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Wednesday, September 3, 2025
Mangalam Organics Ltd Vs N Ranga Rao And Sons Pvt Ltd
Renaissance Hotel Holdings Inc. Vs. B. Vijaya Sai
Section 29 (4) of Trademarks Act 1999 applies only to dissimilar goods and not relevant to identical services
Introduction
In the realm of intellectual property, where brands battle for supremacy, Renaissance Hotel Holdings Inc. v. B. Vijaya Sai and Others emerges as a landmark showdown before the Supreme Court of India. Decided on January 19, 2022, this case pits a global hospitality giant against a local hotel operator over the use of the trademark "RENAISSANCE." The dispute encapsulates the tension between statutory trademark rights and claims of honest use, weaving a narrative of legal precision, commercial identity, and judicial interpretation. The Supreme Court’s ruling not only resolves a contentious infringement claim but also illuminates the contours of the Trade Marks Act, 1999, offering a masterclass in statutory application and trademark protection in India’s evolving commercial landscape.
Detailed Factual Background
Renaissance Hotel Holdings Inc., a Delaware-based corporation, stands as a titan in the global hospitality industry, operating under the trademark "RENAISSANCE" since 1981. This mark, registered in India under Class 16 (Registration No. 610567) for printed materials and Class 42 (Registration No. 1241271) for hotel and related services, has adorned its hotels, spas, and merchandise worldwide, including establishments in Mumbai and Goa since 1990. With an annual advertising budget of US$14 million and a domain name (www.renaissancehotels.com), the appellant asserts a formidable trans-border reputation, claiming "RENAISSANCE" as a distinctive symbol of its luxury hospitality empire.
The respondents, led by B. Vijaya Sai, operate two modest hotels in Bangalore (Kadugodi) and Puttaparthi under the name "SAI RENAISSANCE." Devotees of Sri Shirdi Sai Baba and Sri Puttaparthi Sai Baba, they adopted this name in 2001, believing the latter to be a reincarnation of the former—thus, "renaissance" symbolizing rebirth. Their hotels cater primarily to Sai Baba devotees, offering vegetarian fare sans alcohol, a stark contrast to the appellant’s five-star offerings. The respondents’ use of "SAI RENAISSANCE" came to the appellant’s attention in 2008 via the website www.sairenaissance.com, prompting an investigation that revealed alleged copying of signage, business cards, and the "RENAISSANCE" mark, suggesting an unauthorized affiliation.
Detailed Procedural Background
The appellant initiated legal action in 2009, filing O.S. No. 3 of 2009 before the Principal District Judge, Bangalore Rural District, seeking a permanent injunction, delivery of infringing materials, and damages of Rs. 3,50,000. On June 21, 2012, the trial court partly decreed the suit, granting an injunction against the respondents’ use of "SAI RENAISSANCE" or any mark incorporating "RENAISSANCE" in Classes 16 and 42, but denying damages and delivery-up claims. The respondents appealed to the High Court of Karnataka in Regular First Appeal No. 1462 of 2012. On April 12, 2019, a Single Judge reversed the trial court’s decree, dismissing the suit on grounds of no trans-border reputation, honest use by the respondents, and no likelihood of confusion due to differing customer bases. Aggrieved, the appellant escalated the matter to the Supreme Court via Civil Appeal No. 404 of 2022, arising from SLP(C) No. 21428 of 2019, culminating in the January 19, 2022, judgment by a three-judge bench.
Issues Involved in the Case
The case revolves around several critical issues. First, whether the respondents’ use of "SAI RENAISSANCE" infringes the appellant’s registered trademark "RENAISSANCE" under Sections 29(2)(c), 29(3), 29(5), or 29(9) of the Trade Marks Act, 1999. Second, whether the High Court erred in applying Section 29(4) (for dissimilar goods/services) instead of provisions for identical marks and services. Third, whether the respondents’ use qualifies as honest concurrent use under Section 30, shielding them from infringement. Fourth, whether the appellant’s delay in filing the suit constitutes acquiescence, barring relief. Finally, whether "RENAISSANCE"’s generic nature or the respondents’ addition of "SAI" negates infringement.
Detailed Submission of Parties
The appellant, represented by Senior Counsel K.V. Viswanathan, argued that the respondents’ use of "SAI RENAISSANCE" infringed its registered mark under multiple provisions of Section 29. Under Section 29(2)(c), the identical mark and services (hotels) triggered a statutory presumption of confusion per Section 29(3). Section 29(5) was invoked as the respondents used "RENAISSANCE" in their trade name, a direct infringement. Section 29(9) applied due to phonetic and visual similarity. Viswanathan contended that the High Court misapplied Section 29(4), which requires reputation and detriment only for dissimilar goods, irrelevant here given the identical services. Citing precedents, he argued that in infringement cases, confusion need not be proven when marks are identical, and the prefix "SAI" did not mitigate the violation.
The respondents, represented by B.C. Sitarama Rao, countered that the suit was untenable due to delay and the appellant’s lack of legal personhood. They portrayed "RENAISSANCE" as a generic dictionary term, incapable of exclusive appropriation, and justified "SAI RENAISSANCE" as an honest tribute to Sai Baba’s reincarnation, used since 2001 without appellant awareness until 2009. They highlighted distinct customer bases—devotees versus luxury travelers—and differing services (vegetarian versus full-service), negating confusion. Claiming honest concurrent use under Section 12 and protection under Section 30, they relied on precedents to argue that their use neither exploited nor harmed the appellant’s mark.
Detailed Discussion on Judgments Cited by Parties and Their Context
The appellant cited Laxmikant V. Patel v. Chetanbhai Shah [(2002) 3 SCC 65], where the Supreme Court upheld an injunction against a similar mark in the same trade, emphasizing protection of goodwill. In Ruston & Hornsby Limited v. Zamindara Engineering Co. [(1969) 2 SCC 727], the Court ruled that in infringement cases, identical mark use warrants an injunction without proving confusion, distinguishing it from passing off. Kaviraj Pandit Durga Dutt Sharma v. Navaratna Pharmaceutical Laboratories [[1965] 1 SCR 737] reinforced that close similarity in marks negates the need for further evidence in infringement actions. Midas Hygiene Industries (P) Limited v. Sudhir Bhatia [(2004) 3 SCC 90] underscored that injunctions typically follow infringement, irrespective of delay unless adoption is dishonest.
The respondents relied on Khoday Distilleries Limited v. Scotch Whisky Association [(2008) 10 SCC 723], which addressed acquiescence in rectification proceedings, not infringement, rendering it inapposite. Nandhini Deluxe v. Karnataka Cooperative Milk Producers Federation Limited [(2018) 9 SCC 183] distinguished dissimilar marks and goods (milk versus restaurants), unlike the identical services here. Corn Products Refining Co. v. Shangrila Food Products Limited [[1960] 1 SCR 968] and Neon Laboratories Limited v. Medical Technologies Limited [(2016) 2 SCC 672] dealt with distinct contexts (opposition and interim injunctions), offering limited relevance.
Detailed Reasoning and Analysis of Judge
Justice B.R. Gavai, authoring the Supreme Court’s opinion, meticulously dissected the High Court’s errors. The Court traced the evolution of trademark law from the 1940 Act to the 1999 Act, emphasizing the latter’s intent to harmonize global trade practices and prohibit unauthorized use of registered marks in trade names. Under Section 29(2)(c), the identical mark "RENAISSANCE" and identical services (hotels) triggered a presumption of confusion under Section 29(3), rendering further proof unnecessary. Section 29(5) applied as "RENAISSANCE" formed part of the respondents’ trade name, and Section 29(9) covered phonetic and visual similarity, amplifying the infringement.
The High Court’s reliance on Section 29(4) was deemed a misstep, as it pertains to dissimilar goods/services and requires reputation and detriment—irrelevant here given the identical services. The Court criticized the High Court’s focus on customer classes and confusion, citing Ruston & Hornsby to affirm that infringement hinges on mark use, not deception likelihood. The respondents’ Section 30 defense failed, as honest use required both fair practice and no detriment, conditions unmet given the unauthorized adoption. Textual and contextual interpretation, per Reserve Bank of India v. Peerless [(1987) 1 SCC 424], and holistic statutory reading, per Balasinor Nagrik Cooperative Bank [(1987) 1 SCC 606], underscored the High Court’s fragmented approach, ignoring legislative intent.
Final Decision
The Supreme Court allowed the appeal, quashing the High Court’s judgment of April 12, 2019, and reinstating the trial court’s decree of June 21, 2012. The respondents were restrained from using "SAI RENAISSANCE" or any mark incorporating "RENAISSANCE" in Classes 16 and 42, affirming the appellant’s exclusive rights.
Law Settled in This Case
The judgment clarifies that under Section 29(2)(c) and (3), identical marks and goods/services presume confusion, mandating injunctions without further evidence. Section 29(5) prohibits use of a registered mark in trade names, and Section 29(9) extends protection to phonetic/visual similarity. Section 29(4) applies only to dissimilar goods, requiring reputation and detriment, not relevant to identical services. Section 30’s honest use defense demands both fair practice and no detriment, a conjunctive test. The ruling reinforces statutory primacy in infringement actions, distinguishing them from passing off’s common law roots.
Case Title: Renaissance Hotel Holdings Inc. Vs. B. Vijaya Sai and OthersDate of Order: January 19, 2022
Case No.: Civil Appeal No. 404 of 2022 [Arising out of SLP(C) No. 21428 of 2019]
Name of Court: Supreme Court of India
Name of Judges: Justice L. Nageswara Rao, Justice B.R. Gavai, Justice B.V. Nagarathna
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
Tuesday, September 2, 2025
Maryam Bee Versus Shuibham Jain and Ors
Impleadment of Third Parties in Specific Performance Suits
The case titled Maryam Bee versus Shuibham Jain and Ors., with Case Number FAO(OS) (COMM) 199/2024 : 2025:DHC:7318-DB High Court of Delhi at New Delhi on 26 August 2025 by Hon'ble Mr. Justice Anil Ksheterpal and Hon'ble Mr. Justice Harish Vaidyanathan Shankar.
Detailed Summary of the Case
Facts
The underlying dispute originates from a commercial suit for specific performance of an Agreement to Sell (ATS) dated 27 December 2022, concerning a property admeasuring 82.5 square yards, bearing Municipal No. 1806 (Mezzanine Floor to Second Floor with roof rights), Ward No. 4, Chandni Chowk, Dariba Kalan, New Delhi, 110006 (referred to as the "suit property"). The plaintiffs in the original suit (Respondent Nos. 1 to 3 herein, namely Shuibham Jain and others) filed CS (Comm) No. 590/2023 against the appellant, Maryam Bee, seeking specific performance of the ATS. According to the plaintiffs, the ATS was executed for a total sale consideration of Rs. 7,00,00,000 (Rupees Seven Crores Only), and they had made partial payments, but the appellant failed to execute the sale deed in their favor, necessitating the suit.
The appellant (Maryam Bee), however, contended that the total sale consideration was actually Rs. 9,00,00,000 (Rupees Nine Crores Only), as an additional ATS for Rs. 2,00,00,000 (Rupees Two Crores Only) was executed on the same date (27 December 2022). She claimed that the plaintiffs' failure to pay the full amount prevented her from executing the sale deed.
During the pendency of this suit, Respondent No. 4 (the brother-in-law of the appellant) filed an application under Order I Rule 10 of the Code of Civil Procedure, 1908 (CPC), being I.A. No. 23592/2023, seeking to be impleaded as a party to the suit. Respondent No. 4 claimed to be a co-owner of the suit property to the extent of 50%, along with his brother Abdul Malik (the appellant's husband). He asserted that the appellant's ownership claim was based on two Gift Deeds dated 23 August 1981 executed by Late Smt. Zubeda Khatoon and Late Sh. Sheikh Abdul Sattar Sahib (the appellant's mother-in-law and father-in-law, respectively). In contrast, Respondent No. 4 argued that the property was co-shared between him and Abdul Malik.
On 7 May 2024, the learned Single Judge of the Delhi High Court allowed this impleadment application, observing that Respondent No. 4 appeared to have some interest in the property, and excluding him could lead to multiplicity of litigation and conflicting rulings. Aggrieved by this order (specifically the portion allowing impleadment), the appellant filed the present appeal under Order XLIII Rule 1 CPC read with Section 10 of the Delhi High Court Act, 1966 (DHC Act). The appeal was reserved on 6 August 2025 and pronounced on 26 August 2025.
Notably, the plaintiffs (Respondent Nos. 1 to 3) opposed the impleadment in the original application and supported the appellant's claim of sole ownership in the appeal. They had separately challenged another portion of the impugned order (regarding a deposit direction) in FAO(OS)(COMM) 167/2024, which was dismissed on 6 August 2024, rendering the impleadment final as against them.
Dispute
The primary dispute in this appeal revolves around the maintainability and propriety of impleading Respondent No. 4 as a defendant in a suit for specific performance of the ATS. The appellant argued that:
- A third party or stranger to the contract cannot be impleaded in a specific performance suit merely to avoid multiplicity of suits, as it would impermissibly enlarge the scope of the suit from enforcing a contract to determining title and possession.
- Respondent Nos. 1 to 3, as dominus litis (masters of the suit), opposed the impleadment, and their stance should be respected.
- The impleadment converts the suit into one for title, which is not permissible.
In opposition, Respondent No. 4 contended:
- The impugned order is not appealable under Order XLIII Rule 1 CPC, and Section 10 of the DHC Act cannot be invoked due to Section 13(2) of the Commercial Courts Act, 2015 (CCA). He relied on cases like Kandla Export Corpn. v. OCI Corpn. (2018) 14 SCC 715, M.V. Polaris Galaxy v. Banque Cantonale De Geneve (2024) 5 SCC 750, Trex India Pvt. Ltd. v. CDE Asia Limited 2023 SCC OnLine Del 2388, and Alka Traders v. Cosco India Ltd. 2020 SCC OnLine Del 3694.
- Impleadment in specific performance suits depends on facts and circumstances, and no rigid rule prohibits it. He cited Sumtibai v. Paras Finance Co. (2007) 10 SCC 82 and Rajesh Kumar Arora v. Smt. Shila 2016 SCC OnLine Del 1277.
- The impugned order had attained finality against the plaintiffs, as their separate appeal was dismissed.
A preliminary objection was raised on the appeal's maintainability under the CCA and CPC provisions.
Reasoning
The Division Bench of the Delhi High Court, comprising Justices Anil Ksheterpal and Harish Vaidyanathan Shankar, first addressed the preliminary objection on maintainability. They distinguished the relied-upon cases (Kandla Export, M.V. Polaris Galaxy, Trex India, and Alka Traders), noting that those dealt with arbitration appeals, admiralty suits, rejection of plaints, or ex parte proceedings, which were inapplicable here. Instead, relying on Gurmauj Saran Baluja v. Mrs. Joyce C. Salim 1988 SCC OnLine Del 295 and Supreme Court precedents like Shah Babulal Khimji v. Jayaben D. Kania (1981) 4 SCC 8 and Jugal Kishore Paliwal v. S. Sat Jit Singh (1984) 1 SCC 358, the Bench held that the impugned order qualifies as a "judgment" under Section 10(1) of the DHC Act. It affects substantive rights (e.g., enlarging the suit's scope and forcing a de novo trial), making the appeal maintainable even if not expressly listed under Order XLIII CPC.
On merits, the Bench analyzed Order I Rule 10(2) CPC, which allows impleadment only if a party's presence is necessary for complete adjudication of the issues involved. They emphasized that suits for specific performance are contract-centric, adjudicating enforceability between contracting parties, and result in judgments in personam (not in rem). Citing the Supreme Court's seminal ruling in Kasturi v. Iyyamperumal (2005) 6 SCC 733, the Bench reiterated that impleading a third party claiming adverse title enlarges the suit into one for title/possession, which is impermissible. The two tests from Kasturi for a "necessary party" were applied: (i) right to relief against them in the controversy, and (ii) inability to pass an effective decree without them. A "proper party" requires their presence for effective adjudication.
The Bench distinguished Sumtibai (supra), where impleadment was allowed due to prima facie semblance of title via a registered sale deed involving the defendant's legal representatives (LRs), noting it was fact-specific and not a blanket exception. Similarly, Rajesh Kumar Arora was deemed inapplicable, as it involved multiple applications, pending inter se suits among parties, and the appeal on impleadment was dismissed without merit analysis.
The Bench concluded that Respondent No. 4, as a stranger to the ATS, failed the tests under Order I Rule 10 CPC. His impleadment would introduce collateral title issues, contrary to precedents like Anil Kumar Singh v. Shivnath Mishra (1995) 3 SCC 147, Vijay Pratap v. Sambhu Saran Sinha (1996) 10 SCC 53, and Bharat Karsondas Thakkar v. Kiran Construction Company (2008) 13 SCC 658. The learned Single Judge's reasoning (potential interest and multiplicity avoidance) was flawed, as it overlooked the suit's limited scope. Even assuming Respondent No. 4's prima facie interest, it did not make him necessary or proper for adjudicating the contract's enforceability.
Decision
The appeal was allowed, and the impugned order dated 7 May 2024 (allowing I.A. No. 23592/2023) was set aside, thereby reversing the impleadment of Respondent No. 4 as Defendant No. 2 in CS (Comm) No. 590/2023. Respondent No. 4 was granted liberty to pursue his claims via an independent suit before a competent court. The appeal and pending applications were disposed of accordingly, with no other submissions noted from the parties.
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
Suggested Title for This Article
": Delhi High Court Sets Aside Order Allowing Co-Ownership Claim in Contract Dispute"
Karim Hotels Pvt. Ltd. Vs. AL Kareem
Anugraha Castings & Anr. Vs. Anugraha Valve Castings Limited
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
Monday, September 1, 2025
Amgen Inc vs The Assistant Controller of Patents
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 Dispute:
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:
- Section 3(d): Did Amgen’s method for making the dry mix just reuse an old, known process without adding anything new?
- Section 3(e): Was the mix just a simple blend of known ingredients that don’t work together in a special way to create a better result?
- Section 2(1)(ja): Would an average expert in medicine-making (called a person skilled in the art, or PSITA) find this mix obvious by looking at old documents (prior arts D1-D5)?
- Section 10(4): Did Amgen explain their idea fully and clearly in their application, especially since it could apply to 52 variations, but they only tested one?
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 Court’s Careful Reasoning:
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.
1. Rejection under Section 3(d): Mere Use of a Known substabce
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.
2. Rejection under Section 3(e): Mere Admixture Without Synergy
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:
- Table 39: Showed that using at least 1.5% sucrose (a stabilizer) reduced chemical breakdown at high temperatures, while less sucrose led to more spoiling. High amounts of another additive (mannitol) alone didn’t help.
- Tables 40 and 41: Showed that adding polysorbate-20 (a clumping preventer) kept clumping under 0.1%, compared to much higher clumping without it. Tests used different medicine amounts (0.5 mg/mL and 0.3 mg/mL), but this didn’t matter for proving the additive’s teamwork.
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.
3. Lack of Inventive Step under Section 2(1)(ja)
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:
- D1-D3: D1 (Amgen’s work on a different binder) didn’t mention this medicine or drying. D2 (Amgen’s modified proteins) discussed combining parts for longer life but not drying. D3 focused on drying to increase concentration, not stability, so a PSITA wouldn’t apply it here. These didn’t make the mix obvious alone or together.
- D4: Amgen’s own document on the same medicine (including the exact structure, SEQ ID 1017) for ITP treatment. It mentioned dry forms and additives like sucrose but vaguely, without specific drying steps, additive types, or amounts. A PSITA couldn’t reach Amgen’s mix from D4 or D1-D4.
- D5: Described drying a different substance (IL-12, for cancer) with similar additives: 2% sucrose, 4.15% mannitol, 0.02% polysorbate-20, and a buffer at pH 5.6. The Controller suggested combining D4 and D5, but the court disagreed. The substances were different (IL-12 is a paired helper for cancer; romiplostim is a fused piece for platelets). D4 didn’t suggest looking at D5. Scientific literature showed 6-16 options for each additive type, making selection a complex puzzle with thousands of combinations. No standard recipe exists, and a common clumping preventer (polysorbate-80) differed from Amgen’s choice (polysorbate-20).
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.
4. Insufficiency under Section 10(4)
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 Final Decision:
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.
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Species patents following a Markush patent must demonstrate a distinct inventive step Introduction The AstraZeneca AB & Anr. Vs. Intas ...
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किस्सा आसान हो जाऊँ - हर सच से मुँह मोड़कर नादान हो जाऊँ, इतना भी अच्छा नहीं अंजान हो जाऊँ। आईना सच हीं दिखलाए ये ज़रूरी नहीं, बुरा हूँ नहीं इतना कि उससे अंजान हो जाऊँ। हर वा...11 hours ago
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IPL:Spice In, Nationality Out - I was sitting in my office. It was a hot afternoon. The fan was running slowly and making strange sounds like an old typewriter. Files were lying on my d...4 months ago
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