The U.S. Food and Drug Administration (FDA) has issued two new guidance documents related respectively to an “abbreviated” and a “special” approach to the typical 510(K) process for medical devices.
The FDA describes the usual 510(K) process as “a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device…that is not subject to premarket approval.” According to the FDA, “Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval application (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) .”
Before: Newman, Lourie, and Dyk
Summary: Where a request for continued examination has previously been filed, the time between terminating an interference and the notice of allowance is not PTO delay for purposes of calculating patent term adjustment.
HENNY PENNY CORPORATION v. FRYMASTER LLC
Before Lourie, Chen, and Stoll. Appeal from the United States Patent and Trademark Office.
Summary: With respect to secondary considerations of nonobviousness, nexus may be satisfied by showing that objective evidence is tied to a novel combination of known elements.
CURVER LUXEMBOURG, SARL v. HOME EXPRESSIONS INC.
Before Chen, Hughes, and Stoll. Appeal from the United States District Court for the District of New Jersey.
Summary: Claim language specifying the article of manufacture can limit the scope of a design patent where the article is not shown in the figures.
INTELLECTUAL VENTURES I LLC v. CAPITAL ONE FINANCIAL CORP.
Before Prost, Bryson, and Reyna. Appeal from the United States District Court for the District of Maryland.
Summary: The Federal Circuit applied collateral estoppel and thus avoided deciding whether a party with a large patent portfolio that allegedly threatened serial litigation to obtain licensing fees may have violated antitrust laws.
A Chicago jury previously awarded Kolcraft Enterprises more than $3 million in damages based on Artsana’s infringement of U.S. Patent No. 7,376,993, related to infant play equipment. Because the jury awarded Kolcraft almost half-a-million dollars more that Kolcraft requested, Artsana asked that Court overturn the jury verdict or order a new trial.
BOARD OF REGENTS v. BOSTON SCIENTIFIC CORP.
Before Prost, Reyna, and Stoll. Appeal from the United States District Court for the Western District of Texas.
Summary: The patent venue statute governs actions filed by a State as State sovereignty does not apply when a State acts solely as a plaintiff in asserting patent infringement.
ALLERGAN SALES, LLC v. SANDOZ, INC.
Before Prost, Newman, and Wallach. Appeal from the United States District Court for the District of New Jersey.
Summary: A “wherein” clause can be limiting if it is material to patentability.
BIODELIVERY SCIENCES INTL. v. AQUESTIVE THERAPEUTICS, INC.
Before Newman, Lourie, and Reyna. Appeal from the Patent Trial and Appeal Board (PTAB).
Summary: The PTAB has the discretion to not institute inter partes review even if there is a showing of reasonable likelihood of success with respect to at least one challenged claim. The PTAB’s institution decision is not appealable under 35 U.S.C. § 314(d).
GUANGDONG ALISON HI-TECH CO. V. ITC
Before Wallach, Hughes, and Stoll. Appeal from United States International Trade Commission.
Summary: A term of degree is not indefinite so long as the written description provides objective boundaries.
