1.) Recent 505 (b) (2) filings 2.) Delhi High Court case, Wow Momo Foods Private Limited vs. Wow Burger.


Contents

Recent 505 (b) (2) filings

General information

GLP-1 Litigation and the Road Ahead for Independent Pharmacies

Pharmacy groups defend Iowa PBM law amid legal challenge

Intellectual Property

Delhi High Court case, Wow Momo Foods Private Limited vs. Wow Burger.

Recent 505 (b) (2) filings

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 September 2025, 505 (b) (2)/NDA approvals are as follows:

General information

GLP-1 Litigation and the Road Ahead for Independent Pharmacies

The GLP-1 era has moved from innovation to enforcement. Independent pharmacies that once played a critical role in meeting patient demand during shortages now find themselves at the center of a tightening legal vise. Manufacturers are suing, state boards are disciplining, and the FDA has ended its tolerance for shortage-driven compounding, especially where it constitutes “essentially a copy.” News here

Pharmacy groups defend Iowa PBM law amid legal challenge

  • Pharmacy associations are coming to the defense of a controversial Iowa law restricting the business practices of pharmacy benefit managers in a case in front of a federal appeals court.
  • The groups, which represent independent community pharmacies, say that PBM actions targeted by Iowa’s law are driving unaffiliated pharmacies out of business and harming patient access to drugs. Meanwhile, the employer and health plan plaintiffs seeking to overturn the law argue it will significantly raise costs for businesses by upending prescription drug coverage.
News here

Intellectual Property

Delhi High Court case, Wow Momo Foods Private Limited vs. Wow Burger.

Generally, I focus on patent cases that involve inventive steps which are more science-oriented and relatable to the newsletter's audience. Cases involving questions of law are also interesting because they highlight different aspects of patent law across various jurisdictions. However, since I did not find any interesting patent cases before drafting this newsletter, let us examine a trademark case this week. It was decided on 12 September 2025. Background: Wow Momo Foods Private Limited, the Plaintiff, filed a suit against Wow Burger, the Defendants, seeking a permanent injunction to prevent the Defendants from infringing upon the Plaintiff's trademarks. The Plaintiff claimed that the Defendants were using the mark "WOW" / "WOW! BURGER," which was deceptively similar to the Plaintiff's registered trademarks, leading to passing off. The Plaintiff sought an interim injunction pending the resolution of the suit. Plaintiff's Arguments:
  1. The Plaintiff argued that it is a private limited company established in Kolkata and has been using the trademarks "WOW!" / "WOW! MOMO" since 2008.
  2. The Plaintiff asserted that it has built a substantial business with over 600 outlets in more than 30 cities, with a valuation of Rs. 1225 Crores in 2021.
  3. The Plaintiff contended that the mark "WOW!" is the essential and significant feature of all its trademarks, and consumers associate the mark with the Plaintiff alone.
  4. The Plaintiff stated that it has continuous use of the mark "WOW! BURGER" along with other formative marks since 2009, the Plaintiff has garnered goodwill.
  5. The Plaintiff argued that the Defendants were attempting to capitalise on the Plaintiff's goodwill and reputation by using a similar mark.
  6. The Plaintiff pointed out that the Defendants have slavishly copied the dominant/essential feature 'WOW!' for identical goods and services.

Defendant's Arguments: The Defendants did not appear in court to contest the Plaintiff's claims. Since the defendant did not appear in court, no arguments were presented on their behalf.

Court's Analysis and Findings: The Court, presided over by Justice Manmeet Pritam Singh Arora, analysed the arguments and evidence presented by the Plaintiff and made the following key observations and findings:
  1. No Trademark Registration for 'WOW'/'WOW BURGER': The Court noted that the Plaintiff did not have trademark registrations specifically for the marks "WOW!" or "WOW! BURGER".
  2. "WOW" as a Generic and Descriptive Term: The Court emphasised that "WOW" is a common English word used as an exclamation and that any single entity cannot monopolise such generic and descriptive terms. The Court cited several Supreme Court and High Court decisions to support this principle.
  3. Admission of Non-Distinctiveness: The Court highlighted that the Plaintiff itself had previously admitted before the Registrar of Trade Marks that the word "WOW" alone is not distinctive and requires combination with another word to gain distinctiveness.
  4. Secondary Meaning: The Court considered whether the mark "WOW" had acquired secondary meaning due to continuous use, such that it had become uniquely associated with the Plaintiff's products. The Court concluded that the Plaintiff had not provided sufficient evidence to prove that "WOW" had acquired secondary meaning. The court states that the mark has only been in use since 2008, which would not be considered a long period of time.
  5. "WOW! BURGER" Not a Trademark: The Court observed that the Plaintiff had claimed to have a trademark in "WOW! BURGER" and to have been using it since 2009. However, the Court found that the Plaintiff did not have any registration for the said trademark. Additionally, the Plaintiff's own documents revealed that "WOW! BURGER" was last used as a menu item in 2018 and not as a trademark or brand. The court also points out that the Plaintiff currently markets its food item under the name ‘Moburg’ for its burger item.
  6. Comparison of Marks: The court compared the Plaintiff's registered mark 'WOW MOMO' to the Defendant's mark ‘WOW BURGER' and found that, except for the use of the term 'WOW', there was nothing that related them to each other.
 Court's Conclusion and Decision:
  1. Based on its analysis, the Court concluded that the Plaintiff had failed to establish a prima facie case for the grant of an interim injunction. The Court held that the Plaintiff had not demonstrated that "WOW" was a distinctive mark or had acquired secondary meaning. It was also found that the Plaintiff was attempting to monopolise the use of the common dictionary word 'WOW'.
  2. The Court stated, therefore, there was no question of injury and no balance of convenience in favour of the Plaintiff.
  3. Consequently, the Court dismissed the Plaintiff's application for an interim injunction and listed the case for further hearing on 15 January 2026.

Decision here




Location: Mumbai, Maharashtra, India

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