Posted On: January 17, 2012 by James L. Higgins

Judge Robinson Awards Fees to ANDA Defendant.

In a recent decision, Judge Robinson found that although the plaintiffs’ initiation of an ANDA action was not frivolous, its continued prosecution of suit after “agreeing to stipulate” that the defendant did not infringe was “exceptional” and justified an award of attorneys’ fees under § 285. In re: Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., Civ. No. 09-MD-2118-SLR (D. Del. Jan. 12, 2012). Judge Robinson rejected the defendant’s argument that the initiation of the suit in the first place was frivolous, finding that the plaintiffs’ suit legitimately sought to obtain information about the defendant’s generic formulation that the defendant had refused to provide to the plaintiffs voluntarily, and which the plaintiffs argued should have been (but was not) included in the defendant’s Paragraph IV Notice letters. Id. at 4. However, despite "agree[ing] to stipulate to the fact that [the defendant’s] product, as formulated in its ANDA, did not infringe,” id. at 7, the plaintiffs pressed on. They argued that continued prosecution of the action was the only safeguard against a generic bait-and-switch in which the defendant would secure a final judgment of non-infringement on its current generic formulation (which testimony suggested would never gain FDA approval), benefit from the resulting termination of the 30-month stay, and then reformulate in an infringing manner that would quickly be approved by the FDA. Id. at 5-6. Judge Robinson rejected the plaintiff’s rationale, finding that “[t]he decision to . . . maintain the suit in order to ‘police’ against any possible reformulations by [the defendant] warrants a finding of ‘exceptional’ in light of the FDA’s requirement of re-certification once reformulation occurs.” Id. at 7. “In the event [the defendant] changes its formula, plaintiffs should receive another certification notice and be given the opportunity to file an infringement action based upon the amended formulation.” Id. at 6.

In re: Cyclobenzaprine Hydrochloride Patent Litig., Civ. No. 09-MD-2118-SLR