Everything You Need to Know About Patent Law in India

 1. Introduction to Patent Law

1.1 What is a Patent?

A patent is a statutory right granted by the state to an inventor, conferring an exclusive right to exploit an invention for a limited period in exchange for full public disclosure of that invention. In India, the grant confers on the patentee the exclusive right to make, use, offer for sale, sell, or import the patented product or process within the territory of India.

The word “patent” derives from the Latin “litterae patentes”, meaning “open letters.” Historically, these were royal grants of privilege issued under an open seal, distinguishable from litterae clausae (closed letters) addressed to specific individuals. Today, a patent is a bargain between the inventor and society, the inventor discloses the invention fully, and in return, the state grants a time-limited monopoly. Three characteristics define a patent:

• Territorial: A patent granted in India operates only within India.
• Time-limited: The term is 20 years from the date of filing.
• Exclusive: The patentee may exclude all others from working the invention without consent.

1.2 Why Do Patents Exist?

Patent systems rest on several theoretical justifications.

• The Reward Theory: Inventors deserve a reward proportional to the benefit their invention confers on society. The patent monopoly is that reward.
• The Incentive Theory: Without the prospect of exclusive exploitation, rational economic actors will underinvest in research and development. The patent system provides the necessary incentive.
• The Disclosure Theory: Patents ensure that inventions enter the public domain in documented form rather than remaining trade secrets. Full disclosure in the patent specification allows others to build on the invention after the term expires and, in some jurisdictions, even during the term through research exceptions.
• The Commercialisation Theory: Patents facilitate investment by creating an assignable, licensable property right. Venture capital flows more readily to inventions protected by patents, because the protection reduces the risk of free-riding by competitors.

1.3 Brief History of Patent Law

Global History:

The first recognisable patent statute was the Venetian Statute of 1474, which granted ten-year exclusive rights to “new and ingenious devices.” The English Statute of Monopolies, 1624, is widely regarded as the foundation of modern patent law. It abolished royal monopoly grants but preserved protection for “new manufactures” for a term of 14 years.

The United States enacted its first Patent Act in 1790. France introduced patent legislation in 1791. The Paris Convention for the Protection of Industrial Property of 1883 established the first multilateral framework, introducing the right of priority. The Patent Cooperation Treaty (PCT) of 1970 simplified international filing. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), 1994, under the WTO, established minimum standards for patent protection globally.

Indian History:

The Patents Act, 1970 (as amended in 1999, 2002, and 2005) is the governing statute for patents in India today.

2. Patent Law Framework

2.1 The Patents Act, 1970

The Patents Act, 1970 (“the Act”) is the primary legislation governing patents in India. It extends to the whole of India and applies to all inventions filed on or after 20 April 1972, the date on which it came into force.

The Act is structured as follows:

2.2 Patent Rules, 2003

The Patents Rules, 2003 (notified under Section 159 of the Act) govern the procedural aspects of patent applications, examination, opposition, fees, and related matters. The Rules have been amended several times:

• 2005 Amendment: Aligned with the 2005 Act amendments.
• 2012 Amendment: Working statement requirements under Rule 131 strengthened.
• 2016 Amendment: Significant changes to the fee structure, examination timelines, and expedited examination.
• 2019 Amendment: Changes to opposition procedure and other procedural matters.
• 2024 Amendment: Introduced Patent Term Adjustment for delays caused by the Patent Office; revised Form 27 (working statements); modernised several procedural requirements.

2.3 Role of the Patent Office

The Indian Patent Office operates under the Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM). There are four patent offices in India:

An applicant files at the Patent Office within whose territorial jurisdiction the applicant’s principal place of business or residence is located. If the applicant has no place of business or residence in India, the application is filed at the office where the patent agent is located.

The Controller General heads the Patent Office. The Controller functions as a quasi-judicial authority with powers to grant, refuse, amend, revoke, and issue compulsory licences for patents.

Key functions of the Patent Office:

• Receiving and processing patent applications
• Examining applications for patentability
• Granting and sealing patents
• Maintaining the Patent Register
• Conducting opposition proceedings
• Administering compulsory licensing proceedings
• Publishing the Patent Office Journal (weekly)
• Providing search and examination reports as an ISA and IPEA under the PCT (since 2007)

3. Patentable Subject Matter

3.1 What Can Be Patented?

Section 2(1)(j) of the Act defines “invention” as a new product or process involving an inventive step and capable of industrial application. The requirements for patentability are:

1. The subject matter must be a “new” product or process (novelty).
2. It must involve an “inventive step” (non-obviousness).
3. It must be “capable of industrial application” (utility).

Patentable categories include:

• Products: Chemical compounds, formulations, compositions, devices, machines, apparatus, articles of manufacture, and genetically modified organisms (subject to restrictions).
• Processes: Methods of manufacturing, chemical processes, biological processes (non-essentially biological), methods of treatment of materials.
• Improvements: An improvement to a known product or process is patentable if it is novel and involves an inventive step.

3.2 Product Patents and Process Patents

India historically granted only process patents for pharmaceuticals and chemicals (1970 to 2005). The 2005 Amendment restored product patents for all fields of technology, as required under TRIPS Article 27.

Product Patent: Protects the product itself, regardless of the method of manufacture. A product patent on Compound X prevents anyone from making, using, selling, importing, or offering for sale Compound X in India without the patentee’s consent, by any process whatsoever.

Process Patent: Protects a specific method of making a product. A process patent on “Process for making Compound X by Route Y” does not prevent others from making Compound X by a different route.

Section 104A places the burden of proof on the defendant to show that an identical product was not made by the patented process, where the product is new or where the patentee establishes a reasonable likelihood that the identical product was made by the process.

3.3 What Cannot Be Patented?

Section 3 of the Act lists categories of subject matter that are not “inventions” and therefore cannot be patented. Section 4 adds atomic energy inventions.

Section 3 Non-Patentable Subject Matter:

Section 3(d) in Detail:

Section 3(d) is among the most debated provisions in Indian patent law. It provides that the following shall not be patentable:

“the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.”

The Explanation clarifies that salts, esters, ethers, polymorphs, metabolites, pure forms, particle sizes, isomers, mixtures of isomers, complexes, combinations, and derivatives of known substances shall be considered the same substance unless they differ significantly in properties with regard to efficacy.

In Novartis AG v Union of India (2013) 6 SCC 1, the Supreme Court interpreted “efficacy” in the pharmaceutical context as therapeutic efficacy, not merely bioavailability. Enhanced bioavailability without enhanced therapeutic efficacy does not meet the Section 3(d) standard.

Section 3(k) in Detail:

Computer programs “per se” are not patentable. However, the Patent Office’s Computer Related Inventions (CRI) Guidelines recognise that a computer program producing a “technical effect” or solving a “technical problem” may be patentable. The claim must result in a concrete, tangible technical effect beyond the normal physical interactions between software and the hardware on which it runs.

Section 4: Inventions falling within the purview of atomic energy under the Atomic Energy Act, 1962 are not patentable.

4. Requirements for Patent Protection

4.1 Novelty

Section 2(1)(l) defines “new invention” as any invention or technology not anticipated by publication in any document or used in the country or elsewhere in the world before the date of filing of the patent application with complete specification.

Novelty is destroyed by a single prior art document that discloses all the elements of the claimed invention. The test for anticipation is whether the prior document contains “clear and unmistakable directions” to do what the patentee has claimed (the enabling disclosure test).

Grace Period: India does not provide a general grace period for pre-filing disclosures by the inventor. Section 31 provides limited exceptions:

• Disclosure at a recognised exhibition, if an application is filed within 12 months.
• Publication in a paper read before a learned society, if an application is filed within 12 months.
• Publication in a journal of a learned society, if an application is filed within 12 months.
• Disclosure through working in public for reasonable trial, if an application is filed within 12 months.

What Constitutes Prior Art in India:

• Prior publication anywhere in the world.
• Prior use anywhere in the world (including oral prior art and traditional knowledge).
• Prior claims in a co-pending Indian patent application with an earlier priority date.

4.2 Inventive Step

Section 2(1)(ja) defines “inventive step” as a feature of an invention that involves technical advance as compared to existing knowledge, or that has economic significance, or both, and that makes the invention not obvious to a person skilled in the art.

The foundational test for obviousness in India was established in Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries AIR 1982 SC 1444. The Supreme Court held that the question is whether, having regard to the state of the art and common general knowledge at the date of the patent, the invention would have been obvious to a skilled person.

Factors considered in the analysis:

1. The scope and content of the prior art.
2. The differences between the prior art and the claimed invention.
3. The level of ordinary skill in the relevant field.
4. Secondary considerations: commercial success, long-felt need, failure of others to solve the same problem.

The person skilled in the art (PSITA) is a hypothetical person with ordinary skill and common general knowledge in the relevant field, but not an expert or inventor.

4.3 Industrial Applicability

Section 2(1)(ac) defines “capable of industrial application” as an invention that can be made or used in an industry. This requirement is generally satisfied without difficulty. It excludes:

• Inventions that cannot work as described (such as perpetual motion machines).
• Inventions that serve no practical purpose.
• Purely theoretical inventions with no disclosed utility.

The requirement is equivalent to the “utility” requirement in US patent law, though broader and more easily satisfied than the specific, substantial, and credible utility standard applied by the US Federal Circuit.

5. Understanding Patent Specifications

5.1 Provisional Specification

A provisional specification is a preliminary document filed to secure a priority date when the invention has not yet been fully worked out. It need not contain claims. It must:

• Describe the general nature of the invention.
• Disclose the invention sufficiently to establish that the applicant had possession of the invention as of the filing date.

A complete specification must be filed within 12 months of the provisional specification (Section 9(1)). Failure to file within 12 months results in abandonment of the application.

When to file a provisional specification:

• When the invention is still being developed and the inventor needs to secure a priority date immediately.
• When commercial viability needs to be assessed before committing to a full application.
• When an imminent public disclosure (conference, trade fair, publication) necessitates an immediate filing.

5.2 Complete Specification

The complete specification is the full document that discloses the invention in sufficient detail and contains the patent claims. Section 10 prescribes its mandatory contents:

1. Title: Indicating the subject matter of the invention.
2. Field of Invention: The technical field to which the invention belongs.
3. Background/Prior Art: A description of relevant prior art and its drawbacks.
4. Summary of the Invention: A brief summary of the invention and its objects.
5. Detailed Description: A full and particular description of the invention, sufficient to enable a person skilled in the art to perform it (“enabling disclosure”).
6. Claims: The statement of the legal scope of protection sought.
7. Abstract: A brief summary for search purposes.
8. Drawings: Where necessary for understanding the invention.

The specification must disclose the best method known to the applicant for performing the invention, equivalent to the “best mode” requirement under US patent law.

5.3 Patent Claims

Claims are the most legally significant part of a patent specification. They define the metes and bounds of the patent monopoly. Section 10(4) requires that every complete specification shall end with a definite statement of the claim or claims defining the scope of the invention for which protection is claimed.

Types of Claims:

Key Claim Drafting Principles:

• Claims must be clear and succinct.
• Claims must be supported by the description.
• The broadest reasonable claim should be drafted as the independent claim.
• Each claim element (limitation) narrows the scope of protection.
• If the independent claim is found invalid, dependent claims may survive independently.

5.4 Drawings and Abstracts

Drawings are required where the nature of the invention makes them necessary for understanding. Mechanical and electrical inventions almost always require drawings. Chemical inventions may include reaction schemes, structural formulae, or graphs in lieu of traditional drawings.

Abstract: Filed as a separate document; must not exceed 150 words. It is intended solely for technical information and cannot be used to interpret the scope of the claims. The abstract must indicate: the technical field, the technical problem, the main features of the solution, and the principal use of the invention.

6. Patent Application Process

6.1 Who Can Apply?

Section 6 of the Act specifies who may make an application for a patent:

1. A person claiming to be the true and first inventor.
2. A person being the assignee of the right to make the application.
3. A legal representative of a deceased person who was the true and first inventor or an assignee.

Employee Inventions: Section 6 does not directly address employee inventions. The contractual relationship between employer and employee governs ownership. Where an employee invents in the course of employment (where duties include inventing or the employee was specifically assigned to the task), the employer typically owns the invention, unless the contract provides otherwise.

Foreign Applicants: Foreign nationals and corporations may file in India, subject to the foreign filing licence requirement under Section 39 where the invention was developed in India.

6.2 Types of Patent Applications

6.3 Filing Requirements

An application for a patent is made in Form 1. The following documents must accompany the application:

Current filing fees are prescribed in the First Schedule to the Patent Rules and differ based on the type of applicant (natural person/startup/small entity vs. large entity) and mode of filing (e-filing is cheaper). Fees should be verified from the official IP India website (ipindia.gov.in) before filing.

6.4 Publication

Under Section 11A, every application for a patent is published in the Official Journal of the Patent Office after 18 months from the date of filing or the priority date, whichever is earlier.

Early Publication: An applicant may request early publication in Form 9 with the prescribed fee. The application is published within 1 month of such a request.

Effect of Publication:

• The application becomes open to public inspection.
• The applicant receives provisional protection: if a patent is eventually granted, the patentee may claim damages for infringement that occurred after publication (Section 11A(7)).
• Pre-grant opposition proceedings may be initiated after publication (Section 25(1)).

Applications are not published if they have been abandoned or withdrawn before the 18-month period expires, or if they relate to defence purposes (Section 35).

6.5 Examination

Request for Examination: Examination is not automatic. The applicant or any interested person must file a Request for Examination in Form 18 (standard) or Form 18A (expedited) within 48 months from the date of priority or the date of filing, whichever is earlier.

Expedited Examination (Form 18A): Available to:

• Startup enterprises
• Small entities
• Female applicants
• Government undertakings
• Applicants who have chosen India as the International Searching Authority or IPEA in a PCT application
• Applicants in sectors of national importance notified by the Central Government

The examiner searches prior art and examines the application for compliance with the Act and Rules, then prepares a First Examination Report (FER).

6.6 Grant of Patent

Upon acceptance of the complete specification after all objections have been resolved, the Controller grants the patent under Section 43 and causes it to be sealed with the seal of the Patent Office. The grant is published in the Official Journal. Post-grant, any interested person may file a post-grant opposition within 12 months of the date of publication of the grant (Section 25(2)).

7. Patent Examination and Objections

7.1 First Examination Report (FER)

The First Examination Report (FER) is the formal document issued by the Patent Office after examining the application for compliance with the Act and for patentability. Common objections in a FER include:

• Objection under Section 3 (non-patentable subject matter).
• Lack of novelty (anticipation by prior art documents cited as D1, D2, etc.).
• Lack of inventive step (obviousness over one or more prior art references).
• Insufficient disclosure (the specification does not enable a skilled person to perform the invention).
• Unclear or indefinite claims.
• Claims not supported by the specification.
• Formal objections (missing documents, incorrect fees, non-compliance with form requirements).
• Lack of unity of invention (multiple independent inventions in one application).

The applicant must respond to the FER within 12 months from the date of its issuance. This period is not extendable under the current Rules. Failure to respond within 12 months results in the application being treated as abandoned.

7.2 Common Objections and How to Respond

Novelty Objections:

The examiner cites prior art documents and maps them onto the claims element by element. The applicant may respond by:

• Amending claims to include features not disclosed in the prior art.
• Arguing that the prior art does not disclose all claimed elements.
• Arguing that the cited prior art disclosure is non-enabling.
• Distinguishing the prior art on the basis of specific technical features.

Inventive Step Objections:

The examiner argues that the claimed invention is obvious from a combination of prior art references. The applicant may respond by:

• Demonstrating unexpected technical effects of the claimed combination.
• Providing experimental data showing superior or surprising results.
• Arguing that combining the cited references requires impermissible hindsight.
• Amending claims to add distinguishing technical features not suggested by the prior art.

Section 3 Objections:

• For Section 3(d) (pharmaceuticals): Filing comparative data demonstrating enhanced therapeutic efficacy over the known substance.
• For Section 3(k) (software/CRI): Restructuring claims to emphasise the technical effect produced and the hardware integration. Claims directed to a “system” or “apparatus” with specific technical components are more favourably treated than claims to a “method” or “program.”
• For Section 3(i) (methods of treatment): Transforming method-of-treatment claims into Swiss-type claims or product claims specifying a second medical use.

7.3 Hearings and Further Proceedings

If the application is not accepted after the response to the FER, the Controller may:

• Issue a further communication (additional office action).
• Schedule a hearing under Section 14.

At the hearing, the applicant or their registered patent agent presents oral arguments before the Controller. Affidavits, experimental data, expert declarations, and technical literature may be submitted. The Controller then passes a speaking order (a reasoned written order) either accepting the application with or without amendments, or refusing it.

Appeals: An order of refusal may be appealed to the High Court under Section 117A (as amended by the Tribunal Reforms Act, 2021, which abolished the Intellectual Property Appellate Board and transferred its jurisdiction to the respective High Courts).

8. Patent Opposition

8.1 Pre-Grant Opposition

Legal Basis: Section 25(1) of the Patents Act, 1970.

Who Can File: Any person (no requirement to establish interest or locus standi).

When: After publication of the application under Section 11A and before the grant of the patent.

Form: Written representation in Form 7A with the prescribed fee.

Grounds (Section 25(1)):

1. Wrongfully obtained invention.
2. Prior publication anywhere in the world.
3. Prior claiming in an earlier Indian application with an earlier priority date.
4. Prior use in India.
5. Obviousness and lack of inventive step.
6. Non-patentable subject matter (Section 3 or Section 4).
7. Insufficient description.
8. Non-disclosure or wrong mention of the source or geographical origin of biological material.
9. Invention anticipated by traditional knowledge of any community anywhere in the world.

Procedure: The Controller transmits the representation to the applicant for response. The Controller considers both the representation and the applicant’s response. If prima facie satisfied that the opposition has merit, the Controller schedules a hearing. The Controller then either refuses the application or proceeds to grant.

8.2 Post-Grant Opposition

Legal Basis: Section 25(2) of the Patents Act, 1970.

Who Can File: Any person “interested” (interpreted broadly to include competitors, research organisations, patient groups, and public interest entities).

When: Within 12 months from the date of publication of the grant.

Form: Notice of Opposition in Form 7 with the prescribed fee.

Grounds: The same grounds as pre-grant opposition (Section 25(2)(a) to (k)).

Procedure:

1. Filing of Notice of Opposition in Form 7.
2. Appointment of an Opposition Board of three examiners by the Controller.
3. Controller serves notice on the patentee.
4. Patentee files reply statement and evidence.
5. Opponent may file further evidence in reply.
6. Opposition Board examines the matter and submits its recommendations to the Controller.
7. Oral hearing before the Controller.
8. Controller passes a speaking order: maintaining the patent, amending it, or revoking it.
9. An aggrieved party may appeal to the High Court under Section 117A.

Patent Opposition Proceedings in India

PRE-GRANT OPPOSITIONSection 25(1)

After publication; before grant

Any person may file Form 7A

Controller transmits to applicant

Applicant files response

Hearing (if prima facie satisfied)

Grant

Refuse

POST-GRANT OPPOSITIONSection 25(2)

Within 12 months of grant

Person interested files Form 7

Opposition Board appointed (3 examiners)

Patentee files reply statement and evidence

Opponent files further evidence in reply

Opposition Board submits recommendations

Oral hearing before the Controller

Maintain

Amend

Revoke

Appeal to High Court (Section 117A)

9. Rights of a Patentee

9.1 Exclusive Rights

Section 48 of the Act grants the patentee the following exclusive rights in India:

Where the patent is for a product:

The right to prevent third parties who have not obtained the patentee’s consent from making, using, offering for sale, selling, or importing that product.

Where the patent is for a process:

The right to prevent third parties from using that process and from using, offering for sale, selling, or importing the product obtained directly by that process.

Limitations on patentee’s rights:

• Research and experimental use: Acts done for experimental or research purposes, including imparting instructions to students, are not infringement (Section 47(3)).
• Bolar Exemption (Section 107A(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 is not infringement. This permits generic pharmaceutical manufacturers to conduct trials before patent expiry to secure regulatory approval.
• Parallel Imports (Section 107A(b)): Importation of a patented product from a person duly authorised by the patentee to sell or distribute the product is not infringement. India adopts the principle of international exhaustion.
• Government use (Section 47(1), (2)): The government may use a patented invention for its own purposes.
• Compulsory licences (Sections 84 to 92): The patentee’s rights are subject to the compulsory licensing regime.

9.2 Duration of a Patent

Section 53 provides that the term of every patent granted under the Act is 20 years from the date of filing the application. For PCT national phase applications, the term is 20 years from the international filing date.

India does not provide patent term extensions for regulatory delay (unlike the US, which provides Patent Term Extensions for pharmaceutical regulatory delays). The 2024 Patent Rules Amendment introduced Patent Term Adjustment (PTA) to compensate for delays in examination caused by the Patent Office itself, subject to prescribed conditions.

9.3 Renewal and Maintenance

A patent must be renewed annually by payment of renewal fees to remain in force. Renewal fees are due from the third year and must be paid before the end of each succeeding year of the patent term. Failure to pay the renewal fee causes the patent to lapse.

Late payment is permissible within 18 months with a prescribed surcharge (Section 53(2); Rule 80). A lapsed patent may be restored within 18 months of the date of cessation, provided the patentee demonstrates that the failure to pay was unintentional and pays all outstanding fees and a restoration fee (Section 60(2) and (3)).

10. Patent Ownership and Licensing

10.1 Assignment

An assignment is a transfer of ownership in a patent or application. Section 68 requires that an assignment be in writing and registered at the Patent Office to be valid against any subsequent purchaser.

Types of Assignments:

Registration: Form 16 is filed with the Patent Office. The instrument of assignment must be in writing, appropriately stamped, and notarised. An unregistered assignment is invalid against third parties.

Employee Inventions: The Act does not automatically vest title to employee inventions in the employer. A written employment agreement or a separate deed of assignment is required.

10.2 Licensing

A licence is a permission granted by the patentee (licensor) to another party (licensee) to exercise some or all patent rights without transferring ownership.

Types of Licences:

Key terms in a licence agreement:

• Grant clause defining the scope of rights
• Territory and field of use
• Royalty rate and payment mechanism
• Milestone and lump-sum payments
• Minimum working obligations
• Quality control and audit rights
• Duration and grounds for termination
• Sub-licensing rights
• Dispute resolution clause
• Governing law

10.3 Commercialisation of Patents

Patents are commercial assets that can be exploited in several ways:

• Direct exploitation: The patentee manufactures and sells the patented product.
• Licensing: The patentee licenses the invention and earns royalties without manufacturing.
• Joint ventures: Patent holders enter into joint ventures with manufacturing partners.
• Technology transfer: Patents form part of broader technology transfer agreements.
• Patent pools: Multiple patent holders contribute patents to a collective pool, licensed under unified terms (common in standards-essential patents for telecoms and electronics).
• Patent monetisation: Non-practising entities (NPEs) acquire patents and enforce them through licensing or litigation.

Annual Working Statements (Form 27):

Section 146 and Rule 131 require every patentee and licensee to furnish a statement of working of the patented invention on a commercial scale in India. This is due on or before 31 March each year in respect of the previous calendar year. Failure to furnish the statement attracts a fine and may constitute relevant evidence in compulsory licensing proceedings. The 2024 Patent Rules revised Form 27, consolidating it as a single annual statement and adjusting disclosure thresholds.

11. Patent Infringement

11.1 What Constitutes Infringement?

Patent infringement under the Patents Act, 1970 is governed by Chapter XVI (Sections 104 to 115). Infringement occurs when a person, without the patentee’s consent, performs any act that Section 48 reserves exclusively to the patentee.

For a Product Patent: Making, using, offering for sale, selling, or importing the patented product in India.

For a Process Patent: Using the patented process; using, offering for sale, selling, or importing the product obtained directly by the process.

Claim Interpretation:

Infringement analysis is claim-specific. The court first construes the claims (determines their scope and meaning based on the specification and prosecution history) and then compares the allegedly infringing product or process with the construed claims. Infringement exists only if the accused product or process falls within the scope of the claims.

Doctrine of Equivalents: Indian courts have not definitively adopted or rejected the doctrine of equivalents (under which an element that performs substantially the same function in substantially the same way to achieve substantially the same result infringes even if not literally within the claim). The position under Indian law remains unsettled.

Prosecution History Estoppel: Amendments and arguments made during prosecution to distinguish prior art may narrow the scope of claims and limit any equivalents argument.

11.2 Defences to Infringement

11.3 Remedies Available

Civil Remedies (Section 108):

• Injunction: Interim or permanent injunction restraining the defendant from further infringement. Interim injunctions are governed by Order 39 of the CPC (prima facie case, balance of convenience, irreparable harm).
• Damages or Account of Profits: The plaintiff elects between (a) damages (compensation for actual loss: lost profits, price erosion, reasonable royalty) and (b) an account of profits (defendant disgorges profits made from the infringement).
• Seizure, Forfeiture, or Destruction: The court may order infringing goods to be seized, forfeited, or destroyed.
• Costs.

Criminal Remedies: Section 111 provides for criminal proceedings where a person falsely represents that an article is patented in India when it is not.

Jurisdiction: Patent infringement suits are “commercial disputes” under the Commercial Courts Act, 2015 and are heard by Commercial Courts or Commercial Divisions of High Courts. Section 104 provides that no suit for infringement may be instituted in a court inferior to a District Court. The Delhi High Court’s Intellectual Property Division (IPD), established in 2021, handles patent disputes under dedicated IP procedural rules.

Patent Infringement: Legal Action Framework

Discover Potential Infringement

Conduct claim mapping: Does the infringer’s product or process fall within the claim scope?

Assess validity of own patent (pre-litigation freedom-to-operate clearance)

Send Cease and Desist Notice(Optional but common first step)

INFRINGER STOPS

Negotiate settlement orlicence agreement

INFRINGER CONTINUES

File suit in Commercial Court orCommercial Division of High Court

Application for interim injunction(Order 39 CPC: prima facie case,balance of convenience, irreparable harm)

Trial: evidence on infringement and validity

Patent UpheldInjunction + Damages or Account of Profits

Patent RevokedNo relief; costs awarded to defendant

12. Revocation and Compulsory Licensing

12.1 Revocation of Patents

A patent may be revoked by the High Court on a petition by any person interested, or by the Central Government, or as a counter-claim in a suit for infringement. The grounds are set out in Section 64(1):

In infringement proceedings, the defendant may plead revocation as a counter-claim in the same suit without filing a separate revocation petition.

12.2 Compulsory Licences

Section 84 Compulsory Licence:

After three years from the date of grant, any person may apply to the Controller for a compulsory licence on the following grounds:

1. Reasonable requirements of the public with respect to the patented invention have not been satisfied.
2. The patented invention is not available to the public at a reasonably affordable price.
3. The patented invention is not worked in the territory of India.

The Controller considers: the nature of the invention; the time elapsed since grant; measures taken by the patentee to work the patent; the ability of the applicant to work the invention to the public advantage; and the capacity of the applicant to undertake the risk.

Landmark case: Natco Pharma Ltd v Bayer Corporation (2012)

India’s first compulsory licence was granted by the Controller to Natco Pharma for sorafenib tosylate (Nexavar), a kidney and liver cancer drug patented by Bayer. The grounds: the drug was not available at a reasonably affordable price (Bayer’s price was approximately Rs. 2.8 lakh per month; Natco proposed Rs. 8,800 per month) and was not worked in India. Royalty was set at 6% of Natco’s net sales. The IPAB and the Bombay High Court upheld this decision on appeal.

Section 92 Compulsory Licence:

The Central Government may issue compulsory licences at any time in cases of national emergency, extreme urgency, or for public non-commercial use, without the three-year waiting period applicable to Section 84.

Section 92A Compulsory Licence for Export:

Compulsory licences may be granted for export of patented pharmaceutical products to countries with insufficient or no manufacturing capacity, where the importing country has notified an emergency or issued a government use licence. This provision implements the Doha Declaration on TRIPS and Public Health and the TRIPS Amendment Protocol (Article 31bis of TRIPS, in force from 2017).

12.3 Government Use

Sections 100 to 103 permit the Central Government or any person authorised by it to make, use, exercise, or vend a patented invention for government purposes, without the patentee’s consent, subject to the obligation to pay reasonable royalties to the patentee.

13. International Patent Protection

13.1 Paris Convention

India has been a member of the Paris Convention for the Protection of Industrial Property since 1998 (by formal accession; India was associated with earlier versions through its historical context under British rule). The Stockholm revision of 1967 is currently in force.

Key provisions:

• Right of Priority: An applicant who files a patent application in one member country has 12 months to file corresponding applications in other member countries, claiming the priority date of the first filing.
• National Treatment: Member countries must grant to nationals of other member countries the same protection they grant to their own nationals.
• Independence of Patents: A patent granted in one country is independent of patents granted for the same invention in other countries. Revocation in one country does not affect patents in others.

Convention Application in India: Filed under Section 135. Must be filed within 12 months of the first application in the convention country. Priority documents are filed with Form 3.

13.2 TRIPS Agreement

The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Annex 1C to the WTO Agreement, came into force on 1 January 1995. India achieved full TRIPS compliance with the 2005 Patent Amendment.

Key TRIPS requirements for patents:

• Patents must be available for inventions in all fields of technology (Article 27.1).
• No discrimination based on whether products are imported or locally produced.
• Minimum patent term of 20 years from the filing date (Article 33).
• Rights must include the right to prevent others from making, using, offering for sale, selling, and importing (Article 28).
• Reversal of burden of proof for process patents (Article 34).
• Limited exceptions permitted (Article 30): experimental use; regulatory approval use.
• Compulsory licensing subject to conditions (Article 31); government use permitted.

TRIPS Flexibilities used by India:

• Section 3(d): Stricter patentability standard for pharmaceutical derivatives, addressing evergreening.
• Section 3(k): Exclusion of computer programs per se.
• Sections 84 to 92: Compulsory licensing regime.
• Section 107A: Bolar exemption and international exhaustion.

13.3 PCT Applications

The Patent Cooperation Treaty (PCT), administered by WIPO, provides a unified international patent filing procedure. India acceded to the PCT on 7 December 1998. The Indian Patent Office acts as an International Searching Authority (ISA) and International Preliminary Examining Authority (IPEA) under the PCT.

PCT International Application Route

File PCT ApplicationAt the Receiving Office (RO/IN for India as RO)
or directly at WIPO International Bureau (IB)

International Filing Date established — priority date for all designated countries

International Search Report (ISR)Issued by the ISA — typically by 16 months from priority date

International Publication by WIPOAt 18 months from priority date (all designated countries notified)

Optional: Chapter II — IPEA examination (preliminary examination report issued by approx. 28 months)

National Phase EntryWithin 31 months from priority date in each designated country

India(IPO)

USA(USPTO)

Europe(EPO)

China(CNIPA)

Japan(JPO)

Each national office examines independently — grants or refuses on its own merits

Advantages of the PCT route:

• A single filing confers a search report applicable in all 157+ member countries.
• The 31-month window allows the applicant to assess commercial viability in each market before national phase entry costs are incurred.
• The International Search Report and Written Opinion provide early intelligence on prior art.
• Claim amendments made during the PCT phase can reduce prosecution effort in national phases.

13.4 Foreign Filing Licence

Section 39 prohibits a person resident in India from filing a patent application outside India for an invention made in India, without the prior permission of the Controller, unless:

• An application for the same invention has been filed in India at least six weeks before the foreign application; and
• No secrecy direction has been issued or is pending in respect of the Indian application.

Contravention of Section 39 renders the Indian application abandoned and exposes the applicant to criminal penalties (fine or imprisonment). A foreign filing licence is applied for in Form 25.

14. Special Topics

14.1 Pharmaceutical Patents

India’s patent regime for pharmaceuticals is among the most closely watched globally, balancing innovation incentives with public health obligations.

Section 3(d) and Evergreening:

Evergreening refers to the practice of securing multiple secondary patents on incremental modifications of a known drug (new salts, new polymorphs, new formulations, new dosage forms) to extend market exclusivity beyond the original patent term. Section 3(d) directly targets this practice by requiring a new form of a known substance to demonstrate significantly enhanced therapeutic efficacy before a patent is granted.

Data Exclusivity:

India does not provide data exclusivity for clinical trial data submitted for regulatory approval of new chemical entities. Generic manufacturers may rely on the originator’s regulatory data to obtain approval without repeating trials, unlike the US and EU, which provide exclusivity periods of 5 years and 8 years respectively.

Compulsory Licensing and Access:

The Bayer/Natco decision (2012) remains the only compulsory licence granted under Section 84. It established:

• “Reasonable requirements of the public” must be assessed against national need, not global availability.
• “Worked in India” requires local manufacture or at least supply at scale within India; mere importation is insufficient.
• Royalty for a compulsory licence is to be fixed considering the investment made by the patentee and the public health impact of the licence.

International Scrutiny:

India has consistently appeared on the US Trade Representative’s Special 301 Watch List primarily because of Section 3(d), the compulsory licensing framework, the absence of data exclusivity, and procedural challenges to pharmaceutical patents. India maintains that all these measures are fully TRIPS-compliant.

14.2 Software and Computer-Related Inventions (CRIs)

The Legal Exclusion:

Section 3(k) excludes from patentability mathematical or business methods, algorithms, computer programs per se, and rules and methods for performing mental acts or playing games.

The Technical Effect Test:

The CRI Guidelines (2017, as modified) require the examiner to:

1. Properly construe the claim.
2. Identify the actual contribution of the claimed invention.
3. If the contribution lies solely in an excluded category (mathematical method, business method, computer program per se), reject the claim.
4. If the contribution produces a “technical effect” beyond normal computer operation or solves a “technical problem,” the claim may be allowable.

Comparative Framework:

Practical guidance:

Claims drafted as hardware systems (“A processor-implemented system comprising…”) with specific technical components fare better than claims drafted as methods or programs. Claims that produce a concrete, tangible technical result (reduced latency, improved compression ratio, enhanced security output) are more likely to survive examination.

14.3 Biotechnology Patents

What is patentable:

• Isolated and purified microorganisms (if novel and involving inventive step).
• Recombinant DNA molecules and vectors.
• Genetically modified organisms (subject to Section 3(b) ethical constraints).
• Biopharmaceuticals (subject to Section 3(d) for modifications of known substances).
• Hybridomas and monoclonal antibodies.
• Bioprocesses that are not essentially biological in nature.

What is not patentable:

• Plants and animals in their natural state (Section 3(j)).
• Essentially biological processes for the production of plants or animals (natural crossing, selection).
• Methods of treatment of humans or animals (Section 3(i)).
• Traditional knowledge and naturally occurring biological material (Section 3(p)).

Biological Diversity Act, 2002:

Applications for patents involving biological resources originating from India must: (a) disclose the source and geographical origin of the biological material, and (b) obtain approval from the National Biodiversity Authority (NBA) before filing. Non-disclosure is a ground for opposition under Section 25(1)(j) and for revocation under Section 64. Applicants accessing Indian biological resources for commercial purposes must share benefits with local communities under the Act.

Sequence Listings:

Applications disclosing nucleotide or amino acid sequences must comply with WIPO Standard ST.25 (and ST.26 as India transitions to the new standard).

14.4 Artificial Intelligence and Patent Law

AI raises two distinct sets of issues in patent law: the patentability of AI-generated inventions and the patentability of AI-enabled technologies.

AI as Inventor:

The Act requires a “true and first inventor,” a term that contemplates a natural person. The DABUS case (litigated in the UK, US, Germany, South Africa, Australia, and other jurisdictions) raised the question of whether an AI system may be named as an inventor.

• The UK Supreme Court in Thaler v Comptroller General [2023] UKSC 49 held that an AI cannot be an inventor under UK patent law.
• The US Federal Circuit in Thaler v Vidal (2022) reached the same conclusion under US law.
• India has not yet ruled on the question, but the statutory language of the Act, which consistently refers to “a person,” strongly implies that only a natural person qualifies as an inventor.

Patentability of AI Technologies:

• AI claims directed to algorithms or mathematical methods per se face rejection under Section 3(k).
• AI-enabled hardware systems, AI-enabled medical devices, and AI-integrated manufacturing processes may be patentable if they produce a concrete technical effect.
• Claims should be drafted to emphasise the technical problem solved, the technical effect achieved, and the integration of the AI component with specific hardware.

AI in Patent Practice:

AI tools are increasingly used for prior art searching, claim drafting, FER response preparation, translation, and patent landscape analytics. Their use raises professional responsibility obligations (verifying outputs before relying on them) but does not affect the patentability of the underlying invention.

15. Landmark Patent Cases

15.1 Important Indian Decisions

Novartis AG v Union of India (2013) 6 SCC 1 (Supreme Court of India)

The most consequential Indian patent decision. Novartis challenged the rejection of its application for the beta-crystalline form of imatinib mesylate (the active ingredient in Gleevec/Glivec) under Section 3(d). The Supreme Court upheld the rejection, interpreting “efficacy” as therapeutic efficacy in the pharmaceutical context. Enhanced bioavailability without demonstrated enhanced therapeutic efficacy does not satisfy Section 3(d). The decision cemented India’s anti-evergreening policy and confirmed its compatibility with TRIPS.

Natco Pharma Ltd v Bayer Corporation (2012) (Controller of Patents, affirmed by IPAB and Bombay High Court)

India’s first compulsory licence, granted for sorafenib tosylate (Nexavar). The Controller found that Bayer’s drug was not available at a reasonably affordable price and was not being worked in India. Royalty was set at 6% of net sales. The case remains the template for compulsory licensing proceedings under Section 84.

Bishwanath Prasad Radhey Shyam v Hindustan Metal Industries AIR 1982 SC 1444 (Supreme Court of India)

The foundational judgment on inventive step. The Supreme Court adopted the “obvious to a person skilled in the art” test for non-obviousness. The court also held that the test for anticipation is objective: whether the prior art clearly and unmistakably directed the skilled person to do what the patentee has claimed. The court further held that patents obtained for obvious inventions are liable to revocation.

F. Hoffmann-La Roche Ltd v Cipla Ltd (2015) (Delhi High Court, Division Bench)

A landmark pharmaceutical patent infringement case concerning erlotinib (Tarceva). The Division Bench upheld the Single Judge’s refusal to grant an interim injunction to Roche, emphasising the balance of convenience in favour of continued supply of the generic drug and the strong public interest in access to affordable cancer medicines. The case remains an important precedent on the interim injunction standard in pharmaceutical patent disputes.

Bajaj Auto Ltd v TVS Motor Company Ltd (2009) (Supreme Court of India)

The Supreme Court directed that patent infringement suits and interim injunction applications must be decided expeditiously. The court criticised delays in IP adjudication and held that patent monopolies are creatures of statute and must be defended or challenged on merits within a reasonable timeframe, emphasising that unnecessary delays harm both patentees and accused infringers.

Merck Sharp and Dohme Corp v Glenmark Pharmaceuticals Ltd (2013) (Delhi High Court)

An important decision on the interim injunction standard in pharmaceutical patent disputes. The court balanced the patentee’s rights against the impact on generic drug availability and public health, reinforcing that courts must weigh public interest as a distinct consideration in pharmaceutical patent injunction applications.

Enercon (India) Ltd v Aloys Wobben (2013) (Supreme Court of India)

Clarified the jurisdictional division between courts and the IPAB (now the High Courts) in patent disputes, particularly on whether revocation proceedings initiated as counter-claims in infringement suits could be independently maintained before the IPAB. The case was important in defining the procedural boundaries of patent litigation.

15.2 Important International Decisions

Diamond v Chakrabarty, 447 US 303 (1980) (US Supreme Court)

A living, genetically modified bacterium (engineered to degrade crude oil) is patentable subject matter under US law. The decision opened the door to biotechnology patents in the United States. The court held that “anything under the sun that is made by man” may be patentable. This decision influenced global biotech patent policy.

KSR International Co v Teleflex Inc, 550 US 398 (2007) (US Supreme Court)

The court rejected the Federal Circuit’s rigid “teaching, suggestion, motivation” (TSM) test as the sole standard for obviousness. Obviousness is to be assessed using common sense, ordinary skill, and the ordinary creativity of a skilled person. The decision raised the bar for patent grants in the US by strengthening the non-obviousness requirement.

Alice Corporation v CLS Bank International, 573 US 208 (2014) (US Supreme Court)

Abstract ideas implemented on a computer are not patent-eligible merely because they are executed on a computer. The court established the two-step Alice/Mayo test: (1) Is the claim directed to a patent-ineligible concept (abstract idea, natural phenomenon, natural law)? (2) If so, does the claim contain an inventive concept that transforms the abstract idea into a patent-eligible application? This decision fundamentally narrowed software patent protection in the US.

Novartis AG/Rorer (G 2/08) (Enlarged Board of Appeal, EPO, 2010)

The Enlarged Board held that Swiss-type claims (formerly used for second medical use protection) are no longer an appropriate vehicle for applications filed after the decision. Second medical use claims must now be drafted in the EPC 2000 format: “Compound X for use in the treatment of Disease Y.”

Association for Molecular Pathology v Myriad Genetics, Inc., 569 US 576 (2013) (US Supreme Court)

Naturally occurring DNA sequences, including the isolated BRCA1 and BRCA2 genes, are products of nature and not patent-eligible. However, complementary DNA (cDNA), which does not occur naturally, is patent-eligible. This decision shaped the global scope of gene patents, limiting monopolies on naturally occurring genetic sequences while preserving patents on synthetic constructs.

Generics (UK) Ltd v H Lundbeck A/S [2009] UKHL 12 (UK House of Lords)

A product patent may be valid even if the patent does not disclose how to make the product, provided the product is novel and non-obvious. The decision addressed the scope of the inventive concept and sufficient disclosure for pharmaceutical product patents.

16. Patent Searching and Practical Skills

16.1 Prior Art Searches

A prior art search is a systematic search of existing publicly available information to determine whether an invention is novel and non-obvious. Searches are conducted:

• Before filing: patentability search; freedom-to-operate (FTO) search.
• During prosecution: in response to examiner objections.
• During litigation: validity search; invalidity search; non-infringement analysis.
• For licensing and due diligence: portfolio valuation; risk assessment.

Types of Searches:

Search Strategy:

1. Define the invention in terms of its key technical features and underlying principles.
2. Identify keywords, synonyms, technical terms, and related terminology across all relevant languages.
3. Identify relevant International Patent Classification (IPC) codes and Cooperative Patent Classification (CPC) codes.
4. Search multiple databases using keyword queries, classification queries, and combinations.
5. Review results; identify relevant documents.
6. Refine the query based on results; conduct additional targeted searches.

16.2 Patent Databases

Tips for effective searching:

• Search in multiple languages; machine translation in Google Patents and PatentScope enables cross-language searches.
• Use IPC and CPC classification codes alongside keyword searches to reduce noise and cover synonyms.
• Search both granted patents and published applications (many relevant disclosures never proceed to grant).
• Review non-patent literature (NPL): scientific journals, conference papers, technical standards, dissertations.
• For Indian prosecution status and working statements, use IP India’s public portal.

16.3 Reading a Patent

A patent document has a standard structure:

A practical reading order:

1. Read the abstract for a general overview of the subject matter.
2. Read the independent claims to understand the legal scope and key features.
3. Read the description to understand the prior art, the technical problem solved, and the preferred embodiments.
4. Review the drawings to visualise the invention.
5. Check the prosecution history (file wrapper) to understand how claims were narrowed during examination; this is critical for claim construction and for freedom-to-operate analysis.

16.4 Basic Claim Interpretation

Claim interpretation (claim construction) determines the legal scope of a patent claim and is the threshold step in both infringement analysis and validity assessment.

Person Skilled in the Art: Claims are construed as a person skilled in the relevant technical field would read them, at the date of filing.

Plain and Ordinary Meaning: Words in claims carry their plain and ordinary meaning in the art, unless the specification expressly provides a different or narrower definition (a patentee may act as their own lexicographer).

Specification as a Dictionary: The description may define or qualify claim terms, either expressly or by consistent usage. Courts use the specification to understand the context and scope of claim language.

Claim Differentiation: Where two claims differ in wording, each must cover something different. A narrower dependent claim implies the broader independent claim does not include the additional limitation.

Preamble: The preamble (introductory phrase such as “An apparatus for…”) may or may not limit the claim scope, depending on whether it gives life, meaning, and vitality to the claim or merely states an intended purpose.

Key Transitional Phrases:

18. Glossary of Patent Terms