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Professionals 21 results
Capabilities 7 results
Practice Area
Our Patent Litigation Practice is one of the country’s most active and highly regarded. Our seasoned patent litigators bring extensive courtroom experience to every matter we handle. According to Lex Machina, we are among the top three national patent defense firms in the country for number of appearances and cases filed, and we also were the top national defense firm for number of patent trials in the last five years (2018–2022).
Industry
Winston has been a major player in the life sciences industry for decades. We represent market-leading clients across this broad sector, including companies involved in pharmaceuticals, biologics, biosimilars, biotechnology, and medical devices. Our attorneys are seasoned practitioners—many of whom have technical degrees in areas key to the life sciences sector, including biology, chemistry, pharmacy, and biomedical engineering—and bring a unique understanding of the industry and perspective to our representations.
Industry
The medical device industry is currently undergoing monumental change—from supply chain challenges to disruptive technologies and economic fluctuations. To pave the way for a more accessible and innovative health care landscape—including advances in wearables, implants, diagnostics, mobility, drug delivery—the evolving and expansive medical device industry faces wide-ranging legal needs. Clients in this sector can tap the remarkable depth and breadth of our sector-focused and skilled attorneys in the U.S. and abroad. Our Health Care & Life Sciences Industry Group engages clients at all points in the product development life cycle to provide sound advice and practical solutions regardless of the client’s size or the complexity of their need. We help clients navigate today’s complex regulatory landscape, defend products and reputations in the face of high-profile product liability and mass tort claims, protect innovative intellectual property (IP), and leverage cross-border experience to advise on commercial transactions.
Insights & News 46 results
Speaking Engagement
|October 17, 2024
Claire Fundakowski Presents at 2024 Hatch-Waxman and BPCIA Passport to Proficiency Series
Winston & Strawn partner Claire Fundakowski will present during ACI’s Fourth Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA.
Recognitions
|October 2, 2024
|1 Min Read
Chuck Klein and Jovial Wong Named Among Top Attorneys in ANDA Litigation for 2024
Winston & Strawn partners Chuck Klein and Jovial Wong were recognized in Patexia’s report “Top Attorneys in ANDA Litigation: A Spotlight on the Best Performers and Most Active of 2024.”
Speaking Engagement
|April 25, 2024
Ivan Poullaos Discusses Jury Trial Preparedness in ANDA Cases at Paragraph IV Disputes Conference
Winston & Strawn partner Ivan Poullaos spoke at the 20th Annual Paragraph IV Disputes Conference, April 25-26, 2024, in New York City.
Other Results 12 results
Law Glossary
What Are the Patent Litigation Differences Between the BPCIA and Hatch-Waxman Act?
There are fundamental differences between the abbreviated approval processes to obtain FDA approval for biosimilars and generic drugs as those processes relate to patent litigation.
Law Glossary
What Is the Approval Process for Generic Drugs?
Approval for generic drugs are governed by the Hatch-Waxman Act. The Hatch-Waxman Act provides the framework for an applicant to demonstrate that its proposed generic product is bioequivalent to the brand-name drug.
Site Content
Congress enacted the Biologics Price Competition and Innovation Act (BPCIA) to provide an abbreviated pathway for biosimilars to gain FDA approval through submission of an abbreviated Biologics License Application (aBLA).