This past August, Hetero filed one truly odd patent infringement case. I have read close to 10,000 court cases surfacing in the PIV Market, and the Hetero case takes the cake.*

Lose Round 1…

Back in 2011, several ANDA applicants filed over Nuedexta®(dextromethorphan and quinidine) Capsules which led to several PIV cases. These resolved in the favor of the brand company Otsuka. The rulings upheld the last-patent-to-expire 7,659,282.

Afterwards, Hetero submitted its ANDA with a PIV Notice. Otsuka did not file a PIV case, most likely due to prior favorable outcomes. Also, the ‘282 patent expires August 13, 2026.

FDA approved the Hetero application August 28, 2024. Nine months later, on May 22, 2025, Hetero’s lawyer notified Otsuka, “Hey, we are going to launch our product.” Otsuka responded with a lawsuit and a request for a preliminary injunction. Hetero raised a variety of defenses and arguments, some of which the prior ANDA filers had raised.

However, the Delaware District Court did not buy any of its arguments and granted Otsuka its preliminary injunction, preventing Hetero from launching its product until the expiration of the patent. It also decided that Otsuka did not need to purchase a bond to cover Hetero losses in case Otsuka ended up losing its case.

Lose Round 2…

Hetero appealed this decision and lost. On July 1, 2026, the Court of Appeals for the Federal Circuit agreed that the preliminary injunction was appropriate. In other words, it accepted Otsuka’s claims construction and concluded that Otsuka was likely to win the underlying case (the substantive part). However, it concluded that the District Court should have required Otsuka to post a bond and sent the case back to Delaware for this consideration (the procedural part).

Then File a Lawsuit…

Hetero did not take the loss, instead filing its lawsuit on August 10, three days before the patent expired. The case lays out what appears to be the very same arguments it raised before and that were also somewhat considered in the litigation years before. It claims substantial monetary damages because it could not launch its product.

As its Complaint states, “Hetero has suffered an accrued and accruing monetary injury from its exclusion from the market during the injunction period, and resolution of validity, enforceability, and infringement bears directly on whether Hetero was wrongfully enjoined and may recover damages caused by that injunction…” (paragraph 6).

In Plain English…

Essentially, this is what transpired. Otsuka asked the Delaware District Court for a preliminary injunction. Hetero raised X, Y, and Z arguments, but the Court disagreed. The preliminary injunction served its intended purpose – it prevented Hetero from launching its product.

Hetero appealed and raised the X, Y, and Z arguments. The Court of Appeals agreed with the District Court, rejecting X, Y, and Z. Hetero files a new case, raising X,Y, and Z again. The patent expires.

Possible, but not Likely

Technically, Hetero could win. It has to now prove that it would have won the underlying case which the District Court and the Court of Appeals have already rejected (though on a preliminary basis.) To do so, it must convince the same Court and Court of Appeals that they were wrong in the first place, highly unlikely particularly after the both courts favored Otsuka’s claims construction. Lastly, Hetero will now have to surmount the legal hurdles: (1) courts who have considered the same or similar issues are reluctant to re-try them and (2) its failure to pursue the remedy of appealing to the Supreme Court after its loss at the Court of Appeals.

*”Taking the cake” refers to a carnival game “Cake Walk” where the winner receives a cake.