Author – Vishal v v
Occupation-Advocate
Abstract
Patent law grants inventors exclusive, time-bound rights in exchange for public disclosure. Doctors and dentists in India can patent surgical instruments, dental appliances, and diagnostic devices like any other inventor. But Regulation 6.2 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 adds a twist. It permits physicians to hold patents. Yet it also calls it unethical to withhold a patented benefit from the public where a large population’s interest is involved. No other class of Indian patentee faces this rule. This article examines that conflict. It asks whether Regulation 6.2 survives constitutional scrutiny under Articles 14, 19(1)(g) and 21, compares India’s position with several major jurisdictions, and considers newer flashpoints such as AI-based diagnostic patents and patent ownership in hospital settings. It concludes that the provision is legally significant but practically dormant, and proposes specific reforms.
Literature review and research gap
Existing Indian scholarship has focused mainly on the patentability of medical inventions, compulsory licensing under Section 84, and public health limits on pharmaceutical patents, exemplified by extensive commentary on Novartis and Bayer. Very little of this literature examines the interaction between Regulation 6.2 and statutory patent rights specifically. This article addresses that gap by situating the conflict within constitutional doctrine, comparative regulatory practice, and India’s innovation policy, an intersection that has received very limited scholarly attention to date.
To The Point
India’s medical device and dental technology sector is growing fast. Doctors and dentists increasingly invent patentable devices. Patent law protects these inventions once granted. But Regulation 6.2 conditions that protection on public access, without defining what access means. This creates two problems. First, it may be constitutionally suspect, since it singles out one profession for a burden no other patentee faces. Second, it is completely untested. No reported case has ever interpreted or enforced it. This article argues that the silence is not proof the rule works. It may instead show that doctors quietly avoid patenting, or that the rule is too vague to enforce at all.
Use Of Legal Jargon
Key concepts used here include “patentability” (novelty, inventive step, and industrial applicability under Section 2(1)(j) of the Patents Act, 1970); statutory exclusions under Sections 3(f), 3(i), and 3(k); “patent exclusivity” under Section 48; “compulsory licensing” under Section 84; and “reasonable classification” and “intelligible differentia,” the twin tests under Article 14 of the Constitution used to assess whether a law’s unequal treatment of a group is constitutionally valid. The article also uses “reasonable restriction” under Article 19(6), which permits the State to limit the right to practise any profession under Article 19(1)(g), and “delegated legislation,” since Regulation 6.2 was framed under statutory rule-making power and continues in force under the National Medical Commission Act, 2019.
The Proof
Section 2(1)(j) of the Patents Act, 1970 defines a patentable invention without excluding any profession. A dentist’s orthodontic bracket or a surgeon’s clamp is patentable like any corporate invention, subject to Sections 3(f), 3(i) and 3(k). Section 3(i) bars methods of medical treatment outright, so practitioners must claim a device or formulation, not a technique. Once granted, Section 48 gives the patentee twenty years of exclusive commercial control.
Regulation 6.2 and the public-interest override
Regulation 6.2 permits physicians to patent instruments and appliances, but calls it unethical if a patent’s benefits are withheld from the public where a large population is involved. It sets no timeline, no defined trigger, and no forum. The 2002 Code survives today: the NMC’s 2023 Professional Conduct Regulations were placed in abeyance within weeks of notification, and the 2002 Code, including Regulation 6.2, was formally re-adopted.
Constitutional dimension: Article 14
Article 14 permits differential treatment only if it rests on an intelligible differentia bearing a rational nexus to the law’s object. Regulation 6.2 singles out physicians and dentists among all patentees for a public-access duty. A corporate patentee facing identical public health stakes, such as a pharmaceutical company, is instead governed by Section 84’s structured compulsory licensing regime, with defined triggers and judicial oversight. Regulation 6.2 offers no such structure. Whether the differentia (professional identity) rationally connects to the object (ensuring access to essential health innovations) is doubtful when the same object is already served, more precisely, by Section 84 for everyone else. This suggests real Article 14 vulnerability, though it has never been judicially tested.
Constitutional dimension: Article 19(1)(g)
Article 19(1)(g) protects the right to practise a profession, including its economic dimension. Article 19(6) allows reasonable restrictions in the public interest. A vague ethics rule that threatens disciplinary action for ordinary patent commercialisation, without defined standards, risks failing the reasonableness test the Supreme Court applies to professional restrictions. Vagueness itself can render a restriction unreasonable, since a practitioner cannot know in advance what compliance requires.
Article 21, proportionality, and manifest arbitrariness
A stronger justification for Regulation 6.2 may lie in Article 21’s right to health, which arguably permits restricting a physician’s commercial exclusivity where withholding an invention would harm public health. Under the doctrine of proportionality, such a restriction must still be suitable, necessary, and no more burdensome than required to achieve its purpose. Because Section 84 already offers a narrower, judicially supervised mechanism to achieve the same access goal, Regulation 6.2’s open-ended language arguably fails the necessity limb of proportionality. Its complete absence of defined standards may also expose it to challenge under the manifest arbitrariness doctrine, which strikes down state action that is capricious or lacking adequate determining principle.
The counter-argument
A fair counter-view exists. Medicine is not an ordinary trade; physicians accept heightened ethical duties toward patients and society in exchange for professional privileges, as Poonam Verma recognises. Society may legitimately expect a physician-inventor to prioritise patient welfare over pure commercial gain, particularly where an invention addresses a widespread health need. This justifies some public-interest constraint in principle. The difficulty is not the existence of such a duty but its present drafting: an undefined, unenforced standard serves neither patients nor practitioners as well as a precise, structured one would.
Comparative position
No equivalent ethics-based patent restriction exists for physicians in the United States, the United Kingdom, or under the European Patent Convention. The American Medical Association’s ethics code discusses conflicts of interest in patenting but does not mandate public availability of a patented invention. The UK’s General Medical Council similarly regulates conduct and conflicts of interest without touching commercial patent exploitation. The EPC applies uniform patentability rules regardless of the applicant’s profession. Japan, Australia, Canada, and Singapore likewise regulate medical professional conduct without imposing a comparable patent-access obligation. India’s Regulation 6.2 therefore appears to be a comparatively unusual, possibly unique, professional constraint on patent exclusivity.
Other regulated professions and the National IPR Policy
Engineers, scientists, and pharmacists in India may all patent inventions without any equivalent ethical override, even where their inventions carry comparable public significance, such as a pharmacist’s novel drug-delivery device. Singling out physicians and dentists alone raises a further equality question extending beyond medicine. This sits uneasily alongside India’s National IPR Policy, 2016, which expressly promotes innovation and commercialisation across sectors; an undefined ethical constraint unique to one profession runs against that stated policy direction, at a time when India’s medical device market and MedTech and dental-technology startup activity are both expanding rapidly.
Emerging flashpoint: AI-based diagnostic patents
A growing number of doctors are patenting AI-assisted diagnostic tools; consider a radiologist patenting an AI-based tumour-detection algorithm, or a dentist commercialising a machine-learning-driven aligner design. It is unclear whether Regulation 6.2 applies to such software-based inventions at all, since the 2002 Code was drafted long before AI diagnostics existed. This ambiguity could deter physician-led MedTech and dental-AI startups from patenting or licensing their innovations, raising innovation-policy concerns beyond the immediate ethics question.
Patent ownership in institutional settings
A further unresolved issue is ownership. Where a surgeon invents a laparoscopic instrument using a hospital’s funded research facilities, or a medical college sponsors a dentist’s aligner research, the hospital or institution, not the individual practitioner, often owns the resulting patent under standard employment or funding agreements. It is unclear whether Regulation 6.2, addressed to “physicians,” still binds the practitioner personally once a corporate hospital controls commercialisation decisions, or whether the obligation simply lapses once ownership transfers away from the inventor.
Judicial silence
No reported judgment interprets Regulation 6.2, and there is no public record of the National Medical Commission ever issuing a disciplinary notice under it. This silence may reflect several possibilities: practitioners may simply avoid patenting to sidestep the ambiguity; the Commission may never have tested the rule; or the provision may be too vague to support any disciplinary action in the first place. Each explanation points toward the same conclusion: an effectively dormant, untested rule cannot meaningfully guide conduct.
Economic and innovation-policy dimension
Consider a dentist who invests two crore rupees developing a novel implant. Patent exclusivity is the reward that justifies this risk. An undefined obligation to share the invention where a large population’s interest is involved reduces the certainty of that reward. Reduced certainty can discourage investment in research by exactly the practitioners best placed to identify clinical problems worth solving. Regulation 6.2, intended to protect patients, may therefore carry an unintended cost: fewer physician-led inventions reaching the patent system, and fewer disclosed to the public at all, since disclosure is itself a condition of patenting under Section 10 of the Act.
Licensing as a possible middle path
Compulsory licensing is not the only route to reconcile exclusivity with access. A physician-patentee could grant an exclusive licence to a single well-resourced manufacturer to ensure scale, a non-exclusive licence to multiple manufacturers to widen availability, a royalty-free licence for humanitarian distribution, or a public-private partnership with a government health programme. A FRAND-style commitment (fair, reasonable, and non-discriminatory terms), by analogy to standard-essential patent practice, offers a further middle path. Regulation 6.2 does not say whether any such arrangement satisfies its access requirement. Clarifying that a reasonable licensing structure, of whichever kind, discharges the ethical duty, without requiring free or unrestricted access, would preserve incentives to invent while still meeting the regulation’s public-interest goal.
Case Laws
Novartis AG v. Union of India, (2013) 6 SCC 1 — The Supreme Court denied patent protection to a modified drug form under Section 3(d) absent enhanced therapeutic efficacy, embedding public health concerns directly into patentability standards.
Bayer Corporation v. Natco Pharma Ltd., (2014) SCC OnLine Bom 1049 — The Bombay High Court upheld India’s first compulsory licence under Section 84, where a patented drug was not available at a reasonably affordable price. This shows the Act’s own structured route for overriding exclusivity, contrasted with Regulation 6.2’s undefined one.
Allergan Inc. v. Controller of Patents, 2023:DHC:515, and Starpharma Pty Ltd v. Assistant Controller of Patents, (T) CMA (PT) No. 22 of 2023 (Madras HC) — Both permitted amending treatment-method claims into product claims under Sections 57 and 59, confirming that practitioners must frame inventions as products to secure any protection under Section 3(i).
Poonam Verma v. Ashwin Patel, (1996) 4 SCC 332 — The Supreme Court treated medicine as a profession bound by heightened ethical duty, distinct from ordinary trade, lending doctrinal support to stricter conduct standards for physicians generally.
State of West Bengal v. Anwar Ali Sarkar, AIR 1952 SC 75 — The foundational authority on Article 14’s intelligible differentia and rational nexus test, applied here to assess whether singling out physicians for a patent-access duty is constitutionally sound.
Conclusion
Regulation 6.2 places physicians and dentists in a legal position unlike any other Indian patentee. They may hold exclusive patent rights under the Patents Act, 1970, yet face an undefined, profession-specific ethical duty to share the benefit of that patent with the public. This duty likely raises genuine Article 14 and Article 19(1)(g) concerns, has no parallel in the US, UK, or under the EPC, and remains completely untested by any court or disciplinary body.
In this author’s opinion, the absence of enforcement is not reassurance; it is a warning sign of a rule too vague to apply. The National Medical Commission should, in coordination with the Patent Office, undertake specific reforms: define “large population” with a concrete threshold; set a fixed compliance timeline running from the date of grant; confirm that a reasonable licence, exclusive or non-exclusive, discharges the ethical duty without requiring free access; clarify whether the rule extends to AI-based diagnostic patents and to institutionally owned inventions; introduce a mediation step before any disciplinary proceeding; and issue illustrative guidance showing what compliant conduct looks like in practice. Absent such reform, the safer long-term path may be to withdraw Regulation 6.2 entirely and rely on Section 84’s more procedurally rigorous compulsory licensing regime, which already achieves the same public-interest goal for every other class of patentee in India, without singling out one profession for an undefined burden. Future research should examine how AI-assisted diagnostics, surgical robotics, telemedicine, and personalised medicine reshape this same conflict between professional ethics and patent exclusivity as these technologies mature.
FAQ
Q1. Can a doctor or dentist in India patent an invention made during clinical practice?
Yes. The Patents Act, 1970 does not restrict who may be an inventor, provided the invention meets novelty, inventive step, and industrial applicability requirements.
Q2. Can a doctor patent a treatment method itself?
No. Section 3(i) bars patents on methods of medical or surgical treatment. Practitioners must claim the underlying device or formulation instead, as confirmed in Allergan and Starpharma.
Q3. Does Regulation 6.2 violate Article 14 of the Constitution?
It has never been judicially tested, but it singles out physicians for a public-access duty that no other patentee faces, while an equivalent public-interest goal is already served for others through Section 84. This raises a credible, though untested, equality challenge.
Q4. Do other countries impose a similar ethical restriction on physician-patentees?
No clear equivalent exists in the United States, the United Kingdom, or under the European Patent Convention, where physician ethics codes address conflicts of interest but do not mandate public availability of a patented invention.
Q5. Does Regulation 6.2 apply to AI-based diagnostic patents held by doctors?
This remains unclear. The 2002 Code predates AI diagnostics, and neither the National Medical Commission nor any court has clarified whether software-based physician inventions fall within its scope.
Q6. If a hospital owns a doctor’s patent, does Regulation 6.2 still apply?
This is genuinely unsettled. Where a hospital or medical college owns the patent under an employment or funding agreement, it is unclear whether the ethical obligation still binds the individual physician personally, or whether it lapses once commercialisation control passes to the institution.
References
The Patents Act, 1970 (India).
The Constitution of India, 1950, arts. 14, 19(1)(g), 19(6) and 21.
Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002, Regulation 6.2.
National Medical Commission Act, 2019 (India).
National IPR Policy, 2016 (Department for Promotion of Industry and Internal Trade, Government of India).
Novartis AG v. Union of India, (2013) 6 SCC 1.
Bayer Corporation v. Natco Pharma Ltd., (2014) SCC OnLine Bom 1049.
Allergan Inc. v. Controller of Patents, 2023:DHC:515.
Starpharma Pty Ltd v. Assistant Controller of Patents, (T) CMA (PT) No. 22 of 2023 (Madras HC).
Poonam Verma v. Ashwin Patel, (1996) 4 SCC 332.
State of West Bengal v. Anwar Ali Sarkar, AIR 1952 SC 75.
