Patenting Of A Drug Under IPR By - Amresh Swarnkar
Patenting Of A Drug Under IPR
Authored By - Amresh Swarnkar
Maharashtra National Law University,
Aurangabad.
5th year (9th
Semester student), batch of 2018-23.
META DESCRIPTION
In this particular blog the concept
of getting a drug patent has been discussed and the various facets related to
it like-
*What is the concept of Patent in
India.
*Landmark judgement of-
Novartis v. Union of India, which
discusses the essential elements to get a drug patented in India
have also been discussed in order to
make the reader aware about getting a drug patent in India in detail.
INTRODUCTION
This particular blog is on the
subject matter that how a drug patent can be obtained under the patent law in
India and in this context the landmark judgement of the Supreme court- Novartis
v. Union of India has been covered in this blog.
In this blog the various facets with
respect to getting a drug patent have been covered in order to make the reader
aware about getting a drug patent in detail.
The various facets with respect to
getting a drug patent covered in this blog are-
what is the concept of Patent in
India, the landmark judgement of- Novartis v. Union of India, which discusses
the essential elements to get a drug patented in India.
My findings pertaining to getting a
drug patent in India and also related to this landmark judgement have been
mentioned and explained in the conclusion of this blog.
Tags/ Keywords associated with the
article:
·
IPR
·
Patent
of a drug
·
Drug
·
Pharmaceutical
industry
·
Patents
in pharma industry
·
Novartis
v. Union of India.
·
Elements
to get a drug patented.
MAIN BLOG
Introduction to a patent-
A patent is a right granted by the
statute to a particular individual with regards to his invention i.e. the
person can stop others from selling, using, making or importing the product or
process without the prior permission of that inventor.
Therefore, we can say that the
concept of patent helps the inventors a lot as without it their ideas could be
easily stolen and used by the other people to gain advantage over them as a
competitor.
Criteria of patentability in India-
For getting a patent in India the
following conditions should be fulfilled by the invention of a person-
1. The invention should be novel-
it means that the invention should be unique i.e. it should not have been used
or published anywhere in the world before the date of filing the application
for the said patent.
2. The invention should contain an
inventive step- the invention’s feature must be such that contains a
technical advancement compared to the present knowledge or it should have a significance
economically or both.
3. The invention in question should have
industrial application capability- that it should be capable of being
used in an industry.
4. It should not fall under the category
of inventions which are excluded under the said jurisdiction from
patentability.
Landmark case law on patentability of
a drug in India is that of-
Novartis v. Union of India[1]
It is a landmark judgement related to
Indian IPR laws. It is a case related to rejection of a drug patent application
which was neither ‘inventive’ nor had any ‘superior efficacy’.
Facts- In this case a registration of patent
application for a drug Gleevec was filed by the Novartis company.
The company filed this patent
application by the way of covering the drug under the term ‘invention’ which
is mentioned under Section 3 of the Patent Act of 1970.
Decision by the Supreme Court- After a seven years long battle the
application of Novartis was rejected by the Supreme Court and the apex court
for this decision gave two main reasons-
1. The court declared that there was not
an invention of a new drug and a mere discovery of an already existing drug
won’t be regarded as an invention under the Patents Act, 1970.
2. The apex court declared that for a
grant of a patent under pharmaceuticals as per the Patent Act, 1970, apart from
proving the traditional steps of novelty, inventive step and application, a new
test is considered which is the test of improved therapeutic efficacy for
the claims which cover incremental changes to an existing drug and in this
case the Gleevec drug also failed to prove this test.
So as per this case law it is very
clear that for a drug to be patentable it should satisfy the tests of novelty,
inventive step and application, and for the cases where there are claims which
cover incremental changes to an existing drug the test of improved
therapeutic efficacy also plays a key role.
CONCLUSION
In this blog the subject matter of
getting a drug patent in India is discussed in detail with the help of the landmark
judgement on the same topic which is of- Novartis v. Union of India. The
various facets related to this topic covered in the blog are- what is the
concept of Patent in India, the landmark judgement of- Novartis v. Union of
India, which discusses the essential elements to get a drug patented in India.
This particular blog would help the
readers to analyze the subject matter of getting a drug patent in India as all
the various aspects related to it have been dealt in depth in this blog.
Findings-
1. For getting a patent in India-
·
The
invention should be novel
·
The
invention should contain an inventive step
·
The
invention in question should have industrial application capability
·
It
should not fall under the category of inventions which are excluded under the
said jurisdiction from patentability
2. After a well versed research on the
topic I found out that the landmark judgement of Novartis v. Union of India laid
out a new point apart from these that the cases where there
are claims which cover incremental changes to an existing drug the test of improved
therapeutic efficacy also plays a key role i.e. the invention in question
should provide some or the other improvement in the therapeutic efficacy
when compared to the pre- existing drug.
REFERENCES
* Patent Act, 1970
*www.ipindia.gov.in
* All India Reporter
* www.livelaw.