Patent infringement litigation in India is no longer rare or exceptional. Over the last decade, particularly in pharmaceuticals, telecommunications, mechanical engineering and emerging technology sectors, Indian courts have increasingly engaged with complex patent disputes. The Patents Act, 1970 provides the statutory foundation, but the real texture of infringement law emerges in how courts interpret claims, evaluate evidence and grant interim relief. A patent infringement action is rarely confined to a narrow technical comparison. It becomes a combination of statutory interpretation, claim construction, expert evidence, commercial impact and equitable principles governing injunctions. Understanding infringement in India therefore requires examining both the statutory framework and how courts apply it.
Statutory Basis of Patent Rights
The starting point is Section 48 of the Patents Act, 1970. This provision defines the exclusive rights conferred upon a patentee. Where a patent is granted for a product, the patentee has the exclusive right to prevent third parties from Making, Using, Offering for sale, Selling or Importing that product in India without consent. Where the patent is for a process, the patentee can prevent others from Using the process and Using, offering for sale, selling or importing the product obtained directly from that process Infringement, therefore, is essentially the unauthorized exercise of any of these exclusive rights. But the statutory text is only the beginning. The real question in litigation is whether the defendant’s product or process falls within the scope of the claims.
What Constitutes Patent Infringement?
1. Direct Infringement
Direct infringement occurs when a person performs any act that falls within the scope of the claims of a granted patent. The critical exercise here is claim construction. Indian courts follow the principle that the claims define the boundaries of the monopoly. The specification may assist in interpreting the claims, but it cannot expand them beyond what is claimed. Infringement analysis involves:
- Identifying each element of the claim
- Comparing it with the accused product or process
- Determining whether all essential elements are present
If even one essential feature is absent, infringement may fail.
2. Process Patent Infringement and Burden of Proof
Section 104A of The Patent Act deals with burden of proof in process patent cases. Generally the burden lies on the plaintiff to prove infringement. However, where the patent relates to a process for obtaining a product and the product produced by the defendant is identical, the court may shift the burden onto the defendant to prove that their process is different. This is particularly significant in pharmaceutical manufacturing, where internal processes are not publicly visible. However, courts apply Section 104A cautiously. The plaintiff must first establish a reasonable likelihood that the defendant is using the patented process.
3. Importation as Infringement
Importing a patented product into India without authorization constitutes infringement under Section 48. This is especially relevant in cross-border manufacturing structures where goods are produced outside India and sold domestically. Indian courts have held that the place of manufacture is irrelevant if the product is imported and sold within India.
Jurisdiction in Patent Infringement Cases
Section 104 provides that a suit for infringement of patent or for declaration as to non infringement under 105 or for relief in cases of groundless threats of infringement proceedings under section 106 must be filed before a District Court having jurisdiction. However, after the Commercial Courts Act, 2015 and subsequent amendments, most patent infringement matters are heard by designated Commercial Courts or High Courts exercising original jurisdiction. Where a counterclaim for revocation under Section 64 is filed, the suit is transferred to the High Court. In practice, major patent disputes are litigated before High Courts such as Delhi, Bombay, Madras and Calcutta.
In Low Heat Driers Pvt.Ltd vs Biju George, the court observed that
“No suit for a declaration under Section 105 or for any relief under Section 106 or for infringement of a patent shall be instituted in any Court inferior to a district court having jurisdiction to try the suit: Provided that where a counter-claim for revocation of the patent is made by the defendant, the suit, along with the counter-claim, shall be transferred to the High Court for decision”.
Defence in Patent Infringement Actions
An infringement action rarely proceeds without a validity challenge. In fact, almost every serious infringement suit includes a counterclaim for revocation. Common defence includes: NON- INFRINGEMENT, INVALIDITY, RESEARCH AND EXPERIMENTAL USE, BOLAR EXCEPTION and GOVERNMENTAL USE.
1. Non-Infringement
The defendant argues that their product does not fall within the scope of the claims.
2. Invalidity (Section 64)
Grounds include:
- Lack of novelty
- Obviousness
- Non-patentable subject matter (Section 3)
- Insufficient disclosure
- Lack of inventive step
Indian courts permit defendants to challenge validity as a counterclaim.
3. Research and Experimental Use (Section 47)
Section 47 carves out specific acts that do not constitute infringement even when they fall within the scope of a granted patent. These include any act done for the purpose of experiment or research, including the imparting of instructions to pupils. The provision reflects the foundational principle that patent monopoly should not impede the advancement of knowledge.
The research exemption in India is deliberately broader than in some comparable jurisdictions. It covers not merely scientific experimentation aimed at testing the patent itself but also research that uses the patented invention as a tool or starting point. A university researcher working with a patented compound to investigate an unrelated biological question, for instance, would typically fall within the exemption. However, the exemption does not extend to commercial exploitation – research conducted on behalf of a commercial entity with a view to market entry falls outside Section 47 and is instead addressed by Section 107A.
4. Bolar Exception (Section 107A)
Section 107A(a) provides that 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 in India or any other country that regulates the manufacture, construction, use, sale or import of any product shall not be considered infringement.
This provision – commonly called the Bolar exemption after the American litigation that inspired similar statutory reforms internationally – is of decisive commercial importance in the pharmaceutical sector. It permits generic manufacturers to conduct bioequivalence studies, compile regulatory dossiers and file marketing approval applications with the Central Drugs Standard Control Organisation before the relevant patent expires. Without this exemption, a generic manufacturer could not lawfully begin the regulatory approval process until the day of patent expiry, effectively extending the patentee’s market exclusivity by the time required to obtain approval – often two to four years.
The Indian Bolar exemption is drafted broadly. Unlike narrower formulations in some jurisdictions, Section 107A does not restrict the exemption to domestic regulatory submissions – it also covers acts done for submissions required under the law of any other country. This makes India an important jurisdiction for global generic pharmaceutical development programs. The exemption applies equally to biologics and biosimilars, areas of growing commercial significance.
5. Government Use (Section 100)
Sections 99 to 103 of the Patents Act constitute a comprehensive framework for use of patented inventions by or for the government. Section 99 permits the Central or State Government, or any person authorised by a government in writing, to make, use, exercise or vend any patented invention for the purposes of the government. This right exists independently of the patentee’s consent and is not subject to any exclusivity the patent confers on others.
The government use provisions are distinct from compulsory licensing under Section 84. Compulsory licensing requires an application to the Controller and a formal adjudicative process. Government use under Section 100 can be invoked by executive authorisation alone, with compensation determined subsequently if the parties cannot agree. In situations of national emergency, the government’s power to invoke these provisions without prior notice is substantially unrestricted.
These provisions have particular relevance in defence procurement, public health programs and infrastructure projects where patented technologies may be required without the commercial negotiation that private licensing entails. The patentee retains the right to compensation at a level to be agreed or, failing agreement, determined by the High Court – but not the right to prevent government use altogether.
Remedies for Patent Infringement
The Patents Act provides both civil and criminal consequences, but patent infringement in India is primarily a civil remedy. The court may grant relief including an injunction and at the option for the plaintiff either damages or an account of profits
1. Injunction
Injunctions are the most sought-after relief. They may be:
- Interim (temporary)
- Ad-interim (urgent)
- Permanent
Courts apply the traditional three-fold test:
- Prima facie case
- Balance of convenience
- Irreparable injury
In pharmaceutical cases, interim injunctions are frequently the most commercially consequential event in the litigation. A patentee who obtains an interim injunction against a generic competitor effectively preserves its market position for the duration of the proceedings – which in India can extend for several years. Conversely, a generic manufacturer that defeats an interim injunction application can often establish a market presence that makes permanent relief practically hollow even if the patentee ultimately prevails on the merits.
Indian courts apply the three-limbed test drawn from established principles: prima facie case, balance of convenience and irreparable injury. The application of this test in pharmaceutical patent cases has been shaped significantly by decisions including F. Hoffmann-La Roche Ltd. v. Cipla Ltd. (Delhi High Court, 2008), where the Division Bench declined to grant an interim injunction against Cipla’s manufacture of erlotinib despite Roche’s prima facie showing of infringement, holding that the public interest in availability of a cancer drug at accessible prices was a legitimate consideration in the balance of convenience. This decision established that in cases involving life-saving medications, courts retain discretion to weigh broader public health consequences when determining interim relief – a principle that has influenced pharmaceutical injunction practice significantly since.
Merck Sharp & Dohme Corporation v. Glenmark Pharmaceuticals Ltd. (2015) is a further significant instance, where the Supreme Court ultimately addressed the standards of evidence required at the interim stage in pharmaceutical patent disputes and the weight to be given to the defendant’s invalidity arguments when assessing prima facie case.
2. Damages or Account of Profits
Section 108 of the Patents Act provides two alternative monetary remedies between which the plaintiff must elect before judgment: damages, or an account of profits. The two remedies are mutually exclusive – a plaintiff cannot claim both, and the election, once made, is generally binding.
Damages are intended to compensate the patentee for the loss suffered as a result of the infringement. The measure is the difference between what the patentee would have earned absent the infringement and what was actually earned – a calculation that typically requires expert evidence on lost sales, royalty rates and market dynamics. Account of profits, by contrast, strips the infringer of the profit made from the infringement regardless of the patentee’s actual loss. It is particularly attractive where the infringer’s profits substantially exceed the patentee’s demonstrable loss.
Indian courts have historically been conservative in quantum – damages awards in patent cases have not approached the scale seen in United States or United Kingdom litigation. However, a gradual shift is underway. Courts are increasingly requiring detailed commercial evidence at the remedies stage rather than making broad assessments, and recent decisions have signalled willingness to award more realistic compensation where the evidentiary record supports it. Section 108 also specifically provides that where an infringement consists of making a product by a patented process, the court shall award damages with reference to the loss suffered by the patentee by reason of the infringement – a provision that carries particular weight in process patent pharmaceutical disputes.
Enhanced damages for flagrant infringement – equivalent to exemplary or punitive damages in other jurisdictions – are not expressly provided for under the Patents Act, though courts retain inherent discretion in appropriate cases.
3. Delivery Up and Destruction
The court may order infringing goods to be seized, delivered up or destroyed.
4. Anton Piller Orders
Although not explicitly in the statute, courts grant search and seizure orders in appropriate cases to preserve evidence.
Claim Construction
In Indian patent litigation, claim construction is often decisive.
Courts examine:
- Literal meaning of claim terms
- Context within the specification
- Prosecution history (in limited circumstances)
Indian jurisprudence does not formally adopt the American doctrine of equivalents, but courts sometimes examine substance over form where mechanical variations attempt to evade the claim language. Precision in drafting becomes critical at this stage.
From a practical standpoint:
- Plaintiffs must conduct detailed technical comparison before filing
- Expert affidavits are increasingly important
- Interim injunction stage often determines commercial outcome
Many cases settle after interim hearings. Where a patent is close to expiry, delay tactics are common.
Revocation Counterclaims: Tactical Importance
Defendants routinely file revocation counterclaims under Section 64.
This transforms the dispute from a simple infringement comparison into a full validity trial. In many cases, the real contest becomes whether the patent survives.
Pharmaceutical Patent Infringement
Pharma disputes form the backbone of Indian patent litigation.
Key issues include:
- Section 3(d) compliance
- Evergreening arguments
- Polymorph patents
- Process vs product overlap
Courts often balance public interest considerations, particularly where life-saving drugs are involved.
Emerging Areas of Patent Infringement
- Standard Essential Patents (SEPs)
- Telecom licensing disputes
- Software-related patents
- AI and biotech innovation
Conclusion
Patent infringement in India sits at the intersection of technical analysis, commercial strategy and judicial discretion. The statutory framework – Sections 48, 104, 104A, 107A and 108 – defines rights, defences and remedies with reasonable clarity. What the statute cannot define is the manner in which these provisions interact with the specific facts of each dispute, the strength of the patent under challenge, the commercial stakes involved and the equitable considerations that influence interim relief.
For patentees, the practical lesson is that enforcement readiness must be built before infringement occurs. A patentee who has maintained a clean prosecution history, filed Form 27 working statements diligently, kept claims tightly drafted and conducted ongoing market surveillance is in a materially stronger position than one who approaches enforcement reactively. The interim injunction stage, as Cipla Ltd. v. F. Hoffmann-La Roche Ltd. & Another demonstrates, can be won or lost on factors well beyond the technical merits of the infringement comparison.
For defendants and generic challengers, early and rigorous validity analysis is not merely a defensive measure – it is the foundation of strategy. A patent that survives Section 64 revocation is a patent worth settling with. One that does not survive scrutiny should be challenged promptly and comprehensively, because the compulsory licence route and the invalidity counterclaim together give Indian courts significant tools to prevent the patent system from being used against the public interest it is ultimately designed to serve.
References
- The Patents Act, 1970 (as amended) — https://ipindia.gov.in/writereaddata/Portal/IPOAct/1_113_1_The_Patents_Act__1970___incorporating_all_amendments_till_1-08-2024.pdf
- The Patents Rules, 2003 (as amended) — https://ipindia.gov.in
- F. Hoffmann-La Roche Ltd. v. Cipla Ltd., 148 (2008) DLT 598 — https://indiankanoon.org/doc/498416/
- Merck Sharp & Dohme Corporation v. Glenmark Pharmaceuticals Ltd., (2015) 4 SCC 215 — https://indiankanoon.org/doc/34202633/
- Bayer Corporation v. Natco Pharma Ltd., Compulsory Licence Application No. 1 of 2011 — https://indiankanoon.org/doc/28519340/
- Novartis AG v. Union of India, (2013) 6 SCC 1 — https://indiankanoon.org/doc/165776436/
- Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Articles 28, 30 and 31 — https://www.wto.org/english/docs_e/legal_e/27-trips.pdf
- Commercial Courts Act, 2015 — https://www.indiacode.nic.in
- Manual of Patent Office Practice and Procedure — https://ipindia.gov.in
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