Pfizer

News & Analysis as of

Court Report - April 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Forest Laboratories, LLC et al. v. Amerigen Pharmaceuticals, Inc. et al. 1:15-cv-00966; filed October 23, 2015 in the...more

Second Circuit Stresses Control, Not Attribution, In Applying Janus’s “Ultimate Authority” Test, And Also Allows Expert Testimony...

In Janus Capital, the Supreme Court established the “ultimate authority” test to determine who may be liable under Section 10(b) of the Securities Exchange Act of 1934 (“Exchange Act”) as a “maker” of a materially misleading...more

Court Report - April 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals, LLC et al. v. Amneal Pharmaceuticals, LLC 1:15-cv-00964; filed October 22, 2016 in the District...more

FDA Announces Approval of Second U.S. Biosimilar

On April 5, the FDA issued its approval for Inflectra, Celltrion and Pfizer’s biosimilar of Johnson & Johnson’s Remicade (infliximab). Inflectra is now the second biosimilar approved for sale in the United States, after...more

FDA Approves Second Biosimilar – Inflectra™ – The First Monoclonal Antibody Biosimilar

The U.S. Food and Drug Administration announced on April 5 its second ever approval of a biosimilar – Inflectra (infliximab-dyyb) – for multiple indications. Inflectra was developed by Celltrion Inc. and licensed to Pfizer...more

Proposed Regulations Would Fundamentally Change Treatment of Intra-Group Debt Transactions

On April 4, 2016, the U.S. Department of the Treasury and Internal Revenue Service (IRS) issued two sets of regulations, temporary regulations addressing “inversion” transactions and proposed regulations regarding the...more

Your daily dose of financial news The Brief – 4.8.16

The Deal Professor looks back on a wild week of “deal busting” that saw the government [often in the form of Treasury Secretary Jack Lew] put the hurt on Pfizer/Allergan and Halliburton/Baker Hughes alike –...more

Your daily dose of financial news The Brief – 4.7.16

The DOJ has moved to block the proposed Halliburton/Baker Hughes merger in a Delaware-based federal lawsuit that argues that “combining the two oil field services companies would cut competition in the industry to...more

New Temporary Inversion Regulations

The IRS once again is targeting inversions, and this time there have been immediate tangible results. The IRS issued temporary regulations on Monday targeting inversion transactions. An inversion occurs where a foreign...more

Your daily dose of financial news The Brief – 4.6.16

Talk about a regulation with teeth. Within days of the Treasury Department announcing new rules meant to discourage corporate tax inversion deals, Pfizer and Allergan announced they were scrapping their planned $152 billion...more

Your daily dose of financial news The Brief – 4.5.16

Big news from Big Mouse, as the former heir apparent to Bog Iger’s CEO chair—Thomas Staggs—is stepping down, throwing a wrench into Disney’s succession plans (which came under great scrutiny after a troublesome handoff to...more

The Art of the Drug Ad

Television spots touting prescription medications have flooded the airwaves for nearly 20 years. During that time, pharmaceutical companies marketing their products have become surprisingly savvy at delivering the message....more

Fourth Circuit Says Driving May Not Be Essential Job Function for Traveling Salesperson

Most employers would assume that a traveling salesperson who could no longer drive due to a medical condition cannot perform the essential functions of her job. The Americans with Disabilities Act only requires accommodations...more

Is Driving An “Essential Function Of The Job” For Your Road Warriors?

If your employee isn’t a professional driver but spends a lot of time on the road, how “essential” a job function is driving for ADA purposes? Is driving “essential” at all? In what I consider to be a very significant...more

Time Between Original and Corrected Restriction Requirement Nets No Further Patent Term Adjustment (Pfizer, Inc. v. Lee)

Addressing patent term adjustment issues, the U.S. Court of Appeals for the Federal Circuit affirmed the U.S. Patent and Trademark Office’s (USPTO) decision not to adjust the term of a patent, where the 197-day delay resulted...more

Blog: Director Resignation Policies Under Fire

The originator of the “Pfizer model” of “plurality plus” voting for directors — Pfizer — will be facing a shareholder proposal (January 29, from the Chevedden folks) calling for a change to Pfizer’s governing documents and...more

Viagra — Melanoma Lawsuits Mounting

The Judicial Panel on Multidistrict Litigation will hold a hearing to consider a request to establish coordinated national litigation against the manufacturers of Viagra. The Judicial Panel is a group of federal judges who...more

Pfizer, Inc. v. Lee (Fed. Cir. 2016)

Last month, in Pfizer, Inc. v. Lee, the Federal Circuit determined that the District Court for the Eastern District of Virginia did not err in granting summary judgment in favor of the U.S. Patent and Trademark Office on the...more

FDA Regulatory and Compliance Monthly Recap — January 2016

OPDP enforcement reaches record low in 2015 as drugmakers face uncertainty in digital marketing - Enforcement by the OPDP has fallen notably since 2010. The decline has been attributed, in part, to the agency's slow...more

Pfizer v. Lee: A Patent Term Adjustment Double Standard?

In Pfizer v. Lee (No. 2015-1265, January 22, 2016), the Federal Circuit upheld the U.S. Patent and Trademark Office’s (USPTO) determination that the toll period for A-type patent term adjustment (PTA) delay stops upon the...more

Federal Circuit Holds a Defective Restriction Requirement Ends Patent Term Adjustment

In Pfizer v. Lee, the Court of Appeals for the Federal Circuit held that a “defective” restriction requirement was sufficient to stop the period of patent term adjustment granted when the U.S. Patent and Trademark Office...more

Incomplete Restriction Requirement Stops Clock For Patent Term Adjustment

In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running...more

Canadian Court Nixes Class Action for Patent Abuse

The decision relates to an application to certify a proposed class action, commenced by a representative plaintiff, Britton Low, against various Pfizer companies, alleging that Pfizer unlawfully abused the patent system with...more

IRS Continues Focus on Corporate Inversions

The Internal Revenue Service (IRS) continues its focus on perceived abuses in corporate inversion transactions. On November 19, the IRS released Notice 2015-79, which places new limitations on the ability of a U.S....more

Life Sciences Spotlight - Asia Pacific - Issue 6, 2015

Trends and developments in cyber security and data protection: Why pharma and life sciences companies should take action. Pharmaceutical and life sciences companies are increasingly the target of cyber-attacks and...more

93 Results
|
View per page
Page: of 4
JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×