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A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous... more +
A repository for the most well-read content on JD Supra at any given time, along with occasional roundups of popular content by specific topic. Also stop by for monthly recaps of hot articles for the previous thirty days. less -
BakerHostetler

A Later-Discovered Improvement to an Invention Cannot Be Used To Reach Back and Invalidate an Earlier-Filed Patent

BakerHostetler on

Novartis markets and sells a combination therapy of valsartan and sacubitril under the brand name Entresto® for the treatment of various forms of heart failure. MSN submitted an Abbreviated New Drug Application seeking...more

Goodwin

Life Sciences M&A Trends for 2023 and 2024 (Through End of Q3) in Greater China

Goodwin on

Goodwin is presenting a two-part publication series covering life sciences trends involving license deals, M&A, and financing for Greater China’s life sciences sector. ...more

Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

Venable LLP on

As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Polsinelli

Regeneron v Novartis and Vetter: Walker Process Client Update

Polsinelli on

In an appeal that attracted a dozen amici, including the Department of Justice, the Federal Trade Commission, five states, and the District of Columbia, the Second Circuit gave the Walker Process antitrust doctrine a shot in...more

Fish & Richardson

District of Delaware Finds Non-Orange Book-Listed Patents Subject to the Same Pleading Standard as Listed Patents in ANDA...

Fish & Richardson on

As part of the Hatch-Waxman Act, given the lack of information on the allegedly infringing product, courts have found that patentees can satisfy the pleading requirements of Twombly/Iqbal without having access to the accused...more

Skadden, Arps, Slate, Meagher & Flom LLP

Novartis’ $678 Million Settlement Sets Guideposts for Life Sciences Industry Speaker Programs

Skadden, Arps, Slate, Meagher & Flom LLP on

Novartis Pharmaceuticals Corporation (Novartis) recently entered into a civil settlement agreement with the Department of Justice (DOJ) to resolve allegations that the company paid health care practitioners (HCPs) who spoke...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 4 – CIA Structural Requirements

Thomas Fox - Compliance Evangelist on

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Akerman LLP - Health Law Rx

Novartis’ Simultaneous Settlements Break Records

Akerman LLP - Health Law Rx on

Novartis Pharmaceuticals Corporation (Novartis) has started July with significant settlements, putting two different fraud and abuse matters behind them. In what has been identified as the largest settlement of an...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 3 – Compliance Failures

Thomas Fox - Compliance Evangelist on

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Arnall Golden Gregory LLP

CIA Imposes Requirements for Pharmaceutical Speaker Programs and Events

Arnall Golden Gregory LLP on

On July 1, 2020, the United States Department of Justice (DOJ) announced two settlements with Novartis Pharmaceuticals Corporation (“Novartis”), resolving allegations that the company had paid illegal kickbacks to physicians...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 2 – The Corruption Schemes

Thomas Fox - Compliance Evangelist on

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, that enforcement action paled next to two resolutions...more

Thomas Fox - Compliance Evangelist

Novartis US Corruption Settlements: Part 1 – Introduction

Thomas Fox - Compliance Evangelist on

I have written extensively about the Novartis International AG (Novartis) Foreign Corrupt Practices Act (FCPA) settlement, which was announced in late June. However, the enforcement action paled next to the Stipulation and...more

Morrison & Foerster LLP

Top 10 International Anti-Corruption Developments For June 2020

Morrison & Foerster LLP on

In order to provide an overview for busy in-house counsel and compliance professionals, we summarize below some of the most important international anti-corruption developments from the past month, with links to primary...more

Farrell Fritz, P.C.

Novartis Agrees To $678 Million False Claims Act Settlement With SDNY For Sham Speaker Programs

Farrell Fritz, P.C. on

Novartis Pharmaceuticals Corp. agreed earlier this month to pay $678 million to settle an SDNY False Claims Act case. The SDNY alleged that Novartis violated the False Claims Act and the Anti-Kickback Statute by giving...more

Vinson & Elkins LLP

Novartis’ And Alcon’s $345 Million FCPA Case Signals Increased Scrutiny Of Gifts And Entertainment And New Focus On Scientific...

Vinson & Elkins LLP on

On June 25, 2020, Novartis AG, a Swiss multinational pharmaceutical company, and two subsidiaries reached a combined $345 million resolution with the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Data Analytics and Lessons Learned

Thomas Fox - Compliance Evangelist on

This blog post will close my review of the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Fines, Penalties and the Cost of Recidivism

Thomas Fox - Compliance Evangelist on

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

The Volkov Law Group

Novartis and Alcon FCPA Enforcement Action: Lessons Learned (Part III of III)

The Volkov Law Group on

At the outset, Novartis is “lucky” – the settlement is relatively positive, despite its 2016 SEC enforcement action in China.  Given Novartis weak culture of compliance (if anything, a better description may be a culture of...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Internal Controls

Thomas Fox - Compliance Evangelist on

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

The Volkov Law Group

Novartis and Alcon: A Review of Bribery and Accounting Violations (Part II of III)

The Volkov Law Group on

Novartis and Alcon engaged in separate but significant bribery schemes.  Considering the fact that Novartis had a similar violation in 2016 in China involving much of the same conduct, Novartis’ conduct reflects a weak...more

The Volkov Law Group

Novartis and Alcon Settle FCPA Violations for $345 Million (Part I of III)

The Volkov Law Group on

Even during this difficult time of the pandemic, economic uncertainty and social unrest, the Justice Department and the SEC have concluded a major FCPA enforcement action....more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: The Bribery Schemes

Thomas Fox - Compliance Evangelist on

This week I am reviewing the Foreign Corrupt Practices Act (FCPA) enforcement action involving the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte Ltd.,...more

Thomas Fox - Compliance Evangelist

Novartis FCPA Enforcement Action: Introduction

Thomas Fox - Compliance Evangelist on

Proving that the era of large Foreign Corrupt Practices Act (FCPA) enforcement action is not over, the Swiss pharmaceutical company Novartis AG, its Greek subsidiary Novartis Hellas S.A.C.I. (Novartis Greece) and Alcon Pte...more

McDonnell Boehnen Hulbert & Berghoff LLP

Life Sciences Court Report - February 2020

McDonnell Boehnen Hulbert & Berghoff LLP on

About Life Sciences Court Report:  We will periodically report on recently filed biotech and pharma litigation. Allergan USA, Inc. v. Prollenium US Inc. 1-20-cv-00104; filed January 23, 2020 in the District Court of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharmaceuticals Corp. v. West-Ward Pharmaceuticals Int'l (Fed. Cir. 2019)

McDonnell Boehnen Hulbert & Berghoff LLP on

The Federal Circuit exhibited the current status of its obviousness jurisprudence in affirming the District Court's determination that the asserted claims of U.S. Patent No. 8,410,131 were obvious in a decision handed down...more

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