Patent infringement occurs when any person, without authorisation from the patentee, exercises any of the exclusive rights conferred by S.48 (making, using, selling, offering for sale, or importing the patented product/process). Remedies are exclusively civil (no criminal penalties for patent infringement in India). The suit must be filed in a District Court having jurisdiction (S.104).
Why: Unlike trademarks and copyright, patent infringement has no criminal dimension in India because patent disputes involve complex technical questions (claim construction, equivalents) requiring specialised judicial scrutiny rather than criminal investigation.
Legal Framework
| Section | Subject |
|---|---|
| S.104 | Jurisdiction and forum for infringement suits |
| S.104A | Burden of proof for process patents |
| S.105 | Power of court to make declarations of non-infringement |
| S.106 | Power of court to grant relief in infringement suits |
| S.107 | Defences to infringement |
| S.107A | Exceptions (Bolar, parallel imports) |
| S.108 | Reliefs in suit for infringement |
| S.111 | Revocation of patent as counterclaim in infringement suit |
Types of Patent Infringement
| Type | Description | Example |
|---|---|---|
| Literal infringement | Accused product/process falls squarely within the language of patent claims | Reproducing exact chemical formula claimed |
| Infringement by equivalents (Doctrine of Equivalents) | Accused product/process performs substantially the same function, in substantially the same way, to achieve substantially the same result | Using a known equivalent chemical to achieve identical therapeutic effect |
| Contributory infringement | Supplying a component that has no substantial non-infringing use and is especially adapted for use in the patented invention | Not explicitly codified in Indian law; courts apply general principles |
| Indirect infringement | Inducing/abetting another to infringe | Selling components with instructions to assemble patented device |
Claim construction
The claims define the scope of the patent monopoly. Infringement analysis begins with construing (interpreting) the claims:
| Approach | Rule |
|---|---|
| Purposive construction | Claims interpreted to give effect to the inventive concept; not literal nor liberal |
| Specification aids construction | Description, drawings, abstract used to understand claims |
| Prosecution history estoppel | Narrowing amendments during prosecution limit scope (less developed in India) |
| Person skilled in the art | Claims interpreted through eyes of notional skilled person |
Burden of Proof (S.104A)
For process patents: if the product is new, the burden shifts to the defendant to prove that the product was made by a different process.
S.104A: In a suit for infringement of a patent being a process for obtaining a product, where the product is new, the court may direct the defendant to prove that the process used by him is different from the patented process.
Why: Process infringement is nearly impossible for the patentee to detect directly (what happens inside the defendant's factory is secret). Shifting the burden remedies this informational asymmetry.
Exceptions to Infringement (S.107A)
| Exception | Section | Scope |
|---|---|---|
| Bolar exception | S.107A(a) | Making, using, selling for purpose of obtaining regulatory approval (pre-expiry preparation by generic companies) |
| Parallel imports | S.107A(b) | Importation of patented product from a person duly authorised to sell/distribute abroad (international exhaustion) |
Why (Bolar): Without this exception, generic manufacturers could not begin regulatory testing until patent expiry, effectively extending monopoly by 3-5 years (time needed for regulatory approval). The Bolar exception allows generics to enter market immediately upon patent expiry.
Why (Parallel imports): India follows international exhaustion. Once a patented product is legitimately sold anywhere in the world, the patentee's rights over that specific unit are exhausted; it can be freely imported into India.
Defences to Infringement (S.107)
| Defence | Basis |
|---|---|
| Non-infringement | Accused product/process does not fall within patent claims |
| Patent invalidity | Patent should not have been granted (S.64 grounds); counterclaim for revocation (S.111) |
| Bolar exception | Acts done for regulatory approval (S.107A(a)) |
| Parallel imports | Legitimate importation (S.107A(b)) |
| Prior use (S.107) | Person who was using the invention before priority date may continue |
| Government use | Authorised under S.100 |
| Compulsory licence | Holding valid CL |
| Experimental use | Use for experiment/research (implied exception) |
| Exhaustion | Goods purchased from patentee or authorised seller |
Remedies (S.108)
| Remedy | Detail |
|---|---|
| Interim injunction | Restraining order pending trial; balance of convenience, prima facie case, irreparable harm |
| Permanent injunction | Final restraining order after finding infringement |
| Damages | Compensatory: plaintiff's lost profits due to infringement |
| Accounts of profits | Alternative to damages: disgorgement of defendant's profits from infringement |
| Delivery up / destruction | Infringing products and materials delivered up or destroyed |
| Costs | Court may award costs of proceedings |
| Declaration of validity | S.106: court may declare patent valid if infringement proved |
Note: Plaintiff must elect between damages and accounts of profits; cannot claim both.
Considerations for interim injunction in patent cases
| Factor | Consideration |
|---|---|
| Prima facie case | Is patent valid? Is infringement likely? |
| Balance of convenience | Relative hardship if injunction granted vs refused |
| Irreparable harm | Would damages be inadequate remedy? |
| Public interest | Access to medicines, essential products (per Roche v. Cipla) |
| Patent validity presumption | Granted patent enjoys presumption of validity unless challenged |
Illustrations: Bolar Exception Timing
What IS permitted (Bolar, S.107A(a)): Patent for Drug X expires on 31 December 2026. On 1 January 2025 (still within patent term), GenericCo begins manufacturing Drug X in small batches, conducts bioequivalence studies, and files application with CDSCO for marketing approval. GenericCo does NOT sell a single tablet to any patient. This is PERMITTED — it's done solely "for the purpose reasonably relating to the development and submission of information required under any law."
What is NOT permitted: Same scenario, but on 15 March 2025, GenericCo starts selling Drug X to hospitals while the patent is still alive. This IS infringement. Bolar only covers pre-commercial regulatory preparation, not actual commercial sale.
Why Bolar matters (the timing problem without it): Without Bolar, GenericCo could only START regulatory testing on 1 January 2027 (day after patent expires). CDSCO approval takes 2-3 years. So the generic wouldn't actually reach patients until 2029-2030 — effectively extending the monopoly by 3 years beyond the 20-year term. Bolar prevents this by allowing parallel preparation so generics hit the market on Day 1 after expiry.
Parallel imports (S.107A(b)) illustrated: PatentCo sells Drug X in Bangladesh at Rs.500/tablet (price for developing country). An Indian importer buys legitimate Drug X from Bangladesh and imports into India where PatentCo sells at Rs.2,000/tablet. Under international exhaustion (S.107A(b)), this is NOT infringement: PatentCo already received payment when it sold in Bangladesh; its rights over those specific tablets are "exhausted."
Recall Check
- What is the Bolar exception under S.107A(a) and why does it exist?
- How does S.104A shift the burden of proof for process patent infringement?
- Can a defendant in an infringement suit seek revocation of the patent? Under which section?
Key Cases
Roche v. Cipla (Delhi HC, 2015) Hoffmann-La-Roche-v-Cipla-2015 Issue: Whether Cipla's generic erlotinib (cancer drug) infringed Roche's patent and whether interim injunction should be granted. Rule: In pharmaceutical patent cases involving life-saving drugs, public interest in access may outweigh patentee's right to interim injunction; damages may be adequate alternative remedy. Held: Infringement established on merits, but permanent injunction structured to balance access. Court imposed royalty-based arrangement. Demonstrates Indian courts' approach: patent rights enforced, but access concerns modulate relief.
Monsanto v. Nuziveedu Seeds (2019) Monsanto-v-Nuziveedu-Seeds-2019 Issue: Whether Monsanto's patent on Bt cotton technology (Bollgard-II) was valid given S.3(j) exclusion for plants/seeds, and whether sub-licensees could use the technology without paying trait fees. Rule: S.3(j) excludes plants, seeds, and essentially biological processes. The question is whether the patent claims cover the nucleotide sequence (micro-organism/process, potentially patentable) or the plant containing it (excluded). Held: Supreme Court remanded for fresh hearing on patent validity. Key issue: whether patent claims as drafted cover the plant (excluded) or the technology (potentially valid). Case highlights tension between biotech patents and S.3(j) exclusion.
Distinctions
| Parameter | Patent Infringement | Copyright Infringement | Trademark Infringement |
|---|---|---|---|
| What is violated | Claims (functional scope) | Expression (form) | Source identification |
| Independent creation defence | No (absolute right) | Yes (no copying = no infringement) | No (likelihood of confusion) |
| Criminal penalties | None in India | S.63: up to 3 years | S.103: up to 3 years |
| Forum | District Court (S.104) | District Court / Metropolitan Magistrate | District Court (S.134) |
| Burden of proof | Plaintiff (except process patents: S.104A) | Plaintiff | Plaintiff |
| Counterclaim for invalidity | Yes (S.111: revocation) | No equivalent | Rectification possible |
| Public interest in remedy | Significant (access to medicines) | Moderate (educational access) | Limited |
Flashcards
Q: What is literal infringement? A: When the accused product/process falls squarely within the language of the patent claims as properly construed.
Q: What is the Doctrine of Equivalents? A: Infringement exists even if the accused device/process does not literally satisfy claim language, if it performs substantially the same function, in substantially the same way, to achieve substantially the same result.
Q: What does S.104A provide for process patents? A: If the patented process produces a new product and a defendant's product is identical, the court may direct the defendant to prove they used a different process (burden reversal).
Q: What is the Bolar exception? A: S.107A(a): acts done for obtaining regulatory approval (e.g., generic drug testing for CDSCO approval) before patent expiry do not constitute infringement.
Q: Can you get criminal penalties for patent infringement in India? A: No. Patent infringement is exclusively a civil wrong in India; there are no criminal penalties.
Q: What is a counterclaim for revocation (S.111)? A: The defendant in an infringement suit can counterclaim that the patent is invalid and should be revoked under S.64 grounds (lack of novelty, inventive step, S.3 exclusions, etc.).
Q: What is international exhaustion (S.107A(b))? A: Once a patented product is sold legitimately anywhere in the world by or with consent of the patentee, anyone can import that specific product into India without infringing the patent.
Q: Why did the court refuse interim injunction in Roche v. Cipla? A: Public interest in access to a life-saving cancer drug outweighed patentee's interest in exclusivity; damages were an adequate alternative remedy; balance of convenience favoured public access.
Exam Scenario
DrugCo (patent holder for anti-diabetic drug Metabix, patent granted 2023) discovers that GenericCo is manufacturing a bioequivalent version in India and has applied to CDSCO for marketing approval but has not yet started commercial sales.
Advise DrugCo on: (a) Whether GenericCo's pre-approval manufacturing constitutes infringement or falls within the Bolar exception (S.107A(a)). (b) If GenericCo begins commercial sales before patent expiry, what infringement remedies DrugCo can seek. (c) Whether an interim injunction is likely given the public interest in affordable diabetes medication (applying Roche v. Cipla principles). (d) If GenericCo's product is identical to Metabix but it claims a different manufacturing process, how S.104A affects the burden of proof. (e) Whether GenericCo can counterclaim for revocation under S.111 and on what grounds.
See Also
- IoS-3.1 Penal Statutes — criminal penalties for patent infringement strictly construed in favour of accused; S.118-124 penal provisions interpreted narrowly
- IoS-3.3 Beneficial Construction — S.104A (reverse burden of proof for process patents) interpreted beneficially to protect patentees; courts apply liberal construction to shift burden effectively
- Rights, Obligations and Limitations on Patent Rights — Bolar exception and compulsory licensing operate as defences to infringement; limitation on rights directly constrains available remedies