Recently, the Calcutta High Court upheld the rejection of a patent application involving human embryonic stem cells, holding that such inventions fall foul of Section 3(b) of the Patents Act in a matter concerning ethical limits on biotechnology. The Court observed that any use of human embryos for commercial or industrial purposes is contrary to public morality.
Brief Facts:
The matter arose from an appeal challenging the Patent Controller’s decision rejecting a patent application related to the preparation and use of human embryonic stem cells. The applicant sought protection for a composition and related methods, claiming scientific benefits and therapeutic possibilities. After examination, a hearing, and consideration of amended claims, the Controller refused the patent on the ground that the invention required destruction of human embryos, which is barred under Section 3(b) of the Patents Act.
Contentions of the Appellant:
The appellant argued that the rejection violated principles of natural justice and was based on an incorrect reading of Section 3(b). It was submitted that the invention did not inherently require destruction of human embryos and therefore should not be considered unethical or prohibited. The appellant maintained that the Patent Office had misunderstood the scientific process and that the invention deserved protection.
Contentions of the Respondent:
The respondent defended the order, asserting that the Controller had thoroughly examined the claims and correctly concluded that the invention necessarily required extraction of cells from 2–7-day-old human embryos. It was argued that such extraction results in destruction of the embryo and therefore falls squarely within the prohibition under Section 3(b), which excludes inventions contrary to morality, public order, or those causing serious prejudice to human life or health.
Observations of the Court:
Explaining Section 3(b), the Court emphasised that the provision acts as a safeguard against granting patents where the intended use, commercial exploitation, or impact of an invention may offend public order, morality, or cause serious harm to life, health, or the environment. The Court reiterated that the term “serious prejudice,” introduced through the 2002 amendment, reflects the legislature’s intent to prevent protection of inventions posing significant ethical or biological risks.
The Court noted that patent law has long recognised the need to exclude immoral or ethically impermissible inventions. It referred to international norms and comparative jurisprudence explaining that inventions involving human embryos raise complex moral questions and require a careful balancing of scientific advancement with ethical responsibility.
Referring to authoritative commentary and established principles, the Court observed, “Inventions involving the use of human embryos, particularly at the earliest and most delicate stages of formation, require strict scrutiny. When extraction of embryonic material leads to destruction of the embryo, such an invention cannot be patented as it would amount to commercial use of human life in its formative stage, which is contrary to public order and morality.”
Upon examining the specification, the Court found that the stem cell lines described in the application were derived from the inner cell mass of human embryos through methods that necessarily caused destruction of the embryo. The Court held that such use is not only unethical but also falls within the statutory exclusion of inventions intended for industrial or commercial use involving human embryos.
It further noted that the Controller’s findings aligned with the National Guidelines for Stem Cell Research (2017). The Court held that there was no misinterpretation of Section 3(b), nor any perversity or illegality warranting interference.
The decision of the Court:
Concluding that the Patent Controller’s decision was well-reasoned, consistent with the statutory bar under Section 3(b), and in tune with ethical guidelines governing stem cell research, the Court dismissed the appeal.
Case Title: Shroff Geeta vs. Asst. Controller of Patents and Design
Case No.: Public Interest Litigation (PIL) No. - 1118 Of 2025
Coram: Justice Ravi Krishan Kapur
Advocate for Petitioner: Adv. Vindhya S. Mani, Diya Mal
Advocate for Respondent: Adv. Swatarup Banerjee, Mary Datta, Anirban Das
Read Judgment @Latestlaws.com
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