94 Search Results

December 2, 2020 |
Gibson Dunn Named a 2020 Firm of the Year

Law360 named Gibson Dunn a Firm of the Year for 2020 in its November 30, 2020 article "The Firms That Dominated in 2020,” featuring eight firms that received the most Practice Group of the Year awards.  The publication noted that its Firms of the Year are honored “for guiding landmark deals, scoring victories in high-profile disputes and helpi

October 8, 2020 |
LMG Life Sciences Names 13 Partners as Stars

In the 2020 edition of LMG Life Sciences, Gibson Dunn was recognized in six practice areas: Competition & Antitrust, General Corporate, General Patent Litigation, Mergers & Acquisitions, Product Liability & Recall and White-Collar/Government Investigation. The publication also named 13 Gibson Dunn partners as stars in the field of l

September 22, 2020 |
Thirteen Gibson Dunn Partners Recognized in Expert Guides’ Women in Business Law

Expert Guides has named 13 Gibson Dunn partners to its 2020 Guide to the World’s Leading Women in Business Law, which recognizes top female legal practitioners advising on business law. Selection to this guide is determined by a survey of fellow legal practitioners. The Gibson Dunn partners included in the guide are Hong Kong partners Kelly Austi

September 8, 2020 |
Corporate Partner Robert Phillips Joins Gibson Dunn in San Francisco

Gibson, Dunn & Crutcher LLP is pleased to announce that Robert Phillips has joined the firm’s San Francisco office as a partner.  Phillips, formerly a partner at Cooley LLP, will continue to focus on corporate and capital markets transactions for life sciences and technology companies. “We extend an enthusiastic welcome to Rob,” said

June 8, 2020 |
Jane Love Named Among Top Women in IP 2020

New York partner Jane Love was named to Managing IP’s Top 250 Women in IP 2020, which recognizes the “senior female IP practitioners in private practice who have performed exceptionally for their clients and firms in the past year.” The list was published May 29, 2020. Jane Love is Co-Chair of the Life Sciences practice group. She is a fir

May 13, 2020 |
Update on Intellectual Property-Related Issues in the Response to COVID-19

This Alert reports on the steady pace of patent litigation and patent review filings during the COVID-19 pandemic, and notes that some aspects of ongoing patent litigation are also proceeding as usual.  The Alert also discusses intellectual property litigation involving a hand sanitizer manufacturer, and provides brief updates on

May 6, 2020 |
Webcast: Pharma, Medical Device, and Biotech Antitrust Update: New Developments and What They Mean

Antitrust authorities in the U.S. and Europe have increasingly emphasized the importance of policing competition in innovation-driven health care markets, including pharmaceuticals, biologics, medical devices, and biotech. During and after the COVID-19 crisis, companies can expect greater demands on industry participants to collaborate, as governme

April 1, 2020 |
Jane Love Named a Health Care/Life Science Trailblazer

The National Law Journal named New York partner Jane Love among its 2020 Health Care/Life Science Trailblazers. Love was recognized for her work representing “Novartis AG’s multiple sclerosis drug Gilenya in cases impacting patent owners and challengers across the pharmaceutical and biotech industries.” The report was published on April 1, 2

March 30, 2020 |
COVID-19 And Life Sciences Companies – 10 Actions To Consider

The COVID-19 outbreak has caused major disruptions in global economies, including in particular to life sciences companies that are conducting clinical trials and manufacturing and marketing pharmaceutical products. The following ten actions are among those that life sciences companies may wish to consider in light of current event

March 17, 2020 |
Life Sciences Partner Karen Spindler Joins Gibson Dunn

Gibson, Dunn & Crutcher LLP is pleased to announce that Karen Spindler has joined the firm’s San Francisco office.  Spindler, formerly a partner at Goodwin Procter, will continue to focus on advising life sciences companies on complex corporate, commercial and intellectual property transactions. “We welcome Karen to the firm,” said Ke

November 12, 2019 |
Law360 Names Nine Gibson Dunn Partners as 2019 MVPs

Law360 named nine Gibson Dunn partners among its 2019 MVPs and noted that Gibson Dunn was one of two law firms with the most MVPs this year.  Law360 MVPs feature lawyers who have “distinguished themselves from their peers by securing hard-earned successes in high-stakes litigation, complex global matters and record-breaking deals.” The list

August 15, 2019 |
Gibson Dunn Lawyers Recognized in the Best Lawyers in America® 2020

The Best Lawyers in America® 2020 has recognized 158 Gibson Dunn attorneys in 54 practice areas. Additionally, 48 lawyers were recognized in Best Lawyers International in Belgium, Brazil, France, Germany, Singapore, United Arab Emirates and United Kingdom.

June 18, 2019 |
Four Gibson Dunn Partners Recognized in Who’s Who Legal 2019 in Tax, Life Sciences and Insurance

Four Gibson Dunn partners were recognized by Who’s Who Legal in their respective fields. In Who’s Who Legal Thought Leaders – Tax 2019, two partners were recognized: London partner Sandy Bhogal and New York partner Eric Sloan. Orange County partner William Rooklidge was recognized in the 2019 edition of Who’s Who Legal Life Sciences. In the

May 20, 2019 |
Supreme Court Holds That Courts, Not Juries, Must Decide Whether The FDA’s Rejection Of A Proposed Warning Label Provides “Clear Evidence” To Preempt A State-Law Failure-To-Warn Claim

Decided May 20, 2019 Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290  Today, the Supreme Court unanimously held that courts, not juries, must decide as a matter of law whether there is “clear evidence” that the FDA would not have approved a proposed label warning about a risk of a drug, thereby preempting a state-law

February 12, 2019 |
2018 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

Last January, we observed that the new administration had yet to upend pre-existing enforcement and regulatory trends in the pharmaceutical and medical device industries.  But in the past 12 months several Trump administration priorities began to coalesce.  From initiatives to address the opioid epidemic, to efforts to police pat

October 31, 2018 |
LMG Life Sciences Recognizes Gibson Dunn in Six Practices and Names 11 Lawyers Stars

The 2018 edition of LMG Life Sciences highlighted six Gibson Dunn practices – Corporate, Mergers & Acquisitions, Intellectual property, Antitrust, Product Liability and White-Collar/Government Investigation – in the area of Life Sciences. Additionally the guide noted 11 Gibson Dunn lawyers as “Life Science Stars” including Palo Alto p

October 17, 2018 |
SEC Warns Public Companies on Cyber-Fraud Controls

On October 16, 2018, the Securities and Exchange Commission issued a report warning public companies about the importance of internal controls to prevent cyber fraud.  The report described the SEC Division of Enforcement's investigation of multiple public companies which had collectively lost nearly $100 million in a range of cybe

October 1, 2018 |
Federal Circuit Update (October 2018)

This edition of Gibson Dunn's Federal Circuit Update offers a reminder of the upcoming American Intellectual Property Law Association (AIPLA) Annual Meeting and of Supreme Court's upcoming review of decisions coming up from the Federal Circuit.  We also briefly recap the rules for obtaining a stay of an order pending Federal Circu

September 27, 2018 |
Three Gibson Dunn Partners Recognized Among Americas Rising Stars

Euromoney Legal Media Group recognized three Gibson Dunn partners among its inaugural list of Americas Rising Stars. Blaine Evanson was named Best in Litigation: Appellate; Stacie Fletcher was named Best in Environment; and John Partridge was named Best in Life Sciences. Stacie Fletcher was also recognized for her work on behalf of International Pa

September 12, 2018 |
Gibson Dunn Win Recognized at LMG Life Sciences Awards

Gibson Dunn was recognized at the annual LMG Life Sciences Awards, where the firm’s win in Biogen IDEC MA v. EMD Serono et al. was named a Patent Impact Case of the Year.  The awards were presented on September 12, 2018.  

July 31, 2018 |
Federal Circuit Update (July 2018)

This July 2018 edition of Gibson Dunn's Federal Circuit Update discusses the recent Federal Circuit Bar Association Bench and Bar Conference, provides a summary of the pending Helsinn Healthcare case before the Supreme Court regarding the on-sale bar, and briefly summarizes the joint appendix procedure at the Federal Circuit.  Thi

July 30, 2018 |
2018 Mid-Year Government Contracts Litigation Update

In this mid-year analysis of government contracts litigation, Gibson Dunn examines trends and summarizes key decisions of interest to government contractors from the first half of 2018.  This publication covers the waterfront of the opinions most important to this audience issued by the U.S. Court of Appeals for the Federal Circui

June 20, 2018 |
Acting Associate AG Panuccio Highlights DOJ’s False Claims Act Enforcement Reform Efforts

On June 14, 2018, Acting Associate Attorney General Jesse Panuccio gave remarks highlighting recent enforcement activity and policy initiatives by the Department of Justice ("DOJ").  The remarks, delivered at the American Bar Association's 12th National Institute on the Civil False Claims Act and Qui Tam Enforcement, included extens

May 25, 2018 |
Who’s Who Legal Recognizes Six Gibson Dunn Partners

Six Gibson Dunn partners were recognized by Who’s Who Legal in their respective fields. In Who’s Who Legal France 2018 guide Paris partners Nicolas Baverez and Jean-Pierre Farges were recognized in Administrative Litigation and Restructuring & Insolvency respectively. In Who’s Who Legal Restructuring & Insolvency 2018 Los Angeles part

April 17, 2018 |
FDA Releases Draft Guidance Proposing a Significant Expansion of the Abbreviated 510(k) Pathway for Medical Devices

On April 12th, 2018, the Food and Drug Administration ("FDA") released draft guidance proposing a significant expansion of the abbreviated 510(k) pathway for medical devices that would allow applicants to rely on performance characteristics rather than direct comparisons to predicate devices ("Draft Guidance").[1]  FDA plans to ma

March 29, 2018 |
Federal Circuit Update (March 2018)

This March 2018 edition of Gibson Dunn's Federal Circuit Update discusses the three pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings and extraterritorial damages, and a brief summary of the process for seeking an interlocutory appeal.  This Update also provides a

January 30, 2018 |
TC Heartland and Hatch-Waxman: Square Peg in a Round Hole

New York partners Jane Love, Robert Trenchard and Paul Torchia are the authors of "TC Heartland and Hatch-Waxman: Square Peg in a Round Hole," published in Law360 on January 30, 2018.

January 23, 2018 |
2017 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

As 2016 came to a close, pharmaceutical and medical device companies waited expectantly and wondered aloud about what 2017 and the arrival of the Trump Administration would bring.  With 2017 behind us, we now have initial indications—and some answers—about what the arrival of this new Administration means for drug and device c

November 30, 2017 |
Federal Circuit Update (November 2017)

This November 2017 edition of Gibson Dunn's Federal Circuit Update discusses the recent Friedman Lecture on Appellate Advocacy by Judge Alan Lourie, the two pending Federal Circuit cases before the Supreme Court that consider issues regarding inter partes review proceedings, and the Federal Circuit's en banc procedures.  This Update also provides

August 25, 2017 |
2017 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

At the midpoint of 2017, much has changed, and yet much has stayed the same for U.S. manufacturers of pharmaceuticals and medical devices.  Although the new administration arrived in January, Dr. Scott Gottlieb, the new U.S. Food and Drug Administration ("FDA") Commissioner, was not confirmed until May.  Not surprisingly, t

August 8, 2017 |
Cybersecurity & Data Privacy: An Overview for Health Care, Pharmaceutical, and Biotech Companies

Cyberthreats are ubiquitous, and significant cyberattacks on private and publicly traded companies occur on a near-daily basis.  As a result of the ongoing barrage of increasingly advanced and evolving cyberattacks, even companies with sophisticated security systems are potentially susceptible to a cybersecurity breach.  A breach may lead

August 2, 2017 |
Webcast: 2017 Mid-Year Update: The False Claims Act and Drug and Device Manufacturers

​The False Claims Act (FCA) is well-known as one of the most powerful tools in the government’s arsenal to combat fraud, waste and abuse anywhere government funds are implicated. The U.S. Department of Justice has made clear that vigorous FCA enforcement is here to stay,  with newly filed cases remaining at historical peak levels and the DOJ 

June 15, 2017 |
TC Heartland—A Renewed Opportunity to Challenge Venue in Patent Infringement Cases

On May 22, 2017, the U.S. Supreme Court narrowed the scope of proper venue for patent infringement actions for domestic corporations.  See TC Heartland LLC v. Kraft Foods Grp. Brands LLC, No. 16-341 (May 22, 2017).[1]  The TC Heartland decision reverses the approach to venue previously adopted by the U.S. Court of Appeals for the Federal

March 28, 2017 |
Federal Circuit Update (March 2017)

This March 2017 edition of Gibson Dunn's Federal Circuit Update discusses summary affirmance at the Federal Circuit, two recent Supreme Court decisions on laches and exhaustion, and the Federal Circuit cases now pending before the Supreme Court.  This update also provides an overview of the process for petitioning for mandamus before the Feder

January 26, 2017 |
Federal Circuit Update (January 2017)

This January 2017 edition of Gibson Dunn's Federal Circuit Update discusses current news and pending Federal Circuit cases before the Supreme Court and provides an overview of the oral argument process and panel assignment at the Federal Circuit.  Also included are summaries of the two pending en banc cases involving motions to amend claims du

January 12, 2017 |
2016 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

This January more than most, it is tempting to focus on questions regarding what is to come. Aside from the uncertainties associated with a new administration, two key pieces of legislation seem to be heading in opposite directions. In the coming year, the 21st Century Cures Act will take effect, ushering in new rules to streamline drug approvals a

January 1, 2017 |
Using and Defending Against Statistical Sampling in False Claims Act Cases

​Washington, D.C. associate Jonathan Phillips is the co-author of "Using and Defending Against Statistical Sampling in False Claims Act Cases," [PDF] published in AHLA Connections in January 2017.

December 7, 2016 |
2015/2016 Federal Circuit Year in Review

We are pleased to present Gibson Dunn's fourth "Federal Circuit Year in Review," providing a statistical overview and substantive summaries of the 134 precedential patent opinions issued by the Federal Circuit over the 2015-2016 year. This term was marked by three en banc decisions concerning: (1) the scope of the patent exhaustion d

November 15, 2016 |
The Trump Presidency: Selected Initial Observations and Considerations

There is widespread speculation regarding what President-elect Donald Trump and a Republican-controlled Congress will choose to prioritize and pursue in 2017 and beyond.  With the majority of pollsters and media observers incorrectly forecasting a victory for Hillary Clinton, many are just now beginning to assess how they will operate under, a

October 3, 2016 |
Compliance Perspectives on the Developing Contours of the PSQIA

​Washington, D.C. associates Jonathan Phillips and Julie Rapoport Schenker are the authors of "Compliance Perspectives on the Developing Contours of the PSQIA" [PDF] published in the October 2016 issue of Compliance Today.

September 29, 2016 |
Federal Circuit Update (September 2016)

This September 2016 edition of Gibson Dunn's Federal Circuit Update discusses the steep rise in appeals from the Patent Trial & Appeal Board due to the America Invents Act.  The Update also includes a practice tip regarding the procedure for seeking rehearing of an adverse panel decision.  Also included are summaries of the pending en

July 27, 2016 |
2016 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

From the Supreme Court to the Congress and from the federal agencies to the state legislatures, 2016 has produced noteworthy legal and regulatory developments for companies in the pharmaceutical and medical device industries.  Like our 2015 Year-End FDA and Health Care Compliance and Enforcement Update, this update begins with an overview of g

May 26, 2016 |
Federal Circuit Update (May 2016)

Included in this May 2016 edition of Gibson Dunn's Federal Circuit Update is a brief summary of last month's Federal Circuit Judicial Conference, a summary of the pending en banc case (Medicines Co.), and a practice update regarding a clerical change to one of the Federal Circuit's rules of practice.  Also included are summaries of a number of

March 24, 2016 |
Federal Circuit Update (March 2016)

Included in this March 2016 edition of Gibson Dunn's Federal Circuit Update is a brief overview of the upcoming Federal Circuit Judicial Conference, a summary of the pending en banc case (Medicines Co.), and a practice update regarding a proposed change to one of the Federal Circuit's internal operating procedures.  Also included are summaries

January 27, 2016 |
Federal Circuit Update (January 2016)

Gibson Dunn is pleased to announce its inaugural edition of the Federal Circuit Update, a bimonthly electronic newsletter designed to provide our clients and friends with a concise summary of recent activity at the U.S. Court of Appeals for the Federal Circuit, and a companion to Gibson Dunn's annual Federal Circuit Year In Review.  Each editi

January 19, 2016 |
2015 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

While massive mergers and pharmaceutical pricing dominated industry headlines in 2015, the U.S. Government continued to shape the drug and device industries through enforcement actions and other regulatory activities this past year.  The U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA"), in particular, pursued dr

January 7, 2016 |
Patent Disputes Over Biologics: Will Anyone Come To The Dance?

​Dallas partner Tracey Davies, of counsel Michael Valek, and associates Andrew Lin and Theodore Kwong are the authors of "Patent Disputes Over Biologics: Will Anyone Come To The Dance?" [PDF] published on January 7, 2016 by The Texas Lawyer.

January 6, 2016 |
2015 Year-End False Claims Act Update

A bit less, but no less impressive--that is how we would characterize False Claims Act enforcement in 2015.  This past year, the federal government recovered approximately $3.6 billion in either settlements or judgments in cases brought under the False Claims Act ("FCA" or the "Act").  An impressive amount, no doubt.  But what is remarkable is t

January 5, 2016 |
2015 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

2015 was a blockbuster year in corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA"), by sheer numbers alone.  Skyrocketing to 100, in 2015 the number of agreements more than doubled the numbers in every prior year since 2000, when Gibson Dunn first began tracking NPA and DPA data.  T

January 1, 2016 |
Damages for Infringement of a Pharmaceutical Patent: A Novel Analysis

​Orange County partner Jeffrey Thomas and associate Anne Brody are the authors of "Damages for Infringement of a Pharmaceutical Patent: A Novel Analysis" [PDF] published on January 1, 2016 by the Bloomberg BNA Pharmaceutical Law & Industry Report.

November 20, 2015 |
M&A Report – Depomed Decision Highlights Importance of Careful Monitoring of M&A Non-Disclosure & Use Obligations

On November 19, 2015, in Depomed, Inc. v. Horizon Pharma plc, the Superior Court of California, County of Santa Clara granted Depomed's request for a preliminary injunction to enjoin Horizon's hostile exchange offer to acquire Depomed. The injunction was issued based on Horizon's misuse of Depomed's confidential information under a pre-existing con

November 9, 2015 |
2014/2015 Federal Circuit Year in Review

We are pleased to present Gibson Dunn's third "Federal Circuit Year In Review," providing a statistical overview and substantive summaries of the 110 precedential patent opinions issued by the Federal Circuit over the 2014-2015 year. This term was marked by two en banc decisions, cases of first impression regarding post-issuance proceedin

August 13, 2015 |
Another Successful Challenge to Restrictions on Off-Label Promotion

​In a pointed and thoughtful repudiation of FDA's longstanding policy, the U.S. District Court for the Southern District of New York held on August 7, 2015, that the First Amendment precludes the prohibition and criminalization of truthful, non-misleading off-label speech under the Federal Food, Drug, and Cosmetic Act ("FDCA").  Am

August 3, 2015 |
RICO Suits Challenge Off-Label Drug Marketing

​Denver associate John D.W. Partridge is the co-author of "RICO Suits Challenge Off-Label Drug Marketing" [PDF] published on August 3, 2015 by Law360.

July 27, 2015 |
Amgen v. Sandoz: Like a song from the ’80s, the Federal Circuit says “You can dance if you want to . . .”

On July 21, 2015, the Federal Circuit issued its much anticipated decision in Amgen v. Sandoz (No. 2015-1499) construing two key provisions of the Biologics Price Competition and Innovation Act ("BPCIA").  The split decision held something for both sides, providing that the information disclosure and exchange provisions of the B

July 16, 2015 |
2015 Mid-Year FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

Over the past half year, the U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA") sustained their enforcement efforts against both businesses and individuals, raking in significant civil recoveries while pursuing criminal cases against industry participants. In the meantime, FDA released important

July 8, 2015 |
2015 Mid-Year Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

2015 came in like a lion, bringing with it remarkable policy changes regarding corporate non-prosecution agreements ("NPA") and deferred prosecution agreements ("DPA").  The Department of Justice's ("DOJ") leadership has articulated new bright-line approaches to post-resolution conduct, including the unprecedented

July 8, 2015 |
2015 Mid-Year False Claims Act Update

I.    INTRODUCTION There is no end in sight to the False Claims Act gold rush. After a record-setting 2014, which saw $5.7 billion in recoveries under the federal False Claims Act (FCA), 31 U.S.C. § 3729 et seq., 2015 looks to be another banner year.  In just the first six months of 2015, the government and qui tam relators have racked up mo

July 1, 2015 |
EU Merger Control in the Pharmaceutical Sector

​Brussels associates Pablo Figueroa and Alejandro Guerrero are the authors of "EU Merger Control in the Pharmaceutical Sector" [PDF] published in the July 2015 issue of The Merger Control Review.

June 12, 2015 |
A Practical Guide to the Use of the Commissioned Public Report as an Effective Crisis-Management Tool

Washington, D.C. partner F. Joseph Warin and associates Oleh Vretsona and Lora MacDonald are the authors of "A Practical Guide to the Use of the Commissioned Public Report as an Effective Crisis-Management Tool" [PDF] published in the Notre Dame Journal of Law, Ethics & Public Policy, Volume 29, Issue 1.

April 22, 2015 |
U.S. SEC Adopts Final Rules Implementing “Regulation A+” Offering Exemption for Offerings of up to $50 Million

On March 25, 2015, in a unanimous vote, the U.S. Securities and Exchange Commission (the "SEC" or the "Commission") approved final rules to create a new avenue for certain issuers to raise capital in transactions exempt from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act").

March 2, 2015 |
2014 Year-End FDA Compliance and Enforcement Update – Food and Dietary Supplements

In 2014, food safety spurred significant rulemaking, enforcement activity, and litigation by regulators and lawmakers at both the federal and state levels.  The U.S. Food and Drug Administration ("FDA") and the U.S. Department of Justice ("DOJ") enforced current good manufacturing practice ("cGMP") regulations and

February 17, 2015 |
Cybersecurity and Data Privacy Outlook and Review: 2015

Concerns about cybersecurity and data privacy have exploded into the public consciousness in recent years, accompanied by a host of new and rapidly developing legal issues.  From data breaches potentially affecting millions of consumers, to increasingly active policing of cybersecurity by the FTC and other U.S. regulators, to the protection of "th

January 14, 2015 |
2014 Year-End Health Care Compliance and Enforcement Update – Providers

It is no secret to those in the health care industry that since the U.S. Department of Justice ("DOJ") and Department of Health and Human Services ("HHS") joined forces to create the Health Care Fraud Prevention and Enforcement Action Team ("HEAT") in 2009, government enforcement actions against health care providers h

January 14, 2015 |
2014 Year-End FDA and Health Care Compliance and Enforcement Update – Drugs and Devices

Pharmaceutical and medical device manufacturers are among the most highly regulated enterprises in the United States, and 2014 demonstrated that the regulatory landscape continues to be a minefield for these companies.  This past year, the Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("FDA") susta

January 7, 2015 |
2014 Year-End False Claims Act Update

Just two years ago we noted the staggering level of the federal government's recovery-- approximately $5 billion--under the False Claims Act, 31 U.S.C. §§ 3729-3733 (the "FCA" or the "Act"). Not to be outdone, 2014 saw a new, historical high-water mark of $5.7 billion in recoveries. And this recent history, and forecasts for 2015, suggest the flo

January 6, 2015 |
2014 Year-End Update on Corporate Non-Prosecution Agreements (NPAs) and Deferred Prosecution Agreements (DPAs)

The U.S. Department of Justice ("DOJ") and the U.S. Securities and Exchange Commission ("SEC") continue to deploy DPAs and NPAs aggressively.  This past year left no doubt that such resolutions are a vital part of the federal corporate law enforcement arsenal, affording the U.S. government an avenue both to punish and refor

September 11, 2014 |
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.

September 9, 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.

July 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.  In that time period alone, the Department of Justice ("

July 8, 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. federal prosecutors continue to rely significantly on Non-Prosecution Agreements ("NPAs") and Deferred Prosecution Agreements ("DPAs") (collectively, "agreements").[1]  Such agreements have emerged as a flexible alternative

May 5, 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. § 314 are not immediately reviewable by the Federal Circuit, either through an app

May 1, 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 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.

January 23, 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. ___ (2014), ruling unanimously that a patentee defendant bears the burden of proving infringement in a declaratory judgment action.Medtronic arose out of two patents assigned to Mirowski Family Ventures, which Mirowski licensed to Medtronic in

January 8, 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. §§ 3729-33 (the “FCA” or the “Act”).[1]   This amount marks the second largest haul in history and the fourth consecutive fiscal year in which the government recovered more t

January 7, 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”)[1] have become embedded in the toolbox of U.S. federal prosecutors to address allegations of corporate misconduct.  Prosecutors and companies alik

December 25, 2013 |
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.

August 1, 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.

July 10, 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. §§ 3729-3733 (the "FCA" or the "Act"), in 2012.[1]  More than 782 new FCA matters were filed in that year, and more than 640 of those were initiated by "whistleblowers" filin

April 23, 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

February 27, 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").[1]  In addition to demonstrating the safety and efficacy of the medicinal product, manufacturing authorisation holders are obliged to guarantee the cons

February 22, 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. State and federal governments recovered an astounding $7.2 billion from the health care industry through settlements in calendar year

January 14, 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.  

January 8, 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.  In 2012, those efforts remained unabated.  The federal government recovered approximately $5 billion in the last fiscal year alone from settlements and judgments in cases filed under

January 3, 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. Department of Justice's Criminal Division, declared on September 13, 2012.[1]  Corporate Deferred Prosecution Agreements ("DPAs") and Non-Prosecution Agreements (

December 4, 2012 |
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 Feder

November 1, 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.

July 12, 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.  And now, as if waking to the thunderous sound of the Department of Justice's own efforts, the new Acting Assistant Attorney General, "ha[s] been struck by the sheer volume of the cases that are brought -- and the recoveries that are obtai

July 10, 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. Department of Justice ("DOJ") for resolving allegations of corporate criminal wrongdoing.  Since 2000, DOJ entities have entered into 230 re

June 29, 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 p

June 19, 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").  Christopher v. SmithKline Beecham Corp., No. 11-204, 567 U.S. ____ (2012).  In rejecting an interpretation of the relevant regulations that

March 21, 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. § 101.  While Section 101 provides that "any new and useful process, m

February 6, 2012 |
2011 Year-End Health Care Compliance Update

Health care compliance enforcement exploded in 2011.  The trends we have seen in recent years--historical settlements, increased enforcement activity, stricter settlement terms, and tougher penalties for individuals--not only continued unabated in 2011, but the pace of enforcement activity skyrocketed. This was a year of unparalleled settlement