List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic and Trademark case for J&J's ORS-L brand (Delhi HC decision)

 Contents

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

General information

Unicycive Therapeutics, Inc. Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology

Weak regulation causing deaths due to contaminated medicines, WHO says

Intellectual Property

Delhi HC Trademark decision registered marks for ORS-L and ORSL

List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic

The FDA maintains a list of approved new drug applications (NDAs) that are no longer under patent or exclusivity and for which the FDA has not approved an abbreviated new drug application (ANDA) referencing that NDA. The list is updated every six months (in June and December) to enhance transparency and promote the development and submission of ANDAs in markets with limited competition. The June list was published recently and can be found here. Some oral dosage formulations for which the FDA has not approved an ANDA are listed below.

General information

Unicycive Therapeutics, Inc. Announces the Publication of Oxylanthanum Carbonate Pivotal Trial Data in Clinical Journal of the American Society of Nephrology

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035. News here

Weak regulation causing deaths due to contaminated medicines, WHO says

The World Health Organization said on Thursday systemic weaknesses in the oversight of the global pharmaceutical supply chain have resulted in medicines formulated with poisonous chemicals claiming lives and compromising the health of patients, mainly children. In a report, jointly released with the United Nations Office on Drugs and Crime, the WHO said there have been more than 300 deaths in Africa, Asia and the Pacific since 2022 linked to syrups containing industrial-grade chemicals such as diethylene glycol and ethylene glycol.

News here

Intellectual Property

Delhi HC Trademark decision registered marks for ORS-L and ORSL

This week, let's discuss a Trademark case. This is a summary of a judgment from the Delhi High Court in a case between Johnson & Johnson Pte. Ltd. (the plaintiff J&J) and Mr. Abbireddi Satish Kumar & Ors (the defendants-Abbireddy). The case involves trademark infringement and passing off, where Johnson & Johnson claims that the defendants (Abbireddy) are using marks and trade dresses similar to their registered marks for ORS-L and ORSL (Oral Rehydration Salts). The court rules in favour of Johnson & Johnson, granting a permanent injunction against the defendants (Abbireddy) and awarding damages. Background Johnson & Johnson filed the suit under Section 134(1) of the Trade Marks Act, 1999, claiming that the defendants' (Abbireddy’s) marks, particularly "ORSI," were deceptively similar to their registered trademarks. The plaintiff (Johnson & Johnson) asserted that they had been using the ORS-L brand since 2003 and had acquired rights to the marks through an assignment deed with Jagdale Industries Limited. The defendants (Abbireddy) were involved in the business of energy and refreshment drinks. Defendant No. 1, trading as M/s Sree International India, and Defendants Nos. 2 to 5, partners of M/s Pure Tropic, were accused of manufacturing and marketing products with the impugned marks. Plaintiff's Arguments Johnson & Johnson argued that the defendants had copied their distinctive packaging, style of writing, color combination, and overall trade dress. They emphasised the considerable revenue generated from ORSL products and the extensive advertising investments made to promote the marks. The plaintiff also highlighted that the defendant's (Abbireddy) mark was virtually identical to their mark and that Abbireddy had sought to confuse the consumer by using a similar font. Defendant's Arguments The defendants (Abbireddy) raised several objections, including jurisdictional challenges and assertions that the suit was not in accordance with the Code of Civil Procedure (CPC) and the Trade Marks Act. They argued that they were only service providers and that they had not been properly served with the Cease-and-Desist notice. The defendants also claimed that M/s Pure Tropic only provided mixing and blending services and had no involvement in the trademarks or trade dress.

Court's Analysis The Court considered the arguments and noted that the defendants (Abbireddy) had failed to file written statements. It observed that the averments made in the plaint, substantiated by documentary evidence, stood admitted. The Court rejected the defendant's jurisdictional challenge, referring to a prior judgment in the matter. The Court examined the marks and packaging of both parties and concluded that the defendants (Abbireddy) had attempted to come as close as possible to the plaintiff's (J&J’s) marks. It highlighted that the overall impression created by the marks and trade dress was deceptively similar and likely to cause confusion among consumers. Local Commissioner Reports The Court relied on the reports of Local Commissioners who had visited the defendant's (Abbireddy’s) premises and found substantial quantities of infringing goods. These reports provided evidence of the defendant's (Abbireddy’s) continued manufacturing and distribution of products bearing the infringing marks, even after the injunction order. Culpability of Defendants The Court found Defendant Nos. 2 to 5 (M/s Pure Tropic) culpable despite their argument of being mere service providers. The Court found that they had knowledge of the proceedings and the injunction order and continued to manufacture the goods with the infringing marks. Defendant No. 6 was also found liable based on the business activity and the possession of infringing goods. Defendant Nos. 7 and 8, being distributors, were also held responsible. Defendant No. 1, being the primary infringer and proprietor, was deemed the most liable. Damages and Costs The Court noted the blatant infringement and passing off by the defendant (Abbireddy). It considered the number of infringing products found at the defendants' premises and took an average price of Rs. 12/- per piece to calculate the damages. It granted compensatory damages of Rs. 52,56,864/- against Defendant No. 1. Additionally, it awarded punitive damages of Rs. 50,00,000/- against Defendant No. 1 for violating the injunction order. Damages were also awarded to be paid by Defendant Nos. 2 to 8. Judgment

1. The Delhi High Court ruled in favour of Johnson & Johnson. It issued a permanent and mandatory injunction against the defendants (Abbireddy), prohibiting them from using the infringing marks and trade dress. The Court also awarded damages to the plaintiff (J &J) and ordered that the actual litigation costs be recovered from Defendant No. 1.
2. In short, the Court remarked, the present is a case of blatant infringement and passing off,” and awarded cumulative damages in favour of Johnson & Johnson to the tune of Rs 1,21,56,864.
3. This case clearly illustrates the Court's dedication to safeguarding trademark rights and preventing infringement and passing off. The court determined that even actions by individuals claiming to be service providers can be liable for producing goods with infringing marks.

Decision here