Sign In
Events
Newsletters
Search

Close

Close Search

Cancel

SEARCH
MY LAW.COMNEW

Minnesota Mining and Manufacturing Co. v. Barr Laboratories, Inc.

Manufacturer lacked private right of action under FFDCA to determine another party's statutory compliance; district court was entitled to dismiss patent infringement action with prejudice, thus triggering ANDA filer's 180-day exclusivity period.

X

Thank you for sharing!

Your article was successfully shared with the contacts you provided.
Opinion for the court filed by Circuit Judge DYK. Opinion concurring in judgment filed by Circuit Judge GAJARSA.

This case presents a question under the Hatch-Waxman Amendments to the Federal Food, Drug, and Cosmetic Act (“FFDCA”), which were enacted as part of the Drug Price Competition and Patent Term Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984), codified at 21 U.S.C. �� 355, 360cc, and 35 U.S.C. �� 156, 271, 282. Appellants, Minnesota Mining and Manufacturing Co. (“3M”) and Alphapharm Pty. Ltd. (“Alphapharm”), urge that the district court should have dismissed 3M’s infringement action against appellee, Barr Laboratories, Inc. (“Barr”), without prejudice pursuant to Rule 41(a)(2) of the Federal Rules of Civil Procedure, so that the dismissal of that suit would not have triggered the running of a 180-day waiting period under 21 U.S.C. � 355(j)(5)(B)(iv)(II) for approval of Barr’s Abbreviated New Drug Application (“ANDA”). Appellants urge that a dismissal without prejudice was required because Barr improperly caused the 3M suit to be brought. Barr allegedly did so by failing to provide 3M with information (before 3M filed suit) showing that Barr did not infringe. In particular appellants alleged that Barr failed to comply with the requirement of 21 U.S.C. � 355(j)(2)(B)(ii) that it provide “a detailed statement of the factual and legal basis of the applicant’s opinion that the patent is not valid or will not be infringed.” Pursuant to our decisions in Mylan Pharmaceuticals, Inc. v. Thompson, 268 F.3d 1323, 60 USPQ2d 1576 (Fed. Cir. 2001) and Andrx Pharmaceuticals, Inc. v. Biovail Corp., 276 F.3d 1368, 61 USPQ2d 1414 (Fed. Cir. 2002), we hold that � 355(j)(2)(B) cannot be enforced by a private party in a patent infringement action, but must be enforced, if at all, only in the context of an action under the Administrative Procedure Act (“APA”), 5 U.S.C. �� 702-706. We also conclude that the district court did not lack subject matter jurisdiction to determine the form of dismissal or otherwise abuse its discretion in declining to dismiss without prejudice. We accordingly affirm the judgment of the district court.

I.

Trending Stories

 
Reprints & Licensing
Mentioned in a Law.com story?

License our industry-leading legal content to extend your thought leadership and build your brand.

LEARN MORE

More From ALM

Premium Subscription
With this subscription you will receive unlimited access to high quality, online, on-demand premium content from well-respected faculty in the legal industry. This is perfect for attorneys licensed in multiple jurisdictions or for attorneys that have fulfilled their CLE requirement but need to access resourceful information for their practice areas.
View Now
Team Accounts
Our Team Account subscription service is for legal teams of four or more attorneys. Each attorney is granted unlimited access to high quality, on-demand premium content from well-respected faculty in the legal industry along with administrative access to easily manage CLE for the entire team.
View Now
Bundle Subscriptions
Gain access to some of the most knowledgeable and experienced attorneys with our 2 bundle options! Our Compliance bundles are curated by CLE Counselors and include current legal topics and challenges within the industry. Our second option allows you to build your bundle and strategically select the content that pertains to your needs. Both options are priced the same.
View Now
Go to CLE Center
Middle East Legal Awards 2024
April 25, 2024
Dubai

Law firms & in-house legal departments with a presence in the middle east celebrate outstanding achievement within the profession.


Learn More
BenefitsPRO Broker Expo 2024
April 29, 2024 - May 01, 2024
Aurora, CO

The premier educational and networking event for employee benefits brokers and agents.


Learn More
Pennsylvania Legal Awards 2024
May 15, 2024
Philadelphia, PA

The Legal Intelligencer honors lawyers leaving a mark on the legal community in Pennsylvania and Delaware.


Learn More
Go to Events Go to Webcasts
Legal Writing & Research Professional

Atlanta s John Marshall Law School is seeking to hire one or more full-time, visiting Legal WritingInstructors to teach Legal Research, Anal...


Apply Now ›
Premises Liability Litigation Attorney Needed (3-6 yr.)

Lower Manhattan firm seeks a premises liability litigator (i.e., depositions, SJ motions, and/or trials) with at least 3-6 years of experien...


Apply Now ›
Deputy District Attorney III

Join the Mendocino County District Attorney s Office and work in Mendocino County home to redwoods, vineyards and picturesque coastline. ...


Apply Now ›
Go to Lawjobs
MELICK & PORTER, LLP
04/15/2024
Connecticut Law Tribune

MELICK & PORTER, LLP PROMOTES CONNECTICUT PARTNERS HOLLY ROGERS, STEVEN BANKS, and ALEXANDER AHRENS


View Announcement ›
Apruzzese, McDermott, Mastro & Murphy, P.C.
04/11/2024
New Jersey Law Journal

Professional Announcement


View Announcement ›
Robbins Alloy Belinfante Littlefield
04/08/2024
Daily Report

Daily Report 1/2 Page Professional Announcement 60 Days


View Announcement ›
Go to Professional Announcements