A trio of patents still stands between Viatris and the launch of its Symbicort generic, but the company could be absolved of treading on AstraZeneca’s intellectual property, a U.S. appeals court ruled this month. The opinion marks the latest move in a three-year patent kerfuffle over AZ’s nearly $3 billion asthma and chronic obstructive pulmonary disease (COPD) med.
The U.S. Court of Appeals for the Federal Circuit has vacated a judgement of infringement against Viatris and its partner Kindeva Drug Delivery after it determined that a federal court in West Virginia misinterpreted part of Symbicort’s patents. At the same time, the appeals court upheld the lower court’s decision not to invalidate the three AZ patents in question, effectively upholding the IP barrier against Viatris’ copycat.
The court documents list the defendants as Kindeva and Mylan. Mylan last year merged with Pfizer’s Upjohn unit to create new company Viatris.
The case stems back to 2018, when AstraZeneca sued Mylan for allegedly stepping on several Symbicort patents with its application for a generic version of the British drugmaker’s blockbuster inhaler. Mylan, for its part, sought to show that claims in three of the patents were invalid. In March, the U.S. District Court for the Northern District of West Virginia ruled in AstraZeneca’s favor, upholding the validity of its patents.
Now, it’s up to the district court to determine whether Mylan did in fact infringe, U.S. circuit judges Kara Stoll and Todd Hughes said in a court filing last week.
The disagreement hinges on small amounts of an excipient used to make the drug. The patented version of Symbicort must include 0.001% of the ingredient. AstraZeneca has argued that figure covers a range from 0.0005% to 0.0014%, while Viatris and Kindeva contend that the patent calls for greater specificity.
Patent feud aside, AstraZeneca’s asthma and COPD inhaler has continued on its blockbuster track. The drug generated $2.72 billion in 2020, up 9% from the previous year. AstraZeneca charted those gains in part thanks to the launch of its own, unbranded version of the drug in the U.S. in January 2020. Meanwhile, Symbicort pulled in $676 million in 2021’s third quarter and has so far garnered about $2.04 billion for the year, AZ reported last month.
Viatris and Kindeva, for their parts, earlier this year scored tentative FDA approval for what would be the first-ever Symbicort generic. Still, the launch of the inhaled treatment would require the partners to surmount AZ’s intellectual property barrier.
Viatris hasn’t included revenues from generic Symbicort in its 2021 guidance. Once the product does debut, Kindeva will support the launch using commercial filling and packaging lines at its plant in Northridge, California.