Founded in 1819, Cravath, Swaine & Moore LLP is widely recognized as one of the preeminent law firms in the world. Each of its practices is highly regarded and its lawyers are recognized for their commitment to the representation of their clients' interests in the United States and internationally.
Cravath represents some of the largest and most highly regarded companies in the life sciences industry on a variety of corporate and litigation matters. We have played a leading role in critical and complex transactions and cases that have defined the life sciences industry, including handling one of the first suits to proceed under the Biologics Price Competition and Innovation Act, in which we represented Amgen in a lawsuit arising from its anticipated introduction of the first biosimilar to AbbVie's biologic drug, Humira®.
Our attorneys bring to the table an understanding of the life sciences industry coupled with extensive corporate and litigation experience handling high-level matters in other areas, giving us both the depth and breadth of expertise to creatively and effectively solve problems affecting all aspects of our clients' businesses.
The Firm represents pharmaceutical, biotechnology, healthcare services and medical device companies in significant intellectual property and antitrust litigation; complex shareholder derivative and securities suits; breach of contract and licensing disputes; and arbitrations. We also handle government and internal investigations; regulatory enforcement; and compliance matters for life sciences clients, as well as regulatory clearance and antitrust advice relating to mergers and acquisitions.
On the corporate side, we advise life sciences companies and their boards of directors in mergers and acquisitions; corporate governance matters, including defense against activist hedge funds; capital markets offerings and banking and credit transactions; financial restructuring and reorganization; tax; and executive compensation and benefits matters. Cravath's environmental lawyers work with its life sciences clients on acquisition and disposition strategies as well as financings and advise on the challenges and opportunities associated with environmental, social and governance ("ESG") issues, sustainability concerns and climate change. Our corporate IP lawyers advise on acquisitions and divestitures; multiparty joint ventures and strategic investments; licensing agreements; and portfolio development and exploitation.
Cravath's clients in this area have included: Abiomed, Actelion, Akorn, Amgen, Chemed, Insys Therapeutics, Johnson & Johnson, Medinol, Merck & Co., Mylan Laboratories, Novartis Pharmaceuticals, OrbusNeich, RedHill Biopharma, Roivant Sciences and Vitaworks.
As a preeminent boutique IP law firm, Green Griffith focuses on pharmaceuticals, chemistry and biotechnology — and specializes in litigation. Their attorneys share decades of experience partnering with both brand and generic companies to navigate the most complex IP and related FDA issues, including the Hatch-Waxman Act.
IP Litigation Specialists Acknowledged leaders in the field, Green Griffith helps clients build and execute targeted, timely and cost-effective IP strategies from project initiation through litigation, with an eye toward securing market position and overcoming obstacles to new product entry. Their range of services includes counseling regarding strategic formulation, portfolio and due diligence, as well as handling all stages of trial and appeals concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2) and ANDA applications, as well as the BPCIA and biologics, and their related drug products and therapies.
Each of their attorneys have extensive scientific backgrounds — many with Ph.D.s — that permit exploration of technical solutions at a deep level. This expertise, coupled with their unparalleled experience litigating at the PTO and in the federal courts, positions them to craft and execute the best strategy to attain clients’ goals.
Their extensive experience, technical expertise, big picture vision and integrated strategy consistently produce favorable outcomes for companies developing, protecting and commercializing their products, processes and therapies.
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.
Commercial Litigation 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.
RMMS consists of over 30 attorneys focused exclusively in the field of pharmaceutical and biopharmaceutical patent and regulatory counseling, and litigation under Hatch-Waxman, the Medicare Modernization Act (MMA), the Biologics Price Competition and Innovation Act (BPCIA), as well as post-grant review before the Patent Trial and Appeal Board.
RMMS attorneys embrace the science of a case, and make it an integral part of our winning strategy. Indeed, a majority of our attorneys have technical degrees or backgrounds in a variety of areas and disciplines, including chemistry, biochemistry, biology, molecular biology, microbiology, genetics, bacteriology, bioengineering, biomedical engineering, chemical engineering and pharmacy, and many of our attorneys are registered with the USPTO. RMMS also employs full-time Ph.D. technical advisors specializing in chemistry, biological sciences, and pharmaceutics/pharmacy.
Our experience is unparalleled in the industry. Since the firm’s inception over 15 years ago, RMMS has handled over 300 Hatch-Waxman/BPCIA and related pharmaceutical litigation matters (including declaratory judgment, patent infringement, Administrative Procedure Act (APA), and commercial dispute matters) involving at least 160 different drug products for over 25 pharmaceutical clients. In addition to our substantial litigation experience, our attorneys also have extensive regulatory and legislative experience.
We understand that patent litigation is not an end-game, and that the business decisions made throughout the entire product and patent evaluation, regulatory review, litigation, and commercialization process are equally critical to the company’s strategic plans involving any one product or group of products. Our goals are aligned with those of our clients: to ensure that each client obtains value from its applications, whether through the eventual commercial marketing of the product, the sale or assignment of the asset, or relationship-building with other companies through joint development agreements, active pharmaceutical ingredient (API) and finished dosage form supply agreements, licensing agreements, and co-promotion and marketing agreements.