IP Newsflash

In considering claims to a method of reducing cardiovascular events, the Federal Circuit held that the term a “clinically proven effective” amount did not render the claims patentable over the prior art. Specifically, the Federal Circuit held that the “clinically proven effective” amount, whether limiting or not, could not be used to distinguish the prior art because the claims also specified the exact amount of the drugs to be administered in the method. The Federal Circuit also rejected patentee’s evidence of unexpected results because that evidence was tied solely to the “clinically proven effective” limitation.

The Federal Circuit reversed a district court’s denial of judgment as a matter of law on non-infringement, thereby setting aside a $106 million jury verdict, after holding that prosecution history estoppel barred the patentee from asserting infringement under the doctrine of equivalents.

The Federal Circuit has affirmed the PTAB’s determination that a patent challenger did not show the challenged claims were unpatentable for obviousness. The Federal Circuit concluded that substantial evidence, which included expert testimony, showed there was no motivation to combine the references.

Earlier this year, the Federal Circuit’s decision in Qualcomm Inc. v. Apple Inc. (Qualcomm II) raised questions about the extent to which petitioners can rely on applicant admitted prior art (“AAPA”) in inter partes review proceedings.  The Federal Circuit’s recent decision in Shockwave Medical, Inc. v. Cardiovascular Sys., Inc. largely cabins the Qualcomm II decision to its particular facts and makes clear that AAPA can be used as evidence of background knowledge as part of an obviousness argument.

The Federal Circuit recently reversed a PTAB determination on remand that a patent was obvious over applicant admitted prior art (“AAPA”) in combination with prior art patents, holding that expressly designating AAPA as a “basis” for a ground is improper under 35 U.S.C. § 311(b). In doing so, the Court rejected the PTAB’s “blanket rule” that “AAPA used in combination with prior art patents or printed publications under § 311(b) is ipso facto not the basis or part of the basis of a ground.” Ultimately, while the case clarifies that expressly listing AAPA in an IPR ground is improper, the precise line between proper and improper uses of AAPA in other instances remains unclear.

The Federal Circuit affirmed a District of Delaware finding of non-infringement in an ANDA litigation due to the patentee’s clear and unmistakable disavowal of claim scope during prosecution. Specifically, the court held that statements made during prosecution of a parent application before the asserted claims were allowed amounted to a prosecution disclaimer that extended to subsequent patents in the family. In reaching this conclusion, the court rejected an attempt by the patentee to resurrect the claim scope through a unilateral, self-serving statement made in later applications in the family.

The Federal Circuit recently affirmed a district court’s holding that patent term extension (PTE) for a reissued patent was properly based on the issue date of the original patent and not that of the reissued patent. The Federal Circuit concluded that, where both the original and reissued patents claimed a drug product under regulatory review, using the issue date of the original patent to calculate PTE comports with both the purpose of the Hatch-Waxman Act and the related statutory context.

The Federal Circuit recently refused to apply collateral estoppel to claims of a patent asserted in district court litigation based on a Patent Trial and Appeal Board (PTAB) decision finding similar claims from the same patent unpatentable because the PTAB applied a lower burden of proof than what is required to invalidate claims in district court.

The Federal Circuit affirmed a Patent Trial and Appeal Board (PTAB) final written decision holding that the prior art exception of AIA Section 102(b)(2)(B) does not apply to a prior sale by an inventor when the sale is conducted in private. According to the Federal Circuit, a sale must disclose the relevant aspects of the invention to the public to qualify for the prior art exception of Section 102(b)(2)(B).