Global IP Matrix - Issue 5

Patent Linkage
and Indian Laws
Bio: Ms. Swati Gupta is a Patent
Agent and holds a master’s degree
in Pharmaceutical Sciences, besides
holding an advanced certification
from WIPO in IP Management. She is
also a registered pharmacist. Swati is
an Associate, working with the Patents
Science team.
Patent linkage may be regarded as a
link between the marketing approval
of the generic product and the patent
status of the originator reference
(innovator) product. Marketing
Approval ensures the safety and efficacy
of a pharmaceutical product. However,
the patent gives exclusive rights to a
patent holder to prevent others from
making, selling, using, importing, and
offering to sell a patented product. A
patent provides exclusive rights to a
patent holder for a period of 20 years
and no generic could be brought to the
market for sale until the patent of the
originator reference product is in force.
Therefore marketing approval cannot
override the patent rights.
In some jurisdictions, a link between the
marketing approval of the generic product and
the patent status of the new product known
as Patent linkage has been established. Patent
linkage disallows the marketing approval of the
generic drug until the patent of the originator
reference drug is valid. The US is the first country
to adopt Patent linkage as a part of the Hatch
Waxman Act (1984). The use of Patent linkage
in the US intends to stimulate innovation in the
field of pharmaceuticals and on the same side
intends to facilitate the timely entry of generic
medicines in the market.
Under the Hatch-Waxman Act, an Abbreviated
New Drug Application (ANDA) now contains
the bioequivalence data which facilitates the
entry of generics into the US market without
any requirement of submitting costly clinical
(humans) and preclinical (animal) data to ensure
safety and efficacy. All the innovator or generic
drugs approved by the FDA are entered in the
orange book. However, ANDA applicants must
have to certify the following conditions:
(1) the drug has not been patented
(2) the patent of the innovator drug has
expired
(3) the generic drug will not be placed on
the market until the patent expires
(4) the patent is not infringed on or is
invalid
If the patent of the reference originator
(innovator) product is in force than the Applicant
of the generic drug has to either wait till the patent
expires or must notify the innovator company of
its filing and describe why the generic product
is not infringing the patented product or can
also prove the patent of the innovator product is
invalid or unenforceable.
India has not adopted Patent linkage yet. A
generic manufacturing company can apply for
the marketing approval of a generic product even
if the patent status of the originator reference
product is valid. However, the approved generic
drug cannot be brought to the market if the
patent of the originator drug is in force. There
are different authorities responsible for the
grant of a patent and marketing approval in
India. The authority responsible for the granting
of patents is the Indian Patent Office, and the
national regulatory authority responsible for
giving marketing approval to pharmaceutical
products is the Central Drugs Standard Control
Organisation (CDSCO). The Drug Comptroller
General of India (DCG) provides marketing
approval in accordance with the Drug and
Cosmetic Act 1940. Moreover, the CDSCO
does not maintain any register of patented
pharmaceuticals like the orange book in the US.
There is no linkage between the patent rights and
marketing approval of generic drugs in India.
Patent linkage is not applicable in India, but
a direct attempt to push Patent linkage was
attempted by Bristol-Myers Squibb Company
(Bristol-Myers Squibb Company & Ors v.
8 www.gipmatrix.com
As discussed by Ms. Swati Gupta & co-authored by Manisha Singh,
LexOrbis - www.lexorbis.com
Dr. BPS Reddy & Ors, I.A.No. 3696 of 2013,
I.A.No. 13386 of 2013, I.A.No. 11383 of 2014
in CS(OS) No. 2680 of 2008 prohibiting the
Drug Comptroller General of India (DCGI)
from granting marketing approval for a generic
version of Sprycel (dasatinib, used to treat
chronic myeloid leukemia) and secured an ex
parte injunction.
Next came the High court judgement of Bayer
Corporation and Ors v. Cipla of India (UCI) and
Ors, 162 (2009) DLT 371, which has given clarity
over Patent linkage in India. Bayer has attempted
to prohibit the Drug Comptroller General of
India (DCGI) from granting marketing approval
to Cipla for a generic version of Soranib. The
Court has disapproved Patent
linkage citing several reasons for its decision:
1) Two state authorities (Indian Patent Office and
DISCO) operate solely with different objectives.
The Drug and Cosmetic Act has no statute
which denies the approval of generic drugs
when the patent is in force. Moreover, the DCGI
is only responsible for the safety and efficacy
of the generic drug and the ensuring of other
necessary infrastructural facilities required for
the manufacturing of the drug. Furthermore, the
market approval of the drug is only liked to the
conditions given in the Drug and Cosmetic Act.
2) The Court has further clarified that courts
cannot establish or decree a Patent linkage,
desired by Bayer as it would be a policy choice
avoided by the Parliament.
3) The Court has clarified that Article 27 of
the TRIPS agreement clearly states that the
patents are to be made available without any
discrimination of technology and Patent
linkage applies to pharmaceuticals only.
Conclusion:
Patent linkage is favourable for the
Big Pharma companies that invest
a significant sum of money in the
research and development of new
and innovative drugs as it provides
second-tier protection for a patent
monopoly. As discussed, the High
Court has already decided that there
is no provision of patent linkage in
India. However, it can be a beneficial
provision, if adopted carefully taking
into consideration the public health,
interests of big pharma companies and the
generic manufacturing companies.