Area of Focus | Hatch-Waxman



Generic pharmaceutical companies need counsel who understand all aspects of their business.

Brinks' Hatch-Waxman litigation practice group clears the legal and regulatory pathway for our generic pharmaceutical clients.  We leverage our legal experience and strong technical backgrounds to provide useful advice and solve the legal problems faced by the contemporary pharmaceutical marketplace.

We understand clients' top priorities, including responsiveness, efficiency, and budgeting.   Litigation tactics must align with the client's business objectives; hence we invest the time to understand those objectives, and develop a litigation plan to achieve them.

ANDA litigation requires an intimate knowledge of patent litigation strategies, Hatch-Waxman regulations and FDA procedures. Brinks' pharmaceutical litigators have that knowledge and experience as a result of dozens of Hatch-Waxman cases involving drugs from A (atomoxetine) to Z (zolpidem). These cases have covered virtually every type of drug technology, including compounds, formulations, polymorphs, and methods of treatment.



Preliminary Injunction     

In a case directed to a $600 million/year antibiotic, Brinks defeated a TRO and motion for preliminary injunction and then successfully defended that decision at the Federal Circuit.

Summary Judgment

In a first-to-file opportunity for its generic client, Brinks obtained summary judgment of invalidity and non-infringement for the majority of asserted claims. All remaining claims were settled on the eve of trial, allowing Brinks’ client to launch its generic drug product three years before patent expiry.


In a case related to a $1B/year asthma drug, Brinks lawyers obtained a final judgment of invalidity after a seven-week bench trial. The judgment was affirmed on appeal. Prior to Brinks’ involvement, the district court and Federal Circuit ruled against another generic company on the exact same patent.


Brinks took over a case on appeal after an adverse district court judgment. Brinks convinced the Federal Circuit to vacate the district court judgment. In the interim, Brinks filed a successful request for reexamination that resulted in the invalidity of every asserted claim.

For a list of representative molecules and drug products on which we have worked with, click here.