Cipla v F Hoffmann-La Roche (2015)
High Court of Delhi·27 November 2015
Latest update: . Case: Ab Initio Technology LLC v Assistant Controller of Patents. Doctrine: Appeals from the Controller.
Is making a patented product without permission an infringement in India?
Under section 48(a), making of a patented product without the consent of the patentee will amount to infringement.
Doctrine last updated on 26 September 2026
Direct Infringement of a Product Claim, Ali on Patents, www.aop.onl/direct-infringement
1Where the subject matter of the patent is a product, any act by a third party, of making, using, offering for sale, selling or importing for those purposes, such product in India, without the consent of the patentee, will amount to infringement.
2Making of a patented product without the consent of the patentee will amount to infringement. Similarly, making and selling separate parts of a patented instrument, whose parts can be put together without any difficulty by any ordinary skilled workman, will constitute an infringement of the patented product. (See United Telephone Co v Dale (1884) 25 Ch D 778, pp 782-83.) The person who manufactures the parts and the customers who assemble will be liable as joint tortfeasors. (See Rotocrop International Ltd v Genbourne Ltd [1982] FSR 241, p 259. See also Lacroix Duarib SA v Kwikform (UK) Ltd [1998] FSR 493, p 499.) However, the making of an article which per se does not infringe a patent, but may be used for infringing a patent, will not amount to infringement of the patent. (See Dunlop Pneumatic Tyre Co Ltd v David Moseley & Sons Ltd [1904] 1 Ch 612, pp 618-19, (1904) 21 RPC 274, p 280 (CA).)
3Possession with the intention of ‘using’ the articles for trade purposes and for the securing of a profit would amount to an infringement. (See Hoffmann-La Roche & Co AG v Harris Pharmaceuticals Ltd [1977] FSR 200, p 207; SmithKline Corpn v DDSA Pharmaceuticals Ltd [1978] FSR 109, pp 112-13 (CA).) But possession by a carrier or a warehouseman, who innocently carried or stored the infringing goods for a consignor or consignee, will not amount to an infringement. (See SmithKline & French Laboratories Ltd v RD Harbottle (Mercantile) Ltd (1980) RPC 363, p 370, [1979] FSR 555, p 563; Kalman v PCL Packaging (UK) Ltd (1982) FSR 406, p 417.) An injunction, in respect of a patented product, may be granted even if there is no actual infringement by the user of the product. Even if there is no actual use, an injunction may be granted where there is a threat of potential use. (See Adair v Young (1879) LR 12 Ch D 13, p 19 (CA), per Cotton LJ, where injunction was granted to restrain the master of a ship from using certain patented pumps in ships though there was no evidence of them being used.) Application to the regulatory authority for approval to market the product will not however come under the ambit of use. (See Patents Act 1970, s 107A.) It will be difficult to include mere use of the information with regard to the product under this provision.
4‘Offering for sale’ would include an advertisement or a pre-contractual negotiation to supply a patented product. (See Gerber Garment Technology Inc v Lectra Systems Ltd (1995) RPC 383, pp 411-12, where the expression ‘offer to dispose of’ in s 60(1)(a) of the UK Patents Act 1977 was held to mean ‘an offer for supply during the life of the patent’.) If, pursuant to the offer, the supply of the product happens during the term of the patent, it would certainly amount to infringement. An injunction may be obtained to restrain such acts. (See Kalman v PCL Packaging (UK) Ltd [1982] FSR 406, pp 417-18, where no injunction was granted as the plaintiff failed to prove a good arguable case for the cause of action alleged as per the United Kingdom law. It was held that the concept of ‘disposal’ introduced by s 60 of the UK Patents Act 1977 includes ‘selling’.) But negotiations during the term of a patent to supply after the expiry of the patent will not amount to infringement. (See Gerber Garment Technology Inc v Lectra Systems Ltd (1995) RPC 383, pp 411-12.)
5The expression ‘selling’ or ‘sale’ would include any form of commercialisation. The sale has to take place within the territory of India. If the conclusion of sale was done abroad, it will not come under the ambit of ‘selling’ or ‘vending’. (See Badische Anilin und Soda Fabrik v Hickson [1906] AC 419, p 422, (1906) 23 RPC 433 (HL) per Lord Davey, a case decided in the context a similar provision in the United Kingdom.) There can be no infringement if the property is passed on to a purchaser in a foreign country. (See Sabaf SpA v MFI Furniture Centres Ltd (2005) RPC 10 (HL).)
6If the patentee sells the article without any clear and express limitation, the buyer will be entitled to do as he pleases. (See Betts v Willmott (1871) LR 6 Ch App 239, p 245.) “In the case of patented products sold by a licence, the extent to which the article is released from the patentee’s patent rights will depend on the extent of the authority conferred by the licence. (See Beecham Group Ltd v International Products Ltd [1968] FSR 162, pp 167-68, (1968) RPC 129 (High Court of Kenya).) If the patentee has assigned his rights in the patent, the patentee will not be allowed to manufacture the product abroad and import them to sell the same in a country where the said patent has already been assigned. (See Betts v Willmott (1871) LR 6 Ch App 239, pp 244-45.) Though export of an article will not come under the ambit of ‘selling’, the acts that precede an export will usually be accompanied by infringing acts like ‘importing with a view of selling in export market’, ‘purchase and possession with a view to sale’, etc. (See SmithKline Corpn v DDSA Pharmaceuticals Ltd [1978] FSR 109, pp 111-14 (CA) for a detailed summary of cases on what constitutes use of a patented invention.) An injunction may be granted to restrain the defendants from exporting the allegedly infringing goods. (See British Thompson-Houston Co Ltd v Charlesworth, Peebles & Co (1922) 39 RPC 399.)
7‘Importing’ should be understood in the context in which it is used in s 48(a) of the Patents Act. What is covered under the said sub-section is the import for the purposes of ‘making, using, offering for sale or selling’ a product in India without the consent of the patentee. Where the subject matter that is imported is covered by a patent, for the purpose of distributing and selling them in a country, it would amount to infringement of that patent. (See Pfizer Corpn v Ministry of Health [1965] AC 512, pp 557-58, (1965) RPC 261 (HL).) Both the vendor and the purchaser will be liable for infringement. Regardless of the person in whom the property in the goods vested, they would be jointly implicated in a transaction the effect of which was to infringe the patent law of the country, and they will both be liable as principals in the transaction. (See Badische Anilin und Soda Fabrik v Johnson and the Basle Chemical Works [1897] Ch 332, p 334, (1897) 14 RPC 919 affirmed by the House of Lords in [1898] AC 200 (HL).) In determining an importer, the court shall have regard to the person who has possession to the title of the goods. (See Sabaf SpA v MFI Furniture Centres Ltd (2005) RPC 10, para 38.)
8The act of importing a patented product for uses relating to the development and submission of information required under any law in India or abroad that regulates the import of any product will not amount to an infringement. (Patents Act 1970, s 107A(a).) Similarly, the importation of patented products by any person from a person who is duly authorised under the law to produce and sell or distribute the product will also not amount to an infringement of such a product. (Ibid, s 107A(b).)
9In Cipla v F Hoffmann-La Roche (2015) the Division Bench held that the issue “is not and indeed cannot be whether Roche and Cipla’s products are identical but whether Cipla’s product is covered in the claims of Roche’s patent” (para 107), that “The correct test of infringement in this case is to map Cipla product against the Roche’s patent claims” (para 109), and, of the compound claimed, “This compound may exist in several polymorphic forms, but any and all such forms will be subsumed within this patent.” (para 114)
10In Merck Sharp and Dohme v Glenmark Pharmaceuticals (2015) the Division Bench held that “Glenmark cannot produce Sitagliptin Phosphate without producing Sitagliptin first and thus infringing MSD’s patent. This is irrespective of whether Sitagliptin phosphate and Sitagliptin are same and are claimed in a single patent” (para 79).
High Court of Delhi·20 March 2015
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Doctrine page · Written by Prof. Feroz Ali
www.aop.onl/direct-infringement