Third Circuit backs pharma firm in antitrust clash
Years-long dispute centred on treatment for gastroesophageal reflux disease | Case invited questions concerning Noerr-Pennington doctrine and immunity | Takeda | Zydus.
In a win for Takeda, the US Court of Appeals for the Third Circuit has affirmed a lower court’s decision to throw out an antitrust litigation brought by Zydus Pharmaceuticals.
The Third Circuit—in a decision handed down on Friday, December 9—said that Takeda had an “objective basis” for bringing its patent infringement claims against Zydus, which doesn’t provide a basis for antitrust liability.
Back in 2009, Zydus filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) to market a generic version of Prevacid SoluTab. Takeda’s Prevacid is an orally disintegrating tablet used to treat gastroesophageal reflux disease.
In response, Takeda filed an infringement suit at the US District Court for the District of New Jersey. It claimed that Zydus’ generic version infringed three Takeda patents, including US patent number 6,328,994, which was issued in December 2001.
While Zydus originally obtained a favourable judgment, it did not immediately obtain FDA approval to market a generic of Prevacid. Zydus amended its ANDA with a new formulation of the product to address FDA concerns.
Takeda again sued Zydus, alleging that the new formulation of the product infringed the same patents.
Zydus, in a counterclaim, said 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 dismiss its antitrust claims. Both parties moved for summary judgment on the claims.
Last year, Chief Judge Freda Wolfson of the New Jersey court granted Takeda’s motion to dismiss and denied Zydus’s cross-motion.
The court concluded that Takeda was immune from antitrust liability under the Noerr-Pennington doctrine, which offers immunity against First Amendment activity such as antitrust litigation.
Wolfson said 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.
“Takeda is entitled to Noerr immunity because Zydus has not demonstrated that Takeda's patent infringement suit was both objectively and subjectively baseless,” said Wolfson.
Zydus appealed against the decision to the Third Circuit. However, in a victory for Takeda, the Third Circuit affirmed the New Jersey court’s decision.
Circuit Judge Patty Shwartz, on behalf of the court, said Takeda had “two objectively valid bases for bringing its second patent infringement suit against Zydus: (1) literal infringement and (2) the doctrine of equivalents”.
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