Destructive Use of Human Embryos as Non‑Patentable Subject Matter under Section 3(b):
A Detailed Commentary on Shroff Geeta (OA/10/2019/PT/KOL) v. Assistant Controller of Patents and Designs

Court: High Court at Calcutta (Original Side – Intellectual Property Rights Division)

Case No.: IPDPTA/88/2023

Parties: Shroff Geeta (OA/10/2019/PT/KOL) v. Assistant Controller of Patents and Designs

Judge: Ravi Krishan Kapur, J.

Date of Judgment: 17 November 2025

Statutory Focus: Section 3(b), Patents Act, 1970; Section 117A, Patents Act, 1970

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1. Introduction

This judgment of the Calcutta High Court occupies a significant place in Indian patent jurisprudence at the interface of biotechnology, ethics, and public policy. The Court was called upon to decide whether an invention involving compositions of human embryonic stem cells (hESCs) and their derivatives, along with methods of use and preparation, is patentable in light of the morality and public order exclusion under Section 3(b) of the Patents Act, 1970.

The Court ultimately upheld the Patent Office’s refusal, confirming that:

• Inventions that necessarily involve the destructive use of human embryos, especially at an early developmental stage (2–7 days), and
• Whose exploitation is of an industrial or commercial nature

are barred from patentability under Section 3(b) as being contrary to public order and morality, and as involving serious ethical concerns.

The case is therefore an important Indian precedent on:

• How Section 3(b) is to be interpreted for life-science and stem cell–based inventions;
• The role of ethical and policy guidelines (here, the National Guidelines for Stem Cell Research, 2017) in patent decision‑making; and
• The scope of judicial review over technical and ethical determinations made by the Patent Office.

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2. Factual and Procedural Background

2.1 The Patent Application

The appellant, Dr. Geeta Shroff, filed a patent application (No. 3853/COL/MP-2008) on 22 September 2008 titled:

“Composition comprising human embryonic stem cells and their derivatives, methods of use and methods of preparation.”

While the full claim set is not reproduced in the judgment, the essential subject matter, as characterised by the Patent Office and endorsed by the Court, involved:

• Derivation of human embryonic stem cells from the inner cell mass of human embryos (2–7 days old embryos at the blastocyst stage);
• Isolation of such cells using immunological or mechanical methods;
• Establishment of human embryonic stem cell lines; and
• Use of such cells and compositions for therapeutic or related purposes, presumably in a way that would be industrially and commercially exploited.

2.2 Examination Before the Patent Office

Upon filing a request for examination, a First Examination Report (FER) was issued. The appellant responded to the objections, and a hearing was subsequently held. After the hearing:

• The appellant submitted written submissions and an amended set of claims (1–56);
• The Assistant Controller nonetheless, by order dated 24 September 2018, rejected the application, primarily invoking Section 3(b) of the Patents Act.

The crux of the Patent Office’s factual finding, as recorded by the High Court, was that:

• The invention required collection of 2–7 day old human embryos in a medium;
• hESC lines were “necessarily produced by a destructive use of human embryos”—in other words, the embryo does not survive the process of extraction of the inner cell mass;
• Such use of embryos led to abortion or destruction of human embryos, and was therefore considered unethical and contrary to Section 3(b).

2.3 Appeal Under Section 117A

An appeal was filed before the Calcutta High Court under Section 117A of the Patents Act, 1970, which provides for appellate review of certain orders of the Controller of Patents by the High Court.

The matter came up before the Intellectual Property Rights Division (IPD) of the Calcutta High Court and was reserved for judgment on 6 November 2025. Judgment was delivered on 17 November 2025.

2.4 Rival Submissions

Appellant’s Contentions

According to the judgment, the appellant argued:

• The impugned order was passed in violation of principles of natural justice;
• There had been an erroneous interpretation of Section 3(b) of the Act;
• The invention, properly understood, did not necessarily entail destruction of human embryos and therefore was not barred by Section 3(b);
• There was a misappreciation of the subject invention, warranting setting aside of the refusal.

Respondent’s Contentions

The Assistant Controller, represented before the Court, defended the order on the basis that:

• The impugned order was a reasoned decision which engaged with the nature of the invention;
• The claimed invention did contemplate and require destruction of 2–7 day old human embryos for the derivation of hESC lines;
• Such use necessarily involved abortion or destruction of embryos and was unethical;
• The invention therefore fell within the prohibition of Section 3(b), rendering it non-patentable.

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3. Issues Before the Court

Although the judgment is concise, the core legal issues can be distilled as follows:

1. Interpretation of Section 3(b):
   • Does an invention involving derivation and use of human embryonic stem cells, in a manner that involves destruction of human embryos and their commercial exploitation, fall within the scope of the exclusion in Section 3(b) as:
     • Contrary to public order or morality, and/or
     • Causing serious prejudice to human life or health?
2. Factual Characterisation of the Invention:
   • Did the invention, on its own terms, necessarily involve destruction of human embryos, or was such destruction avoidable, as claimed by the appellant?
3. Scope of Judicial Review under Section 117A:
   • To what extent can the High Court interfere with:
     • the Controller’s interpretation of Section 3(b); and
     • the Controller’s scientific and ethical assessment of the technology?
4. Alleged Violation of Natural Justice:
   • Was the impugned order vitiated by a procedural lapse, such as lack of adequate hearing or reasons?

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4. Summary of the Judgment

The High Court dismissed the appeal and upheld the Patent Office’s refusal. The key holdings may be summarised as follows:

1. Correctness of the Section 3(b) Application: The Court held that the Controller had correctly invoked Section 3(b). The invention, as understood by the Controller and endorsed by the Court, involved:
   • derivation of hESCs from the inner cell mass of human embryos,
   • which necessarily entails destruction of the embryo, and
   • the use of such cells for industrial or commercial purposes.
   This was held to be contrary to public order or morality and to fall within the category of non‑patentable subject matter under Section 3(b).
2. Focus of Section 3(b): The Court explained that Section 3(b) is meant to safeguard the public by excluding from patentability any invention:
   • whose primary or intended use is problematic;
   • whose commercial exploitation could harm public health, safety, or the environment;
   • that is contrary to public order or morality; or
   • that causes serious prejudice to human, animal, or plant life or health, or to the environment.
   The addition of the word “serious” in the 2002 Amendment was noted as indicating a threshold of significant impact.
3. International and Doctrinal Support: The Court referred to:
   • the concept of “ordre public and morality” as understood in international patent law, citing a passage (via Harvard College v. Canada (Commissioner of Patents)) that reflects the European Patent Office’s interpretation of Article 53(a); and
   • the academic discussion by Justice Prathiba M. Singh on patent law with respect to use of human embryos for industrial or commercial purposes.
4. Deference to Technical and Ethical Assessment: The Court stated that, in such complex matters of scientific and ethical judgment, it is not for the Court to re-examine the wisdom of the experts. There was no illegality or irrationality in the impugned decision that warranted interference under appellate jurisdiction.
5. Alignment with Stem Cell Research Guidelines: The Court observed that the Controller’s decision was in conformity with the National Guidelines for Stem Cell Research (2017), reflecting India’s regulatory stance on ethical stem cell research and commercialisation.
6. Natural Justice Objection Rejected: Although briefly, the Court concluded that there was no violation of natural justice. The impugned order had considered the parties’ submissions and was “adequately reasoned”.

On this basis, the High Court dismissed IPDPTA 88 of 2023, affirming the non‑patentability of the invention.

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5. Detailed Analysis

5.1 Statutory Framework: Section 3(b) of the Patents Act, 1970

Text of Section 3(b) (as quoted in the judgment):

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;

Several important features emerge from this text, as highlighted and structured by the Court:

1. Primary or Intended Use: The first limb focuses on the purpose for which the invention was developed. Even if the technology is neutral in the abstract, if its primary or intended use is problematic (e.g., for inhumane warfare, torture devices, or ethically unacceptable biomedical interventions), it may be excluded.
2. Commercial Exploitation: Patent law is concerned not just with ideas but with their commercial deployment. Section 3(b) expressly contemplates whether the commercial exploitation of an invention “could be contrary to public order or morality”. Thus, an invention might be scientifically valuable but still non‑patentable if its intended or foreseeable market exploitation is ethically unacceptable.
3. Public Order and Morality: These terms are inherently open‑textured and context‑dependent. “Public order” (or ordre public) covers public security, peace, and the integrity of social order. “Morality” reflects socially accepted ethical standards at a given time. Patent systems worldwide use such concepts to deny patents for inventions that society is not willing to legitimise or incentivise.
4. Serious Prejudice to Life, Health, or Environment: The second limb of Section 3(b) deals with inventions that cause “serious prejudice” to human, animal, or plant life or health, or to the environment. The Court notes that the insertion of the word “serious” by the 2002 Amendment signals a threshold of gravity: trivial or marginal risks are not enough, but substantial or significant harmful impact is.

Importantly, an invention can be excluded if either:

• its primary or intended use or commercial exploitation could be contrary to public order or morality; or
• it causes serious prejudice to life, health, or the environment.

The Court’s application of this provision to human embryonic stem cell inventions indicates a robust reading of both limbs, especially where destruction of human embryos is involved.

5.2 Precedents and Authorities Cited

5.2.1 Harvard College v. Canada (Commissioner of Patents) and the EPO’s Notion of “Ordre Public”

The judgment cites Harvard College v. Canada (Commissioner of Patents), [2002] 3 S.C.R. 519, a decision of the Supreme Court of Canada concerning the patentability of the so‑called “oncomouse”. In that context, international discussions on Article 53(a) of the European Patent Convention (EPC) — which excludes from patentability inventions contrary to “ordre public or morality” — were considered.

The Court reproduces a key passage (originally from European Patent Office jurisprudence) explaining ordre public:

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 prejudice the environment are to be excluded from patentability as being contrary to “ordre public”.

By endorsing this understanding, the Calcutta High Court:

• Aligns Section 3(b) with a well‑established international understanding of “ordre public” as embracing:
  • public security,
  • physical integrity of individuals, and
  • protection of the environment; and
• Reaffirms that the ethics‑based exclusions in patent law are not unique to India, but reflect a comparative international policy consensus on denying patents for morally or socially unacceptable inventions.

This comparative reference is especially important because hESC‑related patentability has been hotly debated in Europe as well, and the EPO and European courts have similarly adopted restrictive stances towards inventions involving the use of human embryos for industrial or commercial purposes.

5.2.2 Academic Authority: Justice Prathiba M. Singh on Patent Law

The Court also relies on the treatise Prathiba M. Singh on Patent Law (Edition 1, Vol. I, p. 140). The passage highlighted concerns:

• Ethical and legal challenges arising from:
  • cloning of human beings,
  • modification of human germline genetic identity, and
  • use of human embryos for industrial or commercial purposes;
• The need to address three core questions in evaluating such inventions:
  1. What is a human embryo?
  2. What is the use to which it is being put?
  3. Is that use of an industrial or commercial character?

By invoking this academic analysis, the Court signals that:

• Indian patent law scholarship has already identified use of human embryos for industrial or commercial purposes as a paradigmatic example of morally sensitive biotechnology;
• Section 3(b) should be read in a way that responds to precisely these kinds of ethical concerns; and
• The case at hand squarely raises these issues and is therefore an appropriate context to apply the morality/public order exclusion.

5.3 The Court’s Legal Reasoning

5.3.1 Characterisation of the Invention as Involving “Destructive” Use of Embryos

The central factual premise of the Court’s reasoning is that derivation of human embryonic stem cells from the inner cell mass of 2–7 day old human embryos necessarily results in the destruction of those embryos. This is scientifically accurate: at the blastocyst stage, the inner cell mass gives rise to the embryo proper; isolating it, as current technology stands, destroys the blastocyst.

The Court notes (para 10) that:

• Embryonic stem cells were “derived from human embryo inner cell mass using either immunological or mechanical methods for isolation”;
• Such cell lines were “necessarily produced by a destructive use of human embryos”; and
• The invention “requires the use of human embryos for industrial or commercial purposes within the meaning of Section 3(b)”.

On this basis, the Court accepts the Controller’s ethical conclusion that such destructive use leading to abortion or destruction of embryos is “unethical” and that commercialisation of the claimed invention would be contrary to public order or morality.

5.3.2 The Fourfold Focus of Section 3(b)

In paragraph 6, the Court breaks down Section 3(b) into four aspects:

1. Primary or intended use of the invention — what the invention is designed to do.
2. Potential for commercial exploitation in a harmful manner — whether commercial use could harm health, safety, or environment.
3. Contrariness to public order or morality — whether the invention disrupts public order or is ethically unacceptable.
4. Serious prejudice to human, animal, or plant life or health, or environment — with “serious” indicating significant impact.

Applying this framework, the Court effectively reasons:

• The primary use of the invention is in therapies or compositions involving hESC, which presuppose destructive extraction of embryonic inner cell mass.
• The commercial exploitation involves scaling such procedures and distributing such compositions, thereby institutionalising and incentivising an ethically controversial practice.
• Destructive use of early human embryos is sufficiently offensive to prevailing moral standards to be contrary to public order and morality.
• Such practice implicates the protection of human life at its earliest stages, thus also engaging the “serious prejudice to human life or health” limb, or at least strongly reinforcing the moral objection.

5.3.3 Role of “Public Order or Morality” in Biotechnological Patenting

The Court sets the case within a broader framework of ethically sensitive biotechnologies, stating that:

• Patent laws should not grant protection for “immoral” inventions;
• Biological inventions such as:
  • cloning of human beings,
  • germline genetic modification, and
  • industrial/commercial use of human embryos
  have been globally recognised as ethically contentious.

While the Court does not undertake an extended moral-theory analysis, it affirms that the destructive use of human embryos for commercial gain falls into the category of inventions the public patent system should not legitimise or promote.

5.3.4 Deference to Expert and Administrative Decision‑Making

A notable aspect of the reasoning is the Court’s explicit deference to the technical and ethical expertise of the Patent Office:

In a complex matter of such nature it is not for this Court to re-examine the wisdom of the experts.

The Court holds that:

• There is no incorrect interpretation of Section 3(b);
• No illegality, irrationality, or contravention of law is shown;
• The impugned order is “adequately reasoned” and is in conformity with the National Guidelines for Stem Cell Research (2017).

This reflects a restrained appellate role under Section 117A: the Court will not substitute its own ethical or scientific evaluation where the statutory authority has reasonably assessed the issues within its expertise, unless clear legal error or perversity is demonstrated.

5.3.5 Disposal of the Natural Justice Challenge

The appellant had alleged violation of principles of natural justice. While the judgment does not elaborate at length, it implicitly rejects this plea:

• The procedural record indicates:
  • issuance of a FER,
  • opportunity to respond,
  • a hearing, and
  • submission of written arguments with amended claims.
• The Court records that all contentions were “considered” and the order was “adequately reasoned”.

In effect, the Court finds no procedural irregularity serious enough to invalidate the order. The natural justice ground therefore fails.

5.4 Interaction with the National Guidelines for Stem Cell Research, 2017

The Court emphasises that the Controller’s refusal is in conformity with the National Guidelines for Stem Cell Research (2017). These guidelines, issued by Indian biomedical authorities, broadly:

• Regulate derivation, storage, and use of stem cells, including hESC;
• Impose ethical constraints on:
  • the source of embryos (e.g., surplus IVF embryos),
  • consent requirements,
  • prohibition of reproductive cloning and certain germline interventions, and
  • commercial exploitation of embryos and embryonic material.

By relying on these guidelines as a normative backdrop, the Court reinforces several jurisprudential points:

1. Patent law does not operate in a vacuum – it must be interpreted consistently with broader biomedical regulatory policy.
2. Ethically permissible research under regulatory guidelines does not automatically translate into patentable subject matter; however, violation of ethical standards is a strong indicator of non‑patentability under Section 3(b).
3. The guidelines provide an authoritative expression of India’s ethical policy on stem cell research, which the Patent Office and courts are entitled to take into account when applying “public order and morality”.

5.5 Judicial Review under Section 117A: Limited to Legal and Rationality Checks

The Court’s approach to its appellate role is notable. It:

• Confines itself to checking for legal error (misinterpretation of Section 3(b)),
• Assesses whether the decision is irrational or perverse, and
• Considers whether there is procedural unfairness.

Finding none of these, it refuses to reweigh expert moral and scientific conclusions. This reflects a general administrative‑law principle:

• Where the statute entrusts technical determinations to a specialised authority, courts tend to show deference, intervening only for:
  • jurisdictional error,
  • misinterpretation of law,
  • procedural unfairness, or
  • manifest unreasonableness.

In the patent context, this means:

• The High Court will ordinarily not substitute its own judgment on complex scientific or bioethical matters if the Controller has demonstrably considered them in a reasoned manner; and
• Applicants challenging refusals on Section 3(b) grounds must show a clear error in principle, not merely disagreement with the ethical assessment.

5.6 Impact and Implications of the Judgment

5.6.1 For Stem Cell and Regenerative Medicine Patents

This decision establishes, or at least strongly reinforces, the following proposition:

Inventions involving the derivation and use of human embryonic stem cells obtained through destructive use of early human embryos, for industrial or commercial purposes, are not patentable in India under Section 3(b).

Practical implications for future patent applications include:

• Direct hESC inventions: Claims that:
  • explicitly involve deriving hESCs from human embryos, and
  • do not credibly avoid destruction of the embryo,
  are likely to be refused under Section 3(b).
• Downstream applications of hESC lines: The judgment focuses on the derivation process and the need to use embryos for commercial purposes. A question that may arise in future is whether:
  • inventions that use pre‑existing hESC lines (derived under regulated conditions, for research purposes) without any further embryo destruction,
  also attract the Section 3(b) bar. While this judgment leans towards a restrictive stance, it leaves room for nuanced arguments in downstream cases.
• Preference for alternative technologies: Technologies such as:
  • induced pluripotent stem cells (iPSCs), which do not require embryo destruction; and
  • adult stem cell–based therapies,
  are more likely to be legally acceptable and patentable, assuming other criteria (novelty, inventive step, etc.) are met.

5.6.2 For Patent Office Practice

The judgment gives the Patent Office:

• Judicial endorsement of a cautious and ethics‑sensitive approach to:
  • stem cell–related inventions, and
  • other life‑science technologies involving human embryos, germline modifications, or cloning.
• A clear signal to:
  • closely scrutinise the source and derivation methods of biological materials, not just their end uses; and
  • explicitly apply Section 3(b) when destruction of human embryos is implicated.

5.6.3 For the Relationship Between Patent Law and Bioethics

The decision underscores several broader themes:

• Patents as ethical gatekeepers: By denying patents, the state:
  • refuses to confer exclusive rights and economic incentives on practices regarded as morally objectionable; and
  • sends a signal that certain lines of research and commercialisation are not to be encouraged through IP protection.
• Non‑patentability is not the same as illegality: A crucial conceptual point (implicit in the judgment) is that:
  • denial of a patent does not automatically criminalise or prohibit the underlying research; but
  • it withholds the reward mechanism that patents represent.
  Actual permissibility of research on embryos is governed by separate biomedical regulations and ethics guidelines.
• Dynamic moral standards: “Public order” and “morality” are not static; they evolve with societal values. Nonetheless, the Court indicates that, as of now in India:
  • destructive industrial use of human embryos is beyond the pale of acceptable practice for patent incentivisation.

5.6.4 For Judicial Role in Highly Technical Ethical Disputes

Finally, the decision illustrates a judicial stance of:

• High deference to expert agencies in matters involving:
  • technical complexity, and
  • ethical controversy within a regulated scientific field.
• Reluctance to undertake an independent ethical balancing exercise where:
  • the Patent Office has relied on recognised guidelines and scholarly views; and
  • no manifest legal error is demonstrated.

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6. Complex Concepts Simplified

6.1 What Are Human Embryonic Stem Cells (hESCs)?

• Human embryonic stem cells are cells derived from very early-stage human embryos (often 2–7 days old, at the blastocyst stage).
• They are pluripotent, meaning they have the capacity to differentiate into almost any type of cell in the human body (e.g., nerve, muscle, blood cells).
• To obtain hESCs, scientists typically:
  • Isolate the inner cell mass from the blastocyst, which destroys the embryo in the process.

Because of this destructive derivation process, the use of hESCs raises significant ethical debates, particularly about the moral status of very early human embryos.

6.2 “Ordre Public” and Morality in Patent Law

• Ordre public (public order) broadly covers:
  • public peace and security,
  • physical safety and integrity of individuals, and
  • environmental protection.
• Morality concerns society’s basic ethical standards at a given time — what is considered fundamentally right or wrong.

In patent law, these concepts are used to exclude certain inventions from patentability. For instance:

• An otherwise technically brilliant invention could be refused a patent if:
  • it facilitates torture or terrorism (public order), or
  • it involves grossly unethical treatment of humans or animals (morality).

Section 3(b) is India’s expression of these global principles.

6.3 “Industrial or Commercial Use” of Human Embryos

The phrase “use of human embryos for industrial or commercial purposes” (as discussed by the Court and the cited treatise) means:

• Using human embryos or materials derived from them primarily:
  • as part of commercial products or services (e.g., therapies, cell lines sold to laboratories, pharmaceutical compositions), or
  • within a profit-driven industrial process (e.g., mass production of biological materials for sale).

This is distinct from:

• purely non‑commercial basic research under strict ethical oversight, which may still be controversial but is conceptually different from commercial exploitation.

The judgment indicates that when embryos are destroyed as part of a process that is then claimed for industrial or commercial benefit, Section 3(b) is likely to be triggered.

6.4 Non‑Patentability vs. Prohibition of Research

It is crucial to distinguish:

• Non‑patentability: The state chooses not to:
  • grant exclusive economic rights, or
  • incentivise the technology through the patent system.
  This is what Section 3(b) does.
• Illegality of research or practice: This is governed by:
  • biomedical regulations,
  • criminal law, and
  • ethical oversight frameworks.
  Research may be permissible under tight controls even if the invention is not patentable.

In other words, the Court is not criminalising hESC research; it is saying that such research, if it involves destructive use of embryos for industrial/commercial exploitation, will not be rewarded with a patent monopoly.

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7. Conclusion: Key Takeaways and Broader Significance

Shroff Geeta v. Assistant Controller of Patents and Designs is an important articulation of how Section 3(b) of the Patents Act, 1970 operates in the context of advanced biomedical technologies involving human embryos.

The key takeaways are:

1. Clear Application of Section 3(b) to hESC Inventions: The Court affirms that inventions involving the destructive derivation and industrial/commercial exploitation of human embryonic stem cells fall within:
   • the “public order or morality” exclusion, and
   • the protective aim of preventing serious prejudice to human life or health.
2. Integration of Ethical Guidelines into Patent Decision‑Making: By aligning the refusal with the National Guidelines for Stem Cell Research (2017), the Court:
   • bridges patent law with bioethics regulation; and
   • confirms that ethical policy documents can inform the interpretation of Section 3(b).
3. Comparative and Doctrinal Support: The Court draws on:
   • the EPO’s concept of ordre public (via Harvard College v. Canada), and
   • scholarly commentary by Justice Prathiba M. Singh,
   situating Indian law in a broader international and doctrinal context that consistently regards destructive industrial use of human embryos as ethically problematic.
4. Judicial Deference to Expert Agencies: The High Court adopts a restrained appellate role, declining to re‑evaluate complex scientific and ethical findings where:
   • the Patent Office has given a reasoned decision, and
   • no clear legal or procedural error is shown.
   This sets a precedent for highly technical patent appeals under Section 117A.
5. Policy Signal to Innovators: The decision signals to the biotechnology and regenerative medicine community that:
   • innovations that avoid embryo destruction (e.g., iPSCs, adult stem cells) are more likely to be compatible with patent policy;
   • patents will not be granted where the underlying process is anchored in commercial destruction of human embryos.

In the broader legal landscape, the judgment reinforces the idea that patent law in India is not a morally neutral instrument. It functions as a gatekeeper, channelling technological innovation along pathways that are consistent with societal values, ethical frameworks, and public policy objectives. Where an invention crosses the line into unacceptable exploitation of human life at its earliest stages, Section 3(b) provides a robust doctrinal basis for denying it the state’s imprimatur in the form of a patent.

Consequently, Shroff Geeta will serve as an important reference for:

• future patent applications involving human embryos or similar ethically sensitive subject matter;
• the Patent Office in framing Section 3(b) objections and decisions; and
• courts and practitioners seeking guidance on the intersection between intellectual property law, bioethics, and public morality in India.