Justia U.S. Federal Circuit Court of Appeals Opinion Summaries

Plaintiff owns a patent on an FDA-approved (21 U.S.C. 355(b)(2) ) pharmaceutical nasal spray Fortical, used to treat osteoporsis, with the active ingredient salmon calcitonin. In its FDA filing, plaintiff identified the drug as bioidentical to Miacalcin. Defendant filed an Abbreviated New Drug Application with the FDA, stating intent to make, use, offer to sell, sell, and/or import a generic version of Fortical product before the expiration of plaintiff's patent. Plaintiff claimed infringement. Defendant alleged invalidity under 35 U.S.C. 101, 102, 103,and 112, noninfringement and inequitable conduct in failure to disclose an allegedly material piece of prior art and making allegedly misleading statements during patent prosecution. The district court found that the patent would not have been obvious at the time of invention, denied defendant's motion to breach the attorney-client privilege under the crime-fraud exception, and determined that defendant had waived several counter-claims. The Federal Circuit affirmed. Even accepting that there was a design need and market pressure to develop a pharmaceutical formulation bioequivalent to Miacalcin, there was no evidence that the claim would be an obvious solution to those motivations.

Plaintiff, a pharmaceutical company, owns a patent that claims conjugated estrogen pharmaceutical compositions for use in hormone replacement therapies. Plaintiff alleged infringement of the patent based on defendant's Abbreviated New Drug Application for a generic version of plaintiff's hormone replacement therapy product, arguing the doctrine of equivalents. The district court entered summary judgment for defendant. The Federal Circuit affirmed. Plaintiff failed to rebut the presumption of prosecution history estoppel based on unforeseeability. The doctrine of prosecution history estoppel prevents a patent owner from recapturing, through the doctrine of equivalents, subject matter surrendered to acquire the patent. Because plaintiff narrowed the scope of the patent's claims in response to a prior art rejection, a presumption of prosecution history estoppel applies.