Posts Tagged: Hatch-Waxman Act


Filer of an ANDA Paragraph III Certification has Standing to Appeal from PTAB in IPR

The ‘650 patent covers a compound called fesoterodine, which is an antimuscarinic drug marketed as Toviaz® and used to treat urinary incontinence. Mylan Pharmaceuticals petitioned for IPR of …

Federal Circuit Upholds Patent Term Extension for Novartis Drug

The United States Court of Appeals for the Federal Circuit recently affirmed a district court decision finding the '229 patent valid, unexpired, enforceable, and infringed, and granting …

CAFC Overturns Preliminary Injunction on Generic Suboxone Film Over Newman Dissent

The Federal Circuit issued a nonprecedential decision in Indivior Inc. v. Dr. Reddy’s Laboratories, S.A., which vacated a preliminary injunction handed out by the District …
By Steve Brachmann
1 year ago 1

IPR Outcomes of Orange Book Patents and its Effect on Hatch-Waxman Litigation

Out of the 230 Orange Book patents challenged in IPR proceedings, 90.4% (208) of these patents were also challenged in Hatch-Waxman litigation perhaps due to the lucrative 180-day exclusivity incentive …
By Tulip Mahaseth
1 year ago 3

Federal Circuit Reverses, Finds Opioid Addiction Treatment Patent Nonobvious

The Federal Circuit reversed the District of Delaware’s decision to invalidate Orexo’s opioid treatment patent as obvious because obviousness was not proved by clear and …

The Updated PTAB Trial Practice Guide – Not Quite There Yet

While the changes to the Trial Practice Guide begin to move the rules in the right direction, more is needed before post-grant proceedings will be accepted as …
By Russell Slifer
2 years ago 2

Federal Circuit Treatment of ‘Commercial Success’ in Hatch-Waxman Cases

In order to establish that the commercial success factor supports a non-obviousness finding, the patentee must establish that a connection (or nexus) exists between the novel aspects …
By Theodore Chiacchio
2 years ago 1