News & Analysis as of

Abbreviated New Drug Application (ANDA) Discovery

Dechert LLP

Finding MDL Ground in Venue for Hatch-Waxman Cases

Dechert LLP on

When there are multiple ANDA filers for the same drug, it may not be possible for a branded pharmaceutical company to bring Hatch-Waxman Act patent infringement suits against all of them in the same court consistent with the...more

American Conference Institute (ACI)

[Virtual Event] Paragraph IV on Virtual Trial - COVID-19 Edition - August 20th, 8:45 am - 6:00 pm EDT

Join us for a one-day virtual event for Counsel for Hatch-Waxman Litigators. While COVID-19 prevented us from meeting in person this April in NYC, we are pleased to announce a special one-day virtual event Paragraph IV on...more

Knobbe Martens

Federal Circuit Review - May 2018

Knobbe Martens on

Priority Claims Cannot Be Incorporated by Reference - In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, Appeal Nos. 2016-2707 and 2016-2708, the Federal Circuit held that when a patent for a...more

McDermott Will & Emery

Deference, Discovery and District Court Findings

Giving deference on discovery issues and non-infringement findings, the US Court of Appeals for the Federal Circuit affirmed a non-infringement determination, finding the district court did not abuse its discretion by...more

Foley & Lardner LLP

Par’s Hatch-Waxman Claims Too Speculative and Discovery Requests Too Broad

Foley & Lardner LLP on

The recent decision from the New Jersey District Court in Par Pharmaceutical, Inc. v. Luitpold Pharmaceuticals, Inc., Civ. No. 16-02290 (WHW)(CLW) (D.N.J. April 24, 2017) provides an interesting look at the boundaries of...more

WilmerHale

Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month Regulatory Stay in Hatch-Waxman Litigation

WilmerHale on

Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of Food and Drug Administration approval...more

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