Dey Pharma, LP v. Sunovion Pharm., Inc., No. 11-1507 (Fed. Cir. 2012)
Annotate this Case
A brand-name company seeking FDA new drug approval must submit information about patents for which a claim of infringement could reasonably be asserted, 21 U.S.C. 355(b)(1), for publication in the Orange Book. A generic company may seek FDA approval using abbreviated new drug application (ANDA), including, for each patent in the Orange Book, certification that approval is not sought until the patent expires or paragraph IV certification that such patent is invalid or will not be infringed. If an ANDA contains only paragraph IV certifications, it may be approved unless the holder sues for patent infringement within 45 days. The first generic company to file an ANDA containing paragraph IV certification receives a 180-day exclusivity period from the date of its first commercial marketing. The period can be forfeited by failure to launch after final judgment of noninfringement or invalidity. An ANDA filer, not sued within 45 days, can seek declaratory judgment under 28 U.S.C. 2201. Plaintiffs obtained declaratory judgment that a generic pharmaceutical did not infringe defendant's patent. The Federal Circuit affirmed, rejecting a challenge to the district court’s jurisdiction, based on a covenant not to sue contained in an earlier settlement between the parties.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.