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

Plaintiff had no adverse reaction to receiving the hepatitis B vaccine in 1997 until after her third dose. At that time, her chest pain was not attributed to the vaccine. Plaintiff saw other doctors for various symptoms and, in 1998, doctors identified "post vaccine syndrome." Plaintiff has had unrelated medical problems, suffered the loss of a child, and has had jobs that involved working with chemicals and bodily fluids. Her 1999 claim for compensation under the Vaccine Act (42 U.S.C. 300aa-1) was denied. The Federal Circuit affirmed, stating that if was an "unfortunate case," in which plaintiff suffered a multitude of symptoms but could not prove they were caused by the vaccine.

The district court granted summary judgment that all of the claims in plaintiff's patents were ineligible under 35 U.S.C. 101, which excludes from patentability "laws of nature, natural phenomena, and abstract ideas" because they were directed to the "abstract idea" that there is a relation between the infant immunization schedule for infectious diseases and the later occurrence of chronic immune-mediated (non-infectious) disorders. The Supreme Court vacated the Sixth Circuit's 2008 decision. On remand the Federal Circuit affirmed with respect to one patent's ineligibility, but vacated a portion of the judgment granted under the "safe harbor" provision of 35 U.S.C. 271(e)(1). One set of claims did not include putting knowledge to practical use, but was directed to the abstract principle that variation in immunization schedules may have consequences for certain diseases. Others require the further act of immunization in accordance with a lower-risk schedule, moving from abstract scientific principle to specific application.

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.