GlaxoSmithKline

News & Analysis as of

Weight Loss Supplement Alli Recalled Nationwide

Just to be safe, drugmaker GlaxoSmithKline (GSK) Consumer healthcare will remove all of its weight loss drug alli from stores shelves in the U.S. and Puerto Rico due to fear of contamination. There have been at least 20...more

If Written Description Matches Claim Scope, No § 112 Problem - GlaxoSmithKline LLC v. Banner Pharmacaps, Inc.

The U.S. Court of Appeals for the Federal Circuit affirmed a district court rejection of a written description challenge to patentability, concluding that under either parties’ construction of a disputed claim term the...more

“Brand” New Law: Illinois Court Holds Brand Manufacturers Owe Duty of Care to Generic Users

Last week, a federal district court in Illinois held that GlaxoSmithKline (GSK), a branded drug manufacturer, owed a duty of care to a patient who took the generic version of its drug. Dolin v. SmithKline Beecham Corp., No....more

Federal Circuit Finds Easy Solution to Avodart Solvate Written Description Question

Are claims that recite a “solvate” of a chemical compound invalid for lack of written description if the patent does not describe any specific solvates? In GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., the Federal Circuit...more

Federal Circuit Finds Sufficient Written Description

The Federal Circuit recently affirmed the District of Delaware’s rejection of a lack of written description defense in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc., No. 2013-1593 (Fed. Cir. 2014). GlaxoSmithKline sued...more

GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. (Fed. Cir. 2014)

The Federal Circuit issued an opinion on Monday in GlaxoSmithKline LLC v. Banner Pharmacaps, Inc. illustrating how difficult it can be to overturn a district court determination based on a question of fact, at least when the...more

District of New Jersey Finds Settlement Without Reverse Payment Is Not Subject To Anti-Trust Scrutiny

On January 24, 2014, in In re Lamictal Direct Purchaser Antitrust Litigation, No. 12-cv-995, 2014 U.S. Dist. LEXIS 9257 (D.N.J. Jan. 24, 2014), Senior District Judge William H. Walls dismissed a putative, antitrust-class...more

Little Help From My Friends – Predictions For Ethics And Compliance In 2014

When it comes to predicting ethics and compliance trends and events for the new year, I admit I needed some help. So I reached out to two leading ethics and compliance specialists in the industry – Donna Boehme and Michael...more

What Hath GSK Wrought? More Compliance Lessons From China

In an article, entitled “GSK China probe flags up wider worries”, in the Wednesday edition of the Financial Times (FT) reporters Andrew Jack and Patti Waldmeir discussed the ongoing bribery and corruption scandal involving...more

GlaxoSmithKline Announces Further Limits on Payments to Physicians and on Sales Compensation

GlaxoSmithKline (“GSK” or the “Company”) announced yesterday that it will stop paying health care professionals to promote its drug products and will no longer tie the compensation of its worldwide sales force to individual...more

Letter From China-Interview With Amy Sommers

Ed. Note-this article is one of a continuing series of interviews of thought leaders in FCPA, Bribery Act and anti-corruption/anti-bribery. In this blog post, I interview Amy Sommers, partner in the Shanghai office of K&L...more

Joan Fontaine And The Evolution Of Compensation Issues In A Compliance Program

Compliance programs evolve just as the thinking on best practices has changed over the past few years. One of the areas that has not received as much attention in compliance programs is the amount of compensation paid to...more

The Miami Dolphins-A Code Red For Compliance

Tom Cruise: Did you order a Code Red? Jack Nicolson: You’re G__D__ right I ordered a Code Red. The above lines were spoken in the movie version of “A Few Good Men”. If there was ever one scene which demonstrated...more

Does Motive Matter In Anti-Bribery And Anti-Corruption Enforcement?

Do the intentions behind enforcement of domestic or international anti-corruption laws matter? Or is ‘the law the law’ and it really does not matter what a government’s motives are in enforcing laws that it has on the books....more

FCPA Compliance and Ethics Report-Episode 15-GSK in China: a Game Changer in Compliance [Video]

In this Episode 15, I am interviewed by Mary Flood about my recent eBook, GSK in China: a Game Changer in Compliance. I believe that this case will be one of the most significant international anti-corruption developments in...more

1066 And All That: Why The International Fight Against Corruption?

If there is one event in history of Western Civilization which could be said to be a true turning point, today is the anniversary of one of the very top echelon. On this date in 1066, William the Conqueror defeated Harold II,...more

The Harvest Moon Will Shine A Light On Compliance

The Harvest Moon is generally considered to be the full moon closest to the Autumn Equinox; the day in the fall when night and day are most equal in length. In folklore, the Harvest Moon was a symbol of fruitfulness allowing...more

GSK In China: A Game Changer for Compliance

The allegations of bribery and corruption by the UK company GlaxoSmithKline are a true game changer for the compliance world. This is the first time that the Chinese have enforced their domestic anti-corruption laws against...more

The Risks Of A Defective Internal Investigation

Lawyers and compliance professionals repeatedly tout the importance of an internal investigation to protecting a company from devastating consequences from an enforcement action....more

Welcome Back My Friends To The Show That Never Ends

...“Welcome back my friends” would certainly seem to be an excellent way to introduce today’s topic; that being the stunning report in the Sunday New York Times (NYT), that JP Morgan is under Foreign Corrupt Practices Act...more

Where’s The Ball? Lesson For The Compliance Practitioner In China

Where’s the ball? That iconic question was asked by Oakland A’s center fielder Chris Young to Houston Astro left fielder Robbie Grossman near second base late Wednesday night, as Grossman was returning to the dugout after...more

To Blow or Not to Blow — this is the Whistleblower’s Question

Cheryl D. Eckard was drug giant GlaxoSmithKline's (GSK) quality manager. In 2002, she was sent to the company's primary plant in Puerto Rico to fix problems cited by the U.S. Food & Drug Administration (FDA). Eckard quickly...more

GSK And Missed Red Flags In China

One of the questions that GlaxoSmithKline PLC (GSK) will have to face during the next few years of bribery and corruption investigations is how an allegedly massive bribery and corruption scheme occur in its Chinese...more

The Films Of Satyajit Ray And The GSK China Investigation: Both Game-Changers

If you are in London this week, I might suggest that you drop by the British Film Institute (BFI), which is celebrating the work of the Indian film maker, Satyajit Ray....more

Lessons Learned from the GlaxoSmithKline Bribery Investigation

The recent enforcement of Chinese anti-bribery laws against British pharmaceutical company GlaxoSmithKline (GSK) highlights the compliance challenges faced by foreign companies operating in China....more

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