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Capabilities 28 results

Industry

Medical Devices

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....Read more

Industry

Life Sciences

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....Read more

Practice Area

Patent Litigation

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)....Read more

Experience 5 results

Experience

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April 23, 2025

Voyager Acquisition Corp. and VERAXA Biotech Announce Business Combination

Experience

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January 29, 2025

Drugs Made In America Acquisition Corp. Announces Closing of $200,000,000 Initial Public Offering

Experience

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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....Read more
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Insights & News 377 results

Client Alert

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May 1, 2025

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3 Min Read

April 2025 Executive Order Targets Prescription Drug Price Reduction

On April 15, 2025, President Trump signed an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The subject matter of this executive order criss-crosses considerable policy ground in the overall U.S. pharmaceutical distribution chain. The executive order sets forth the administration’s statement of objectives to reduce prescription medication costs by promoting competition and eliminating practices that lead to high drug prices. Referencing regulatory and policy actions from the first Trump administration and the Biden administration’s policy steps, including the Inflation Reduction Act of 2022 aimed at lowering prescription drug prices for Medicare beneficiaries, the executive order sets forth a broad agenda to impact Medicare prescription drug costs, including in the Medicare Part D program.[1] The order directs the Secretary of Health and Human Services (HHS) to propose and seek comment on guidance for the Medicare Drug Price Negotiation Program and collaborate with Congress to align the treatment of small molecule drugs with biological products, citing concerns about industry investment distortions and cost increases for Medicare and its beneficiaries.[2]...Read more

Government Program Fraud, False Claims Act & Qui Tam Litigation Playbook

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May 1, 2025

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10+ Min Read

Future FCA Enforcement Expectations in Light of New Administration Priorities and 2024 Recoveries

The annual False Claims Act (FCA) recovery statistics issued by the U.S. Department of Justice for Fiscal Year 2024, coupled with the Trump administration’s focus on the elimination of waste, fraud, and abuse in government spending and apparent intentions to rely on the FCA to pursue other administration priorities, signal a likely increase in FCA investigations and actions throughout 2025 and beyond.

Product Liability & Mass Torts Digest

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April 23, 2025

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5 Min Read

Supreme Court Opens Door to Civil RICO Claims Arising from Personal Injury

The Supreme Court just opened the doors to civil RICO suits against defendants alleged to have caused personal injury. This ruling could have major implications for product manufacturers and sellers, which may now face RICO claims—and treble damages—alongside traditional state-law claims in product-liability cases.

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Other Results 35 results

Law Glossary

What Is a Generic Drug?

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....Read more

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....Read more

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....Read more
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