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.< p/>

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.

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.
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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.
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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
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

News

Contacts

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Mitchell S. Bloom

Chair, Life Sciences Practice
Partner
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Kingsley L. Taft

Co-Chair, Life Sciences Practice
Partner
Meet the Team