Bar Exam Toolbox Podcast Episode 306: Spotlight on Civil Procedure (Part 3 – The Civil Lawsuit)
The Briefing: Diana Copeland – “Surviving R. Kelly” But Not Netflix’s Motion to Dismiss
(Podcast) The Briefing: Diana Copeland – “Surviving R. Kelly” But Not Netflix’s Motion to Dismiss
RICO's Person/Enterprise Distinction - RICO Report Podcast
Bar Exam Toolbox Podcast Episode 286: Listen and Learn -- Conclusory Pleadings Under Rule 12(b)(6) (Civ Pro)
Navigating Civil Standing Requirements for Defense Success — RICO Report Podcast
Episode 322 -- Checking in on Caremark Cases
Bar Exam Toolbox Podcast Episode 208: Listen and Learn -- Motions to Dismiss a Case
Podcast: The Briefing by the IP Law Blog - The Yonays Take the First Sortie in Copyright Fight With Paramount Over Top Gun Maverick
The Briefing by the IP Law Blog: The Yonays Take the First Sortie in Copyright Fight With Paramount Over Top Gun Maverick
The Briefing by the IP Law Blog: Paramount is Ready to Dogfight in Top Gun Maverick Copyright Lawsuit
Podcast: The Briefing by the IP Law Blog - Paramount is Ready to Dogfight in Top Gun Maverick Copyright Lawsuit
Podcast: The Briefing by the IP Law Blog - Cookie Co’s Motion to Dismiss Trademark Lawsuit by Restaurant Crumbles
The Briefing by the IP Law Blog: Cookie Co’s Motion to Dismiss Trademark Lawsuit by Restaurant Crumbles
Second Circuit Decision Potentially Broadens RICO Proximate Cause Element - RICO Report Podcast
Anatomy of a Successful Motion to Dismiss in RICO Case
A Discussion on the Kollaritsch v. Michigan State University Board of Trustees Decision
I-16 – Kneeling, Indefinite Leave, DC Updates, Non-Compete Consideration, and Pretty as a Protected Class
Case Involving Burger King Employee Spitting in Officer’s Burger Goes Before WA Supreme Court
Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater...more
The case relates to so-called "skinny labels," in which the filer of an Abbreviated New Drug Application ("ANDA") seeks FDA approval to market a generic version of a branded drug, but "carves out" from its label certain...more
Biofrontera AG (“Petitioner”) filed an unopposed motion to dismiss the petition during the preliminary phase of the proceedings. Here, DUSA Pharmaceuticals, Inc. (“Patent Owner”) had not yet filed a Preliminary Response, and...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
Allele v. Pfizer – The Basics. On April 23, 2021 Pfizer, Inc., BioNTechSE, and BioNTech US, Inc. (“Pfizer and BioNTech”) filed a joint reply supporting of their previously filed motion to dismiss a patent infringement...more
At the end of last month, Judge Connolly denied defendants Hospira and Pfizer’s motion to dismiss following a telephone conference with the parties. We previously reported back in February 2020 that Amgen sued Pfizer and its...more
Somewhat remarkably, there is no settled Federal Circuit precedent regarding where a patentee can bring suit against a generic competitor in Hatch-Waxman litigation under 35 U.S.C. § 271(e)(2). While recognizing that this...more
As we previously reported, on February 11, 2020, Amgen sued Pfizer and its affiliate Hospira, alleging that their proposed biosimilar of Amgen’s NEULASTA (pegfilgrastim) would infringe U.S. Patent No. 8,273,707 (“the ’707...more
BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...more
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) was passed as part of health reform signed into law by President Obama in March 2010. This year, the BPCIA turns 10. While the U.S. Biosimilars Pathway has...more
THE COURT GRANTED PLAINTIFFS’ MOTION TO DISMISS DEFENDANT’S ANTITRUST AND PATENT MISUSE COUNTERCLAIMS AND RELATED AFFIRMATIVE DEFENSES. Case Name: Duke Univ. v. Akorn, Inc., Civ. No. 3:18-cv-14035-BRM-TJB, 2019 U.S. Dist....more
Please see full Chart below for more information....more
In March this year, Amgen sued Adello Biologics under the BPCIA in the District of New Jersey for infringement of seventeen patents, based on Adello’s submission of an aBLA for a biosimilar of Neupogen® (filgrastim). In...more
As previously reported, the amended Patented Medicines (Notice of Compliance) Regulations (“Regulations”) came into force on September 21, 2017, heralding significant changes to the landscape for pharmaceutical companies in...more
Teva succeeds in section 8 bortezomib action; infringement counterclaim dismissed - On July 18, 2018, Justice Locke of the Federal Court granted Teva’s claim for compensation under section 8 of the Patented Medicines...more
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more
We have been following the Delaware Amgen v. Coherus (pegfilgrastim case). In response to Amgen’s Complaint, Coherus filed a motion to dismiss the entire suit arguing that Amgen’s Complaint failed to state a plausible claim...more
The US District Court for the Eastern District of Texas granted defendants' motion to amend their pleadings after the deadline for amending had passed. Allergan v. Teva Pharmaceuticals USA, No. 15-1455-WCB, 2017 WL 1512334...more
In Mylan v. Aurobindo the Circuit affirms the grant of a preliminary injunction based upon the infringement of one of the three patents in suit. However, the panel reverses the injunction as to the other two patents based on...more
On March 17, 2017, District Judge Robert Sweet (S.D.N.Y.) granted plaintiff Icahn School of Medicine at Mount Sinai's ("Mt. Sinai") motion to strike defendant Neurocrine Biosciences ("Neurocrine") affirmative defenses of...more
On-Sale Bar Is No Bar for Selling Manufacturing Services to the Inventor - Addressing what constitutes an invalidating “sale” under § 102(b), the US Court of Appeals for the Federal Circuit sitting en banc affirmed the...more
The Federal Circuit has now issued two decisions interpreting the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In Amgen v. Sandoz, the first decision to interpret the BPCIA, the majority held that...more
Magistrate Recommends That Defendants' Motion to Dismiss Be Allowed for Kit Claims and Denied for Method Claims - Last month, in Oxford Immunotec Ltd. v. Qiagen, Inc., Magistrate Judge Donald L. Cabell of the U.S....more
As we reported, in a litigation regarding Hospira’s planned biosimilar for Amgen’s epoetin alfa, sold under the brand names Epogen and Procrit, in May, 2016, the District Court (D.Del., J. Andrews) denied Amgen’s motion to...more
Judge Chesler of the U.S. District Court for the District of New Jersey has dismissed one of Amgen’s pending lawsuits against Sandoz under the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act...more