Patent Infringement: Meaning, Types, and Legal Remedies

Patent Infringement: Meaning, Types, and Legal Remedies. Patent infringement happens when someone makes, uses, sells, distributes, or imports a patented invention without the permission of the patent holder during the period of protection. In India, it is governed mainly under the Patents Act, 1970 (as amended). 
What Constitutes Patent Infringement?
A patent gives the owner an exclusive right to exploit the invention. If any third party engages in the following without consent or license, it amounts to infringement i.e., making the patented product or using the patented process, using the invention commercially, selling or offering for sale the invention and importing the patented product or a product made through the patented process. 
Types of Patent Infringement
    The following are the types of infringements:

Direct Infringement: Unauthorized use of the patented product or process falling under this category.

Indirect/Contributory Infringement: Supplying components or assisting someone else in infringing belongs to this category.

Literal Infringement: Under this category, it is infringed by way of duplicating every element of a patent claim that is copied exactly.

Doctrine of Equivalents: In this category, even if not an exact copy, if the accused product or process performs substantially the same function in substantially the same way, it may still be infringing.

Defenses Against Patent Infringement 
     The alleged infringers may defend themselves by proving:

The patent is invalid by way of showing the reasons (lacks novelty, inventive step, or industrial applicability).

Their activity does not fall within the scope of the patent claims.

The patent has expired or was not enforceable.

They are using it under government authorization or for research/experimental purposes (exceptions under the Act).

Remedies for Patent Infringement 
     If infringement is established, the patent holder may seek:

Injunction: Filing a request in court to issue a court order to stop the infringer.

Damages or Account of Profits: The patentee can file a demand in court for monetary compensation or surrender of profits earned from infringement.

Seizure/Destruction: The patentee can ask confiscation or destruction of infringing goods.

Indian Case Law Examples
We wish to furnish an infringement case example on Frimline vs. K-Smatco  regarding making, using, offering for sale, selling, distributing, advertising, marketing, exporting, importing or in any manner, directly or indirectly, the product 'FERROTOK PLUS' and/or the composition as claimed in the suit patent i.e., IN 382949 in the name of Frimline and/or any other ad-mixture/ combination/ formulation products containing the composition as claimed in the suit patent, during the subsistence of the suit patent. 
Here’s a practitioner-oriented checklist of acts that can amount to infringement of Frimline’s IN 382949 (composition for anaemia) by K-Smatco or anyone else, for the full life of the patent in India assuming the accused product falls within the claimed composition (Claim 1) and/or its process (Claim 14) or their equivalents. 
What the suit is about (context you can cite)?
The Delhi High Court suit pleads infringement of IN 382949 (“A pharmaceutical composition for anaemia”) against K-Smatco; the impugned product includes FERROTOK PLUS. The Court has issued restraint on sale/process use at the interim stage. 
The claimed invention (family) covers a synergistic composition of lactoferrin + guanosine nucleotide(s) (e.g., GMP) with optional elemental iron/folate/vitamin C, and a process for preparing it. 
Direct product-based acts (Section 48(a)) 
Any without-consent act in India involving a product that embodies Claim 1 (or its equivalents):

Manufacturing/compounding/formulating the composition (including pilot/commercial batches; contract/toll manufacturing).

Using the product commercially (clinical supply, hospital supply, MRs’ in-clinic demo use, patient starter kits).

Selling the product (B2B/B2C, distributor to stockist, institutional sales).

Offering for sale (tender bids, price lists, catalogues, e-commerce listings, pre-orders, WhatsApp/Google-Form order drives).

Importing the patented product into India (finished packs, bulk for repack).

Direct process-based acts (Section 48(b)) 
If Claim 14 (process) is practiced:
 6) Using the patented process in India at any scale.
 7) Using/offering/selling/importing a product obtained directly by the patented process (even if the sale happens by a different group entity). 
Acts typically treated as (or evidencing) “offer for sale”/commercial exploitation

Advertising that solicits orders/provides prices/lists availability (print, digital, HCP details, brochures with “order now”).

Stocking/warehousing inventory for sale (with price lists/SKU codes/dispatch notes) often treated as part of the sale chain.

Sampling to doctors, distributors, or trial sites as a commercial rollout (beyond genuine research/approval activities).

Co-pack/kitting the claimed composition with other actives (the kit still “uses” the patented product).

(While Sec. 48 doesn’t spell out advertising/stocking, Indian courts routinely read        
      “Offer for sale” broadly in patent suits; use these as actionable hooks with proof.) 
“Colorable changes” that still infringe (Doctrine of Equivalents)

Salt/grade/substitute swaps that don’t change the function way result (e.g., swapping disodium GMP for another G-nucleotide salt; changing iron source to ferrous bis-glycinate within claimed/insubstantially different ranges).

Adding extra excipients/vitamins while keeping the lactoferrin + guanosine nucleotide synergy intact.

(The Delhi High Court has reaffirmed DoE principles; the Frimline order notes that claims define scope and equivalents can capture insubstantial variations.) 
Indirect/secondary liability touchpoints (use to bind the network)

Authorizing, directing, or procuring third-party CMOs, packers, printers, or distributors to perform any of A–C.

Supplying all essential ingredients + instructions to assemble the claimed composition with knowledge of infringement (argued as indirect/contributory infringement in Indian practice while not codified, courts have entertained such theories in IP suits under common-law principles).

Export scenarios from India

Manufacturing in India for export still an infringing “making” act in India (destination doesn’t cleanse domestic manufacture).

Export sales disguised as “samples” where use is commercial (not limited to bona fide regulatory work).

(Caveat / carve-out below for the Bolar/Section 107A research exemption.) 
Typical documentary/evidentiary acts you should treat as infringement-enabling (to plead & prove)

Drug license filings/stockist circulars/ GST e-invoices naming the composition.

MR detailing slides, HCP monographs, tender submissions, batch records (MFR/BMR), COAs matching the claim recipe.

Import/export documents (BoE/packing lists) showing composition elements mapping to the claim (e.g., lactoferrin + GMP + iron/folate).
 (Use these to prove A–F; they’re not separate statutory acts but core proof of infringing exploitation.)

The key carve-outs (use to fence defendants’ “defence” narratives)

Bolar/Section 107A: making/using/selling (incl. “export”) solely for development and submission of information required under any law in India or any foreign jurisdiction is not infringement but the defendant must show a reasonable relation to regulatory use (quantities, recipients, paperwork, timing).

Government-use/Section 47(4): Government import or use of medicines for its own use or distribution via specified hospitals/dispensaries is carved out; private sales via commercial channels won’t qualify.

How to map acts to IN 382949 (what to check)

Composition match: presence of lactoferrin + guanosine nucleotide(s) (e.g., GMP) ± elemental iron/folate/vitamin C, within claimed (or insubstantially different) ranges. Use labels, COAs, and lab tests (HPLC/assay) to confirm.

Process match: steps and solvents/excipients aligning with Claim 14; if so, product of process provisions bites even where the exact recipe isn’t on the label.

K-Smatco conduct listings/sales of FERROTOK PLUS or any rebranded SKU featuring the above composition; interim reports indicate the Court has restrained such sales and process use.

Conclusion
Patent infringement is the unauthorized use of a patented invention. The scope of protection depends on the claims in the patent document, and courts assess infringement by comparing the claims with the alleged infringing product or process. During the patent’s subsistence, any commercial making, using, selling, offering for sale, or importing of a product embodying Claim 1 (or obtained by Claim 14’s process) including look-alike admixtures/“fortified” variants that preserve the claimed synergy is actionable infringement, along with authorizing/causing others to do so. Only narrow statutory exceptions (Sec. 107A research/regulatory, Sec. 47(4) limited government use) stand outside this net. 
FAQs 
Q1. What is patent infringement?
Ans. Unauthorized making, using, selling, offering for sale, or importing a patented product; or using a patented process and dealing in the product directly obtained by that process during the patent term. 
Q2. Which law applies?
Ans. The Patents Act, 1970 (as amended) and the Commercial Courts Act 2015 for procedure/timelines. 
Q3. Who can sue?
Ans. The patentee, an exclusive licensee (often alongside the patentee), and an assignee of record.
Q4. Where is the suit filed?
Ans. In a competent Commercial Court/High Court with territorial jurisdiction (where infringement occurs or defendant resides/carries on business). If the defendant files a revocation counterclaim, the suit is heard by a High Court. 
Q5. What actions count as infringement?
Ans. a] Making/compounding/formulating the patented product
   b] Using it commercially (including institutional supply)
   c] Selling/stocking and offering for sale (catalogues, tenders, listings)
   d] Importing it and
   e] Using the patented process; and dealing in the product of that process. 
Q6. Is “offer for sale” broad?
Ans. Yes. Tenders, pricelists, brochures, e-commerce listings, and sales pitches that solicit orders typically qualify. 
Q7. What if only some claim elements are present?
Ans. Missing an essential element avoids literal infringement. However, Doctrine of Equivalents may still catch insubstantial variations that achieve the same function, in the same way, with the same result. 
Q8. What is indirect (contributory) infringement?
Ans. Courts can hold liable those who aid/abet infringement e.g., supplying all essential components with knowledge they’ll be assembled into the patented product though the Act doesn’t codify it expressly. 
Q9. What are common defences?
Ans. Non-infringement (no claim element match)

Invalidity (lack of novelty, inventive step, industrial applicability; added matter; insufficiency) via counterclaim

Exhaustion/parallel import (see Q11)

Statutory exceptions (see Q10)

Q10. What are the statutory exceptions/safe harbours?
Ans. A] Section 107A (“Bolar”): acts reasonably related to development and submission of information to regulators in India or abroad (includes certain exports for data).and
B] Section 47 & 100: limited Government use/import for Government purposes. 
Q11. Is parallel import allowed?
Ans. Yes, Section 107A(b) permits import of a patented product from a person duly authorized under the foreign law to produce/sell it (i.e., international exhaustion for patents in defined terms). 
Q12. What about research/academic use?
Ans. Genuine non-commercial research may be sheltered, but commercial scale “sampling” or disguised launches are risky facts matter. 
Q13. What if the patent isn’t worked in India?
Ans. Non-working isn’t a defence to infringement. It may support compulsory licensing (separate proceeding), not absolve liability. 
Q14. What is the burden of proof in process patent cases?
Ans. Section 104A can shift the burden to the defendant to prove their process is different when the product is new or there’s a substantial likelihood the identical product is made by the patented process.
Q15. What remedies are available?
Ans. I] Interim/permanent injunctions (including John-Doe/Ashok-Kumar orders),
         II] Damages (lost profits or reasonable royalty) or account of profits (elect one),
         III] Delivery up/destruction of infringing stock, and
         IV] Costs and disclosure of accounts 
Q16. When will courts grant an interim injunction?
Ans. On prima facie case, balance of convenience, irreparable injury, and sometimes public interest (especially in pharma/healthcare). 
Q17. How are damages calculated?
Ans. Based on sales evidence, market share loss, price erosion, or hypothetical royalty. Indian courts more often award reasonable royalty plus costs; punitive damages are rare but possible with egregious conduct.
Q18. Is patent infringement a crime in India?
Ans: No, infringement is a civil wrong. (Certain offences like false marking exist, but not criminal infringement per se.) 
Q19. How long do I have to sue (limitation)?
Ans. Generally, 3 years from each actionable cause of action (each infringing act is fresh). Continuous infringement keeps the cause alive for new relief.
Q20. What evidence should a patentee collect?
Ans. Accused product samples, labels, batch/MFR/BMR records, COAs, invoices, tender documents, marketing decks, website captures, import/export docs, and expert reports mapping claim elements. 
Q21. Do I need a claim chart?
Ans. Not mandated, but a claim-by-claim element chart greatly strengthens both interim and final relief. 
Q22. Can I amend claims during litigation?
Ans. Limited post-grant amendments (to disclaim or narrow) may be sought, provided they don’t add matter or broaden scope; courts scrutinize timing and prejudice. 
Q23. Does a license end infringement risk?
Ans. A proper written license with clear field/territory/royalty terms can. Breach may revive infringement exposure. 
Q24. How do compulsory licenses interact with infringement?
Ans. A granted CL permits acts within its scope and terms prospectively; pre-grant acts remain actionable. 
Q25. What about SEPs and FRAND?
Ans. SEP suits add FRAND considerations to remedies/royalties, but the infringement test remains claims based.

Patent infringement happens when someone makes, uses, sells, distributes, or imports a patented invention without the permission of the patent holder during the period of protection. In India, it is governed mainly under the Patents Act, 1970 (as amended).

What Constitutes Patent Infringement?

A patent gives the owner an exclusive right to exploit the invention. If any third party engages in the following without consent or license, it amounts to infringement i.e., making the patented product or using the patented process, using the invention commercially, selling or offering for sale the invention and importing the patented product or a product made through the patented process.

Types of Patent Infringement

The following are the types of infringements:

Direct Infringement: Unauthorized use of the patented product or process falling under this category.
Indirect/Contributory Infringement: Supplying components or assisting someone else in infringing belongs to this category.
Literal Infringement: Under this category, it is infringed by way of duplicating every element of a patent claim that is copied exactly.
Doctrine of Equivalents: In this category, even if not an exact copy, if the accused product or process performs substantially the same function in substantially the same way, it may still be infringing.

Defenses Against Patent Infringement

The alleged infringers may defend themselves by proving:

The patent is invalid by way of showing the reasons (lacks novelty, inventive step, or industrial applicability).
Their activity does not fall within the scope of the patent claims.
The patent has expired or was not enforceable.
They are using it under government authorization or for research/experimental purposes (exceptions under the Act).

Remedies for Patent Infringement

If infringement is established, the patent holder may seek:

Injunction: Filing a request in court to issue a court order to stop the infringer.
Damages or Account of Profits: The patentee can file a demand in court for monetary compensation or surrender of profits earned from infringement.
Seizure/Destruction: The patentee can ask confiscation or destruction of infringing goods.

Indian Case Law Examples

We wish to furnish an infringement case example on Frimline vs. K-Smatco regarding making, using, offering for sale, selling, distributing, advertising, marketing, exporting, importing or in any manner, directly or indirectly, the product 'FERROTOK PLUS' and/or the composition as claimed in the suit patent i.e., IN 382949 in the name of Frimline and/or any other ad-mixture/ combination/ formulation products containing the composition as claimed in the suit patent, during the subsistence of the suit patent.

Here’s a practitioner-oriented checklist of acts that can amount to infringement of Frimline’s IN 382949 (composition for anaemia) by K-Smatco or anyone else, for the full life of the patent in India assuming the accused product falls within the claimed composition (Claim 1) and/or its process (Claim 14) or their equivalents.

What the suit is about (context you can cite)?

The Delhi High Court suit pleads infringement of IN 382949 (“A pharmaceutical composition for anaemia”) against K-Smatco; the impugned product includes FERROTOK PLUS. The Court has issued restraint on sale/process use at the interim stage.

The claimed invention (family) covers a synergistic composition of lactoferrin + guanosine nucleotide(s) (e.g., GMP) with optional elemental iron/folate/vitamin C, and a process for preparing it.

Direct product-based acts (Section 48(a))

Any without-consent act in India involving a product that embodies Claim 1 (or its equivalents):

Manufacturing/compounding/formulating the composition (including pilot/commercial batches; contract/toll manufacturing).
Using the product commercially (clinical supply, hospital supply, MRs’ in-clinic demo use, patient starter kits).
Selling the product (B2B/B2C, distributor to stockist, institutional sales).
Offering for sale (tender bids, price lists, catalogues, e-commerce listings, pre-orders, WhatsApp/Google-Form order drives).
Importing the patented product into India (finished packs, bulk for repack).

Direct process-based acts (Section 48(b))

If Claim 14 (process) is practiced:

6) Using the patented process in India at any scale.

7) Using/offering/selling/importing a product obtained directly by the patented process (even if the sale happens by a different group entity).

Acts typically treated as (or evidencing) “offer for sale”/commercial exploitation

Advertising that solicits orders/provides prices/lists availability (print, digital, HCP details, brochures with “order now”).
Stocking/warehousing inventory for sale (with price lists/SKU codes/dispatch notes) often treated as part of the sale chain.
Sampling to doctors, distributors, or trial sites as a commercial rollout (beyond genuine research/approval activities).
Co-pack/kitting the claimed composition with other actives (the kit still “uses” the patented product).

(While Sec. 48 doesn’t spell out advertising/stocking, Indian courts routinely read

“Offer for sale” broadly in patent suits; use these as actionable hooks with proof.)

“Colorable changes” that still infringe (Doctrine of Equivalents)

Salt/grade/substitute swaps that don’t change the function way result (e.g., swapping disodium GMP for another G-nucleotide salt; changing iron source to ferrous bis-glycinate within claimed/insubstantially different ranges).
Adding extra excipients/vitamins while keeping the lactoferrin + guanosine nucleotide synergy intact.

(The Delhi High Court has reaffirmed DoE principles; the Frimline order notes that claims define scope and equivalents can capture insubstantial variations.)

Indirect/secondary liability touchpoints (use to bind the network)

Authorizing, directing, or procuring third-party CMOs, packers, printers, or distributors to perform any of A–C.
Supplying all essential ingredients + instructions to assemble the claimed composition with knowledge of infringement (argued as indirect/contributory infringement in Indian practice while not codified, courts have entertained such theories in IP suits under common-law principles).

Export scenarios from India

Manufacturing in India for export still an infringing “making” act in India (destination doesn’t cleanse domestic manufacture).
Export sales disguised as “samples” where use is commercial (not limited to bona fide regulatory work).

(Caveat / carve-out below for the Bolar/Section 107A research exemption.)

Typical documentary/evidentiary acts you should treat as infringement-enabling (to plead & prove)

Drug license filings/stockist circulars/ GST e-invoices naming the composition.
MR detailing slides, HCP monographs, tender submissions, batch records (MFR/BMR), COAs matching the claim recipe.
Import/export documents (BoE/packing lists) showing composition elements mapping to the claim (e.g., lactoferrin + GMP + iron/folate).

(Use these to prove A–F; they’re not separate statutory acts but core proof of infringing exploitation.)

The key carve-outs (use to fence defendants’ “defence” narratives)

Bolar/Section 107A: making/using/selling (incl. “export”) solely for development and submission of information required under any law in India or any foreign jurisdiction is not infringement but the defendant must show a reasonable relation to regulatory use (quantities, recipients, paperwork, timing).
Government-use/Section 47(4): Government import or use of medicines for its own use or distribution via specified hospitals/dispensaries is carved out; private sales via commercial channels won’t qualify.

How to map acts to IN 382949 (what to check)

Composition match: presence of lactoferrin + guanosine nucleotide(s) (e.g., GMP) ± elemental iron/folate/vitamin C, within claimed (or insubstantially different) ranges. Use labels, COAs, and lab tests (HPLC/assay) to confirm.
Process match: steps and solvents/excipients aligning with Claim 14; if so, product of process provisions bites even where the exact recipe isn’t on the label.
K-Smatco conduct listings/sales of FERROTOK PLUS or any rebranded SKU featuring the above composition; interim reports indicate the Court has restrained such sales and process use.

Conclusion

Patent infringement is the unauthorized use of a patented invention. The scope of protection depends on the claims in the patent document, and courts assess infringement by comparing the claims with the alleged infringing product or process. During the patent’s subsistence, any commercial making, using, selling, offering for sale, or importing of a product embodying Claim 1 (or obtained by Claim 14’s process) including look-alike admixtures/“fortified” variants that preserve the claimed synergy is actionable infringement, along with authorizing/causing others to do so. Only narrow statutory exceptions (Sec. 107A research/regulatory, Sec. 47(4) limited government use) stand outside this net.

FAQs

Q1. What is patent infringement?

Ans. Unauthorized making, using, selling, offering for sale, or importing a patented product; or using a patented process and dealing in the product directly obtained by that process during the patent term.

Q2. Which law applies?

Ans. The Patents Act, 1970 (as amended) and the Commercial Courts Act 2015 for procedure/timelines.

Q3. Who can sue?

Ans. The patentee, an exclusive licensee (often alongside the patentee), and an assignee of record.

Q4. Where is the suit filed?

Ans. In a competent Commercial Court/High Court with territorial jurisdiction (where infringement occurs or defendant resides/carries on business). If the defendant files a revocation counterclaim, the suit is heard by a High Court.

Q5. What actions count as infringement?

Ans. a] Making/compounding/formulating the patented product

b] Using it commercially (including institutional supply)

c] Selling/stocking and offering for sale (catalogues, tenders, listings)

d] Importing it and

e] Using the patented process; and dealing in the product of that process.

Q6. Is “offer for sale” broad?

Ans. Yes. Tenders, pricelists, brochures, e-commerce listings, and sales pitches that solicit orders typically qualify.

Q7. What if only some claim elements are present?

Ans. Missing an essential element avoids literal infringement. However, Doctrine of Equivalents may still catch insubstantial variations that achieve the same function, in the same way, with the same result.

Q8. What is indirect (contributory) infringement?

Ans. Courts can hold liable those who aid/abet infringement e.g., supplying all essential components with knowledge they’ll be assembled into the patented product though the Act doesn’t codify it expressly.

Q9. What are common defences?

Ans. Non-infringement (no claim element match)

Invalidity (lack of novelty, inventive step, industrial applicability; added matter; insufficiency) via counterclaim
Exhaustion/parallel import (see Q11)
Statutory exceptions (see Q10)

Q10. What are the statutory exceptions/safe harbours?

Ans. A] Section 107A (“Bolar”): acts reasonably related to development and submission of information to regulators in India or abroad (includes certain exports for data).and

B] Section 47 & 100: limited Government use/import for Government purposes.

Q11. Is parallel import allowed?

Ans. Yes, Section 107A(b) permits import of a patented product from a person duly authorized under the foreign law to produce/sell it (i.e., international exhaustion for patents in defined terms).

Q12. What about research/academic use?

Ans. Genuine non-commercial research may be sheltered, but commercial scale “sampling” or disguised launches are risky facts matter.

Q13. What if the patent isn’t worked in India?

Ans. Non-working isn’t a defence to infringement. It may support compulsory licensing (separate proceeding), not absolve liability.

Q14. What is the burden of proof in process patent cases?

Ans. Section 104A can shift the burden to the defendant to prove their process is different when the product is new or there’s a substantial likelihood the identical product is made by the patented process.

Q15. What remedies are available?

Ans. I] Interim/permanent injunctions (including John-Doe/Ashok-Kumar orders),

II] Damages (lost profits or reasonable royalty) or account of profits (elect one),

III] Delivery up/destruction of infringing stock, and

IV] Costs and disclosure of accounts

Q16. When will courts grant an interim injunction?

Ans. On prima facie case, balance of convenience, irreparable injury, and sometimes public interest (especially in pharma/healthcare).

Q17. How are damages calculated?

Ans. Based on sales evidence, market share loss, price erosion, or hypothetical royalty. Indian courts more often award reasonable royalty plus costs; punitive damages are rare but possible with egregious conduct.

Q18. Is patent infringement a crime in India?

Ans: No, infringement is a civil wrong. (Certain offences like false marking exist, but not criminal infringement per se.)

Q19. How long do I have to sue (limitation)?

Ans. Generally, 3 years from each actionable cause of action (each infringing act is fresh). Continuous infringement keeps the cause alive for new relief.

Q20. What evidence should a patentee collect?

Ans. Accused product samples, labels, batch/MFR/BMR records, COAs, invoices, tender documents, marketing decks, website captures, import/export docs, and expert reports mapping claim elements.

Q21. Do I need a claim chart?

Ans. Not mandated, but a claim-by-claim element chart greatly strengthens both interim and final relief.

Q22. Can I amend claims during litigation?

Ans. Limited post-grant amendments (to disclaim or narrow) may be sought, provided they don’t add matter or broaden scope; courts scrutinize timing and prejudice.

Q23. Does a license end infringement risk?

Ans. A proper written license with clear field/territory/royalty terms can. Breach may revive infringement exposure.

Q24. How do compulsory licenses interact with infringement?

Ans. A granted CL permits acts within its scope and terms prospectively; pre-grant acts remain actionable.

Q25. What about SEPs and FRAND?

Ans. SEP suits add FRAND considerations to remedies/royalties, but the infringement test remains claims based.