Patent Infringement in India: What Constitutes Infringement

A patent, at its core, is a bargain between the inventor and the state. The inventor discloses the invention to the public in full; the state, in return, grants a limited monopoly for twenty years. The value of that monopoly depends entirely on how effectively it can be enforced. An unenforceable patent right is no right at all it is merely a document. Section 48 of the Patents Act, 1970 is the provision that gives the patent its teeth. It defines the exclusive rights of the patentee and, by necessary implication, defines what conduct by a third party without the patentee’s authorisation will amount to infringement. Every patent dispute in India, whether before the Delhi High Court or the commercial courts, begins and ends with the question of whether the defendant’s conduct falls within the four corners of Section 48.

What makes Section 48 both powerful and complex is that the Patents Act, 1970 does not separately define “infringement.” The Act does not say, in one place, “this is what infringement looks like.” Instead, as the WIPO International Patent Judicial Guide on India rightly observes, courts regard any violation of the rights accorded under Section 48 as an infringement. The provision must therefore be read carefully not as a formality, but as the foundation of every enforcement action in India. This article examines Section 48 in full: its text, its structure, how courts have interpreted and applied it, what conduct it covers and what it excludes, the doctrines that courts have developed to deal with near-infringement and equivalents, the defences available to defendants and the remedies a successful patentee can obtain. The discussion draws on genuine and verified Indian case law, including the landmark decisions of the Delhi High Court and the Supreme Court and reflects the current state of Indian patent enforcement jurisprudence.

Section 48 and Its Structure

Section 48 of the Patents Act, 1970 confers upon the patentee exclusive rights of a dual character, one for product patents and one for process patents. Section 48(a) deals with product patents and provides that the patentee has the exclusive right to prevent third parties who do not have the patentee’s consent from making, using, offering for sale, selling or importing the patented product in India. Section 48(b) deals with process patents and provides that the patentee has the exclusive right to prevent third parties from using the patented process and also from using, offering for sale, selling or importing into India the product obtained directly by the patented process again without the patentee’s consent.

Several things about this structure deserve close attention. First, the rights under Section 48 are rights to prevent third-party conduct. They are negative rights. Section 48 does not say the patentee has the right to make or sell the invention it says the patentee has the right to stop others from doing so. This is consistent with the position globally and reflects the fact that a patent does not automatically confer a commercial licence; it confers an exclusionary right. The patentee’s own freedom to commercialise the invention may still be subject to other laws, regulatory requirements or third-party rights. Second, the conduct prohibited is a specific enumerated list: making, using, offering for sale, selling or importing. Each of these is a distinct act. A person who only offers a patented product for sale but has not yet sold it is already within the reach of Section 48(a). A person who imports a product that was made using a patented process is within Section 48(b), even if that person did not know about the process. Third, the rights are expressly subject to the other provisions of the Act, including Section 47 (which carves out government use), Section 49 (which provides an exemption for foreign vessels in transit) and Section 107A (which provides the research exemption and Bolar-type exemption).

What Counts as “Making” And Why It Matters

The act of making a patented product is the most direct form of infringement. Manufacturing a product that falls within the claims of a granted patent, without authorisation, is an infringement of Section 48(a) even if the product is never sold. In the pharmaceutical context, this becomes acutely relevant because generic manufacturers typically manufacture the allegedly infringing product first and then seek regulatory approval to sell it. The question of whether the act of manufacturing for regulatory submission purposes constitutes infringement is resolved by Section 107A(a) of the Act, which provides a statutory exemption analogous to the Bolar exemption in US law for any act of making, constructing, using or selling a patented invention solely for uses reasonably relating to the development and submission of information required under any law for the time being in force, in India or in a country that regulates the manufacture, use or sale of any product.

Outside the Bolar exemption, the manufacturing of a product covered by patent claims is an infringement, full stop. The patentee does not need to show that the defendant has sold or profited from the product. The act of making is itself the infringement.

Using, Offering for Sale and Selling

The act of “using” a patented product or process is the broadest of the prohibited acts. Using a machine covered by a product patent or using a process covered by a process patent, constitutes infringement regardless of whether the output is sold commercially. An industrial user who incorporates a patented component into its manufacturing line, without authorisation and without a licence, is infringing Section 48(a). The prohibitions on “offering for sale” and “selling” cover the full commercial chain. Offering for sale captures the moment before a transaction is completed the advertisement, the catalogue listing, the price quotation. This is why interim injunctions in India can be obtained as soon as a threat of market entry is detected, often before a single unit has changed hands. A patentee who sees a competitor announcing the impending launch of an infringing product can commence proceedings immediately on the basis of the offer to sell, even without waiting for actual sales.

The Delhi High Court has held that the term “sale” in the context of the Patents Act includes exports. This is a point of considerable commercial significance. An Indian manufacturer who exports a patented product or a product made by a patented process to foreign markets, without the patentee’s consent, commits an infringement of Section 48 in India even though the ultimate consumer is abroad. In Telefonaktiebolaget LM Ericsson (Publ) v. Mercury Electronics & Anr., CS(OS) 442/2013 (Delhi High Court, 2013), Ericsson sued Micromax and Mercury Electronics for infringement of eight patents declared essential to the 2G and 3G telecommunications standards. The Delhi High Court granted an ex-parte interim injunction on the very first day of listing and also directed Customs Authorities to notify Ericsson whenever a consignment was imported by Micromax. This case, one of the earliest and most significant Standard Essential Patent disputes in India, illustrated that Section 48 rights extend to all five prohibited acts making, using, offering for sale, selling and importing and that courts will act quickly when infringement is asserted by a rights holder with a clear prima facie case.

Importing the Patented Product

The importation limb of Section 48 is the provision that matters most in the Indian pharmaceutical and technology sectors. India has historically been a major market for imported patented products, particularly in pharmaceuticals. The right under Section 48(a) to prevent importation of a patented product means that parallel importation importing a genuine patented product from a jurisdiction where it is sold at a lower price is in principle an infringement in India, unless the patentee has given consent. India has not enacted an international exhaustion regime for patents, which means the patentee’s right to control importation is preserved even for goods that the patentee itself sold in another country.

For process patents under Section 48(b), the importation right is particularly powerful. If a foreign manufacturer uses a process that is patented in India to make a product and then exports that product to India, the Indian patentee can prevent the import even though the manufacturing happened entirely outside India. The burden of proof in such cases can shift to the defendant under Section 104A of the Act, which provides that where the subject matter of the patent is a process for obtaining a new product or where there is a substantial likelihood that an identical product was made by the patented process and the patentee cannot through reasonable efforts determine the actual process used by the infringer, the court may direct the defendant to prove that the process is different from the patented process.

Product Patents Versus Process Patents: The Critical Distinction

The distinction between product and process patent infringement is not merely academic. It has significant implications for claim drafting, litigation strategy and the burden of proof. Under Section 48(a), the product patent gives the patentee control over the product itself, regardless of how it was made. Any method of making the product, if the end result falls within the claims, is irrelevant the product is the thing that is protected. Under Section 48(b), the process patent gives control only over the use of that specific process and over the product obtained directly by it. If the alleged infringer uses a different process to arrive at the same product, the product patent’s equivalent claims may still be infringed, but the process patent will not be, unless the doctrine of equivalents applies.

This distinction was at the heart of the dispute in FMC Corporation & Ors. v. Natco Pharma Limited, FAO(OS)(COMM) 301/2022 (Delhi High Court, Division Bench, December 5, 2022). FMC held Indian Patent No. 298645 (IN’645), a process patent for preparing the insecticide chlorantraniliprole (CTPR) using sulfonyl chloride as a key reagent in a specific reaction sequence. Natco used thionyl chloride instead, in a different sequence of reactions, to manufacture the same end product. FMC argued that Natco’s process infringed IN’645 under the doctrine of equivalents, since the different reagent performed the same function in substantially the same way to achieve the same result. The Division Bench of the Delhi High Court rejected this argument. The Court held that the doctrine of equivalents applies to examine whether the substituted element does the same work in substantially the same way to accomplish the same result, but that sulfonyl chloride was an essential element of the suit patent not a mere incidental feature and its replacement by thionyl chloride, coupled with a different reaction sequence, constituted a material and non-trivial variation. The Court clarified that in a process claim, the monopoly is restricted to the method by which the product is manufactured and that the same product made by a different process does not infringe the process patent. This judgment is currently the leading Indian authority on the doctrine of equivalents as applied to process patents.

The Doctrine of Equivalents: Protecting the Substance of the Invention

India’s Patents Act, 1970, does not codify the doctrine of equivalents. There is no provision in the Act that expressly states that infringement extends beyond the literal scope of the claims to cover substantially equivalent variants. However, Indian courts have recognised and applied the doctrine through their inherent equitable jurisdiction and through the principle of pith and marrow a concept with deep roots in common law patent jurisprudence which states that a defendant cannot escape infringement by making trifling or insubstantial variations to an invention.

The doctrine was expressly discussed by the Delhi High Court in Raj Parkash v. Mangat Ram Chowdhry, AIR 1978 Delhi 1, where the Court applied the pith and marrow test and held that even if there was no direct, literal infringement of patent claims, an action for infringement would succeed if the pith and substance of the patented subject matter was replicated by the defendant. The Bombay High Court applied a similar principle in Ravi Kamal Bali v. Kala Tech and Ors., 2008 (38) PTC 435 (Bom), a case involving patent rights in tamper-proof seals and locks, where the Court held that mere superficial differences or altered non-essential elements could not distinguish a defendant’s product from the patented invention. In the more recent FMC v. Natco decision discussed above, the Division Bench synthesised these authorities and held that the doctrine of equivalents is applied by asking whether the substituted element in the infringing product does the same work, in substantially the same way, to accomplish the same result the classic triple-identity or function-way-result test. The Court, however, made clear that the doctrine has limits: where the substituted element is not a trivial or insubstantial variation but a material departure from an essential element of the claim, the doctrine cannot rescue an infringement case.

The Roche v. Cipla Litigation: Infringement, Interim Relief and Public Interest

No discussion of Section 48 in India can be complete without a detailed treatment of F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Ltd., CS(OS) 89/2008 (Delhi High Court, Single Judge, March 19, 2008); FAO(OS) 188/2008 (Division Bench, April 24, 2009); and RFA(OS) 92/2012 and 103/2012 (Division Bench, November 27, 2015). The case concerned Indian Patent No. 196774, which protected erlotinib hydrochloride an anti-cancer drug marketed by Roche under the name Tarceva and selling at approximately Rs. 1.4 lakh per month of treatment. Cipla launched a generic version called Erlocip at approximately Rs. 46,000 per month and later at lower prices. Roche filed an infringement suit under Section 48(a) seeking a permanent injunction.

At the interim stage, the Single Judge, Justice S. Ravindra Bhat, declined to grant an ad-interim injunction, holding that as between the public interest in granting an injunction to affirm a patent during the pendency of an infringement action and the public interest in access to a life-saving drug, the balance had to tilt in favour of the latter. The Court directed Cipla to maintain faithful accounts and file quarterly sales statements, thereby protecting Roche’s monetary interests while allowing the drug to remain available to patients. This decision became the defining statement on the intersection of patent rights under Section 48 and the public interest defence at the interim stage.

The Division Bench, in 2009, dismissed the appeal against the interim order. The matter went to trial and after years of proceedings, the Division Bench in November 2015 held that Cipla had infringed Roche’s patent. The Court held that the patent IN’774 expressly stated that all polymorphic forms of erlotinib hydrochloride were subsumed within the patent and that since the preparation of any polymorph necessarily involved first creating erlotinib hydrochloride itself, Cipla’s manufacture of Erlocip constituted infringement under Section 48(a). The Court also laid down important procedural guidelines for infringement proceedings: the correct approach is to map the defendant’s product against the patent’s claims, not against the patentee’s commercially marketed product; infringement is assessed by comparing the allegedly infringing product to the patent specification and claims; and the test is objective and claim-centred, not product-centred.

Exemptions and Defences to Infringement Under Section 48

Section 48 rights are not absolute. The Act itself carves out several exemptions and the courts have recognised defences that defendants may raise to resist infringement claims.

Section 47 provides that an invention can be used by the Central Government and persons authorised by it for government purposes, including for research and instructional purposes by the government. Section 49 exempts the use of a patented invention in the body of a foreign vessel, aircraft or land vehicle that temporarily or accidentally enters Indian territory, provided reciprocity is available to Indian vessels in that foreign country. Section 107A(a) provides the Bolar exemption for acts done solely for regulatory submission purposes. Section 107A(b) provides an exemption for importation of patented products by any person who is duly authorised under the law of the country of manufacture. These exemptions must be read narrowly and cannot be expanded beyond their express terms by judicial interpretation.

Under Section 107(1) of the Act, any ground that would justify revocation of a patent under Section 64 can be raised as a defence in an infringement suit. This means that a defendant can challenge the validity of the suit patent on grounds of lack of novelty, lack of inventive step, non-disclosure or any other ground in Section 64 within the infringement proceedings itself, without filing a separate revocation petition. This provision has been used actively by Indian generic pharmaceutical companies to resist interim injunctions, as the prospect of a credible validity challenge significantly affects the balance of convenience analysis that courts undertake when deciding whether to grant interim relief.

The Standard Essentials Patent Context:

Ericsson and the Scope of Section 48 The infringement of standard-essential patents (SEPs) raises issues that go beyond ordinary Section 48 analysis. In the Ericsson cases Telefonaktiebolaget LM Ericsson (Publ) v. Micromax Informatics Ltd., CS(OS) 442/2013 and the related Intex litigation Ericsson asserted eight patents declared essential to 2G and 3G telecommunications standards before the Delhi High Court. Because these were standard-essential patents in respect of which Ericsson had given a FRAND (Fair, Reasonable and Non-Discriminatory) commitment to ETSI, every manufacturer of 2G or 3G-compliant devices necessarily used the patented technology and was therefore necessarily within the scope of Section 48. There was no design-around possible; compliance with the standard itself constituted infringement.

The Delhi High Court granted interim injunctions in these cases, directing Micromax and Intex to pay interim royalties while the suit was pending. The Court held that Ericsson had demonstrated a prima facie case of infringement and compliance with its FRAND obligations and that Micromax and Intex had delayed and prolonged negotiations rather than taking a genuine licence. The broader legal question of whether the Competition Commission of India had jurisdiction to inquire into Ericsson’s royalty practices was eventually resolved by the Division Bench in Telefonaktiebolaget LM Ericsson v. Competition Commission of India, W.P.(C) 464/2014 (Delhi High Court, Division Bench, 2016), which held that the CCI had jurisdiction to investigate Ericsson’s conduct under the Competition Act, 2002 and that there was no irreconcilable repugnancy between the Patents Act and the Competition Act. This litigation remains the most significant treatment of SEP infringement and the scope of Section 48 in the technology sector.

Remedies for Infringement Under Sections 108 and 111

A patentee who successfully proves infringement under Section 48 is entitled to remedies under Section 108 of the Act. Section 108(1) provides for an injunction which may be interim, interlocutory or permanent restraining the defendant from infringing the patent. Section 108(2) provides that the patentee may claim either damages or an account of profits, at the patentee’s election. The patentee cannot claim both simultaneously; the election between damages and account of profits must be made and once made it is binding. Section 111 of the Act restricts the power of the court to grant damages or profits in certain circumstances in particular where the defendant was not aware and had no reasonable grounds for believing that the patent existed at the time of infringement, though the marking of the product with the word “patent” or “patented” is deemed to constitute notice.

The interim injunction remains the most commercially significant remedy in Indian patent litigation. The principles governing the grant of an interim injunction prima facie case, balance of convenience, irreparable injury were applied specifically in the Roche v. Cipla litigation as discussed above and remain the governing standard. The courts have been particularly cautious about granting unconditional interim injunctions in pharmaceutical patent cases where public access to life-saving medicines is in issue, following the principles articulated by the Single Judge in Roche v. Cipla. In other sectors, particularly technology and industrial patents, courts have been less reluctant to grant injunctive relief at the interim stage.

Conclusion

Section 48 of the Patents Act, 1970 is the cornerstone of patent enforcement in India. It defines with precision what the patentee’s monopoly covers the making, using, offering for sale, selling and importation of a patented product and the use of a patented process and importation or sale of its direct product and it provides the legal basis for every infringement action brought before Indian courts. What makes Indian patent enforcement jurisprudence distinctive is not the text of Section 48, which broadly mirrors Article 28 of TRIPS, but the judicial and legislative overlay that shapes how those rights are actually enforced: the doctrine of equivalents as articulated in FMC v. Natco, the public interest balancing at the interim stage as developed in Roche v. Cipla, the treatment of SEP infringement as established in the Ericsson litigation, the Bolar exemption under Section 107A and the unrestricted defendant’s right under Section 107 to challenge validity in infringement proceedings.

The trajectory of Indian patent enforcement points toward greater sophistication in claim analysis, increasing use of court-appointed scientific advisors in technical disputes and a more structured approach to FRAND licensing in the SEP context. At the same time, India’s courts have been consistent in refusing to allow patent rights under Section 48 to operate as barriers to public health a policy choice embedded in Section 83 and visibly operative in every pharmaceutical infringement case. For the practitioner, this means that winning on Section 48 requires not just proving that the defendant’s product or process falls within the claims: it requires anticipating and defeating the validity challenge, managing the balance of convenience and in pharmaceutical cases especially addressing the public interest dimension from the very first pleading. In Indian patent litigation, Section 48 is the starting point, not the finishing line.

References

Patents Act, 1970 Section 48 https://www.indiacode.nic.in/show-data?actid=AC_CEN_11_61_00002_197039_1517807321764&sectionId=15918&sectionno=48&orderno=50
WIPO International Patent Judicial Guide India Chapter 6 (Infringement) https://www.wipo.int/patent-judicial-guide/en/full-guide/india/6.5
F. Hoffmann-La Roche Ltd. v. Cipla Ltd., CS(OS) 89/2008 (Delhi High Court, March 19, 2008) https://indiankanoon.org/doc/64813/
F. Hoffmann-La Roche Ltd. v. Cipla Ltd., FAO(OS) 188/2008 (Delhi High Court, Division Bench, April 24, 2009) https://indiankanoon.org/doc/131401110/
F. Hoffmann-La Roche Ltd. v. Cipla Ltd., RFA(OS) 92/2012 and 103/2012 (Delhi High Court, Division Bench, November 27, 2015) https://indiankanoon.org/doc/57798471/
FMC Corporation & Ors. v. Natco Pharma Limited, FAO(OS)(COMM) 301/2022 (Delhi High Court, Division Bench, December 5, 2022) https://indiankanoon.org/doc/197847691/
Telefonaktiebolaget LM Ericsson v. Competition Commission of India, W.P.(C) 464/2014 (Delhi High Court, Division Bench, 2016) https://indiankanoon.org/doc/164770226/
TRIPS Agreement, Article 28 Rights Conferred https://www.wto.org/english/docs_e/legal_e/27-trips_04d_e.htm
CGPDTM Patent Office Practice and Procedure Manual https://ipindia.gov.in/patent-manual.htm
Novartis AG v. Union of India, (2013) 6 SCC 1 https://main.sci.gov.in/judgment/judis/40212.pdf

Patent Infringement in India: What Constitutes Infringement under Section 48 of the Patents Act, 1970

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