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16 June 2022Big PharmaMuireann Bolger

Zydus challenges ruling in Takeda antitrust dispute

Zydus Pharmaceuticals has attempted to revive an antitrust lawsuit accusing Takeda Pharmaceuticals of attempting to delay generic competition and of abusing its dominant market position.

Zydus appealed its loss against Takeda in an antitrust dispute to the US Court of Appeals for the Federal Circuit on June 15.

In 2010, Zydus filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking to introduce a generic version of Prevacid SoluTab, an orally disintegrating tablet used to treat gastroesophageal reflux disease.

Takeda filed an infringement suit in the US District Court for the District of New Jersey   alleging that Zydus’s generic version violated three Takeda patents, including US patent number 6,328,994, which was issued in December 2001.

Zydus counterclaimed, arguing that Takeda filed a “sham suit” to maintain its monopoly power in violation of the Sherman Act and the New Jersey Antitrust Act, and sought damages for the delayed launch of its product.

After testing Zydus’ generic version in discovery, Takeda voluntarily dismissed its claims, but Zydus did not.

Takeda argues that its suit is protected by the Noerr-Pennington doctrine, which immunises First Amendment activity such as litigation from antitrust liability.

Zydus counters that Takeda's suit falls under the narrow exception to Noerr-Pennington for litigation that is both objectively and subjectively baseless, and as such,Takeda should not be permitted to raise that defence.

In 2021, Chief Judge Freda Wolfson found that Takeda had an objective basis to sue Zydus for patent infringement and that to conclude otherwise, Zydus must string together contested inferences from three years of patent litigation.

She wrote that: “Takeda is entitled to Noerr immunity because Zydus has not demonstrated that Takeda's patent infringement suit was both objectively and subjectively baseless.”

LSIPR has contacted both parties for comment.

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10 August 2023   Patent-in-suit relates to a synthetic drug used to treat nicotine dependence | Development comes after USFood and Drug Administration sets new guidelines forcing the withdrawal of another big pharma firm’s rival drug.