Mylan gets Fed Circ reprieve in inhaler dispute
In a win for Mylan Pharmaceuticals, a US Court of Appeals for the Federal Circuit panel has ruled it can revisit a decision that held the generic maker infringed patents covering AstraZeneca's inhaler asthma treatment, Symbicort.
The three-judge panel handed down the split ruling yesterday, December 8, sending the case back to a federal court in Virginia for another hearing.
Circuit Judges Todd Hughes and Kara Stoll delivered the majority judgment in the precedential opinion, while Judge Richard Taranto dissented.
In 2020, AstraZeneca sued Mylan, alleging that its planned product would infringe a trio of patents, US numbers 7,759,328, 8,143,239 and 8,575,137 covering the blockbuster product, Symbicort Turbohaler.
The patents describe and claim a suspension composition in a pressurised metered dose inhaler for the treatment of asthma and other respiratory diseases.
Mylan countered that the ‘328, ‘239 and ‘137 patents were invalid, unenforceable and not infringed by the manufacturing of its proposed generic of a “budesonide and formoterol fumarate dihydrate inhalation aerosol”.
In March this year, the US District Court of the Northern District of West Virginia ruled in AstraZeneca’s favour, finding that Mylan failed to prove by clear and convincing evidence that the asserted claims were invalid as obvious.
Mylan appealed the decision, challenging the district court’s claim construction upon which the judgment of infringement was based. Secondly, it also disputed several factual findings underlying the district court’s determination that the patents-in-suit were valid and obvious.
This week, the Federal Circuit agreed with Mylan’s argument that the lower court’s decision was based on an improper reading of the patent language, but dismissed the challenges to the court’s findings that the patents were nonobvious.
The majority also found that while it “was a close call”, Mylan’s proposed construction, albeit articulated differently, was correct “because it most naturally aligns with the patent’s description of the invention”.
The majority panel vacated the earlier judgment of infringement and remanded the case to the federal court in Virginia to reassess whether Mylan’s generic infringes the asserted patents under the proper claim construction.
However, Judge Taranto dissented with the majority view of the need to revisit the claim construction and affirmed the lower court’s judgment of infringement.
He found flaws with Mylan’s argument over the construction claim that had been upheld by his fellow judges.
“On its merits, this construction should be rejected, for the simplest of claim-construction reasons. Adopting this construction requires rewriting the claim term. And that rewriting is counter to the specification and prosecution history,” he wrote.
LSIPR has approached Mylan and AstraZeneca for comment.
