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Professionals 157 results
Capabilities 34 results
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).
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.
Experience 10 results
Experience
|February 12, 2024
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.
Experience
|December 15, 2021
Arbor Investments' Acquisition of Oregon Freeze Dry
Winston & Strawn LLP represented Arbor Investments, a specialized private equity firm that focuses exclusively on investing in food, beverage, and related industries, in its acquisition of Oregon Freeze Dry (“OFD” or the “Company”) from Endeavour Capital. OFD is North America’s largest and most technologically advanced freeze-dryer of food, probiotics, enzymes, proteins, specialty ingredients, and lyophilized pharmaceutical inputs. With nearly six decades of institutional knowledge and proprietary lyophilization expertise, OFD manufactures innovative and value-added freeze-dried products for a diversified and high-growth mix of end markets. OFD brings an innovative approach to designing and commercializing successful product concepts and is a key contract manufacturing partner to an enviable list of sophisticated customers.
Insights & News 284 results
Government Program Fraud, False Claims Act & Qui Tam Litigation Playbook
|March 13, 2025
|6 Min Read
On February 18, 2025, the United States Court of Appeals for the First Circuit issued its decision in United States v. Regeneron Pharmaceuticals, Inc. adopting the more stringent “but for” causation standard for alleged violations of the False Claims Act (FCA) based on violations of the Anti-Kickback Statute (AKS).
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.
Press Release
|February 25, 2025
|2 Min Read
Dallas – February 25, 2025 – Winston & Strawn LLP announced today that Damien Diggs, former United States Attorney for the Eastern District of Texas, has joined the firm’s Litigation Department as a partner in its Dallas office and a member of its Government Investigations, Enforcement, and Compliance Practice. With 18 years of experience in the U.S. Department of Justice in Washington, D.C. and Texas, Damien brings a wealth of experience and an impressive record in all stages of criminal, civil, and appellate matters.
Other Results 28 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
A biologic—or biologic product—is a medicine made from or by living cells, typically through a series of complex processing steps. The Public Health Service Act defines a “biological product” as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or another trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.” (42 U.S.C. § 262(i).)
Law Glossary
How Does an Applicant Establish Biosimilarity?
An applicant typically demonstrates biosimilarity based on non-clinical analyses that focus on the structure and functional differences between the biosimilar and reference product.