Cephalon v. Sandoz, No. 11-821-SLR (D. Del.)
In January 2010, Sandoz sent a Paragraph IV notice letter to Cephalon in connection with its ANDA for a generic version of Cephalon's FENTORA (fentanyl citrate) buccal tablets. Cephalon responded by filing suit against Sandoz under 35 USC § 271(e)(2), alleging infringement of U.S. Patent Nos. 6,200,604 and 6,974,590 based on Sandoz's Paragraph IV certifications on the two patents.
On January 4, 2011, U.S. Patent Nos. 7,862,832 and 7,862,833 were issued. On April 25, 2011, Cephalon submitted the '832 and '833 patents for listing in the Orange Book with respect to FENTORA. But because Cephalon did not submit the '832 and '833 patents for listing within 30 days of issuance, Sandoz was not required to (and did not) file an amended patent certification with respect to the two patents in its ANDA. See21 CFR § 314.94(a)(12)(vi):
(vi)Late submission of patent information. If a patent on the listed drug is issued and the holder of the approved application for the listed drug does not submit the required information on the patent within 30 days of issuance of the patent, an applicant who submitted an abbreviated new drug application for that drug that contained an appropriate patent certification before the submission of the patent information is not required to submit an amended certification.