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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.
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.
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).
Experience 5 results
Experience
|April 23, 2025
Voyager Acquisition Corp. and VERAXA Biotech Announce Business Combination
Experience
|January 29, 2025
Drugs Made In America Acquisition Corp. Announces Closing of $200,000,000 Initial Public Offering
Experience
|December 20, 2021
ACON Investments' Acquisition of Vitalis Group
Winston & Strawn LLP represented ACON LatAm Management, L.L.C.; ACON Latin America Opportunities Fund V, L.P.; and certain of their respective affiliates in the acquisitions of the companies that form the Vitalis Group (Vitalis), a leading manufacturer and wholesaler of generic injectable pharmaceuticals with production facilities in Colombia and Mexico, with sales to more than 20 countries, mainly in Latin America. Vitalis is representative of ACON's Latin American investment strategy over the last three decades, where it is now investing its fifth fund for the region. ACON believes that Vitalis offers a unique platform to grow and cross-sell its more than 700 pharmaceutical products to multiple countries across Latin America.
Insights & News 389 results
News
|August 4, 2025
|3 Min Read
Key Takeaways from Winston’s Fifth Annual Health Care & Life Sciences Summit
Winston & Strawn was pleased to host its fifth annual Health Care & Life Sciences Summit. This year’s event brought together clients, colleagues, and industry leaders for an afternoon of insightful discussions, networking, and perspectives on the shifting dynamics across the health care and life sciences sector.
Competition Corner
|July 28, 2025
|9 Min Read
New Legislation and Enforcement Initiatives: The State Enforcement Future and Impact
As federal antitrust enforcement continues to evolve, adjust priorities, and in some cases, stall out, states are increasingly enhancing their enforcement focus, resources, and law.
Webinar
|July 15, 2025
The Revival of Most-Favored-Nation Pricing: What Pharma Needs to Know
Winston hosted a webinar exploring the evolving antitrust landscape as it intersects with drug pricing policy and regulation under the current administration. Reviving the “most-favored-nation” drug pricing principle of the prior Trump administration, this administration is leveraging antitrust tools to address high pharmaceutical costs, signaling a shift toward increased regulatory scrutiny of market power and pricing disparities. Our lawyers covered the latest executive orders and proposed agency actions, potential implications for pharmaceutical companies and the broader healthcare industry, and how to navigate this changing regulatory environment.
Other Results 35 results
Law Glossary
Generic drugs are typically small, chemically synthesized molecules—that is, they have relatively low molecular weights, frequently less than 1000 daltons and usually between 300 and 700 daltons. Biosimilars, on the other hand, are typically substantially larger in molecular weight than small molecule drugs. For example, a monoclonal antibody—a typical biosimilar drug—generally has a molecular weight in excess of 150,000 daltons. In contrast, aspirin—a typical small molecule drug—has a molecular weight of 180 daltons.
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.
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.