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.

  • Achieved victory for NDA holder in face of a challenge to the agency’s approval of its cutting-edge 505(b)(2) application for ARISTADA®.
  • Goodwin successfully defended Alkermes’ FDA approval of the schizophrenia drug ARISTADA in the face of an Administrative Procedure Act challenge by another drug manufacturer. The case involved issues of first impression under the Federal Food, Drug, and Cosmetics Act (FDCA), concerning exclusivity the FDA grants to manufacturers that conduct studies on new ways to use an already approved drug. Goodwin helped Alkermes win a resounding victory in July 2016, when the federal district court rejected all the challenger’s claims seeking to vacate Alkermes’ approval. The decision is likely to be an important and precedent-setting one for life sciences companies seeking approval of drugs under the Section 505(b)(2) pathway.

  • Protected ANDA holder’s interest in retaining regulatory approval for the first generic launch of Nexium®.
  • Goodwin successfully defended Teva in a challenge to the FDA’s decision to approve the first generic version of Nexium. Another generic drug manufacturer contended that it was entitled to 180-day first-generic-entrant marketing exclusivity. The district court denied the challenger’s claims, resolving several issues of first impression concerning 180-day exclusivity.  Goodwin led the efforts on appeal among multiple generic intervenors, and the generic drug challenger dismissed its appeal on the eve of oral argument.

  • Defended ANDA holders’ approvals to launch the first-ever generic versions of the blockbuster drug Abilify®.
  • Goodwin led the defense of several generic drug manufacturers in the fact of a challenge to the FDA’s decision to approve generic versions of the blockbuster drug, Abilify. The manufacturer of Abilify contended that an interplay between orphan drug exclusivity and pediatric uses precluded generic drug approvals. Deciding an issue of first impression, the district court denied the challenges and upheld the generic drug companies’ right to market generic versions of Abilify. The challenger declined to appeal.

Related Practices

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

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.”

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

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

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

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
Related Practices
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
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.”

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
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
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
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

Viewpoints

Alert
FDA Draft Guidance on Updating Generic Labels When RLD Withdrawn
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