Generic drug maker fails to avoid inhaler patent lawsuit

A Virginia court was unconvinced that the Hatch-Waxman Act did not apply.

Mylan Pharmaceuticals has been unable to persuade a Virginia court that it should not face  an AstraZeneca Pharmaceuticals lawsuit centring on a generic of the asthma inhaler Symbicort.

US District Judge John Preston Bailey delivered the decision on Tuesday, July 12, at the US District Court for the District of Virginia.

AstraZeneca sued generic drugmakers Mylan and Kindeva in April alleging patent infringement arising after the companies filed an Abbreviated New Drug Application (ANDA), number 211699 with the US Food and Drug Administration (FDA).

According to the filing, this action would infringe the ‘558 patent number and AstraZeneca has sought injunctive relief precluding infringement, attorneys’ fees, and any other relief the court deems just and proper.

Mylan and Kindeva filed a motion to dismiss on June 1, 2022, which the court denied this week.

According to the filing, the US Patent and Trademark Office issued the ‘558 patent, entitled “Composition for Inhalation,” on April 26, 2022, to AstraZeneca upon assignment from the inventors Nayna Govind and Maria Marlow.

The patent is directed to pharmaceutical formulations, including Symbicort, in which the active ingredients budesonide and formoterol are suspended in a liquid hydrofluoroalkane propellant (HFA 22) with the excipients polyvinyl pyrrolidone (“PVP”) and polyethylene glycol (PEG).

But Mylan and Kindeva argued that because the ‘558 patent was not even in existence during the time in which Mylan’s ANDA was awaiting FDA approval, the Hatch-Waxman Act provisions do not apply.

The defendants state that the plaintiffs’ claim that the submission of Mylan’s ANDA infringed the ‘558 patent “cannot be” because Mylan’s ANDA “was already approved before the ‘558 patent issued, mooting the need to amend its ANDA to include a Paragraph IV certification to the ‘558 patent, which was not even listed in the Orange Book until May 20, 2022, three weeks after AstraZeneca filed this suit”.

But Bailey found that the complaint alleged enough facts to state a claim to relief that is plausible on its face for infringement by “identify[ing} the ANDA and alleg[ing] that the proposed ANDA products will infringe,” and that the “allegations contained in plaintiffs’ complaint go well beyond plausibility”.

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