We offer the legal and technical experience and global awareness needed to understand the opportunities offered and challenges presented to these industries.
Our life sciences practice consists of a multidisciplinary team of lawyers with extensive industry knowledge and resources. The group comprises lawyers from across the firm’s practices. These lawyers are experienced in dealing with the issues affecting the life sciences industries globally, including: transactions, intellectual property (IP), dispute resolution, antitrust and competition, risk management, investigations and compliance, government and global trade, tax and transfer pricing, and regulatory and environmental matters.
At Mayer Brown, we have a long history of providing clients in these industry sectors with practical and effective legal support. Our clients range from start-ups to some of the largest life sciences companies in the world.
We also represent a significant number of regional, national and global banks, investment banks and other investors in capital markets and structured finance transactions relating to the life sciences industries.
Our geographic reach and on-the-ground presence in most of the world’s key business and finance centers allow us to assist our clients in structuring and coordinating cross-border transactions and other transnational legal matters. Our in-depth experience, gained by working across business areas and issues with life sciences companies and networking with leading industry organizations, provides our lawyers with the necessary insights for handling the legal and regulatory challenges facing these industries.
Our Life Sciences practice provides advice on the full range of issues, including:
Transactions
Intellectual Property
Hatch-Waxman Counseling & Litigation
Licensing
Dispute Resolution
Antitrust and Competition
Risk Management, Investigations and Compliance
Government and Global Trade
Tax and Transfer Pricing
Regulatory and Environmental
Experience
Our Life Sciences practice provides advice on the full range of issues, including:
Transactions
Intellectual Property
Hatch-Waxman Counseling & Litigation
Licensing
Dispute Resolution
Antitrust and Competition
Risk Management, Investigations and Compliance
Government and Global Trade
Tax and Transfer Pricing
Regulatory and Environmental
Transactions
Clients turn to us for advice in structuring, managing and documenting their transactions, including their most complex, time-sensitive and critical deals.
We have represented domestic and multinational clients in all forms of transactions, including mergers and acquisitions, divestitures/disposals, contested transactions, management and other buyouts, recapitalizations, reorganizations, tender offers and joint ventures. Our team has extensive experience in assisting with all aspects of a given transaction, including: marketing and promotion arrangements; product development alliances; clinical trial agreements; licenses; site separation mechanics; shared facility agreements; business, site and other service agreements; lease agreements; toll and contract manufacturing agreements; supply agreements; power arrangements; and IP-related agreements.
We provide competition and antitrust advice on a variety of cross-border transactions to ensure compliance with regulations and other guidelines in the United States, Europe and Asia. We also draw upon our litigation experience to assist companies in evaluating potential product and commercial liability risks in formal and informal due diligence, including risks of existing or emerging toxic torts, product liability and commercial disputes.
We work with most of the Fortune 100 companies, most leading global banks and many of the world’s largest broker-dealers, asset managers and insurance companies, providing legal knowledge, market experience and international insight with the financial products central to these financial institutions. The upshot of this experience is that our clients gain thoughtful, creative solutions to the challenges encountered in capital markets transactions.
Our experience in the life sciences industries allows us to quickly and seamlessly provide the proper context for the regulatory, disclosure and other commercial issues that arise during the course of a capital markets transaction. There is no substitute for having lawyers on a deal team who have a sophisticated understanding of their client’s business.
With our multi-jurisdictional capabilities and deep understanding of the capital markets and structured finance (including securitization), we are ideally placed to advise on global project finance. The firm’s award-winning Project Finance Group is regularly involved in some of the largest and most innovative projects across the globe. Our experience ranges across sectors and hemispheres, including countries in Europe, Asia and the Middle East.
The depth and quality of our domestic and international teams bring together skills in risk assessment, project appraisal and project documentation — including concession agreements, project development agreements, partnership and joint venture agreements, acquisition agreements, management agreements and sub-contracting arrangements — for a diverse group of clients, including developers, sponsors, investors, contractors, operators, commercial and investment banks, and governments and public agencies.
Intellectual Property
The firm’s IP practice offers a full range of services, including litigation and enforcement, counseling, patent and trademark prosecution, transactional support and agreement drafting. Our global IP capabilities, coupled with our multidisciplinary approach to today’s emerging issues in the development, protection and exploitation of intellectual property assets, are well-matched for life sciences companies.
We offer comprehensive assistance from our locations in key business centers around the world. Many of our IP lawyers in the United States are admitted before the US Patent and Trademark Office (PTO). In addition, several of our US IP lawyers have technical degrees in such fields as biochemistry, chemistry, pharmacy, microbiology, electrical, mechanical and chemical engineering and computer science, and a number of them worked as scientists and engineers before becoming lawyers.
Our European lawyers deal with cross-border patent issues and strategically manage some of the largest and most recognized global brands. In Asia, we have a highly experienced team of focused IP lawyers who have practiced in Hong Kong, China and the broader Asian region for many years. As a result, we know not only IP law, but also its practical application.
Hatch-Waxman Counseling and Litigation
In Hatch-Waxman and other patent litigation, Mayer Brown has successfully represented innovator pharmaceutical companies against generic manufacturers and other parties alleging non-infringement, patent invalidity, inequitable conduct and antitrust violations. In these cases, we have used creative strategies to develop new data—and new arguments—supporting patentability, which were later upheld by the Federal Circuit.
Because almost every new drug product will be the subject of generic attack, we routinely counsel our clients on Hatch-Waxman and product management issues. We recognize that IP is the lifeblood of the life sciences industries, and that optimal success is achieved by a product management process aligning the business, regulatory and patent assets and objectives. Our counseling activities have included:
- Pre-litigation analysis of Orange Book listed patents at an early stage (e.g., upon FDA approval of the NDA) to identify possible risks and avoid the 45-day pressure of having a ready legal and scientific team upon the receipt of a Paragraph IV certification.
- Assessments of extending FDA and patent exclusivities throughout the entire product lifecycle based on, for example, new formulations, new strengths or indications, improved pharmacokinetic profiles, dosage form dissolution profiles, and new salt, enantiomeric or polymorphic forms. Our creativity and experience in this area help our clients maximize the value of their IP.
- Due Diligence assessments of Hatch-Waxman and antitrust litigation relating to the purchase of pharmaceutical products and companies where we have been involved — both as sellers’ and buyers’ counsel — in extensive document reviews and witness interviews.
- Preparation of detailed timelines and scenario planning to align the business, regulatory and patent objectives and likely outcomes.
- Strategic advice regarding patent term extensions.
- Analyses and strategies for non-Orange Book eligible patents.
- Advice and representation before the FTC and courts with respect to settlements of ANDA litigation.
Licensing
Mayer Brown has extensive experience in representing both major pharmaceutical companies and academic research institutions in negotiating IP licenses covering a wide range of technologies.
Our European offices have handled a broad range of licensing and regulatory issues, including advice on centralized and decentralized procedures for drug licensing with the European Medicines Agency (EMEA) as well as orphan drug designation licenses and related proceedings with national agencies, including the German Federal Agency for Drugs and Medical Devices (BfArM). The advice on regulatory compliance matters also comprises all kinds of marketing and sales issues and other European Union regulatory matters. Our European offices also closely interact with the Federal and State pharmaceutical authorities in Europe.
Likewise, our Asian offices regularly represent multi-national clients in protecting trademarks and other IP rights in virtually every major country in southeast Asia. This practice includes the Peoples Republic of China, where our Beijing office provides an on-the-ground presence that few other US firms can offer.
Dispute Resolution
We have successfully handled the entire spectrum of litigation that affects life sciences companies, including civil and criminal enforcement actions, IP litigation, environmental litigation (statutory cleanup actions, refusal of environmental permits and environmental prosecutions), products liability cases, and mass tort and toxic tort actions. We have experience with large cases that combine governmental investigations or prosecutions and mass civil claims. Our work has included defending pharmaceutical and chemical companies, suppliers and insurers against a wide range of consumer and product liability claims, and we have worked on matters dealing with some of the most well-known pharmaceuticals, medical devices, and substances (such as asbestos) to those on the cutting edge of emerging claims and litigation.
Of particular interest to the life sciences industries, the firm’s Supreme Court & Appellate practice has comprehensive experience in the area of preemption, and has been deeply involved in shaping the preemption defense as it applies to life science companies. Lawyers in the group have been involved in virtually every Supreme Court product liability preemption case of the past 10 years, representing either a party or an amicus. And, unlike many other firms, we believe in an integrated trial approach in which our appellate group regularly assists at the trial level, briefing and arguing pre-trial motions, handling post-trial motions and working closely with trial counsel to shape legal strategy and properly preserve the record for appeal. Our litigation teams regularly represent life sciences companies in litigating preemption issues, and have successfully obtained dismissals on federal preemption grounds in lawsuits and purported class actions in a wide spectrum of cases, including products liability claims against life sciences manufacturers, automobile companies, and others, state attempts to interfere with federal environmental rules (including the Clean Air Act), and state schemes that interfere with federal regulatory systems governing numerous industries.
We also provide advice on a broad range of commercial disputes, including various forms of breach of contract and warranty, post-closing matters, business torts, qui tam and “whistleblower” litigation, securities and ERISA “stock drop” litigation and employment litigation.
In addition to our work in courtrooms around the world, we have extensive experience in international arbitrations and other domestic arbitrations and mediations of disputes. Supporting our dispute resolution work is our leadership in electronic discovery and records management.
Antitrust and Competition
Mayer Brown’s Antitrust & Competition practice works with clients on a broad variety of issues as they apply to the life sciences industries, including mergers and acquisitions, internal investigations, government investigations and enforcement proceedings, and civil litigation related to price fixing, allocation of markets, monopolization and other abuse of dominance charges.
We are experienced in representing clients in the life sciences arena in matters involving the US Department of Justice, the Federal Trade Commission, the European Commission and various national competition authorities, and in private damages actions brought by civil plaintiffs around the world. We also are ideally placed to advise clients with respect to the new competition regime in China thanks to our 2008 combination with leading Asian law firm JSM (formerly Johnson Stokes & Master). In addition, we regularly advise and counsel our clients on all aspects of antitrust compliance and risk assessment.
Furthermore, we are active at the intersection of pharmaceutical intellectual property and antitrust law. With partners and associates who themselves have played important roles in the US antitrust agencies’ intellectual property work, we can represent patent-owning chemical and pharmaceutical clients vigorously and credibly in governmental antitrust/competition investigations and litigation, and help them manage antitrust/competition law risk in utilizing their intellectual property. Similarly, we have deep experience in representing major clients in the chemical and pharmaceutical industries in a wide variety of important antitrust litigation, including both criminal and civil matters.
Risk Management, Investigations and Compliance
Our experience allows us to identify weaknesses in internal controls and business activities that could present risks of enforcement actions. Our lawyers help companies evaluate and enhance their best compliance practices and develop appropriate procedures and policies in response to the changed regulatory landscape, including the Sarbanes-Oxley Act and Regulation FD, the Foreign Corrupt Practices Act, and the increasingly aggressive enforcement efforts of prosecutors and regulators across the globe. Using our insight into how prosecutors apply criminal law to alleged business crimes, we work with clients to undertake compliance audits and draft, implement and monitor compliance plans.
Our defense team conducts independent internal investigations on behalf of corporate management, boards of directors, audit or special litigation committees, government agencies and other investigators; we have suggested corrective measures that have resolved or lessened later enforcement actions. We are able to staff these matters with a diverse team of seasoned criminal defense and compliance lawyers whose prior government and investigative experience make them the optimal choice for these assignments.
In addition to these broad capabilities, we are advocates of the concept of “product stewardship,” which is aimed at spotting potential problems and minimizing the associated risks as early as possible. We can also advise on whether and how to augment insurance coverage in connection with potential product liability claims.
An analytical approach is the foundation of our insightful risk management advice that helps clients reduce and manage the risks of litigation and claims on an ongoing basis. We provide practical ways that companies can limit their risk exposure and we help them to develop model supplier and vendor agreements, review product labels, draft and review compliance programs, develop document retention policies and assess existing or contemplated processes for potential risks and advise on ways to minimize potential litigation or regulatory exposures.
Government and Global Trade
Mayer Brown’s Government and Global Trade practices have earned international recognition for using sophisticated political experience and leading-edge legal knowledge to help shape government and trade policy, legislation and regulations in the United States, Europe and key countries and regions around the world. The lawyers, lobbyists and other professionals in our groups are strategic thinkers who help clients to advance their domestic and global goals.
Tax and Transfer Pricing
With more than 100 tax lawyers worldwide, the breadth of Mayer Brown’s tax practice is difficult to match. We provide legal services to approximately 80 percent of the members of the Pharmaceutical Research and Manufacturers of America (PhRMA). When it comes to tax and transfer pricing advice in particular, we have advised 10 of the world’s 20 largest pharmaceutical companies. Our experience includes companies ranging from among the industries’ largest publicly held conglomerates to privately owned specialty companies that are leaders in specific therapeutic areas.
Our lawyers regularly advise on domestic and cross-border restructurings and related planning projects and have represented clients in many major corporate transactions. We also represent companies of all sizes in any phase of a tax dispute, from before a tax audit begins through litigation.
We have particular experience in the area of transfer pricing and have advised life sciences companies on the tax, customs and VAT ramifications of all facets of their value chains, including the development, transfer and use of high-value intangibles, related and unrelated party manufacturing and worldwide distribution. Our team understands that if incorrectly designed, implemented and defended, transfer pricing policies can become unwieldy, interfere with business flexibility and, in some cases, even compromise a company’s ability to protect its intellectual property.
Thus, the development of successful transfer pricing policies requires careful coordination with other disciplines within the company to protect the company’s most valuable assets. For this reason, we emphasize coordination with the company’s non-tax personnel, including business and finance staff, manufacturing experts, IP attorneys and litigation and transactional counsel.
Mayer Brown has experience with many tax issues often encountered in the industries, including some that have been identified by the US Internal Revenue Service as “Tier 1” and “Tier 2” compliance issues:
- Issues arising across the value chain: research, manufacturing, product launch, marketing, and life cycle management;
- Taxation of government payments and Department of Justice settlements;
- Treatment of upfront fees, milestones, royalties and deferred income items;
- Research and development tax credits;
- Section 936 exit strategies and other outbound migrations or cost sharing of intangibles;
- Section 199 domestic manufacturing deductions; and
- Section 965 Homeland Investment Act repatriations.
Regulatory and Environmental
The life sciences industries, and the products they create, are subjected to intensive legal regulation throughout all jurisdictions, particularly at a very early and crucial stage. Ensuring regulatory compliance is a key element for these businesses, so we provide in-depth regulatory advice throughout the Americas, the European Union and Asia. Our advice includes complex cross-jurisdictional matters related to pharmaceutical R&D, clinical trials, product development, pricing, data protection and privacy, record retention, marketing and promotional activities.
We also represent our clients in disputes related to regulatory matters and in contract negotiations. In regulatory matters, including the REACH legislation and global climate change issues, we have experience in all relevant jurisdictions. For example, we have a multidisciplinary regulatory team that includes in-house scientific knowledge and experience. This team provides leading-edge assistance to help our life sciences clients comply with and manage complex regulatory requirements, such as the regulations adopted in the European Union and elsewhere.
We have experienced and accomplished lawyers who advise on transactional and regulatory matters related to environmental concerns, and who regularly handle related litigation matters. In transactional matters, we identify, evaluate and manage regulatory and environmental risks in multi-jurisdictional corporate and finance transactions. We take an appropriate, consistent and cost-effective approach to managing the due diligence/disclosure process with the aim of delivering practical, commercially effective solutions.
Lawyers in the group also participated in the Framework Convention on Climate Change (FCCC) and the Kyoto Protocol negotiating process and are now involved in developing a post-Kyoto agreement architecture. At the same time, we have a thorough understanding of the broader regulatory context in which our clients operate.
Our lawyers have been at the forefront of developing policy on the legal aspects important to the life science industries. Our broad understanding of regulatory issues offers insight that is valuable in helping life sciences companies ensure global market access in compliance with regional and local regulatory requirements.
