Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC

Under the doctrine of equivalents, the accused product was found to infringe one set of patents’s “delayed release” claim element, and also infringe another set of patents’ limitation requiring that the drug not reduce skin microflora.

August 27, 2018

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

Case Name: Galderma Labs., L.P. v. Amneal Pharmaceuticals LLC, No. 16-207-LPS, 2018 U.S. Dist. LEXIS 151037 (D. Del. Aug. 27, 2018) (Stark, C.J.)

Drug Product and Patent(s)-in-Suit: Oracea® (doxycycline); U.S. Patents Nos. 8,206,740 (“the ’740 patent”), 8,394,405 (“the ’405 patent”), 8,470,364 (“the ’364 patent”), and 7,749,532 (“the ’532 patent”) (collectively, the “Chang patents”); 7,211,267 (“the ’267 patent”), 7,232,572 (“the ’572 patent”), 8,603,506 (“the ’506 patent”), and 9,241,946 (“the ’946 patent”) (collectively, the “Ashley patents”)

Nature of the Case and Issue(s) Presented: Plaintiffs manufacture and market doxycycline capsules to treat rosacea under the Oracea brand. Defendants filed an ANDA seeking to market a generic version of the drug. Plaintiffs sued, alleging infringement of the Chang and Ashley patents. After a bench trial, the court concluded that defendants infringed the ’740, ’405 and ’364 Chang patents, and the ’506 and ’946 Ashley patents. The court also determined that defendants did not infringe the ’532 Chang patent and that Plaintiffs were estopped form asserting infringement of the ’267 and ’572 Ashley patents.

Why Galderma Prevailed: Plaintiffs argued that defendants’ generic product infringed the Chang patents under the doctrine of equivalents. First, the court determined that plaintiffs were not barred from asserting the doctrine of equivalents because there was no vitiation or clear disavowal or disclaimer in the prosecution history. The court then turned to plaintiffs’ equivalents argument, and found that defendants’ generic product performed the same function, in the same way, to obtain the same result as the Oracea delayed-release product. Biologically, the two products were equivalent. The parties’ dispute thus focused on the “delayed release” nature of the products. The court relied on evidence that Defendants’ generic product released doxycycline at times other than “immediately” after oral administration. This fit the accepted definition of “delayed release.” Thus, the generic product was the equivalent of the claimed invention.

The court did find, however, that defendants did not infringe the ’532 Chang patent. The claims of the ’532 Chang patent required that the delayed-release portion of the capsule be coated with at least one enteric polymer. Because plaintiffs did not present any evidence that a POSA would view the coating of the generic product as interchangeable with an enteric polymer, plaintiffs did not satisfy their burden of proving infringement.

Turning to the Ashley patents, the court found that defendants’ generic product infringed the claims of the ’506 and ’946 patents. Here, the parties disputed whether or not the generic product met the claim element requiring that the amount of doxycycline not reduce skin microflora during a six-month treatment. Defendants’ own label for the generic product served as evidence that the generic product met this element, as it specifically stated that, administered as instructed, the product would have no effect on skin microflora. Further, because the label provided instructions for doctors and patients to administer the generic product, defendants indirectly infringed the claims of the ’267 and ’572 Ashley patents by both inducing and contributing to the direct infringement.

Finally, the court determined that plaintiffs were collaterally estopped from asserting the ’267 and ’572 Ashley patents. Plaintiffs had previously asserted the ’267 and ’572 Ashley patents in a prior litigation. There, the court determined that a once-daily treatment of 40 mg doxycycline (as in defendants’ generic product) did not infringe the ’267 and ’572 Ashley patents. The court concluded that this case presented an identical issue that was previously litigated. Accordingly, estoppel applied, even if new evidence was presented in the present case, because plaintiffs had a full and fair opportunity to litigate the issue.

Back to Top