Unique among leading global law firms, Goodwin’s Late Stage Drug Development practice focuses on obtaining and enforcing patent protection that extends patent term on late stage products. Whether positioning patent portfolios for late stage investors, or simply protecting a company’s revenue stream, our team comprised of life sciences patent lawyers, Hatch-Waxman and biologics litigators with decades of experience representing both brands and generics, and FDA regulatory experts craft late stage patent, regulatory, and exclusivity strategies for life science companies developing therapeutics. We also advise on commercial launch strategy, inspections and marketing campaigns. We know how patents and regulatory exclusivities operate, how to obtain additional patents that provide additional term, how to obtain patent term extensions, and how patent and generic challengers think. We have had significant successes for clients in helping them maximize and defend patent protection for therapeutics closer to approval, as well as at and after product launch.
Whether advising companies on pre-approval strategies, patent and regulatory procurement, patent office challenges, FDA challenges, litigation, regulatory compliance or IP matters relevant to exits via IPOs and acquisitions, our Late Stage Drug Development team seamlessly advises companies and investors on late stage IP and regulatory issues.
Companies regulated by the Food and Drug Administration (FDA) know that expertise and practical advice are critical to the bottom line. Goodwin’s experienced FDA practice, a key component of the firm’s Technology & Life Sciences team, provides strategic counseling and skillful advocacy to companies subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and related federal and state laws.
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 and generic companies in Hatch-Waxman litigation. Our portfolio of clients includes some of the largest innovator and generic companies in the world, and we have represented our clients in patent cases involving some of the world’s biggest blockbuster drugs.
Our firm is also a leader in the emerging field of biologics and biosimilars litigation. Our lawyers were involved in the legislative process that resulted in the Biologics Price Competition and Innovation Act (BPCIA), and our work counseling clients as they advance their biologic and biosimilar development programs has been a natural outgrowth of our extensive work on behalf of the pharmaceutical industry. Clients consistently praise our blog, BigMoleculeWatch.com, for its timely and relevant posts on biosimilar-related litigation, legislation and regulatory developments. In addition, our team authored Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed., a first of its kind publication that explores the BPCIA.
Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. And with the breakneck pace of technology disrupting industries on a global scale, Goodwin’s depth of experience not only in the life sciences space, but also in collaboration with our technology, healthcare, real estate and private equity lawyers, makes our team exceptionally suited to address whatever the future brings. We partner with clients to embrace the promise and potential of innovation to make a profound and lasting impact.
Goodwin’s fully integrated, globally recognized destination life sciences practice is dedicated to serving the needs of innovators and investors working collaboratively to improve patients' lives. Our team of more than 150 lawyers is devoted to life sciences companies across the entire company lifecycle, and team members are strategically located across the major life sciences hubs in the U.S., Europe and Asia.
In order to survive and thrive, emerging-growth biotech and specialty pharmaceutical companies depend on the ability to strategically develop, exploit and monetize their intellectual property and product portfolios. Goodwin’s licensing and partnering practice does just that. We offer unmatched counsel and a deep bench of talented lawyers located in biotech, medical and scientific innovation centers throughout the United States.
Forming, operating and financing an emerging life sciences company can be challenging and time consuming. The experienced lawyers on Goodwin’s Life Sciences team can help guide you through these matters in addition to the varied legal issues that emerging life sciences companies face, allowing you to focus on your core business. With the breakneck pace of technology disrupting industries around the world, and in a highly competitive and fast-paced market, our team has unparalleled experience partnering with emerging life sciences companies – from formation through financing to an exit event. In just the last three years the Goodwin Life Sciences team has advised life science companies on over 170 life sciences equity financing deals alone. Our team takes the time to get to know and understand you and your business so that we can better advise you.
Life sciences companies face unique issues in accessing capital markets, including matters related to due diligence, public relations, regulatory and intellectual property. Goodwin offers a team of sophisticated life sciences lawyers who have expertise with these issues and extensive experience across the full breadth of equity and debt capital markets, advising issuers, sponsors, underwriters and investors in a variety of transactions to ensure deals close smoothly and in a timely way.
Pricing pressure, the reimbursement landscape, eroding margins, low valuations and the tax-friendly political climate are just a few of the factors positioning the life sciences industry for a ramp-up of M&A activity. The climate will be competitive for both buy and sell side prospects, and expert legal advice is critical for companies to be able to seize attractive, strategic opportunities. Thinking about M&A, even as a mere twinkle in your strategic plan? Goodwin can help.
Intellectual property protection is a crucial component for all life science companies. Our life sciences patent lawyers, patent agents and technical staff help assure that the best intellectual property strategy is in place to position and secure intellectual property protection, including patent protection, of our client’s core technology and lead therapeutic moieties, including small molecules, biologics, formulations, delivery systems, companion diagnostics, and medical devices. We have extensive experience in providing intellectual property diligence and assessment of patent landscapes to assist our clients, including operating companies, investors and financial institutions in connection with funding events, including public offerings and private financings, and to solidifying intellectual property positions for acquisition or other exit strategies.
The number of securities class actions filed against publicly traded pharmaceutical, biotechnology, medical device and health care product and services companies has grown exponentially over the last few years, particularly in 2017. Federal courts are continually issuing complex decisions in these cases. In this continually changing landscape, you need experienced litigation counsel who understands your business and industry, can readily assist you in making informed disclosure decisions and reduce litigation risk, and expertly defend these cases when they are filed.
Goodwin has a long track record of successes for our clients in these matters.
Companies regulated by the Food and Drug Administration (FDA) know that expertise and practical advice are critical to the bottom line. Goodwin’s experienced FDA practice, a key component of the firm’s Technology & Life Sciences team, provides strategic counseling and skillful advocacy to companies subject to the Federal Food, Drug, and Cosmetic Act, the Public Health Service Act, and related federal and state laws.
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 and generic companies in Hatch-Waxman litigation. Our portfolio of clients includes some of the largest innovator and generic companies in the world, and we have represented our clients in patent cases involving some of the world’s biggest blockbuster drugs.
Our firm is also a leader in the emerging field of biologics and biosimilars litigation. Our lawyers were involved in the legislative process that resulted in the Biologics Price Competition and Innovation Act (BPCIA), and our work counseling clients as they advance their biologic and biosimilar development programs has been a natural outgrowth of our extensive work on behalf of the pharmaceutical industry. Clients consistently praise our blog, BigMoleculeWatch.com, for its timely and relevant posts on biosimilar-related litigation, legislation and regulatory developments. In addition, our team authored Guide to Biosimilars Litigation and Regulation in the U.S., 2019-2020 ed., a first of its kind publication that explores the BPCIA.
Succeeding in the life sciences industry is as much about strategy and execution as it is about research and development. And with the breakneck pace of technology disrupting industries on a global scale, Goodwin’s depth of experience not only in the life sciences space, but also in collaboration with our technology, healthcare, real estate and private equity lawyers, makes our team exceptionally suited to address whatever the future brings. We partner with clients to embrace the promise and potential of innovation to make a profound and lasting impact.
Goodwin’s fully integrated, globally recognized destination life sciences practice is dedicated to serving the needs of innovators and investors working collaboratively to improve patients' lives. Our team of more than 150 lawyers is devoted to life sciences companies across the entire company lifecycle, and team members are strategically located across the major life sciences hubs in the U.S., Europe and Asia.
In order to survive and thrive, emerging-growth biotech and specialty pharmaceutical companies depend on the ability to strategically develop, exploit and monetize their intellectual property and product portfolios. Goodwin’s licensing and partnering practice does just that. We offer unmatched counsel and a deep bench of talented lawyers located in biotech, medical and scientific innovation centers throughout the United States.
Forming, operating and financing an emerging life sciences company can be challenging and time consuming. The experienced lawyers on Goodwin’s Life Sciences team can help guide you through these matters in addition to the varied legal issues that emerging life sciences companies face, allowing you to focus on your core business. With the breakneck pace of technology disrupting industries around the world, and in a highly competitive and fast-paced market, our team has unparalleled experience partnering with emerging life sciences companies – from formation through financing to an exit event. In just the last three years the Goodwin Life Sciences team has advised life science companies on over 170 life sciences equity financing deals alone. Our team takes the time to get to know and understand you and your business so that we can better advise you.
Life sciences companies face unique issues in accessing capital markets, including matters related to due diligence, public relations, regulatory and intellectual property. Goodwin offers a team of sophisticated life sciences lawyers who have expertise with these issues and extensive experience across the full breadth of equity and debt capital markets, advising issuers, sponsors, underwriters and investors in a variety of transactions to ensure deals close smoothly and in a timely way.
Pricing pressure, the reimbursement landscape, eroding margins, low valuations and the tax-friendly political climate are just a few of the factors positioning the life sciences industry for a ramp-up of M&A activity. The climate will be competitive for both buy and sell side prospects, and expert legal advice is critical for companies to be able to seize attractive, strategic opportunities. Thinking about M&A, even as a mere twinkle in your strategic plan? Goodwin can help.
Intellectual property protection is a crucial component for all life science companies. Our life sciences patent lawyers, patent agents and technical staff help assure that the best intellectual property strategy is in place to position and secure intellectual property protection, including patent protection, of our client’s core technology and lead therapeutic moieties, including small molecules, biologics, formulations, delivery systems, companion diagnostics, and medical devices. We have extensive experience in providing intellectual property diligence and assessment of patent landscapes to assist our clients, including operating companies, investors and financial institutions in connection with funding events, including public offerings and private financings, and to solidifying intellectual property positions for acquisition or other exit strategies.
The number of securities class actions filed against publicly traded pharmaceutical, biotechnology, medical device and health care product and services companies has grown exponentially over the last few years, particularly in 2017. Federal courts are continually issuing complex decisions in these cases. In this continually changing landscape, you need experienced litigation counsel who understands your business and industry, can readily assist you in making informed disclosure decisions and reduce litigation risk, and expertly defend these cases when they are filed.
Goodwin has a long track record of successes for our clients in these matters.
