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Professionals 13 results
Capabilities 4 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 17 results
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.
Client Alert
|April 16, 2021
|3 Min Read
Demonstrating ongoing commitment to enforcement of pharmaceutical manufacturers’ regulatory obligations to, among other things, establish and maintain identified Risk Evaluation and Mitigation Strategies (“REMS”) programs, the U.S. Food and Drug Administration (“FDA”) announced it will pull five generic opioids from the market after the products’ manufacturers failed to satisfy regulatory requirements associated with the holding of an abbreviated new drug application (“ANDA”).
Client Alert
|November 16, 2020
|2 Min Read
Venue Is Proper Only in Districts Where Actions Related to the Submission of an ANDA Occur
Valeant Pharmaceuticals North America LLC et al. v. Mylan Pharmaceuticals Inc. et al., No. 2019-2402 (Fed. Cir. November 5, 2020)
Other Results 8 results
Law Glossary
What Is the Standard for the FDA to Grant a Generic Drug License?
An Abbreviated New Drug Application (ANDA) must contain evidence that the proposed generic drug product is bioequivalent to the reference drug.
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.
Location
Launched in 2013, Winston & Strawn’s Silicon Valley office is home to nationally recognized attorneys that draw clients from Fortune 500 companies, startups, and everything in between. Led by Kelly Hunsaker—who has deep roots in Silicon Valley spanning nearly three decades—the office draws from the firm’s deep bench strength and global network of resources to serve clients in a variety of industries, including the semiconductor, computer hardware and software, telecommunications, life sciences, and pharmaceutical sectors. The office’s intellectual property attorneys have litigated extensively in all the top national patent litigation venues, as well as before the International Trade Commission and the Patent Trial and Appeals Board of the USPTO.