On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more
1/12/2017
/ Abbreviated New Drug Application (ANDA) ,
Bayer ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Permanent Injunctions ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On October 6, 2016, nearly thirteen years after passage of the Medicare Modernization Act (MMA), FDA published a final rule in the Federal Register implementing amendments and revisions to title 21 of the Code of Federal...more
On July 11, 2016, the Federal Circuit, en banc, overruled the merits panel and affirmed the District of Delaware’s decision in The Medicines Company v. Hospira, Inc. finding that an assignee’s entry into a manufacturing...more
The on-sale bar defense under 35 U.S.C. § 102(b) remains a topic of interest for the Federal Circuit. For example, the Federal Circuit, en banc, is considering whether a supplier exception should exist to the on-sale bar...more
The doctrine of claim vitiation prevents application of the doctrine of equivalents in a way that would completely eliminate a claim element – i.e., renders the claim limitation inconsequential or ineffective. This doctrine...more
On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more
1/13/2016
/ Abbreviated New Drug Application (ANDA) ,
Eli Lilly ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Motion To Stay ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Patents ,
USPTO
On May 28, 2015, we reported on the Supreme Court’s decision in Commil USA, LLC v. Cisco Systems, Inc., 135 S. Ct. 1920 (2015) which reversed the Federal Circuit’s earlier decision and held that, inter alia, a reasonable...more
On November 16, 2015, the Federal Circuit vacated and remanded a Patent Trial and Appeal Board (PTAB, also the “Board”) inter partes review (“IPR”) decision holding that a prior art reference, though not identified as an...more
The Federal Circuit recently affirmed that a generic pharmaceutical company’s use of post-approval quality control testing was not “making” under 35 U.S.C. § 271(g). See Momenta Pharmaceuticals, Inc. et al. v. Teva...more
On November 10, 2015, the Federal Circuit issued its opinion in Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc. et al., No. 14-1634, -1635, slip op. (Fed. Cir. Nov. 10, 2015) affirming the district court’s decision...more
On October 2, 2015, the Federal Circuit affirmed a district court’s holding (1) that a substantially pure compound would have been obvious when a lesser pure compound (“the 50/50 mixture”) and the pure compound were known in...more
In December of last year, the Federal Circuit vacated and remanded the U.S. District Court for the District of Maryland’s (“the Court”) decision finding U.S. Patent No. 7,101,576 (“the ‘576 patent”) invalid as obvious. See...more
Whether or not a prior art reference constitutes “analogous art” for purposes of an obviousness inquiry under 35 U.S.C. § 103 has been the subject of debate in many instances. On July 28, 2015, the Federal Circuit, in Circuit...more
8/6/2015
/ Analogous Art ,
Appeals ,
Inventions ,
Judgment As A Matter Of Law ,
Jury Verdicts ,
Obviousness ,
Patent Invalidity ,
Patent-in-Suit ,
Patents ,
Prior Art ,
Reversal ,
Young Lawyers
On July 2, 2015, the Federal Circuit issued a decision in The Medicines Company v. Hospira, Inc., --- F.3d ---, 2015 WL 4033143 (Fed. Cir. July 2, 2015) reversing the District of Delaware’s finding that the asserted claims...more
Following last year’s decision in Limelight Networks, Inc. v. Akamai Technologies, Inc. et al., 572 U.S. ____ (2014) (holding that a finding of induced infringement requires that all infringing acts be performed by a single...more
5/29/2015
/ Cisco ,
Cisco v CommilUSA ,
Good Faith ,
Honest Belief Defense ,
Induced Infringement ,
Limelight v Akamai ,
Patent Infringement ,
Patent Invalidity ,
Patents ,
Presumption of Validity ,
Scienter ,
SCOTUS