Posts Tagged ‘Federal Circuit’

Apotex Petitions Supreme Court to Review Therasense Standards

Thursday, May 21st, 2015

Magnesium SaltIn Apotex, Inc. v. UCB, Inc., Appeal No. 2013-1674 (Fed. Cir. August 15, 2014) the court affirmed the district court’s ruling that one actor, Dr. Sherman, the chairman of Apotex had committed inequitable conduct by engaging in what the court found was a perfect storm of misrepresentations during the prosecution of U.S. Pat. No. 6,767,566 that claimed a method to make the magnesium (Mg) salt of Moexipril. The Fed. Cir. found that Dr. Sherman, the named inventor on the application withheld prior art, mischaracterized the cited art in arguments and via a Rule 132 Declaration, and included examples in the application that had not been performed. In fact, this was characterized as an attempt to patent a competitor’s drug.  The  competitor, UCB, had listed in the Orange Book, as the hydrochloride salt – although the court found that Dr. Sherman was aware that the process disclosed in the listed patent, U.S Patent No. 4,743,450, would yield the Mg salt of Moexipril, which imparted substantial stability. The Fed. Cir. agreed with Apotex that Dr. Sherman had no duty to disclose his own suspicions or beliefs regarding the prior art (that he suspected that the ‘450 process would in fact yield the stable Mg salt) but rested its holding on its opinion that Dr. Sherman “affirmatively and knowingly misrepresented material facts regarding the prior art.” Slip op. at 15.

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Enzo Biochem V. Applera Corp. – When “Words Can Hurt You”

Thursday, March 19th, 2015

iStock_000010676885_SmallOn March 16, 2015 (Appeal no. 2014-1321), the Fed. Cir. reversed the district court’s construction of a claim term relating to the scope of “A,” a moiety capable of direct or indirect signaling that is attached by a linker to a nucleotide base. (A copy of the decision can be found at the end of this post.) The claim read: “wherein A comprises at least one component of a signaling moiety capable of producing a detectable signal [wherein the linker does not interfere] with formation of the signaling moiety or detection of the detectable signal….”

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Novartis Wins Landmark Biosimilar Approval

Monday, March 9th, 2015

iStock_000013653107_SmallNovartis Navigates The FDA-ACA Maze – Gets Approval For Generic Neuprogen.

Amgen will soon find itself in a price war with Sandoz – a Novartis company – as it tries to maintain its share of the market for Neuprogen (filgraslim). The drug is used to treat neutropenia –often a side effect of anti-rejection drugs or chemotherapy. No matter what you think of “Obamacare,” whoever slipped in a relatively small section authorizing biosimilar products and outlining a pathway to approval, may end up saving many consumers much more than they might realize from affordable health care. Sandoz will market the drug as Zarxio. Read more here.

Pacing Technologies v. Garmin – D&D Explained

Friday, February 20th, 2015

disclaimer marked on rubber stampIn this decision—No. 2014-1396 (Fed. Cir., Feb. 18, 2015)—the court affirmed a grant of summary judgment (a copy can be found at the end of this post) that Garmin’s exercise products do not infringe the claims of Pacing’s US Pat. No. 8,101,843. The court reviewed the case de novo because the district court had relied entirely on the intrinsic evidence. The claims were directing to a systems comprising  “playback devices” that the judge ruled do not play target tempo or pace information as “audio, video or visible signals,” e.g., while the user is running.

The panel affirmed that the preamble should be given weight as a claim limitation because:

“[w]hen limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” Eaton Corp. v. Rockwell International Corp., 323 F.3d 1332 (Fed. Cir. 2003).

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