Recent ANDA approvals and Trademark Case: Chemco Plastic Industries Vs Chemco Plast

Contents

Recent ANDA approvals

General information

Eli Lilly Invests $6 Billion as Active Pharmaceutical Ingredient (API) Production Expands in Huntsville, Alabama

China’s Fosun Pharma Soars After Pfizer Snaps Up Global Rights to New Weight-Loss Drug

Intellectual Property

Trademark Case: Chemco Plastic Industries Vs Chemco Plast

Recent ANDA approvals

We follow ANDA approvals. In November 2025, the USFDA issued a total of 91 ANDA approvals, of which 25 were tentative. A tentative approval is a formal notification from the USFDA indicating that a generic drug application has met all scientific and regulatory requirements for safety, efficacy, and quality, but cannot be granted final marketing approval due to unexpired patents or market exclusivities held by the original brand-name drug.

The companies that could seek more than two ANDA approvals (including tentative ones) in November were as follows.

Some of our other comments about a few ANDA approvals sought by Indian companies are listed below.

General information

Eli Lilly Invests $6 Billion as Active Pharmaceutical Ingredient (API) Production Expands in Huntsville, Alabama

1. Eli Lilly announces a $6 billion investment in a cutting-edge pharmaceutical manufacturing plant in Huntsville, Alabama.
2. The plant will produce orforglipron, the company’s first oral GLP-1 receptor agonist.
3. Huntsville was chosen from over 300 applicants, thanks to its strong bioscience sector, skilled workforce, and proximity to HudsonAlpha Institute for Biotechnology.
4. The project will create 450 high-value jobs, with an additional 3,000 construction positions.
5. This development marks a significant step in Eli Lilly’s broader $50 billion investment in U.S. manufacturing.

News here

China’s Fosun Pharma Soars After Pfizer Snaps Up Global Rights to New Weight-Loss Drug

Shares in Shanghai Fosun Pharmaceutical surged as much as 6.7 per cent in Hong Kong today after the Chinese pharmaceutical giant said it has granted US drugmaker Pfizer the global commercialisation rights to a new insulin-regulating, weight-loss drug developed by one of its subsidiaries in a deal worth as much as USD2 billion. News here

Intellectual Property

Trademark Case: Chemco Plastic Industries Vs Chemco Plast

This write-up outlines a legal dispute between Chemco Plastic Industries Private Limited (Plaintiff) and Chemco Plast (Defendant) concerning trademark infringement and passing off involving the mark "CHEMCO." Passing off is a common law that protects a business's goodwill and reputation from misrepresentation. It occurs when a trader misrepresents their goods or services as being those of another trader, typically by using a similar brand name, logo, or get-up. Background of this case: The Plaintiff claims to be the flagship company of the "CHEMCO" group, manufacturing and trading a wide range of plastic goods under the "CHEMCO" trademark since 1973 through its predecessor. They hold multiple trademark registrations for "CHEMCO" and its logo in various classes, with user claims dating back to 1973 and 1996 for the mark and logo, respectively. The Defendant, a registered partnership firm, also manufactures similar plastic articles and claims to have used "CHEMCO" as part of its trading name ("CHEMCO PLAST") since 1977 through its predecessor, Chemco Industries. Plaintiff's Arguments: The Plaintiff alleges that the Defendant's use of "CHEMCO" (as a mark, trading name, and domain name) constitutes infringement of its registered trademarks and passing off. They assert that their goods and the Defendant's goods are similar, targeting the same customers, leading to confusion. The Plaintiff also contends that "CHEMCO" is a "well-known mark," making infringement applicable even for dissimilar goods. They argue that the Defendant's adoption and use of the mark is dishonest and fraudulent. Defendant's Arguments: The Defendant denies the Plaintiff's claim of prior user dating back to 1973, stating that the Plaintiff's initial company was incorporated in 1996 under a different name. They assert continuous and open use of "CHEMCO PLAST" since 1977. The Defendant argues there is no evidence of assignment of the "CHEMCO" mark from the Plaintiff's alleged predecessor to the Plaintiff. They claim the Plaintiff was aware of their use for many years due to common business interactions and trade association membership, implying delay and acquiescence. The Defendant also distinguishes their goods (B2B, bulk/made-to-order) from the Plaintiff's (B2C) and claims they use "CHEMCO" only as a trading name, not as a mark on goods, therefore falling under a different section of the Trade Marks Act or making passing off inapplicable. They maintain their use was honest. Regarding delay, the Plaintiff stated they took action (cease and desist, criminal complaint) upon becoming aware in 2015, and mere delay does not excuse dishonest infringement. Court's Consideration: The court examined the claims of prior user from both sides. It found that the Plaintiff's claim of an unbroken chain of user from 1973 through its predecessor was not clearly established, as the Plaintiff's initial company incorporation and the continued existence of the alleged predecessor firm created a "snapped" link. The Plaintiff failed to provide sufficient documentary evidence for the assignment of the mark. However, despite the Defendant's claim of using "CHEMCO" only as a trading name, the court found prima facie evidence (from Defendant's abandoned trademark applications and website) that the Defendant had used or attempted to use "CHEMCO" as a mark in relation to its goods. This led the court to believe that the Plaintiff had made out a prima facie case for trademark infringement of its registered mark. Regarding passing off, the court found it prima facie unsustainable because, at the time the Defendant commenced its individual use (around 1999), the Plaintiff had not established a "formidable goodwill and reputation" sufficient to demonstrate misrepresentation. On the defence of delay and acquiescence, the court noted the significant time lag about 18 years between the Defendant's individual use (1999) and the Plaintiff's actions (2015). Considering the similar start of individual use and the Plaintiff's possible awareness through various interactions, the court found that the Defendant's user was not "dishonest" or "clandestine." Order: Considering the serious factual disputes regarding prior user and the aspects of delay and acquiescence, the court partially allowed the interim application. Bombay High Court bars Chemco Plast from infringing the Plaintiff's registered trademarks by using "CHEMCO" or "CHEMCO PLAST" or any deceptively similar mark as a trademark in relation to impugned goods such as plastic bottles, caps, and other plastic packing materials or similar goods/services.

All other prayers, including restraining the Defendant from using "CHEMCO" as a trading name or domain name, and the action for passing off, were rejected. The execution of the order was stayed for six weeks. Decision here