Exploring Procedural Justice | Judge Steve Leben | Texas Appellate Law Podcast
Handling Post-Conviction Death Penalty Cases Pro Bono | McKenzie Edwards | Texas Appellate Law Podcast
Inside the Fourth Court of Appeals’ Clerk’s Office | Michael Cruz | Texas Appellate Law Podcast
Supersedeas and Other Recent Rule Changes | Texas Appellate Law Podcast
Supreme Court Miniseries: Tribal Rights in the 21st Century
SDNY Chooses “Time Approach” to Calculating Lease Termination Damages Collectible Against a Bankrupt Estate
AGG Talks: Home Health & Hospice - Reimbursement Audits and Appeals
After ALJ: Options and Opportunities in the Face of an Unfavorable ALJ Decision
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Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care
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Law Brief®: Rich Schoenstein and New York State Senator Luis Sepúlveda Discuss The Chief Judge Controversy
Appellate Justice for Domestic Violence Survivors
Jury Charges and Oral Argument | David Keltner | Texas Appellate Law Podcast
The Evolution of Texas Appellate Practice| David Keltner | Texas Appellate Law Podcast
Podcast: California Employment News - Time to Do Away With Rounding Policies
Two Federal Courts Deal Blow to Biden Administration’s Federal Student Loan Forgiveness Program: A Close Look at the Decisions
This Am Law 50 senior counsel cements his authority through two appellate analytics blogs - Legally Contented Podcast
An Inside Look as a Juror - FCRA Focus Podcast
Reflections on 100 Episodes | Texas Appellate Law Podcast
Federal Court of Appeal (FCA) dismisses appeal on finding of inducement: Apotex Inc v Janssen Inc, 2023 FCA 220 - Apotex appealed the trial decision, finding that Apo-Macitentan would infringe Canadian Patent No. 2,659,770...more
The Federal Court of Appeal (FCA) dismissed an appeal by Merck from a decision of the Federal Court... dismissing Merck’s application for judicial review of Health Canada’s refusal to add Canadian Patent No. 2,830,806 (806...more
In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more
The U.S. Court of Appeals for the Federal Circuit’s New Year’s eve opinion in Ball Metal v. Crown Packaging, though nonprecedential, raises important considerations for pharmaceutical and biologics patents – where patent...more
The US Court of Appeals for the Federal Circuit’s February 10 decision in Acetris Health, LLC v. United States provides important guidance regarding the determination of a product’s country of origin, which is a gating issue...more
AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more
In a patent owner’s declaratory judgment action under the Biologics Price Competition and Innovation Act (“BPCIA”) a Federal Circuit panel in Amgen Inc. v. Sandoz Inc., Appeal No. 2018-1551 (Fed. Cir. May 8, 2019) narrowly...more
Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more
FCA overturns cefaclor damages decision on prejudgment interest issue, provides guidance on NIA defence - On November 23, 2018, the Federal Court of Appeal (FCA) allowed in part Apotex’s appeal of a decision awarding Eli...more
Assertions of obviousness based on prior art references in combination with “routine optimization” by one skilled in the art are common in the chemical and biological fields. The Federal Circuit recently addressed this issue...more
The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more
Apotex granted damages from contract research organization for delayed FDA approval of two products - Appeal of summary dismissal under PMNOC Regulations: dismissal order stayed...more
A federal court has handed CMS an initial legal victory enabling drastic cuts in Medicare Part B payment to take effect for separately payable drugs and biologicals purchased by hospitals under the 340B Drug Discount Program...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
On June 12, 2017, in Sandoz Inc. v. Amgen Inc., the United States Supreme Court unanimously held that a drug manufacturer may give a required 180-day notice of its intent to market a biosimilar drug before receiving FDA...more
On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more
On January 13, 2017, the Supreme Court granted certiorari in Amgen v. Sandoz, 794. F.3d 1347 (Fed. Cir. 2015) and Sandoz v. Amgen, 773 F.3d 1274 (Fed. Cir. 2014), appealed from the Federal Circuit. The petitions involve the...more
The 21st Century Cures Act ushers in significant changes to the regulatory review of drug/biologic/device combination products. The regulation of combination products has been somewhat unpredictable and muddled over the last...more
Anticipation by inherent disclosure requires that a single prior art reference necessarily includes the unstated limitation. The unpredictable nature of biological processes means that winning summary judgment of invalidity...more
Amgen has filed its appeal brief in Amgen v. Hospira, following the Federal Circuit’s denial of Hospira’s motion to dismiss the appeal for lack of jurisdiction. The appeal presents an important question for biosimilar...more
In an opinion that details many intricacies of both the Biologics Price Competition and Innovation Act of 2009 (BPCIA) and related portions of the Patent Act, the US Court of Appeals for the Federal Circuit affirmed a...more
The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more
Biosimilar Applicants Must Provide Notice of Commercial Launch: What You Need To Know - Case Background - In an opinion released today in Amgen v. Apotex, the Federal Circuit held biosimilar applicants who...more
On October 16, 2015, the Court of Appeals for the Federal Circuit (“Federal Circuit”) opted not to rehear its previously issued split decision in the court’s first analysis of the Biologics Price Competition and Innovation...more
The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more