Order Date: 22.08.2025
Case Number: CRP.No.2480 of 2025
Name of Court: The High Court of Judicature at Madras
Name of Judge: The Hon'ble Mr. Justice P.B. Balaji
Information on this blog is being shared only for the purpose of creating legal awareness in public at large, especially in the field of Intellectual Property Right. As there may be possibility of error, omission or mistake in legal interpretation on the contents of this blog, it should not be treated as substitute for legal advise.
Medicines like romiplostim, made from living sources, are delicate. They can break down or clump together if not handled carefully, much like milk curdling outside the fridge. To solve this, Amgen developed a way to freeze-dry the medicine (a process called lyophilization), turning it into a stable powder that’s easier to store, ship, and mix with water for use later.
Amgen applied for a patent in India on 9 September 2008, under application number 5857/CHENP/2008, titled “Lyophilized Therapeutic Peptibody Formulations.” They described a specific dry mix: the main medicine (romiplostim, structured as Formula V in their papers) showing the mix stays stable, doesn’t clump, and that the additives work together better than alone.
Amgen asked the Indian Patent Office to review their application. On 20 July 2013, the office issued a First Examination Report (FER), raising objections under Sections 3(d), 3(e), and 2(1)(ja) of the Patents Act, 1970. These rules block patents for things like reusing known methods, simple mixes without special effects, or ideas that aren’t creative enough compared to existing documents (called prior arts D1-D6). Amgen responded, narrowing their claims to focus on Formula V, which covered 52 slight variations of the main medicine part.
Then, Intas Pharmaceuticals Limited, an Indian company, objected on 18 July 2016, under Sections 25(1)(e) (obviousness), 25(1)(f) (not an invention), and 25(1)(g) (incomplete explanation). After hearings, the Assistant Controller rejected the application on 31 March 2023, citing the same rules: Section 2(1)(ja) (not creative), Section 3(d) (reusing known methods), Section 3(e) (simple mix), and Section 10(4) (not fully explained). They pointed to prior arts and said there was no proof of real improvement.
Amgen appealed to the Madras High Court under Section 117A of the Patents Act, 1970, which allows challenging patent rejections.
The core issue was whether Amgen’s dry medicine mix qualified as a patentable invention under the Indian Patents Act, 1970. Patents are granted only for ideas that are new, involve a creative step, and can be used industrially, but certain rules block patents for specific cases. The court had to answer four key questions:
Amgen argued their mix was unique for their medicine, their tests showed the ingredients teamed up to prevent spoiling and clumping, picking the right additives and amounts was a creative challenge, and their explanation was enough with one example representing the group. The opponents (the Patent Office and Intas) countered that it was obvious by combining old documents, just a simple mix, and not fully explained for all variations.
The Hon'ble judge beganexplaining in simple terms how medicines from living sources are fragile, need injections (not pills), and why choosing additives is like solving a puzzle—each medicine needs its own perfect recipe. Let’s dive into how the court handled each legal issue, keeping the law’s language intact.
Section 3(d) of the Patents Act, 1970, says you can’t patent “the mere use of a known substabce” unless it creates a new product or uses a new ingredient. The Assistant Controller rejected claim 9 (the method for preparing and drying the mix with specific additives and amounts), saying it was just using the old freeze-drying process, pointing to prior art D4 (which mentioned the medicine) and general knowledge.
The court examined claim 9 and disagreed. It found no prior art showed exactly how to dry this specific medicine with these additives in these amounts. Prior art D4 mentioned freeze-drying vaguely, saying compositions “may be in dried powder, such as lyophilized form,” but gave no steps or details. Prior art D5 described drying a different substance but had no method steps. The court concluded that claim 9’s process, with its specific additives and amounts, wasn’t just reusing a known method—it added something new. Thus, the rejection under Section 3(d) was not sustainable.
Section 3(e) blocks patents for “a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof.” This means a mix where the parts just do their usual jobs, adding up normally, isn’t patentable. The mix must show synergy—where the whole is better than the sum of the parts, like ingredients in a cake that create a unique flavor together.
The Assistant Controller said Amgen’s mix was a simple blend because they didn’t provide data comparing the mix before and after drying to prove better stability. The court rejected this, saying Section 3(e) doesn’t always require before-and-after drying data. The goal is to show the ingredients interact to produce a result greater than their individual effects. Amgen’s tests (Tables 39-41) did this:
The Controller argued the different amounts made the data weak, but the court said the tests’ purpose was to show synergy (polysorbate-20’s effect on clumping), not to compare amounts. Unlike prior art D3, which aimed to increase substance concentration, Amgen’s goal was stability, so before-and-after drying data wasn’t needed. The court found clear synergy, setting aside the Section 3(e) rejection.
Section 2(1)(ja) requires an “inventive step”—a feature that makes the invention not obvious to a person skilled in the art (PSITA), defined as an average medicine-making expert with common knowledge but no extraordinary creativity. The Controller said the mix was obvious based on prior arts D1-D5 (D6 and D7 weren’t used in the appeal).
The court played the role of the PSITA and analyzed each prior art:
The court concluded that choosing these additives and exact amounts for this medicine wasn’t obvious—it took creative work. The Section 2(1)(ja) rejection was unsustainable.
Section 10(4) requires a patent application to fully and clearly describe the invention, including the best method known, so others can recreate it. Amgen’s Formula V covered 52 variations of the medicine’s core part, but tests (Tables 39-41) only showed one (SEQ ID 1017). The court noted that these variations differ in structure, affecting how they behave. Without guidance for the other 51, the application didn’t fully enable them. However, the tested variation (and its close family, SEQ ID 1012-1017) was well-explained. The court partly upheld this objection, narrowing the patent to cover only the tested variation (SEQ ID NO. 459).
The Madras High Court allowed Amgen’s appeal under Section 117A, setting aside the Assistant Controller’s rejection order dated 31 March 2023. The patent application was sent back for approval, but with amendment. This ruling is a milestone for medicine patents in India. It shows that courts will protect creative solutions in complex fields like biologics if they demonstrate real teamwork between ingredients and aren’t obvious combinations of old ideas. However, inventors must fully explain their work, especially for broad claims with many variations.
The case is Actavis UK Limited and others (Appellants) v Eli Lilly and Company (Respondent), decided by the United Kingdom Supreme Court on 12 July 2017, with the case number UKSC 48. The judgment was delivered by Lord Neuberger, President, with Lords Mance, Clarke, Sumption, and Hodge concurring.
The factual background involves pemetrexed, a chemical known for therapeutic effects on cancerous tumors but with significant toxic side effects when used alone. The patent in question, European Patent (UK) No 1 313 508, owned by Eli Lilly, disclosed that these side effects could be mitigated by administering pemetrexed disodium with vitamin B12, enabling a successful medicament marketed as Alimta since 2004. The patent claims focused on using pemetrexed disodium in medicaments combined with vitamin B12 for cancer treatment. Actavis developed products with pemetrexed diacid, pemetrexed ditromethamine, or pemetrexed dipotassium instead of pemetrexed disodium and contended that these did not infringe Eli Lilly’s patent. Eli Lilly argued that Actavis’s products infringed the patent directly or indirectly.
The main dispute was whether Actavis’s products infringed the patent claims limited to pemetrexed disodium. The lower court, Arnold J, initially found no infringement, with the Court of Appeal confirming no direct infringement but accepting indirect infringement. Eli Lilly appealed the rejection of direct infringement, and Actavis cross-appealed the finding of indirect infringement.
The Supreme Court held that Actavis’s products did directly infringe Eli Lilly’s patent in the UK and corresponding designations in France, Italy, and Spain, and dismissed Actavis’s cross-appeal on indirect infringement. The Court applied a nuanced approach to patent claim interpretation, emphasizing the Protocol on the Interpretation of Article 69 of the European Patent Convention, which calls for a balance between fair protection for patentees and legal certainty for third parties. The Court reformulated the established 'Improver' questions to determine infringement under the doctrine of equivalents, requiring that a variant achieves substantially the same result in substantially the same way, that it would be obvious to a skilled person that the variant works equivalently, and that the patentee did not intend a strict literal interpretation excluding such variants.
The Court found that although Actavis’s products did not literally fall within the claims limited to pemetrexed disodium, they were equivalent variants achieving the same therapeutic result through substantially the same means under the patent. The prosecution history limiting claims to pemetrexed disodium did not preclude the doctrine of equivalents extending protection to other pemetrexed salts or the free acid. The Court also confirmed that indirect infringement applies where the Actavis products, when dissolved in saline for administration, effectively produce pemetrexed disodium in solution.
This case clarified the application of the doctrine of equivalents in patent infringement, endorsing a purposive interpretation of patent claims that balances the literal wording with the inventive concept and the principle of equivalents. It provided guidance on how courts should approach equivalence, endorsing a more pragmatic approach whereby the skilled person assesses variants knowing the variant works, rather than speculating on outcomes without such knowledge. The decision is influential for patent law concerning pharmaceutical patents and equivalents.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
Disclaimer: This information report is intended for informational purposes only and does not constitute legal advice.
Introduction: The case of Promoshirt SM SA Vs. Armasuisse and Anr. is a pivotal decision by the High Court of Delhi that addresses the maintainability of Letters Patent Appeals (LPAs) under the Trade Marks Act, 1999, in light of Section 100-A of the Code of Civil Procedure, 1908 (CPC). This case arose from a challenge to a Single Judge’s judgment on appeals against the Deputy Registrar of Trade Marks’ order, raising a significant preliminary objection regarding the applicability of Section 100-A, which bars further appeals from a Single Judge’s appellate decisions. The Division Bench examined whether an LPA is permissible when a Single Judge exercises appellate jurisdiction under a special statute like the 1999 TM Act. The decision clarifies the scope of Section 100-A, the nature of the Registrar of Trade Marks as a non-civil court, and the preservation of Letters Patent remedies in trademark disputes, offering critical insights into appellate jurisdiction in intellectual property law.
Factual Background: Promoshirt SM SA, the appellant, sought registration of certain trademarks under the Trade Marks Act, 1999. Armasuisse, the respondent, opposed these applications, but the Deputy Registrar of Trade Marks, on July 25, 2022, rejected Armasuisse’s opposition and directed that Promoshirt’s trademark applications be processed for registration. Aggrieved, Armasuisse appealed to the High Court of Delhi under Section 91 of the 1999 TM Act, which allows appeals against the Registrar’s orders to be heard by a Single Judge. On January 4, 2023, the Single Judge delivered a judgment, prompting Promoshirt to file two Letters Patent Appeals (LPAs 136/2023 and 137/2023) before the Division Bench. Armasuisse raised a preliminary objection, arguing that Section 100-A of the CPC barred these LPAs, as the Single Judge was exercising appellate jurisdiction. The dispute centered on whether the Registrar’s orders constituted decrees or orders of a civil court under the CPC and whether the 1999 TM Act’s appellate framework permitted further appeals under the Letters Patent.
Procedural Background: The procedural journey began with the Deputy Registrar’s order on July 25, 2022, accepting Promoshirt’s trademark applications and rejecting Armasuisse’s opposition. Armasuisse invoked Section 91 of the 1999 TM Act to appeal this order to a Single Judge of the High Court of Delhi. The Single Judge’s judgment on January 4, 2023, led Promoshirt to file LPAs under Clause 10 of the Letters Patent, challenging the maintainability of the Single Judge’s decision. Armasuisse’s counsel, Mr. Pravin Anand, argued that Section 100-A of the CPC, which prohibits further appeals from a Single Judge’s appellate decisions, rendered the LPAs non-maintainable. The Division Bench was tasked with resolving this preliminary objection before addressing the substantive merits of the appeals, focusing on the interplay between the CPC, the 1999 TM Act, and the Letters Patent powers of the High Court.
Legal Issue: The primary legal issue was whether a Letters Patent Appeal is maintainable against a Single Judge’s judgment rendered under Section 91 of the Trade Marks Act, 1999, in light of Section 100-A of the Code of Civil Procedure, 1908, which bars further appeals from a Single Judge’s decisions in appeals from original or appellate decrees or orders? The court had to determine whether the Registrar of Trade Marks’ decisions constitute decrees or orders of a civil court under the CPC and whether the 1999 TM Act’s appellate provisions, lacking explicit reference to CPC rules, preserve the right to an LPA under the Letters Patent.
Discussion on Judgments: The court extensively referenced prior judgments to address the maintainability of the LPAs, with both parties citing precedents to support their positions. Armasuisse relied on Kamal Kumar Dutta & Anr. v. Ruby General Hospital Ltd. & Ors. ((2006) 7 SCC 613), where the Supreme Court held that Section 100-A overrides Letters Patent powers, barring further appeals from a Single Judge’s decision in an appeal from an original order of the Company Law Board (CLB). The court noted the CLB’s quasi-judicial nature and its trappings of a court, applying Section 100-A to preclude an LPA. Armasuisse argued this precedent conclusively settled the issue, as the Registrar’s orders were akin to those of the CLB.
The court also considered P.S. Sathappan v. Andhra Bank Ltd. ((2004) 11 SCC 672), a Constitution Bench decision cited by Armasuisse, which clarified that Section 100-A, as amended in 2002, specifically excludes LPAs when a Single Judge hears an appeal from an original or appellate decree or order. The court emphasized the legislature’s intent to limit appeals, reinforcing Armasuisse’s contention that Section 100-A applied universally.
Subal Paul v. Malina Paul ((2003) 10 SCC 361) was referenced, with Armasuisse highlighting the Supreme Court’s observation that statutory bars to appeals, like Section 100-A, must be expressly stated. This supported their argument that Section 100-A’s non-obstante clause overrides Letters Patent provisions. Similarly, Gandla Pannala Bhulaxmi v. Managing Director, A.P. SRTC (2003 SCC OnLine AP 525) and United India Insurance Co. Ltd. v. S. Surya Prakash Reddy & Ors. (2006 SCC OnLine AP 434), Full Bench decisions of the Andhra Pradesh High Court, were cited by Armasuisse. These cases held that Section 100-A bars LPAs in matters arising under special statutes like the Motor Vehicles Act, as the non-obstante clause overrides Letters Patent powers, even for tribunals with court-like functions.
Kesava Pillai Sreedharan Pillai v. State of Kerala (2003 SCC OnLine Ker 293), a Kerala High Court Full Bench decision, was invoked by Armasuisse to argue that Section 100-A’s amendments in 1999 and 2002 aimed to abolish intra-court appeals, except in writ petitions, applying to appeals under statutes like the Land Acquisition Act. Rouf Ahmad Zaroo v. Mst. Shafeeqa (2014 SCC OnLine J&K 137) was cited, where the Jammu and Kashmir High Court, relying on Kamal Kumar Dutta, held that Section 100-A barred an LPA from a Single Judge’s appellate order under the Guardians and Wards Act, reinforcing Armasuisse’s position.
Promoshirt countered with National Sewing Thread Co. Ltd. v. James Chadwick & Bros. (AIR 1953 SC 357), where the Supreme Court held that an appeal under Section 76 of the Trade Marks Act, 1940, to a Single Judge is subject to High Court rules, including Letters Patent appeals, unless the statute expressly bars further appeals. Promoshirt argued that the 1999 TM Act’s silence on further appeals preserved the LPA remedy. Mahli Devi (unreported, cited in the judgment), a Delhi High Court Full Bench decision, was referenced to assert that LPAs are maintainable under Section 54 of the Land Acquisition Act, as it lacks a bar on second appeals, supporting Promoshirt’s claim that the 1999 TM Act’s structure allows LPAs.
Resilient Innovations Pvt. Ltd. v. Phonepe Private Limited and Anr. (2023 SCC OnLine Del 2972) and V.R. Holdings v. Hero Investocorp Limited & Anr. (2023 SCC OnLine 4673), recent Delhi High Court decisions, were cited by Promoshirt. These cases held that LPAs are maintainable under the 1999 TM Act, as it lacks provisions excluding Letters Patent appeals, unlike its predecessors. The court in Resilient Innovations emphasized that the absence of CPC application in the 1999 TM Act preserves the LPA remedy under Clause 10 of the Letters Patent.
Avtar Narain Behal (not fully cited but discussed extensively) was a Delhi High Court Full Bench decision relied upon by Armasuisse, interpreting Section 100-A to bar LPAs under the Indian Succession Act, 1925, due to its adoption of CPC appeal provisions. Promoshirt distinguished this, arguing that the 1999 TM Act does not similarly incorporate CPC rules. Nahar Industrial Enterprises Ltd. v. Hong Kong & Shanghai Banking Corpn. ((2009) 8 SCC 646) was cited by Promoshirt to argue that tribunals like the Registrar of Trade Marks are not civil courts, as they lack the full attributes of a civil court, supporting the maintainability of LPAs.
Paramjeet Singh Patheja v. ICDS Ltd. ((2006) 13 SCC 322) was referenced by Promoshirt to clarify that non-civil court decisions, like arbitration awards, are not decrees under the CPC, reinforcing that the Registrar’s orders do not fall under Section 100-A. Additional cases included Sharda Devi v. State of Bihar ((2002) 3 SCC 705), supporting LPAs under the Land Acquisition Act; Aswini Kumar v. Arbinda Bose (AIR 1952 SC 369) and Madhav Rao Scindia v. Union of India (AIR 1971 SC 530), on the scope of non-obstante clauses; and I.T.C. Ltd. v. State of Karnataka (1985 Supp SCC 476) and Kulwant Kaur v. Gurdial Singh Mann ((2001) 4 SCC 262), on the supremacy of central legislation, all contextualizing the interplay between CPC and special statutes.
Reasoning and Analysis of the Judge: The Division Bench began by examining Section 100-A’s language, which bars further appeals from a Single Judge’s decisions in appeals from original or appellate decrees or orders, noting its non-obstante clause overriding Letters Patent provisions. However, the court emphasized that Section 100-A’s applicability hinges on the definitions of “decree” and “order” under Sections 2(2) and 2(14) of the CPC, which require adjudication by a civil court. The Registrar of Trade Marks, as a statutory authority, does not qualify as a civil court, as it lacks the power to conduct trials under the CPC or Evidence Act, failing the “trappings of a court” test articulated in Nahar Industrial Enterprises and Paramjeet Singh Patheja.
The court distinguished precedents like Kamal Kumar Dutta, which applied Section 100-A to the CLB due to its quasi-judicial status and statutory deeming provisions under the Companies Act, 1956. Unlike the CLB or Motor Accident Claims Tribunals, which have limited civil court status under their statutes, the 1999 TM Act contains no such provision, and the Registrar’s role is administrative, not judicial. The court also contrasted the 1999 TM Act with its predecessors, noting that Sections 76(3) of the 1940 TM Act and 109(8) of the 1958 TM Act applied CPC rules to appeals, a feature absent in the 1999 TM Act, indicating legislative intent to preserve Letters Patent remedies.
Analyzing Avtar Narain Behal, the court clarified that its holding applied to the Indian Succession Act, 1925, because Section 299 explicitly subjects appeals to CPC provisions, attracting Section 100-A’s bar. In contrast, Section 91 of the 1999 TM Act is silent on CPC application, aligning with National Sewing Thread and Mahli Devi, which upheld LPAs absent statutory bars. The court reconciled these precedents by holding that Section 100-A applies only when a special statute adopts CPC appeal rules or when the original decision emanates from a civil court.
The court further addressed the legislative intent behind Section 100-A, noting its aim to limit appeals in civil court matters, as per the CPC’s preamble, which governs “courts of civil judicature.” Extending Section 100-A to all special statutes would overstep its scope, especially for non-civil court authorities like the Registrar. The decisions in Resilient Innovations and V.R. Holdings were upheld as correctly interpreting the 1999 TM Act’s framework, reinforcing that LPAs remain viable absent express exclusion.
Final Decision: The Division Bench overruled Armasuisse’s preliminary objection, holding that the LPAs were maintainable. The court directed that the appeals (LPA 136/2023 and LPA 137/2023) be listed for consideration on their merits on September 19, 2023, affirming that Section 100-A does not bar LPAs against a Single Judge’s judgment under Section 91 of the 1999 TM Act.
Law Settled in This Case: The case established several key principles in trademark and appellate law. First, Section 100-A of the CPC bars further appeals only from decrees or orders of a civil court, as defined under Sections 2(2) and 2(14), and does not apply to decisions of non-civil court authorities like the Registrar of Trade Marks. Second, the Registrar of Trademark does not qualify as a civil court, lacking the attributes of conducting trials under the CPC or Evidence Act, as per the “trappings of a court” test. Third, the 1999 TM Act’s silence on applying CPC rules to appeals, unlike its predecessors, preserves the right to LPAs under the Letters Patent unless expressly barred. Fourth, Section 100-A applies to special statutes only when they explicitly subject appeals to CPC provisions, as in the Indian Succession Act, 1925, but not in the 1999 TM Act. Finally, the court affirmed that Letters Patent remedies remain intact for trademark appeals under Section 91, ensuring an additional layer of judicial scrutiny absent statutory restrictions.
Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.
Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi
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