Williams & Connolly has a long-standing reputation as one of the nation’s premier litigation firms, with a cadre of top-tier trial lawyers. The firm is regularly recognized as a leader in life
sciences, intellectual property, and products liability by Managing IP, LMG Life Sciences, and Chambers USA, among others. Recent recognitions include The National Law Journal’s 2017 “Washington Litigation Department of the Year” for Products Liability, and one of the top four patent litigation practices nationally for 2017 by IAM Patent 1000 - The World’s Leading Patent Practitioners.
Patent litigation and licensing disputes. Williams & Connolly is the “go-to” intellectual property litigation
firm for many of the biggest companies and most important cases. The patent litigation group marries the experience of seasoned firstchair trial lawyers with that of a team of scientifically trained lawyers, including ten former Federal Circuit clerks and thirteen members of the patent bar. Their collective strength is in mastering the technical and scientific issues raised by patent disputes, providing a nuanced understanding of the relevant legal issues, and describing them in ways that both judges and juries easily can understand.
Williams & Connolly represents both U.S. and international market leaders, large and small, in a wide range of sectors for which patent litigation is a critical and essential component of the company’s asset-protection strategy. In the pharmaceutical and biotech sectors companies such as Pfizer, Eli Lilly, Genentech/Roche, AstraZeneca, and its division MedImmune, Bayer, and Novartis and its division Alcon entrust critical patent litigation to the firm.
The firm has represented both patentees and alleged infringers in litigation and post-grant review proceedings spanning a wide range of technologies, including pharmaceuticals, medical devices, biotechnology, electronics, and software. Williams & Connolly’s patent lawyers are outside counsel of choice for many leading corporations in the life sciences arena in matters including:
• Hatch-Waxman pharmaceutical litigation
against generic companies • Wide-ranging patent, licensing, and trade secret litigation for biotechnology companies • Patent and licensing disputes on behalf of medical device manufacturers • Representing petitioners and patent owners in inter partes review proceedings • Representing major law firms in professional responsibility claims of malpractice rising from their patent litigation or prosecution work
Recent practice highlights include: • Successful representation of Pfizer and several of its subsidiaries at trial and on appeal against a generic manufacturer attempting to sell a version of a Pfizer anticancer drug. • Successful representation as lead counsel for Bayer in several Hatch-Waxman cases relating to Bayer’s erectile dysfunction drug products
Levitra® and Staxyn®. • Successful defense of Eli Lilly in two bench trials over the validity and infringement of a Lilly patent protecting its blockbuster anticancer drug Alimta®, which has annual U.S. sales of over $1 billion. • Successful representation of Mirowski Family Ventures in a jury trial that returned a $309 million verdict against Boston Scientific Corporation for breach of contract and patent licensing issues related to its implantable cardioverter defibrillator and won on appeal.
Products liability. Williams & Connolly is also a recognized force in the products liability arena, and is home to some of the most successful products trial lawyers in the country. The team has extensive experience representing pharmaceutical and medical device makers and distributors in all aspects of national and international litigation as lead trial counsel, national or global coordinating counsel, “endgame”/resolution counsel, and appellate counsel. With several dozen attorneys who spend more than half their time on products litigation, the firm regularly represents many of the world’s leading companies in highstakes litigation in the U.S., Europe, Africa and Asia.
Recent practice highlights include: • Representation of Bayer, Genentech, Stryker, Pfizer, Merck, AstraZeneca, Medtronic, and Endo Pharmaceuticals in products litigation • Several recent trial victories for life sciences clients, including jury trial wins for Alcon and for Pfizer/Wyeth • Several recent appellate victories on the issue of “innovator liability” • Multiple defeats of class certification
• Serving as lead national counsel in diabetes products litigation, national counsel on Viagra- melanoma litigation, resolution counsel on two major litigations (each involving thousands of cases), and trial counsel in multiple drug and device litigations
Commercial Litigation. Williams & Connolly lawyers handle virtually every kind of complex commercial litigation imaginable for businesses in the life sciences, pharmaceutical and healthcare industries, with a particular emphasis on preparing and taking cases to trial.
Recent practice highlights include: • Defended Alcon Research against $400+ million in contract and trade secret claims: 2017 jury trial defense verdict on contract claims, and defense summary judgment on trade secret claims. • Represented Pfizer in $100+ million commercial dispute: 2017 arbitration award on all claims before the AAA’s International Centre for Dispute Resolution (ICDR). • Representation of Eli Lilly, Cardinal Health, Pfizer, AstraZeneca, Omnicare, and Bristol- Myers Squibb in a range of complex cases.
Antitrust, white collar and government investigations.
Life sciences clients, including those in the pharmaceutical and other healthcare sectors, also look to Williams & Connolly in the face of significant and complex antitrust, white collar and government investigation matters.
Recent practice highlights include: • Representation of many significant life sciences and healthcare companies navigating government investigations including Pfizer, Wyeth, CVS Health, Medco Health Solutions, Express Scripts, Cardinal Health, Emerge Medical, Liberty Health Care, Omnicare, and Sunrise Senior Living. • Successfully defending AstraZeneca in landmark antitrust litigation seeking $60 billion in alleged damages.
For more information, please visit www.wc.com, or contact our practice co-chairs:
David I. Berl, (202-434-5491, firstname.lastname@example.org)
Jessamyn S. Berniker, (202-434-5474, email@example.com)
Heidi Hubbard (202-434-5451; firstname.lastname@example.org)
Joe Petrosinelli (202-434-5547; email@example.com)
John Schmidtlein (202-434-5901; firstname.lastname@example.org)
Morgan Lewis has purposefully developed our capabilities to serve the complete life sciences product life cycle and all aspects of the healthcare and life sciences industry. We understand and work creatively to solve the business, transactional, regulatory, intellectual property (IP), litigation, and related issues that our clients face along the product life cycle, from innovation protection and emerging business issues, through regulatory development and approval, to reimbursement, marketing, and distribution. Our lawyers handle litigation in all relevant areas (including government enforcement, fraud and abuse, product liability and IP), labor, employment, and benefits, and antitrust, and work closely with clients on mergers and acquisitions, collaborations and licensing agreements, and outsourcing.
Litigation and Dispute Resolution
Our compliance and government investigations team includes lawyers with litigation and regulatory backgrounds to assist clients with a range of criminal and civil healthcare fraud investigations and related litigation, including some of the most significant recent pharmaceutical industry–related matters in the United States. We advise clients at every stage of government enforcement activity, including responding to federal and state grand jury subpoenas and all federal government civil investigative demands and administrative subpoenas (e.g., those issued by the OIG of the US Department of Health and Human Services (HHS) and other agencies). This includes representing clients through the document production and investigation phase, settlement discussions, Corporate Integrity Agreement (CIA) negotiations, pretrial proceedings, trial, and appeal.
We routinely handle parallel criminal, civil, and administrative proceedings that occur simultaneously in multiple jurisdictions involving claims under the Anti-Kickback Statute, Healthcare Fraud Statute, HHS-OIG exclusion authorities, Civil Monetary Penalties Law, Responsible Corporate Officer Doctrine, federal and state false claims acts, and suspension and debarment authorities. Likewise, we routinely deal with state Medicaid Fraud Control Units (that are usually components of the state attorneys general) and multijurisdictional Medicaid Fraud Task Forces organized by the National Association of Medicaid Fraud Control Units.
Additionally, we regularly advise clients on all aspects of the design, negotiation, and implementation of government-mandated compliance agreements, such as CIAs, Deferred Prosecution Agreements, and state consent decrees. Morgan Lewis lawyers have negotiated and assisted dozens of large and small life sciences and healthcare companies with their most important CIA matters and have extensive knowledge of best practice compliance controls within the life sciences sector.
White Collar Litigation
Our white collar litigators regularly represent life sciences companies in Foreign Corrupt Practices Act (FCPA), UK Bribery Act (and all other forms of UK investigations and prosecutions), and other anticorruption matters, as well as US grand jury and civil investigations and criminal trial defense, state attorneys general investigations and litigation, civil False Claims Act litigation, third-party payor class action litigation, civil antitrust class action litigation, and state Bureaus of Consumer Protection actions.
We regularly represent pharmaceutical clients in the full range of business disputes, including trade secrets and noncompete litigation, supplier/purchaser and post acquisition disputes, and consumer class actions and other consumer-related litigation. Whether they are plaintiffs or defendants in such matters, our clients benefit from our experience in these types of cases. Our work in this area has not gone unnoticed – Morgan Lewis was named a "Class Action Practice Group of the Year" by Law360 for 2013 and 2014. This accolade is in addition to two consecutive years on BTI Consulting Group's 2014 and 2015 Litigation Outlook, which ranked us as one of four "powerhouse" firms for class actions and mass torts.
Product Liability Litigation
We routinely represent our clients in medical device industry litigation, including product liability, fraud and abuse, and commercial litigation. Our long-standing, well-recognized product liability practice includes more than 50 lawyers across our US offices. For decades, we have successfully represented clients in class actions, individual lawsuits, multidistrict matters, and mass and toxic tort litigation.
When enforcement concerns have arisen, we have assisted in some of the largest and most complex government investigations and settlements of the last decade. As the FDA, Department of Justice (DOJ), Health Care Financing Administration, and HHS-OIG continue to take an aggressive enforcement stance, we regularly assist clients in responding to civil and criminal enforcement and compliance actions, including FDA Form 483 and Warning Letter responses, Import Alerts, consent decree issues, FDA's integrity policy, OIG suspension and exclusion authority, and debarment penalties from government contracting agencies.
Our deep bench of seasoned trial lawyers is capable of trying the most high-risk cases against the most aggressive adversaries, and frequently serves as US national coordinating and trial counsel to medical device companies in large-scale serial litigation. This experience consists of cases involving pacemakers, cardioverter defibrillators, neurostimulators, drug pumps, insulin pumps, therapeutic blood derivatives, breast implants, femoral knee components, and many other devices.
300+ partners recognized, Chambers, all publications (2016)
Most Recognized for Client Service, BTI Client Service A-Team (2016)
More than 250 international partners and counsel focused on the life sciences industry
More than 1,000 active life sciences clients
Law 360: Life Sciences Practice Group of the Year (2014)
BioPharm Insight: Top five transactional firm (2015)
Modern Healthcare: Ranked as the largest healthcare law firm (2016)
Legal 500: Ranked as a top 10 firm for health insurers and life sciences (2016)
Chambers USA 2016:
National for Life Sciences – Band 3
Washington, DC for Healthcare: Pharmaceutical/ Medical Products Regulatory – Band 3
Law 360 MVPs for life sciences (2012 and 2014) and healthcare (2012)
LMG Life Sciences Award – Healthcare Pricing and Reimbursement Firm of the Year (2013) and Lifecyle Firm of the Year (2015)