In a decision rendered on August 17, 2022, the Federal Court granted Sandoz Canada Inc (Sandoz) leave to amend its Statement of Defence to add new allegations, contingent on an adjournment of the trial and an extension of a...more
The United States District Court for the District of Massachusetts recently denied a motion by Philips North America seeking leave of the Court to amend its claims of patent infringement against Fitbit to include several...more
The question of the proper court for a branded pharmaceutical maker to bring suit against an Abbreviated New Drug Application filer under the Hatch-Waxman Act is surprisingly unsettled seeing as the Act was enacted in 1984. ...more
In a recent decision, Judge Brian R. Martinotti affirmed Magistrate Judge Douglas E. Arpert’s order denying plaintiffs’ motion for leave to amend its complaint. Plaintiffs were attempting to remove their patent infringement...more
In 2019, the U.S. District Court for the District of Utah dismissed Simio's lawsuit against FlexSim Software, finding that the asserted patent was ineligible under Section 101. Simio responded by asking the court to vacate...more
The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more
A district court has denied a request to amend patent infringement contentions to add claims obtained through ex parte reexamination after the case had been substantially narrowed through a parallel inter partes review (IPR)...more
(Updated October 1, 2019) - On July 3, 2019, Eli Lilly was granted leave to amend its pleadings to introduce a new cause of action for direct infringement of claims relating to a new use without including an allegation of...more
The US Court of Appeals for the Federal Circuit reversed a dismissal of a complaint for failing to state a claim under FRCP 12(b)(6), finding error in the district court’s use of judicial notice to do fact-finding outside the...more
Presidio Components, Inc. (“Presidio”) petitioned for inter partes review (IPR) of U.S. Patent No. 6,144,547 (the “‘547 Patent”), which American Technical Ceramics Corp. and AVX Corporation (together “plaintiffs”) asserted...more
Federal Circuit Summary - Before Prost, Wallach, and Hughes. Appeal from the U.S. District Court for N.D. Ohio. Summary: On a Rule 12(b)(6) motion, a district court cannot judicially notice facts that are subject to...more
On the eve of a section 8 trial, the Ontario Superior Court granted Abbott and Takeda leave to amend their pleadings to assert that Apotex’s purported non-infringing alternative (NIA) was unlawful as it would have infringed a...more
This motion arose in the context of a section 8 action in which Apotex claims damages for delay in the issuance of its notice of compliance for its generic lansoprazole product (Takeda's PREVACID), due to prohibition...more
In the span of a week, the Court of Appeals for the Federal Circuit vacated two district court rulings of patent invalidity under 35 U.S.C § 101. The first decision, Berkheimer v. HP Inc., vacated-in-part a grant of summary...more
Federal Circuit Summaries - Before Moore, Reyna, and Taranto. Appeal from the District Court for the Middle District of Florida. Summary: Allegations in the complaint about how the claimed invention solved problems in...more
PMPRB News - PMPRB releases scoping paper relating to proposed amended Regulations - As previously reported, on December 2, 2017, Canada’s Governor-in-Council published proposed Regulations Amending the Patented...more
In Certain Digital Cable and Satellite Products, Set-Top Boxes, Gateways and components Thereof; Inv. No. 337-TA-1049, ALJ McNamara recently denied a motion by Respondents to amend their answer to the complaint to add the...more
On September 26, 2016, District Judge Paul Oetken (S.D.N.Y.) denied defendant Jay Franco & Sons’ (“Franco”) motion to dismiss, granted plaintiff Infinity Headwear & Apparel’s (“Infinity”) motion for leave to amend to assert...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more