Posts Tagged: ANDA


Federal Circuit Weighs in on Proper Venue in Hatch-Waxman Cases Under TC Heartland

Last week, the U.S. Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in …
By IPWatchdog
18 days ago 1

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
3 months ago 4

Patent Filings Roundup: Robot Vacuum Wars, PTAB Filings Dip, Pharma Litigation Abounds

This week’s District Court filings were robust, with a dip in Patent Trial and Appeal Board (PTAB) filings--a big chunk of which were related to a …
By Jonathan Stroud
8 months ago 1

Federal Circuit Decision Delays Generic Osteoarthritis Drug

On October 9, the U.S. Court of Appeals for the Federal Circuit (CAFC) issued a decision in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. affirming the …
By Nancy Braman
1 year ago 2

CAFC: Claim Construction That Misreads Plain Language of Claims and Specification Is Clearly Erroneous

The Federal Circuit recently vacated a district court decision which found a patent for the antipsychotic drug “Saphris,” belonging to Forest Laboratories (Forest), valid as nonobvious, but …

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 …

The Tough Act of Balancing Preliminary Injunction Factors: Indivior Inc. v. Dr. Reddy’s Laboratories, S. A. (Fed. Cir. 2018)

How the likelihood of success on the merits should (or should not) be determined and the four factors balanced in a patent infringement case, are areas in …

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 …

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

Nasal Spray Patents Covering Migraine Drug Zomig Not Invalid As Obvious

The sole question on appeal was whether it would have been obvious to make zolmitriptan into a nasal spray. The Federal Circuit agreed with the district court …

Federal Circuit confirms validity of patent for UCB’s Vimpat®

Appellants were generic drug manufacturers who filed Abbreviated New Drug Applications ("ANDAs"), seeking approval for generic versions of Vimpat®. As a result, the Federal Circuit affirmed the …

TC Heartland Update: Federal Circuit decides ZTE and Bigcommerce

Of the many lingering issues left in TC Heartland’s wake for domestic corporations, a Federal Circuit panel resolved several of them recently. In In re ZTE (…