How Indian Patent Law Regulates Pharmaceutical Industry
The Indian pharmaceutical industry has witnessed constant growth as a
thriving high technology-based industry, specifically in the last three decades
since the Patents Act 1970 was passed.
As the reports by the Government say, The Global Index ranking has risen to 46th
for India in 2021, compared to 81st in 2015-16, as there is a 50% increase in
the filing of patents in 2021-22, in 7 years since 2014-15; and the grant of
patents has also increased five times during the same period. The technological
upgradation has decreased the time required for Indian patent examination to
5-23 months from 72 months in December 2016.
What is the patent law in India?
The Patents Act1970 included the guidelines issued by the Paris Convention for
the Protection of Industrial Property 1883 and the Patent Cooperation Treaty
1970; India was one of the signatories.
Medicine and pharmaceutical products are inevitable daily, resulting in
considerable expertise in reverse engineering drugs. Such pharmaceutical
products are generally patented in developed countries but have patent
applications in India.
As a result, the Indian pharmaceutical market is rapidly developing and selling
a much cheaper version of several drugs patented under the Patents Act of 1970.
They are spreading aggressively to the international market as well with generic
drugs on the expiration of international patents.
What is the patentability status of Biotechnology Products in India?
The IP India Patent Search may not provide a fruitful result for
biotechnologists. It isn't easy to showcase the invention as a novel product,
not a natural process. However, suppose the applicant is determined to proceed
with the patent registration in India. In that case, the applicant must conduct
a minute InPASS patent search and WIPO patent search, assuring that they extract
every point to showcase the biotechnology product as unique and novel.
How is Indian law managing pharmaceutical patents in coordination with
The Trade-Related Intellectual Property Rights (TRIPS) negotiated by the World
Trade Organization led India to sign the General Agreement on Tariffs and Trade
(GATT) on 15th April 1994, mandating compliance with its requirements.
The Patents Act 1970 grants protection for a minimum period of 20 years. The
authority grants the compulsory license based on the merits of each patent
application, without discriminating whether it is a domestic product or an
imported one. Therefore, India is obliged to maintain the minimum standards per
the TRIPS Agreement regarding patents in the pharmaceutical industry.
In compliance with the TRIPS commitments, India has developed the Exclusive
Marketing Rights (EMR) policy under chapter IVA of the Act. It maintains a
mailbox system for five years or till the result of the application is published
- accepted or rejected, whichever is earlier.
Through the Patents (Amendment) Act 1999, the provision of "pipeline protection"
was introduced, which shall grant the applicant EMR on applying on and after 1st
January 1995 in any of the countries that have been the signatory of the Paris
Convention. If the applicant is eligible, the Patents Law in India shall grant
EMR for five years or till the application is rejected or accepted, whichever is
The Amendment has also made it compulsory that the patent application can be
filed in India by the applicant or outside India. Still, the latter requires
prior approval from the appropriate authority.
What has been the impact of the absence of product patent protection for the
There is a chance that the multinationals may limit their portfolios on the
expiration of the patent as the product patent protection for pharmaceuticals is
absent. This can result in a decrease in their market shares, as the local
manufacturers introduce non-advanced medicines through the process of reverse
A royalty is charged from the foreign firms for international drugs while the
local manufacturers reformulate the newest molecules from all over the world to
sell in the Indian market. This absence is a systematic process to weaken the
patent rights for pharmaceutical products in India, leading to the exit of
several international research-based pharmaceutical firms.
Though several pharmaceutical giants have expressed interest in expanding their
operations in the Indian market, they fear patent infringement. This risk has
compelled pharmaceutical companies to be careful about product launching until
their patents are protected enough to prevent breaches.
The obligations introduced by the TRIPS Agreement significantly affect the
formulation-oriented pharmaceutical industry in India. Now companies competing
with multinational has to focus on drug development and producing their own
patented products. Alternatively, Indian companies may opt for creating patented
products under licence from foreign companies while concentrating on generating
revenues from making generic drugs.
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