Recent 505 (b) (2) approvals and Trademark decision regarding London Pride by the Supreme Court.

Contents

Recent 505 (b) (2) Approvals

General information

Xspray Pharma's Regulatory Breakthrough: A New Dawn for CML Treatment and Shareholder Value

Tharimmune Reports Pharmacokinetic Simulation Results for TH104 as Prophylaxis Against Respiratory Depression from Fentanyl and Ultrapotent Opioids

Intellectual Property

The Supreme Court of India's judgment in the Pernod Ricard India Private Limited Vs Karanveer Singh Chhabra case:

Recent 505 (b) (2) Approvals We follow 505 (b) (2) approvals every month. Generally, 505(b)(2) NDAs pertain to changes in comparison to previously approved drugs, such as indication, active ingredient, fixed-combination, dosage form, route of administration, dosing regimen, strength, and formulation (not approvable under section 505(j)). For more details on 505(b)(2) FDA approvals, please visit this link. The details of July 2025, 505 (b) (2)/NDA approvals are as follows:

General information

Xspray Pharma's Regulatory Breakthrough: A New Dawn for CML Treatment and Shareholder Value

- Xspray Pharma submitted an NDA for XS003, a nilotinib formulation with reduced dose and side effects via HyNap™ technology. - FDA review for XS003 is expected by early 2026, alongside Dasynoc® approval (PDUFA: Oct 7, 2025) and $255M in Q2 2025 financing. - The $2.7B CML market opportunity and differentiated clinical profile position Xspray for valuation expansion if both products gain approval. News here

Tharimmune Reports Pharmacokinetic Simulation Results for TH104 as Prophylaxis Against Respiratory Depression from Fentanyl and Ultrapotent Opioids

Tharimmune (THAR, Financial) reports positive pharmacokinetic simulation results for TH104, offering potential advantages over naloxone. TH104, a buccal film, shows 24-hour protection against opioid-induced respiratory depression. The FDA has indicated that no additional clinical trials are needed before a 505(b)(2) NDA submission. News here

Intellectual Property

The Supreme Court of India's judgment in the Pernod Ricard India Private Limited Vs Karanveer Singh Chhabra case:

In a quick search this week, I could not find any relevant patent-related cases; therefore, let us read an interesting trademark case this week. This month, on 14 August, the Supreme Court addressed an appeal concerning trademark infringement and passing off in the context of alcoholic beverages (whisky). Pernod Ricard, the maker of "Blenders Pride" and "Imperial Blue," sought an interim injunction against Karanveer Singh Chhabra, who was marketing whisky under the name "London Pride." Pernod Ricard claimed that "London Pride" was deceptively similar to their registered trademarks, infringing on their rights and potentially causing consumer confusion. The Commercial Court and the High Court both denied Pernod Ricard's request for an interim injunction. The Supreme Court upheld the lower courts' decisions, dismissing the appeal. The court analysed the legal principles surrounding trademark protection, deceptive similarity, and the criteria for granting interim injunctions.

Background Facts

• Pernod Ricard, a well-known liquor manufacturer, owns the trademarks "Blenders Pride," "Imperial Blue," and "Seagram's." "Blenders Pride" has been in use since 1973, and "Imperial Blue" since 1997.
• Karanveer Singh Chhabra was marketing whisky under the mark "London Pride."
• Pernod Ricard filed a civil suit seeking a permanent injunction against Chhabra, alleging trademark infringement, passing off, and copyright violation. They also sought an interim injunction.
• The Commercial Court rejected the interim injunction application, and the High Court affirmed this decision.

Appellants’ (Pernod Ricard's) Arguments

Pernod Ricard argued:

• "London Pride" is deceptively similar to their registered trademarks "Blenders Pride," "Imperial Blue," and "Seagram's."
• The respondent dishonestly adopted the trademarks to misappropriate Pernod Ricard's goodwill and reputation.
• The Appellate Court (High Court) failed to apply the correct test for deceptive similarity, dissecting the mark instead of considering it as a whole (violating the anti-dissection rule).
• The respondent's label and packaging constituted a colourable imitation of "Imperial Blue."
• The term 'PRIDE', which is neither generic nor descriptive in the context of alcoholic beverages, forms the essential and dominant part of the appellants' mark.
• The use of 'Seagram's' embossed bottles constitutes an infringement of the appellants' registered word mark.
• They had established a prima facie case of both infringement and passing off.

Respondent’s (Karanveer Singh Chhabra’s) Arguments

• Karanveer Singh Chhabra contended:
• There was no visual, phonetic, or structural similarity between "London Pride" and Pernod Ricard's trademarks.
• The word "Pride" is a generic and laudatory term, commonly used in the industry, and no exclusive right can be claimed over it.
• The labels of "Imperial Blue" and "London Pride" are entirely distinct, with no deceptive similarity.
• The appellants had failed to establish actual damage or the likelihood of irreparable harm.

Key Legal Principles Discussed by the Court The Supreme Court's judgment extensively discussed several key legal principles related to trademark law:

• Deceptive Similarity: The court emphasised that a mark is deceptively similar if it so nearly resembles another mark as to be likely to cause confusion or deception. The test is not exact similarity but whether an average consumer with imperfect recollection would likely be confused.
• Anti-Dissection Rule: Marks must be compared as a whole, without dissecting them into individual components. This rule reflects how consumers perceive trademarks in the real world.
• Dominant Feature Test: While marks must be viewed in their entirety, courts can consider the dominant feature of a mark—the element that is most distinctive, memorable, and likely to influence consumer perception.
• No Exclusive Right Over Common or Descriptive Terms: Generic, descriptive, or laudatory terms cannot be monopolised. Protection does not extend to those elements unless they have acquired a secondary meaning.
• Average Consumer Test and Imperfect Recollection: The assessment of deceptive similarity must be made from the perspective of an average consumer with imperfect recollection, emphasising the overall commercial impression.
• Passing Off: Passing off is a common law remedy to protect the goodwill and reputation of a trader against misrepresentation by another, which causes or is likely to confuse consumers
• Interim Injunctions: The court reiterated the principles governing the grant or refusal of interim injunctions in trademark infringement and passing off actions, including the need to establish a prima facie case, balance of convenience, and potential irreparable injury. Appellate courts should be circumspect in interfering with discretionary orders of lower courts unless the discretion has been exercised arbitrarily or perversely.

Court's Analysis and Findings The Supreme Court carefully analysed the competing marks, the arguments of both parties, and the relevant legal principles. The court ultimately agreed with the lower courts that Pernod Ricard had not demonstrated a case for interim relief. Key findings included:

• No Deceptive Similarity: When assessed in their entirety, the rival marks ("Blenders Pride," "Imperial Blue," and "London Pride") did not exhibit such visual, phonetic, or structural similarity as to give rise to a real likelihood of confusion.
• Distinct Trade Dress: The overall trade dress, distinctive components, and market presentation of the respondent's product served to distinguish it from that of the appellants sufficiently.
• "Pride" is Publici Juris: The court agreed that the term "Pride" is a commonly used, laudatory term in the liquor industry, and no exclusive rights could be claimed over it.

  (In trademark law, "publici juris" means a term or mark has become so common in the relevant trade that it no longer functions as a unique identifier for a specific company's goods or services.) 

• Discerning Consumers: The products in question were premium and ultra-premium whiskies, targeted at a discerning consumer base who are likely to exercise greater care in their purchase decisions.
• No Embossing: The court upheld the lower court's rejection of the allegation regarding the embossing of “Seagram Quality" on the respondent's bottle.
• No Sustainable Legal Theory: The appellants' attempt to combine elements from two distinct marks to challenge the respondent's mark constituted a hybrid and untenable pleading.

The Judgment Based on these findings, the Supreme Court dismissed the appeal, directing the Commercial Court to proceed with the trial and dispose of the suit on its merits. The court clarified that the present judgment was confined to the adjudication of the application for an interim injunction and should not influence the outcome of the suit. Significance

• The Pernod Ricard case reaffirms several key principles of trademark law in India. The judgment emphasises the importance of considering the overall impression of a mark rather than analysing it into isolated parts.
• It also clarifies that generic or descriptive terms cannot be monopolised and that the perspective of an average consumer is essential in evaluating deceptive similarity. Additionally, the judgment highlights the limited scope for appellate interference with discretionary orders of trial courts in such cases.
• The case also references the recent development of Trademark Jurisprudence, especially regarding the post-sale confusion doctrine. The court stated that although the doctrine of post-sale confusion does not apply to the facts of this case, specific paragraphs from the judgment of the UK Supreme Court remain relevant, particularly to clarify the broader principles concerning mark similarity, likelihood of confusion, and the limits of appellate review of trial court decisions.
• The two-Judge Bench comprising Justice J.B. Pardiwala and Justice R. Mahadevan held that the grant of an interim injunction in trademark cases requires the court to consider multiple interconnected factors: prima facie case, likelihood of confusion, relative merits of the parties’ claims, balance of convenience, risk of irreparable harm, and the public interest. These considerations operate cumulatively, and the absence of any one of these may be sufficient grounds to deny interim relief.

Decision here