Abbreviated New Drug Application litigation
A generic drug maker who is not the first ANDA applicant to file a ¶ IV certification of invalidity or noninfringement is not entitled to 180-day marketing exclusivity, and may be kept out of the market indefinitely by a first ¶ IV filer who defers commercial launch under a “pay-for-delay” agreement with the patent owner. [...]
Read more →The post-grant opposition proceedings created by the America Invents Act, used in parallel with ANDA litigation, will alter the strategies of ¶ IV practice under the Hatch-Waxman Act. The use of USPTO post-grant proceedings in conjunction with ¶ IV certifications may provide collateral benefits to the ANDA applicant, apart from a direct challenge to patentability [...]
Read more →The post-grant opposition proceedings created by the America Invents Act, used in parallel with litigation under the Hatch-Waxman Act, will alter the timetable that has favored branded manufacturers, and can preserve the first ¶ IV filer’s right to 180-day market exclusivity without the necessity of a district court adjudication of invalidity or noninfringement. Generic drug [...]
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