Posts Tagged: Hatch-Waxman Act


Tips for Selecting a ‘Lead Compound’ in Compound Claim Challenges

Patent challenges are an indispensable part of the drug approval process under the provisions of the Hatch-Waxman Act (Hatch-Waxman). To gain early market access, multiple types of …
By Amit Tailor
2 months ago 4

Biogen v. Banner: Patent Term Extension Inquiry Centers on ‘Active Ingredient’, Not ‘Active Moiety’

Section 156 of the Hatch-Waxman Act provides for restoring some of a patent’s term consumed during clinical testing and Food and Drug Administration (FDA) review of a …

FDA Issues Request for Comments on Modernizing Patent Listings in the Orange Book

On June 1, the Food and Drug Administration (FDA) published a notice in the Federal Register announcing that the agency was establishing a public docket for the receipt …
By Steve Brachmann
4 months ago 0

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The Federal Circuit issued a nonprecedential decision in Indivior Inc. v. Dr.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
2 years 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
2 years 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