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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 3 results

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

Experience

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July 17, 2020

Defended Generic Drug Manufacturer in Trade Dress Infringement Case

Experience

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March 29, 2019

Rare Noninfringement Jury Verdict for Teva N.A. in Patent Infringement Case for Suboxone® Tablets

Insights & News 347 results

Capital Markets & Securities Law Watch

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October 30, 2024

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3 Min Read

SEC Charges Four Companies With Misleading Cyber Disclosures on SolarWinds Hack

The Securities and Exchange Commission recently announced charges and million-dollar penalties against four companies for allegedly making materially misleading disclosures regarding cybersecurity risk and intrusions relating SolarWinds hack.

In the Media

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October 24, 2024

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1 Min Read

Susan Nash Discusses Proposed OTC Contraception Regulations with Law360

Winston & Strawn partner Susan Nash was quoted in a Law360 article discussing the Biden administration's proposal to require health insurers and group health plans to cover the cost of over-the-counter contraception with no cost-sharing. The U.S. Department of Labor, U.S. Department of Health and Human Services, and U.S. Department of the Treasury jointly unveiled proposed rules that would require health insurers and group health plans to cover the cost of OTC contraception items, including the no-prescription daily birth control pill, male condoms, and the morning-after pill. ...Read more

Product Liability & Mass Torts Digest

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October 7, 2024

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10 Min Read

Trio of Tylenol Product-Liability Opinions Exemplifies Effective Judicial Gatekeeping

A series of recent opinions by Judge Denise Cote of the U.S. District Court for the Southern District of New York exemplifies the effective judicial gatekeeping contemplated by Federal Rule of Evidence 702 and Daubert v. Merrel Dow Pharmaceuticals. In In re Acetaminophen – ASD-ADHD Products Liability Litigation, Judge Cote repeatedly excluded the plaintiffs’ general causation experts even though each was “eminently qualified” because they did not reliably apply their methodologies. 

View All Insights & News

Other Results 33 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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