IPR
Topic 56 Patent Infringement
Topic 56 — Patent Infringement
Patent infringement is the unauthorised exercise of any of the exclusive rights granted by Section 48 of the Patents Act 1970. Unlike trademark infringement (which has a specific statutory test in Section 29), patent infringement is determined by the doctrine of "claim construction" — analysing whether the defendant's product or process falls within the scope of the patent claims as construed. Indian patent infringement jurisprudence draws heavily from English law (literal infringement, doctrine of equivalents, Improver questions) and US law (claim construction, all-elements test, doctrine of equivalents, prosecution history estoppel). The leading recent Indian authority is the Delhi High Court Division Bench in F. Hoffmann-La Roche v. Cipla (27 November 2015), which set out a comprehensive framework for patent infringement analysis. This topic walks through claim construction, the tests for infringement, the doctrine of equivalents, defences, and key Indian decisions.
1. Statutory Architecture
Section | Subject |
|---|---|
Section 48 | Exclusive rights of patentee — definition of acts that constitute infringement. |
Section 104 | Jurisdiction — District Court / High Court above pecuniary limit. |
Section 105 | Power of court to make declaration as to non-infringement. |
Section 106 | Power of court to grant relief in cases of groundless threats of infringement proceedings. |
Section 107 | Defences in suits for infringement. |
Section 107A | Bolar provision — research / regulatory testing exemption. |
Section 108 | Reliefs in suits for infringement — injunction, damages, account of profits, seizure. |
2. What Constitutes Patent Infringement
A. The Section 48 Acts
Patent infringement occurs when a third party, without the patentee's consent, performs any of the following acts in India:
1 PRODUCT PATENT making/using/offering/selling/importing | 2 PROCESS PATENT using process + product directly obtained |
B. The Test — Claim Construction First
Patent infringement analysis proceeds in two stages:
- Claim construction — what does the claim mean? Construed objectively from the perspective of a person skilled in the art at the priority date.
- Comparison — does the defendant's product/process fall within the construed scope of the claim?
3. Claim Construction — The Foundation
A. The "Person Skilled in the Art" Standard
Claims are construed from the perspective of a hypothetical "person skilled in the art" — the same construct used for inventive step analysis. The construct:
- Has the ordinary skill, knowledge, and creativity of a competent practitioner in the relevant technical field.
- Has read the patent specification.
- Has access to all relevant prior art at the priority date.
- Approaches the claim with a "purposive" rather than literal reading.
B. Purposive Construction
Indian courts adopt the "purposive construction" approach articulated by the House of Lords in Catnic Components Ltd. v. Hill & Smith Ltd. [1981] FSR 60. The approach:
- Read the claim as a person skilled in the art would read it.
- Look at the substance of the invention, not merely the literal words.
- Avoid a "strict literal" reading that would defeat the patentee's reasonable expectations.
- Avoid an excessively broad reading that would extend beyond the actual disclosure.
C. The Improver Questions (Now Catnic-Pumfrey)
A standard analytical framework for purposive construction (Improver Corp. v. Remington Consumer Products Ltd. [1990] FSR 181):
- Does the variant work in the same way as the patent? (If no, no infringement.)
- Would this have been obvious to the skilled person at the priority date? (If no, no infringement.)
- Would the skilled reader have understood that the patentee intended literal compliance? (If yes, no infringement of the variant.)
4. Tests for Patent Infringement
A. Literal Infringement
Literal infringement occurs when the defendant's product/process falls within the literal scope of the claim — every element of the claim is present in the defendant's product/process. Key features:
- "All-elements" test — every claim element must be present.
- Element-by-element comparison.
- Strictest form of infringement; easiest to prove if all elements clearly present.
B. Doctrine of Equivalents
The doctrine of equivalents extends infringement to products/processes that do not literally fall within the claim but achieve substantially the same result through substantially the same means. The doctrine prevents:
- Mere copying of the inventive concept with cosmetic changes.
- Insubstantial modifications that "design around" the claim.
- Defeats of patent value through trivial substitutions.
✅ The "function-way-result" test A common articulation of the doctrine of equivalents is the function-way-result test (originally Graver Tank v. Linde Air, US Supreme Court 1950): does the variant perform substantially the same function (F), in substantially the same way (W), to achieve substantially the same result (R)? If yes, equivalent infringement is established. Indian courts have applied this framework, alongside the Improver questions. |
C. Indirect Infringement — Section 48 and Beyond
Indian law does not separately codify "indirect" or "contributory" infringement, but the concepts arise:
- Inducement — actively encouraging others to infringe is itself a form of liability.
- Contributory infringement — supplying components specifically adapted for use in the patented invention.
- Use of imported components — assembly in India of components imported from abroad may constitute infringement.
5. Roche v. Cipla — The Leading Indian Authority
📖 F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (Single Judge — 7 Sept 2012; Division Bench — 27 Nov 2015) Facts — Roche held Indian Patent IN 196774 on Erlotinib Hydrochloride (marketed as Tarceva for non-small cell lung cancer). In 2008, Cipla launched a generic version under brand ERLOCIP at substantially lower price. Roche sued for infringement. Cipla counter-claimed for revocation under Section 64 (lack of novelty, inventive step, Section 3(d)). Single Judge holding (7 September 2012, Justice Manmohan Singh) — Roche's patent was held valid (Cipla failed to establish revocation grounds). However, Roche failed to prove that Cipla's ERLOCIP infringed IN 774 — primarily because Roche could not establish through evidence that Cipla's product was Erlotinib Hydrochloride (not just Polymorph B which was claimed by a separate rejected application). Division Bench holding (27 November 2015, Justice Pradeep Nandrajog and Justice Mukta Gupta) — Reversed in part. Held that: (i) Roche's IN 774 patent claim covered Erlotinib Hydrochloride compound — not limited to any specific polymorphic form. (ii) Cipla's ERLOCIP (Polymorph B of Erlotinib Hydrochloride) clearly fell within the IN 774 claim because all polymorphic forms are subsumed within the compound claim. (iii) Cipla's revocation challenge for obviousness failed. (iv) Cipla's Section 3(d) challenge failed — Section 3(d) recognises incremental innovation but requires the increment to be substantial; in this case the patent was for Erlotinib itself, not a derivative. Aftermath — Cipla's SLP to the Supreme Court was withdrawn following settlement; Cipla acknowledged the validity of Roche's patent rights. Significance — The leading Indian Division Bench decision on patent infringement framework; comprehensive treatment of claim construction, polymorph claims, Section 3(d) interpretation, and the proper standards for revocation challenges. |
A. Roche v. Cipla Framework — Key Holdings
Issue | Holding |
|---|---|
Compound claim scope | Compound claim covers all polymorphic forms unless expressly limited to a specific form. |
Section 3(d) construction | Recognises incremental innovation; requires substantial efficacy increase. |
Section 3(d) classification | Patent eligibility provision (not patentability ground per se). |
Burden on revocation challenger | Heavy burden to establish revocation grounds. |
Burden on infringement plaintiff | Must prove all claim elements present in defendant's product. |
6. Defences to Patent Infringement — Section 107
Section 107 — Defences in Suits for Infringement "(1) In any suit for infringement of a patent, every ground on which it may be revoked under section 64 shall be available as a ground for defence. (2) In any suit for infringement of a patent by the making, using or importation of any machine, apparatus or other article or by the using of any process or by the importation, use or distribution of any medicine or drug, it shall be a ground for defence that such making, using, importation or distribution is in accordance with any one or more of the conditions specified in section 47." |
A. Major Statutory Defences
Defence | Section | Substance |
|---|---|---|
Invalidity | Section 107(1) + Section 64 | Patent fails on any Section 64 revocation ground. |
Section 47 conditions | Section 107(2) | Government use; research; teaching; government medicines. |
Bolar exemption | Section 107A | Research and regulatory testing for generic launch post-expiry. |
Foreign vessels | Section 49 | Use on foreign vessels temporarily in India. |
Pre-existing use | Common law / equity | Use before priority date by defendant. |
Implied licence | Common law | Acts impliedly authorised by patentee. |
Acquiescence / delay | Common law / equity | Plaintiff sat on rights after knowledge. |
B. Section 107A — The Bolar Exemption
Section 107A "For the purposes of this Act,— (a) any act of making, constructing, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law for the time being in force, in India, or in a country other than India, that regulates the manufacture, construction, use, sale or import of any product; (b) importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product, shall not be considered as a infringement of patent rights." |
C. Section 107A(a) — Research and Regulatory Use
Section 107A(a) — known as the "Bolar provision" after Roche Products v. Bolar Pharmaceuticals (US 1984) — allows generic manufacturers to perform research, testing, and regulatory submissions for generic versions BEFORE the patent expires. This enables generic launch immediately upon expiry. The exemption covers:
- R&D activities for generic version development.
- Bioequivalence testing.
- Regulatory filings (drug master files, ANDAs, NDA submissions).
- Sample preparation for regulatory authorities.
D. Section 107A(b) — International Exhaustion
Section 107A(b) authorises parallel imports of patented products from authorised producers in other jurisdictions. This implements international exhaustion principle in patent law (similar to Section 30(3) for trademarks). The provision allows:
- Importation of patented products lawfully made in another country.
- Parallel imports of pharmaceuticals from countries with lower prices.
- Grey-market goods that are genuine (not counterfeit) but imported through unauthorised channels.
7. Section 108 — Reliefs in Infringement Suits
Section 108 — Reliefs "(1) The reliefs which a court may grant in any suit for infringement include an injunction (subject to such terms, if any, as the court thinks fit) and, at the option of the plaintiff, either damages or an account of profits. (2) The court may also order that the goods which are found to be infringing and materials and implements, the predominant use of which is in the creation of infringing goods shall be seized, forfeited or destroyed, as the court deems fit under the circumstances of the case without payment of any compensation." |
A. Available Reliefs
- Injunction — interim and permanent.
- Damages OR account of profits (election by plaintiff).
- Seizure / forfeiture / destruction of infringing goods and manufacturing implements.
- Costs of litigation.
B. Damages Considerations in Patent Infringement
Patent damages in India follow general civil principles:
- Compensatory damages — plaintiff's actual loss; lost royalties; market displacement.
- Reasonable royalty as hypothetical licence fee — common in pharmaceutical cases.
- Account of profits — disgorgement of defendant's profits.
- Punitive damages — possible for wilful infringement.
8. Strategic Considerations in Patent Litigation
✅ For plaintiffs — twelve points Conduct thorough infringement analysis BEFORE filing — claim construction; element-by-element comparison. For pharmaceutical patents, prepare detailed evidence of product composition (HPLC, NMR, X-ray crystallography). Plead all elements with specificity — vague pleadings risk dismissal under Roche v. Cipla evidentiary standard. Anticipate revocation counter-claims under Section 107(1)/Section 64. For interim injunction, build strong prima facie case; address public interest factor (especially for life-saving drugs). Coordinate with related civil/criminal/customs proceedings. Consider Section 105 declaratory relief in advance for defensive purposes. For damages, plead specific evidence — speculative claims weaken case (post-Toshiba 2024 standard applies in patents too). Use Form 27 working statements as evidence of commercial activity. Maintain robust corroboration for foreign-language patents and translations. For multi-jurisdictional patents, coordinate global enforcement strategy. For generics, monitor Section 107A activities; distinguish Bolar-protected research from infringing commercial activity. |
✅ For defendants — eight points Section 107(1) revocation defence — file counter-claim for revocation under Section 64 grounds. Claim construction — challenge plaintiff's claim construction; argue narrower scope. Demonstrate non-infringement by element-by-element analysis showing missing element(s). Section 107A Bolar — establish regulatory-research purpose for activities. Section 47 statutory conditions — government use; research; teaching. For generics, demonstrate independent development; chain of innovation distinct from patent. Section 108 damages — challenge speculative quantification; require evidence-based calculations. Public interest defences — particularly for life-saving drugs, raise public health considerations. |
🎯 EXAM POINTERS — TOPIC 56
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