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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 48 results
Speaking Engagement
|April 29, 2025
Kathi Vidal and Bryce Cooper Speak at the 2025 Paragraph IV Disputes Conference in New York
Winston & Strawn partner Kathi Vidal co-chaired ACI’s 21st Annual Paragraph IV Disputes Conference, April 29-30 in New York City.
Speaking Engagement
|March 6, 2025
Ivan Poullaos Speaks on ANDA Litigation Strategies at 9th International IP Skills Summit
Winston & Strawn partner Ivan Poullaos was a featured speaker at the 9th International IP Skills Summit (IIPSS) in Hyderabad, India. Winston sponsored the invite-only summit, which focused on Paragraph IV and biosimilar patent litigation and was attended by over 300 participants from around the world, including pharmaceutical IP attorneys and in-house counsel.
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.
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).