The USA’s Generic Pharmaceutical Association (GPhA) says that it has filed an Amicus Brief (“friend of the court” or a person with strong interest in or views on the subject matter of an action, but not a party to the action) in the Upsher-Smith versus Louisiana Wholesale Drug Co relating to patent settlements.
“Simply put, the Third Circuit erred in its conclusion that the presumption of validity of a patent is not a substantive right of the patent holder. All other circuits that have ruled have held that patent settlements are presumptively valid. The Third Circuit ruling is an outlier, says GPhA president and chief executive Ralph Nease.
“This case could determine how an entire industry does business, because it would dramatically affect the economics of each decision to introduce a new generic drug. The current industry paradigm of challenging patents on branded drugs in order to bring new generics to market as soon as possible has produced $1.06 trillion in savings over the past 10 years. The facts are clear. Patent settlements save. They are pro-competition, pro-consumer and have saved consumers and taxpayers billions of dollars,” he stresses.
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