Pharmaceuticals

In the highly competitive and highly regulated pharmaceutical industry, the key to success is multifaceted. Pharmaceutical companies need true strategic partners that understand the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, and protecting existing product lines. 

Goodwin is that partner. We have made servicing the needs of the pharmaceutical industry a strategic priority for more than two decades, and we have one of the largest, most active and most experienced pharmaceutical practices in the United States.

Our interdisciplinary pharmaceutical industry practice is deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, and regulatory matters, as well as Hatch-Waxman and biosimilars patent litigation, products liability, employment and tax. Our depth of experience across the full spectrum of services needed by pharmaceutical clients is just one reason that Goodwin is one of just ten firms consistently recognized by LMG Life Sciences as a “Life Cycle Firm.”

Related Practices

Capital Markets

Companies seeking to grow, increase liquidity for their investors or reduce their cost of capital regularly turn to Goodwin. We have one of the most active capital markets and public company practices in the United States, serving as outside counsel to public companies in a range of industries and who are listed on both U.S. and non-U.S. exchanges. We combine deep industry knowledge with broad technical expertise across all equity and debt securities and alternative investment structures. Over the past five years, we have advised clients in nearly 300 public offerings with an aggregate value approaching $30 billion. Our practice and lawyers are consistently recognized by industry publications as one of the most active and innovative advisers for capital markets transactions and public companies.
Read More

FDA

Companies subject to FDA regulations know how critical compliance can be to the bottom line. Goodwin’s experienced FDA practice provides counsel, representation and strategic advice to companies subject to the Federal Food, Drug, and Cosmetic Act. Our practice covers all aspects of our clients’ interactions with the Food and Drug Administration. We are closely involved in our clients’ pre-market strategies and their implementation, including those involving product development, investigational device submissions, pre-market notification and approval applications, and lifecycle management. On the post-market side, our FDA attorneys have extensive experience advising on agency inspections and answering inspectional findings; counseling on labeling, advertising, good manufacturing practices and product reporting issues; and helping plan and implement remedial actions.
Read More

Life Sciences

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. In this highly competitive business, you need more than the best and brightest ideas – you need a legal and strategic partner that understands the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. As part of our interdisciplinary approach, we also collaborate with attorneys in our patent litigation, products liability, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

Read More

Hatch-Waxman + Biosimilars Litigation

Litigation in the pharmaceutical and biotechnology industry can be particularly complex, requiring counsel that is as well versed across scientific disciplines as it is in the law. Goodwin has made servicing the needs of the pharmaceutical and biotechnology industries a strategic priority for more than two decades, and we have one of the largest and most active life sciences practices in the United States. Our IP litigation team is among the most experienced in the country, successfully representing both brand companies and generics in Hatch-Waxman litigation. Our portfolio of clients include the largest generic companies in the world and, more recently, include enforcement of patents related to numerous blockbuster drugs.

Our firm is also a leader in the emerging field of biosimilars litigation. Our lawyers were involved in the legislative process that resulted in the Biologics Price Competition and Innovation Act, and our work counseling clients as they advance their biosimilar development programs has been a natural outgrowth of our extensive work on behalf of the generic drug industry. Clients consistently praise our biosimilars blog, BigMoleculeWatch.com, for its timely and relevant posts on biosimilar-related litigation, legislation and regulatory developments.
Read More

Intellectual Property

Intellectual property assets represent significant value for businesses in the United States. For some clients, these assets represent an entire career or a body of research; for others, they're a 100-year-old trademark, or a newly acquired license. Whether it’s structuring transactions or resolving high-stakes property disputes, we understand the unique needs of each client, and anticipate how those needs will change over time. With superior experience– from scientists who’ve worked in the field, to litigators with International Trade Commission and federal court experience – we’re privileged to represent national and international companies in a broad cross-section of industries.
Read More

Labor + Employment

Management teams of all sizes and across a broad spectrum of industries rely on Goodwin for advice and representation in all areas of labor and employment law. We provide practical advice to employers on hiring and disciplinary practices, compensation, workplace violence, privacy concerns, issues arising under the Family and Medical Leave Act, loyalty issues, and protection of employer good will and proprietary information via restrictions on post-employment competition.

Our lawyers have extensive employment litigation experience involving all significant employment law issues, including reasonable accommodation of disabilities; sexual harassment; discrimination claims arising out of reductions in force; individual disparate treatment claims; wrongful discharge/public policy claims; employment contract and employee benefits claims; wage and hour disputes; and enforcement of noncompetition obligations.

Read More

Mergers + Acquisitions

Goodwin lawyers have deep experience guiding clients through both public and private mergers and acquisitions transactions of all types including leveraged buyouts, tender offers, spinoffs, divestitures and go-privates (both in the U.S. and abroad). Our lawyers bring a distinctive combination of regulatory and transactional expertise, characterized by a high degree of tax and financial sophistication, and a commercial negotiating style that is essential for success. We blend technical know-how and specific industry experience to get deals done quickly and efficiently. We draw on a firm-wide network of specialists in tax, intellectual property, real estate and executive compensation to help clients find practical, innovative solutions to their problems. 
Read More

Opinions + Counseling

Clients rely on our experienced attorneys and science advisors to help them make sound business decisions.

Lawyers in our patent opinions and counseling practice provide strategic advice to domestic and international companies. We work closely with clients to determine offensive and defensive patent strategies. Issues we routinely address include patent infringement, invalidity, unenforceability, licensing and freedom to operate.

Read More

Products Liability + Mass Torts

Companies facing products liability and mass tort litigation require experienced counsel with a sophisticated, multi-disciplinary practice. At the same time, the stakes for corporate defendants have grown to “bet the company” magnitude in many instances. Companies in these situations count on Goodwin to ensure their interests are optimally protected.
Read More

Tax

Complex tax issues often arise in structuring strategic, commercial and financial transactions and investment products. To find practical solutions to these challenging issues, clients rely on Goodwin’s tax lawyers to advise on the full range of international, federal and state tax issues. Clients seek us out not only to address their tax issues on a transaction, but also to help them gain a competitive advantage by creating structures designed to solve the tax issues faced by the counterparties.
Read More

Appellate Litigation

Goodwin's appellate litigators have briefed and argued hundreds of high stakes appeals, securing victories for clients in federal and state appellate courts throughout the United States. Lawyers in our Appellate Litigation practice are experts at working cooperatively as part of a team — alongside trial counsel and subject-matter experts — to preserve and present the best possible case on appeal and maximize our clients’ chances for success.

Our work begins well before a case goes on appeal: preparing dispositive motions in trial court; preserving error for appellate review; handling post-verdict motions practice; and even initiating litigation, to set aside arbitrary decisions by administrative agencies or to enjoin unconstitutional or invalid laws on legal grounds. Members of the practice have argued more than a dozen cases before the U.S. Supreme Court and have briefed scores of others.
Read More

Securities + Shareholder Litigation

When a company is faced with a securities class action or shareholder derivative litigation, they need a partner who understands what is at stake and can think outside the box to achieve resolution. Goodwin’s deep experience, creative thinking and tenacity has led to our involvement in precedent-setting securities cases in courts across the country. The results we achieve are best of breed and have helped shape the law nationally, including outright dismissals of billions of dollars in putative class action and shareholder derivative claims. Our cases range from defending high tech and biotech companies in class action securities fraud litigation brought following restatements of earnings or the release of bad business news, to resolving shareholder derivative challenges, to multibillion dollar mergers and acquisitions.

Read More

FDA Litigation

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges. 

Read More
Related Practices
Capital Markets
Companies seeking to grow, increase liquidity for their investors or reduce their cost of capital regularly turn to Goodwin. We have one of the most active capital markets and public company practices in the United States, serving as outside counsel to public companies in a range of industries and who are listed on both U.S. and non-U.S. exchanges. We combine deep industry knowledge with broad technical expertise across all equity and debt securities and alternative investment structures. Over the past five years, we have advised clients in nearly 300 public offerings with an aggregate value approaching $30 billion. Our practice and lawyers are consistently recognized by industry publications as one of the most active and innovative advisers for capital markets transactions and public companies.
Read More
FDA
Companies subject to FDA regulations know how critical compliance can be to the bottom line. Goodwin’s experienced FDA practice provides counsel, representation and strategic advice to companies subject to the Federal Food, Drug, and Cosmetic Act. Our practice covers all aspects of our clients’ interactions with the Food and Drug Administration. We are closely involved in our clients’ pre-market strategies and their implementation, including those involving product development, investigational device submissions, pre-market notification and approval applications, and lifecycle management. On the post-market side, our FDA attorneys have extensive experience advising on agency inspections and answering inspectional findings; counseling on labeling, advertising, good manufacturing practices and product reporting issues; and helping plan and implement remedial actions.
Read More
Life Sciences

Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. In this highly competitive business, you need more than the best and brightest ideas – you need a legal and strategic partner that understands the challenges of securing funding, safeguarding intellectual property, establishing partnerships, bringing new products to market, opening up new revenue streams, and protecting existing product lines.

Lawyers in our life sciences practice are deeply experienced in corporate governance, financing and M&A transactions, collaborations and licensing, regulatory matters, and intellectual property law. As part of our interdisciplinary approach, we also collaborate with attorneys in our patent litigation, products liability, employment and tax practices to protect client interests and to advocate on their behalf.

With a full service team of highly experienced lawyers resident in key life sciences hubs, our team helps clients find the strategic paths that foster growth and minimize risk across all phases of the corporate life cycle. Motivated by the knowledge that the work that we do with you is improving people’s lives, we serve as an extension of your team so you can focus on your core business.

Read More
Hatch-Waxman + Biosimilars Litigation
Litigation in the pharmaceutical and biotechnology industry can be particularly complex, requiring counsel that is as well versed across scientific disciplines as it is in the law. Goodwin has made servicing the needs of the pharmaceutical and biotechnology industries a strategic priority for more than two decades, and we have one of the largest and most active life sciences practices in the United States. Our IP litigation team is among the most experienced in the country, successfully representing both brand companies and generics in Hatch-Waxman litigation. Our portfolio of clients include the largest generic companies in the world and, more recently, include enforcement of patents related to numerous blockbuster drugs.

Our firm is also a leader in the emerging field of biosimilars litigation. Our lawyers were involved in the legislative process that resulted in the Biologics Price Competition and Innovation Act, and our work counseling clients as they advance their biosimilar development programs has been a natural outgrowth of our extensive work on behalf of the generic drug industry. Clients consistently praise our biosimilars blog, BigMoleculeWatch.com, for its timely and relevant posts on biosimilar-related litigation, legislation and regulatory developments.
Read More
Intellectual Property
Intellectual property assets represent significant value for businesses in the United States. For some clients, these assets represent an entire career or a body of research; for others, they're a 100-year-old trademark, or a newly acquired license. Whether it’s structuring transactions or resolving high-stakes property disputes, we understand the unique needs of each client, and anticipate how those needs will change over time. With superior experience– from scientists who’ve worked in the field, to litigators with International Trade Commission and federal court experience – we’re privileged to represent national and international companies in a broad cross-section of industries.
Read More
Labor + Employment

Management teams of all sizes and across a broad spectrum of industries rely on Goodwin for advice and representation in all areas of labor and employment law. We provide practical advice to employers on hiring and disciplinary practices, compensation, workplace violence, privacy concerns, issues arising under the Family and Medical Leave Act, loyalty issues, and protection of employer good will and proprietary information via restrictions on post-employment competition.

Our lawyers have extensive employment litigation experience involving all significant employment law issues, including reasonable accommodation of disabilities; sexual harassment; discrimination claims arising out of reductions in force; individual disparate treatment claims; wrongful discharge/public policy claims; employment contract and employee benefits claims; wage and hour disputes; and enforcement of noncompetition obligations.

Read More
Mergers + Acquisitions
Goodwin lawyers have deep experience guiding clients through both public and private mergers and acquisitions transactions of all types including leveraged buyouts, tender offers, spinoffs, divestitures and go-privates (both in the U.S. and abroad). Our lawyers bring a distinctive combination of regulatory and transactional expertise, characterized by a high degree of tax and financial sophistication, and a commercial negotiating style that is essential for success. We blend technical know-how and specific industry experience to get deals done quickly and efficiently. We draw on a firm-wide network of specialists in tax, intellectual property, real estate and executive compensation to help clients find practical, innovative solutions to their problems. 
Read More
Opinions + Counseling

Clients rely on our experienced attorneys and science advisors to help them make sound business decisions.

Lawyers in our patent opinions and counseling practice provide strategic advice to domestic and international companies. We work closely with clients to determine offensive and defensive patent strategies. Issues we routinely address include patent infringement, invalidity, unenforceability, licensing and freedom to operate.

Read More
Products Liability + Mass Torts
Companies facing products liability and mass tort litigation require experienced counsel with a sophisticated, multi-disciplinary practice. At the same time, the stakes for corporate defendants have grown to “bet the company” magnitude in many instances. Companies in these situations count on Goodwin to ensure their interests are optimally protected.
Read More
Tax
Complex tax issues often arise in structuring strategic, commercial and financial transactions and investment products. To find practical solutions to these challenging issues, clients rely on Goodwin’s tax lawyers to advise on the full range of international, federal and state tax issues. Clients seek us out not only to address their tax issues on a transaction, but also to help them gain a competitive advantage by creating structures designed to solve the tax issues faced by the counterparties.
Read More
Appellate Litigation
Goodwin's appellate litigators have briefed and argued hundreds of high stakes appeals, securing victories for clients in federal and state appellate courts throughout the United States. Lawyers in our Appellate Litigation practice are experts at working cooperatively as part of a team — alongside trial counsel and subject-matter experts — to preserve and present the best possible case on appeal and maximize our clients’ chances for success.

Our work begins well before a case goes on appeal: preparing dispositive motions in trial court; preserving error for appellate review; handling post-verdict motions practice; and even initiating litigation, to set aside arbitrary decisions by administrative agencies or to enjoin unconstitutional or invalid laws on legal grounds. Members of the practice have argued more than a dozen cases before the U.S. Supreme Court and have briefed scores of others.
Read More
Securities + Shareholder Litigation

When a company is faced with a securities class action or shareholder derivative litigation, they need a partner who understands what is at stake and can think outside the box to achieve resolution. Goodwin’s deep experience, creative thinking and tenacity has led to our involvement in precedent-setting securities cases in courts across the country. The results we achieve are best of breed and have helped shape the law nationally, including outright dismissals of billions of dollars in putative class action and shareholder derivative claims. Our cases range from defending high tech and biotech companies in class action securities fraud litigation brought following restatements of earnings or the release of bad business news, to resolving shareholder derivative challenges, to multibillion dollar mergers and acquisitions.

Read More
FDA Litigation

Pharmaceutical companies need experienced counsel to protect their regulatory interests. Goodwin’s FDA Litigation practice provides counsel, representation and strategic advice that covers all aspects of our clients’ interactions with the Food and Drug Administration. Our lawyers regularly advise clients on regulatory issues, engage with the FDA and other federal and state agencies through Citizen Petitions, comments, meetings and other petitioning, and represent drug manufacturers in Administrative Procedure Act challenges. 

Read More

News

Contacts

View Bio

Mitchell S. Bloom

Chair, Life Sciences Practice
Partner
View Bio

Elizabeth J. Holland

Partner
View Bio

Kingsley L. Taft

Co-Chair, Life Sciences Practice
Partner
Meet the Team