Life Sciences

127 Search Results

Contingent Value Rights: A Middle Ground in M&A Boom

San Francisco partner Ryan Murr is the author of “Contingent Value Rights: A Middle Ground in M&A Boom” [PDF] published in the September 11, 2014 issue of the Daily Journal.

Client Alert | September 11, 2014

Long-Term Outlook for M&A is More Modest

San Francisco partner Ryan Murr is the author of “Long-Term Outlook for M&A is More Modest” [PDF] published in the August 27, 2014 issue of the Daily Journal.

Client Alert | September 9, 2014

2014 Mid-Year False Claims Act Update

I. INTRODUCTION It has been an explosive past six months in matters under the federal False Claims Act ("FCA"), 31 U.S.C. § 3729 et seq., which prohibits the knowing submission of false claims for payment to the government or false statements material to false claims.

Client Alert | July 9, 2014

2014 Mid-Year Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

As the debate continues over whether and how to punish companies for unlawful conduct, U.S.

Client Alert | July 8, 2014

To Institute or Not to Institute IPR? That Question Is Not Immediately Reviewable by the Federal Circuit

In a series of three opinions issued on April 24, 2014, the Federal Circuit has decided that decisions by the Director of the U.S. Patent & Trademark Office to institute -- or not to institute -- an inter partes review ("IPR") under 35 U.S.C.

Client Alert | May 5, 2014

2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 2)

Washington, D.C. partner Joseph Warin and associates Brendan Fleming and J. Matt Williams are the authors of "2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 2)" [PDF] published in the May 2014 issue of Westlaw Journal's White Collar Crime.Part 1 of this article was published in April 2014 (http://www.gibsondunn.com/publications/Pages/2013-Year-End-Update-on-Corporate.aspx).

Client Alert | May 1, 2014

2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 1)

Washington, D.C. partner Joseph Warin and associates Brendan Fleming and J. Matt Williams are the authors of "2013 Year-End Update on Corporate Non-Prosecution Agreements and Deferred Prosecution Agreements (Part 1)" [PDF] published in the April 2014 issue of Westlaw Journal's White Collar Crime.

Client Alert | April 1, 2014

U.S. Supreme Court Places the Burden of Proving Infringement on Patent Holders in Declaratory Judgment Actions

On January 22, 2014, the Supreme Court decided Medtronic, Inc. v. Mirowski Family Ventures, LLC, 571 U.S.

Client Alert | January 23, 2014

2013 Year-End False Claims Act Update

$3.8 Billion—That is the approximate amount recovered by the federal government last year alone in settlements and judgments under the False Claims Act, 31 U.S.C.

Client Alert | January 8, 2014

2013 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

Since their emergence in the early 1990s, and especially in the past decade, Non-Prosecution Agreements (“NPAs”) and Deferred Prosecution Agreements (“DPAs”) (collectively, “agreements”) have become embedded in the toolbox of U.S.

Client Alert | January 7, 2014

Comparing Strategies in MFW Shareholders and Siga v. PharmAthene

San Francisco partner Thad Davis and associate Leslie Wulff are the authors of “Comparing Strategies in MFW Shareholders and Siga v. PharmAthene” [PDF] published in the December 25, 2013 edition of the Delaware Business Court Insider.

Client Alert | December 25, 2013

World War Z: Why Life Sciences Companies May be in the Path of the “New” Securities Enforcement & Litigation Onslaught, & How to Avoid Trouble

San Francisco partners Thad Davis and Michael Li-Ming Wong are the authors of “World War Z: Why Life Sciences Companies May be in the Path of the ‘New’ Securities Enforcement & Litigation Onslaught, & How to Avoid Trouble” published in Expert Guide: Fraud and White Collar Crime in August 2013.

Client Alert | August 1, 2013

2013 Mid-Year False Claims Act Update

$5 Billion! That's the approximate amount recovered by the federal government from settlements and judgments in cases filed under the federal False Claims Act, 31 U.S.C.

Client Alert | July 10, 2013

United States Sentencing Commission Adopts Greater Penalties for Fraud Offenses and Fixes Anomaly in Sentences for Tax Crimes

On April 10, 2013, the United States Sentencing Commission promulgated its annual amendments to the federal sentencing guidelines.  Reacting to congressional directives, the Commission voted to increase penalties for (1) theft and fraud involving pre-retail medical products, (2) trafficking in counterfeit drugs and military equipment, and (3) foreign dissemination of stolen trade secrets.  The Commission also made an important change that will reduce sentences for tax offenses.  A current rule in several federal circuits frequently causes "tax loss" to be overstated for sentencing purposes because it directs courts to look solely at the amount of undeclared income to determine the tax impact of an offense.  The amendment will require courts also

Client Alert | April 23, 2013

The European Commission Launches a Consultation Process in Relation to the Manufacturing Practices for Medicinal Products

On 17 January 2013, the European Commission (the "Commission") initiated a public consultation in relation to the revision of its Good Manufacturing Practice Guidelines (the "GMP Guidelines").

Client Alert | February 27, 2013

2012 Year-End Health Care Enforcement Update

2012 saw a continuation of the trends we have seen in health care enforcement in recent years--wide-ranging enforcement activity, historic settlements, strict settlement terms, and tough penalties for individuals.

Client Alert | February 22, 2013

Off-Label Promotion: Still a Crime?

San Francisco of counsel Winston Chan and associate Deena Klaber are the authors of “Off-Label Promotion: Still a Crime?” [PDF] published in the January 14, 2013 issue of The Recorder.  

Client Alert | January 14, 2013

2012 Year-End False Claims Act Update

For years, the Department of Justice ("DOJ") has sought recoveries under the False Claims Act, 31 U.S.C. §§ 3729-33 (the "FCA" or the "Act"), with a torrid pace.

Client Alert | January 8, 2013

2012 Year-End Update on Corporate Deferred Prosecution Agreements (DPAs) and Non-Prosecution Agreements (NPAs)

"Over the last decade, DPAs [Deferred Prosecution Agreements] have become a mainstay of white collar criminal law enforcement," Lanny Breuer, the head of the U.S.

Client Alert | January 3, 2013

The End of Off-Label Prosecutions? The Second Circuit Rules That a Pharmaceutical Sales Representative’s Criminal Conviction for Off-Label Promotion Violates the First Amendment

In an opinion with potentially far-reaching ramifications for pharmaceutical and medical device manufacturers, a split panel of the Second Circuit Court of Appeals held on December 3, 2012, that the First Amendment precludes Alfred Caronia's conviction for conspiring to introduce a misbranded drug into interstate commerce in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) because his off-label promotion was constitutionally protected speech.

Client Alert | December 4, 2012

With a Scalpel Not a Sledgehammer: Resolving FDCA Investigations through Deferred Prosecution and Non-Prosecution Agreements

Washington, DC of counsel Steven Tave and associate Jeremy Joseph are the authors of “With a Scalpel, Not a Sledgehammer: Resolving FDCA Investigations through Deferred Prosecution and Non-Prosecution Agreements” [PDF] published in the November/December issue of Update magazine.  Republished with the permission of FDLI.

Client Alert | November 1, 2012

2012 Mid-Year False Claims Act Update

For years, on these pages, we have marveled at the precipitous increase in False Claim Act (FCA) enforcement.

Client Alert | July 12, 2012

2012 Mid-Year Update on Corporate Deferred Prosecution and Non-Prosecution Agreements

Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements ("NPAs") (collectively, "agreements") in recent years have become a primary tool of the U.S.

Client Alert | July 10, 2012

U.S. Supreme Court Issues Long-Awaited Decision on the Constitutionality of the Affordable Care Act

On June 28, 2012, the Supreme Court issued its decision on the constitutional challenges to two components of the Patient Protection and Affordable Care Act of 2010 ("ACA").  The plaintiffs in National Federation of Independent Business v. Sebelius sought to invalidate both (1) the individual mandate, which requires most persons to purchase health insurance beginning in 2014 or pay a penalty for failure to do so; and (2) the expansion of the Medicaid program, which, among other things, requires States to expand Medicaid coverage and threatens the loss of all federal Medicaid funding for States that do not comply.  In a 5-4 decision written by Chief Justice Roberts, the Supreme Court held that although the individual mandate is not a proper exercise of Congress's power u

Client Alert | June 29, 2012

In a Ruling with Important Implications for Courts’ Deference to Agencies, U.S. Supreme Court Rejects Department of Labor Position on Overtime for “Outside Sales” Employees

The United States Supreme Court ruled yesterday that pharmaceutical sales representatives are "outside sales" employees who are exempt from the overtime requirements of the Fair Labor Standards Act ("FLSA").

Client Alert | June 19, 2012

Supreme Court Tightens the Standard for Patent Eligibility Under Section 101 of the Patent Act

On March 20, 2012, the Supreme Court issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. __ (2012), addressing the scope of the "laws of nature" exception to the definition of patentable subject matter set out in 35 U.S.C.

Client Alert | March 21, 2012

2011 Year-End Health Care Compliance Update

Gibson Dunn provides a detailed review of notable settlements and judgments in the health care area in 2011 as well as significant actions and investigations.

Client Alert | February 6, 2012