There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more
As previously reported, the Federal Court released a pair of decisions relating to paliperidone palmitate (Janssen’s INVEGA SUSTENNA), finding in a summary trial that each of Pharmascience and Apotex would induce infringement...more
The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed. Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more
Last week, Samsung Bioepis filed an IPR petition challenging claims of U.S. Patent No. 11,253,572 (“the ’572 patent”), owned by Regeneron Pharmaceuticals. According to the petition, the claims are directed to the use...more
On March 10, 2023, the PTAB denied institution of IPR2022-1524, filed by Apotex Inc. regarding Regeneron’s Patent No. 11,253,572. As we previously reported, Apotex filed an IPR petition against the ’572 patent in...more
Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more
As previously reported, the Federal Court found Janssen’s Canadian Patent No. 2,661,422 (the 422 patent) invalid on the basis of obviousness and dismissed its actions against Apotex, Dr. Reddy’s Laboratories, and...more
Apotex Inc. recently filed an IPR petition, IPR2022-01524, seeking cancellation of claims 1-14 and 26-30 of U.S. Patent No. 11,253,572 assigned to Regeneron Pharmaceuticals, Inc. The challenged claims generally relate...more
On March 8, 2021, the Ontario Superior Court of Justice dismissed Apotex’s claims against Eli Lilly (Lilly) under the Statute of Monopolies, Trademarks Act, and common law conspiracy relating to Canadian Patent No. 2,041,113...more
In a public decision dated July 6, 2022 in an action under the Patented Medicines (Notice of Compliance) Regulations, Justice Pallotta of the Federal Court found that Apotex would infringe Janssen’s patent relating to...more
In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more
On September 27, 2021, the Ontario Superior Court of Justice granted Pfizer’s motion for summary judgment and dismissed Apotex’s claims for treble damages and double costs under the Ontario and English Statutes of Monopolies,...more
As previously reported, Apotex sought leave to appeal a decision of the Federal Court of Appeal (2021 FCA 52) affirming a Federal Court decision finding that the claims of a patent relating to lisdexamfetamine (Shire’s...more
The healthcare industry faces cascading risks – one risk flows to another with compounding financial results. Three generic drug companies just experienced this cascading liability. ...more
September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
Update: On September 28, 2021, Apotex applied to the Supreme Court of Canada for leave to appeal (Docket No. 39851). On July 23, 2021, the Federal Court of Appeal (FCA) dismissed Apotex’s appeal of the Federal Court’s (FC)...more
As previously reported, the Federal Court of Appeal dismissed Apotex’s appeal from a decision holding that the claims of a patent relating to lisdexamfetamine (Shire’s VYVANSE) were valid and prohibiting the Minister of...more
As previously reported, in the final decision released under the pre-amended Patented Medicines (Notice of Compliance) Regulations (Regulations), the Federal Court granted a prohibition order relating to Canadian Patent No....more
Update: On October 7, 2021, the Supreme Court of Canada denied Apotex’s leave to appeal (Apotex v Shire, Docket No. 39662). The Federal Court of Appeal (FCA) recently dismissed an appeal by Apotex from a decision of the...more
Alimta® (pemetrexed disodium) - Case Name: Eli Lilly & Co. v. Apotex, Inc., No. 2020-1328, 2020 WL 7490251 (Fed. Cir. Dec. 21, 2020) (Circuit Judges Prost, Bryson, and Stoll presiding; Opinion by Stoll, J.) (Appeal from...more
2020 has been referred to as an unprecedented year for the world in so many ways—the pandemic, the California and Washington fires, the racial justice protests and calls to action—but that didn’t stop the Federal Circuit from...more
On September 24, 2020, the Supreme Court of Canada denied leave to Apotex (Docket No. 39172) with respect to a decision affirming the quantum of profits payable to the Plaintiffs ADIR and Servier for infringement of ADIR’S...more
CONVERTING FROM A PIV CERTIFICATION TO A PIII CERTIFICATION DOES NOT RID THE DISTRICT COURT OF SUBJECT MATTER JURISDICTION, BUT IT DOES WARRANT GRANTING DEFENDANT’S MOTION FOR JUDGMENT ON THE PLEADINGS. Case Name: H....more
UPDATE: UPDATE: On December 10, 2020, the Supreme Court of Canada dismissed Pfizer’s application for leave to appeal (Docket No. 39150) (see article here). Pfizer seeks leave in pregabalin section 8 case As previously...more
UPDATE: On November 3, 2020, the Federal Court of Appeal dismissed Amgen’s appeal. See our article here. On April 16, 2020, Justice Southcott of the Federal Court issued the first decision under the amended Patented...more