The US Court of Appeals for the Federal Circuit upheld a district court’s findings of invalidity and noninfringement in a Hatch-Waxman case involving two sets of method patents directed to modulating ...

In a Hatch-Waxman case, the District of Delaware denied a motion for summary judgment seeking to apply the ANDA filing date as the date of the hypothetical negotiation used to calculate reasonable ...

The US District Court for Washington, DC has ruled against ISTA Pharmaceuticals Inc. (PDF), which had filed suit against the US Food and Drug Administration (FDA) in a case regarding whether the ...

The US Food and Drug Administration (FDA) has revised its manual of policies and procedures (MAPP) for conducting a filing review of an abbreviated new drug application (ANDA) by the Office of Generic ...

“[T]he Federal Circuit noted that venue in Hatch-Waxman cases is predicated on past acts of infringement instead of planned future conduct, and that such past acts can only happen in districts related ...

Mylan N.V. (NASDAQ, TASE: MYL) today announced that its abbreviated new drug application (ANDA) for fluticasone propionate 100, 250, 500 mcg and salmeterol 50 mcg inhalation powder has been accepted ...