Site Search
Professionals 161 results
Capabilities 35 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 18 results
Experience
|February 12, 2024
Insights & News 327 results
Client Alert
|May 1, 2025
|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]
Product Liability & Mass Torts Digest
|April 23, 2025
|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.
Product Liability & Mass Torts Digest
|April 3, 2025
|5 Min Read
Supreme Court Has a Chance to (Re-)Clarify Albrecht Impossibility Preemption Test
A cert petition filed in March in the long-running In re Fosamax (Alendronate Sodium) Products Liability Litigation gives the Supreme Court a chance to clarify—for the second time—the Third Circuit’s restrictive application of the impossibility preemption defense.
Other Results 27 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.