The Question Your Patent Cannot Answer: Freedom to Operate in India

By Lucy Rana and Huda Jafri

Introduction

For many businesses, the most dangerous intellectual property assumption is also the most common: “We have a patent, therefore we are free to sell our product.”

Indian patent law does not work that way. A patent principally confers an exclusionary right against third parties, namely the right to prevent others from exploiting the patented invention. It does not guarantee that the patentee may itself commercially practice the invention without infringing earlier or broader third-party rights.

That distinction sits at the centre of one of the most commercially significant and frequently neglected exercises in intellectual property strategy: the freedom-to-operate (“FTO”) assessment.

An FTO assessment examines whether a proposed product or process may be made, used, sold, offered for sale, or imported in a given jurisdiction without infringing valid and enforceable patent rights held by others. In practice, it is a legal risk assessment that informs whether a business can safely bring a product to market, scale it, attract investment, and sustain it in the market.

In India, the analysis is shaped principally by Section 48 of the Patents Act, 1970, and by judicial interpretation on claim construction, infringement, and validity.

This article advances five propositions:

• A patent is a right to exclude others, not a right to practice one’s own invention.
• Patentability and freedom to operate are legally and commercially distinct inquiries.
• FTO is fundamentally a prediction of how a court would construe patent claims and assess infringement, if litigation arises.
• Regulatory approval to market a product is not equivalent to patent clearance.
• The value of FTO lies in enabling mitigation before market entry.

1. The Most Expensive Half-Truth

   There is perhaps no sentence in intellectual property law more commercially misleading than: “We have a patent, so we are protected.”

   It is only partially true.

   Under Section 48 of the Patents Act, 1970, a patent grants the patentee the exclusive right to prevent others from making, using, offering for sale, selling, or importing the patented invention in India. The statute confers an exclusionary right. It does not confer affirmative permission to commercialise one’s own product free from third-party rights.

   This distinction matters because innovation is cumulative. A company may obtain a valid patent over an improvement, optimisation, formulation, or implementation while still infringing an earlier and broader patent held by another party.

   An FTO assessment addresses this exposure.

   It is often the difference between:

   • a product launch that proceeds with managed legal risk, and
   • a launch interrupted by cease-and-desist notices or interim injunction proceedings shortly before launch, after significant commercial investment has already been committed.

   A patent is therefore best understood as a sword, not a shield. Freedom to operate is the shield, and it must be built separately.

2. What Freedom to Operate Actually Asks

   A freedom-to-operate assessment asks a practical question:

   Can a particular product or process be made, used, sold, offered for sale, or imported in the relevant jurisdictions without infringing any valid and enforceable third-party patent rights?

   Each element carries legal meaning.

   The listed acts reflect the exclusive rights under Section 48. Liability may arise from any one of them.

   “Relevant jurisdictions” reflects territoriality. Patent rights are national rights, and clearance in one country does not imply clearance elsewhere.

   “Valid and enforceable” excludes expired, lapsed, or revoked patents.

   Importantly, FTO is a professional legal opinion and risk assessment, not a judicial determination. Ultimately, infringement is decided by courts if disputes arise.

   FTO concerns third-party rights. A company’s own patents do not determine freedom to operate.

3. Patentability and Freedom to Operate Are Different Questions

   Patentability and freedom to operate are distinct inquiries.

   Patentability asks whether an invention satisfies statutory requirements for grant, including novelty, inventive step, and patentable subject matter. This determination is made by the Patent Office.

   Freedom to operate asks whether commercial exploitation would infringe enforceable third-party rights. This is assessed commercially through legal analysis and ultimately determined by courts in litigation.

   The outcomes may diverge.

   A product may be patentable yet still infringe an earlier patent.
   A product may be unpatentable yet freely commercialisable if it is in the public domain.

   The grant of a patent answers whether protection is available. It does not answer whether commercialisation is safe.

4. How Indian Courts Assess Patent Infringement

   FTO analysis must reflect how Indian courts assess infringement.

   1. Claims Define the Monopoly

      In Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd., (1979) 2 SCC 511, the Supreme Court recognised that patent validity and scope must be assessed with reference to the claims read with the specification. The specification aids interpretation but does not expand the claims beyond their language.

   2. Essential Elements

      Indian courts examine whether the essential claim elements or integers are present in the allegedly infringing product or process.

      FTO therefore involves structured claim-by-claim mapping, comparing each element against the proposed product.

   3. Variants and Substance Over Form

      In Raj Prakash v. Mangat Ram Choudhary, AIR 1978 Del 1, the Delhi High Court applied the “pith and marrow” principle, holding that infringement may be found where the substance of the invention is taken despite minor variations.

      Indian law does not adopt a strict US-style doctrine of equivalents, but courts do apply purposive construction to prevent avoidance through immaterial changes.

5. The Five Risks a Serious FTO Assessment Must Address

   1. Granted and In-Force Patents

      Only live patents matter. Expired or lapsed patents do not create risk.

   2. Pending Applications

      Published applications under Section 11A may evolve during prosecution. Under Section 11A(7), the applicant acquires provisional rights from the date of publication, but infringement proceedings can only be instituted after grant. Any pre-grant recovery is subject to statutory limitations and is not equivalent to full enforcement rights.

   3. Territoriality

      Patent rights are territorial. Supply chains determine risk geography.

   4. Claim Scope

      Claims, not titles or abstracts, define infringement exposure.

   5. Validity Risk

      A blocking patent vulnerable under Section 64 presents a materially different risk from a robust patent.

6. Regulatory Approval Is Not Patent Clearance

   Regulatory approval does not provide freedom to operate.

   Approval from authorities such as the Central Drugs Standard Control Organisation addresses safety and efficacy, not patent rights.

   India does not follow a patent linkage system requiring regulators to consider patent status during approval.

   This position has been affirmed in Bayer Corporation v. Union of India & Ors. (Delhi High Court, 2009).

   A product may be fully approved yet still infringe valid patents upon launch.

7. The Mitigation Toolkit
   FTO is valuable because it enables mitigation.

   1. Design-Around

      Early modification to avoid claim elements is often the most effective solution.

   2. Licensing

      Where risk is unavoidable, licensing may be commercially rational.

   3. Validity Challenges

      Options include pre-grant opposition (Section 25(1)), post-grant opposition (Section 25(2)), and revocation (Section 64).

   4. Waiting for Expiry

      The patent term in India is 20 years from filing under Section 53.

   5. Geographic Structuring

      Operations may be structured in jurisdictions where patents do not exist.

   6. Section 105 Declaratory Relief

      Section 105 allows a person to seek a declaration of non-infringement after first requesting written acknowledgement from the patentee and receiving refusal or no response. It enables commercial certainty in appropriate cases.

8. Why FTO Matters Commercially

   1. Investment and M&A

      Investors evaluate IP portfolios together with infringement risk.

   2. Litigation Risk Management

      A contemporaneous FTO opinion is a relevant factor in demonstrating good faith, though it is not determinative of liability.

   3. Corporate Governance

      Board approvals based solely on ownership of patents reflect incomplete legal analysis. FTO-informed decisions reflect proper diligence.

Conclusion

A patent is not a commercial clearance document. It is a right to exclude others, not a guarantee of freedom to operate.

That distinction is straightforward in doctrine but commercially decisive in practice.

FTO analysis translates that doctrine into business reality. Done early, it preserves strategic options. Done late, it becomes risk containment after exposure has already crystallised.

For businesses entering or scaling in India, the central question is not whether they have patents. It is whether they have freedom to operate.

Can the product actually be sold, and kept on the market?

That is the question a patent alone cannot answer.