Calcutta High Court
Shroff Geeta (Oa/10/2019/Pt/Kol) vs Asst. Controller Of Patents And Design on 17 November, 2025
Author: Ravi Krishan Kapur
Bench: Ravi Krishan Kapur
IN THE HIGH COURT AT CALCUTTA
ORIGINAL SIDE
(Intellectual Property Rights Division)
BEFORE:
The Hon'ble Justice Ravi Krishan Kapur
IPDPTA/88/2023
SHROFF GEETA (OA/10/2019/PT/KOL)
Vs.
ASST. CONTROLLER OF PATENTS AND DESIGN
For the appellant : Mr. Vindhya S. Mani, Advocate
Ms. Diya Mal, Advocate
For the controller of patent : Mr. Swatarup Banerjee, Advocate
Ms. Mary Datta, Advocate
Mr. Anirban Das, Advocate
Reserved on : 06.11.2025
Judgment on : 17.11.2025
Ravi Krishan Kapur, J.:
1. This is an appeal under section 117A of the Patents Act, 1970 against an
order dated 24 September 2018, rejecting an application for patent being
no. 3853/COL/MP-2008 dated 22 September 2018 titled 'Composition
comprising human embryonic stem cells and their derivatives, methods of
use and methods of preparation' primarily on the ground of section 3 (b)
of the Act.
2. Briefly the application was filed on 22 September 2008. Upon a request
for examination, the First Examination Report (FER) was issued to which
a response was filed by the appellant. Upon completion of the hearing,
the Written Submissions were filed by the appellant alongwith amended
claims 1-56 and the impugned order was passed on 24 September 2018.
3. On behalf of the appellant, it is contended that, the impugned order has
been passed in violation of the principles of natural justice and proceeds
on an erroneous interpretation of section 3(b) of the Act. The subject
invention does not necessarily destroy human embryos and is not
precluded under the Act. As such, there has been a complete
misappreciation of the subject invention and the impugned order is
liable to be set aside.
4. On behalf of the respondent it is contended that, the impugned order is
reasoned and warrants no interference at all. The subject invention has
been discussed and it was found that the invention involved collection of
2 to 7 day old human embryos in minimal essential medium. There is a
categorical finding that the cell invention contemplates destruction and
use of human embryos. As a result, the use of the human embryonic cell
obtained through extraction from the embryo leads to abortion or
destruction of embryos and is unethical. In such circumstances, the
invention has been rejected under section 3(b) of the Act.
5. Section 3(b) of the Act provides as follows:
3. The following are not inventions within the meaning of this Act,--
(b) an invention the primary or intended use or commercial exploitation of which
could be contrary to public order or morality or which causes serious prejudice to
human, animal or plant life or health or to the environment;
6. The section focuses on four major aspects. Firstly, the primary or
intended use of the invention claimed which includes the purpose for
which the invention was actually made. Secondly, the potential for the
invention to be commercially exploited in a manner which could harm
public health, safety, or the environment. Thirdly, whether the claimed
invention is contrary to public order or morality. If the invention
disrupts public order or morality, it is excluded from patentability and
ultimately whether it causes serious prejudice to life or health. The
term "serious" was added by virtue of the 2002 Amendment, indicating
that the impact of the invention must be significant. This aims to
prevent the patenting of inventions which despite being novel and
inventive, pose significant risks to public health, safety, or the
environment.
7. The interplay of patent law with ethical and moral considerations
brings with it complex legal challenges, especially when evaluating
inventions which may affect public health, order, or morality. Section
3(b) of the Act serves as a safeguard by disqualifying inventions which
could potentially harm human, animal, or plant life, health, or the
environment and is contrary to public order and morality. In this
context, Article 53(a) of the Paris Convention refers expressly to "ordre
public or morality". The purpose of the provision is "to deny protection
to inventions likely to induce riot or public disorder, or to lead to
criminal or other generally offensive behaviour. In Harvard College v.
Canada (Commissioner of Patents) [2002] 3 S.C.R. 519 when considering
the scope of Article 53(a) the European Patents Office had held as
follows:
"5. It is generally accepted that the concept of 'ordre public' covers the protection
of public security and the physical integrity of individuals as part of society. This
concept encompasses also the protection of the environment. Accordingly, under
Article 53 (a) EPC, inventions the exploitation of which is likely to breach public
peace or social order (for example, through acts of terrorism) or to seriously
concept encompasses also the protection of the environment. Accordingly, under
prejudice the environment are to be excluded from patentability as being contrary
to 'ordre public'.
8. It is a long-standing principle of patent law that patent laws should not
be granted for immoral inventions. Such issues raise serious practical,
ethical and moral considerations. Some examples of biological
inventions which have created difficulties are (a) processes for cloning
of human beings (b) process for modifying the germ line genetic identity
of human beings (c) use of human embryos for industrial or commercial
use. In this context, the use of human embryos for industrial or
commercial use is somewhat controversial. Any such examination
would necessarily involve (a) what is a human embryo (b) the use of a
human embryo (c) industrial or commercial purpose. [Prathiba M. Singh
on Patent Law, Edition -1, Vol-I at page 140].
9. The impugned order proceeds on the basis that the invention involved
destruction of the human embryo and was found to be unethical.
Inventions with human embryo especially within 2-7 days of formation,
being at a very delicate stage of formation of human life that may or
may not cause permanent damage or even miscarriage of such foetus
must be considered with care and caution. The impugned order has
been passed after having considered all the contentions of the parties
and is adequately reasoned.
10. Upon an examination of the invention it was found that the embryonic
stem cells were derived from human embryo inner cell mass using
either immunological or mechanical methods for isolation. Such human
embryonic stem cells lines were necessarily produced by a destructive
use of human embryos. The invention requires the use of human
embryos for industrial or commercial purposes within the meaning of
section 3(b) of Act. Such use of human embryonic stem cells obtained
through extraction from the embryo leading to abortion or destruction
of embryo has been held to be unethical. The commercialization of the
claimed invention is also held to be contrary to public order or morality
and thus falls within the purview of non-patentable claims under
section 3(b) of the Act.
11. There is nothing in the impugned order which can be described as an
incorrect interpretation of section 3(b) of the Act. There is no illegality
nor irrationality nor contravention of any law which warrants any
interference. In a complex matter of such nature it is not for this Court
to re-examine the wisdom of the experts. The impugned order is also in
conformity with the National Guidelines for Stem Cell Research (2017).
Despite the technical and scientific advancement in the field of research
on stem cells and the revolutionizing through regenerative therapies,
the reasons provided for in the impugned order justify no interference.
12. In view of the above, IPDPTA 88 of 2023 is dismissed.
(Ravi Krishan K apur, J.)
