efficacy. The Chennai
Suite 920, Level 9,
Raheja Towers, Patent Ofice disagreed in rejecting the application.
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
• The Court held that, In the light of above observation, it
COIMBATORE
was held that section 3 (d) of the Patent (amendment) Act
BB1, Park Avenue,
# 48, Race Course Road, 2005 does not violate Article 14 of the Indian Constitution.
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
• With its arguments having been rejected, Novartis brought
its final challenge before India’s highest court, with the
hearing before Honourable Justices Aftab Alam and
Ranajan Prakash Desai.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

16. CHENNAI
3rd Floor, ‘Creative Enclave’, • The Indian Supreme Court has refused to allow one of
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
the world's leading pharmaceutical companies to patent
Tel: +91 - 44 - 2498 4821
a new version of a cancer drug.
BANGALORE
Suite 920, Level 9,
Raheja Towers,
• Novartis lost a six-year legal battle after the court ruled
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
that small changes and improvements to the drug
COIMBATORE Glivec did not amount to innovation deserving of a
BB1, Park Avenue,
# 48, Race Course Road,
Coimbatore - 641018.
patent. The ruling opens the way for generic companies
Tel: +91 - 422 – 6552921
in India to manufacture and sell cheap copies of the
drug in the developing world and has implications for
HIV and other modern drugs too.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

17. CONCLUSION
CHENNAI
3rd Floor, ‘Creative Enclave’, • Section 3(d) forces firms to focus efforts on innovation and hard
148-150, Luz Church Road,
Mylapore,
core research instead of incremental improvement and have
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
patents for every minor innovation. Section 3(d) can also be seen
BANGALORE
as a great boon with generic pharmaceutical firms, AIDS
Suite 920, Level 9,
Raheja Towers, campaign and Non-Governmental Organization (NGO) backing
26-27, M G Road,
Bangalore - 560 001. India.
Tel: +91 - 80 - 6546 2400
COIMBATORE
• India can continue to produce cheap versions of life-saving drugs.
BB1, Park Avenue,
# 48, Race Course Road, • On the other hand, pharmaceutical companies will now think
Coimbatore - 641018.
Tel: +91 - 422 – 6552921 twice before investing money for research in India, thereby
reducing the chances of the country getting more advanced drugs.
EMAIL
info@altacit.com
WEBSITE
www.altacit.com

18. CHENNAI
3rd Floor, ‘Creative Enclave’,
148-150, Luz Church Road,
Mylapore,
Chennai - 600 004.
Tel: +91 - 44 - 2498 4821
BANGALORE
Suite 920, Level 9,
Raheja Towers,
26-27, M G Road,
Bangalore - 560 001.
Tel: +91 - 80 - 6546 2400
COIMBATORE
BB1, Park Avenue,
THANK YOU
# 48, Race Course Road,
Coimbatore - 641018.
Tel: +91 - 422 – 6552921
EMAIL
info@altacit.com
WEBSITE
www.altacit.com