Pharmaceutical

Intellectual Property Litigation and Counseling

We have extensive experience with FDA regulatory issues and ensure that litigation positions and strategies are consistent with regulatory filings and reporting obligations. We have aided clients in preparing Suitability and Citizens’ Petitions and reviewed proposed product labeling to assess compliance with statutory requirements while assessing section viii carve out amenability and evaluating for overlap with key patent limitations. We also work with clients on evaluating patents for Orange Book listing and de-listing, as well as the patent dance pursuant to the BPCIA.

Hatch-Waxman and BPCIA litigations present unique regulatory and commercial complexities. Benesch attorneys have extensive experience representing branded and generic pharmaceutical companies in Hatch-Waxman litigation, biologics, and biosimilar manufacturers in BPCIA litigation and related opinion and counseling matters.  

Our trial-savvy team has litigated and tried pharmaceutical patent cases in key jurisdictions like the District of Delaware and the District of New Jersey and has litigated additional cases in the Southern District of New York, District of Massachusetts, Eastern District of Texas, Central District of California, Southern District of California, Southern District of Florida, Eastern District of Virginia, Northern District of Illinois, District of Nevada and Northern District of West Virginia. We have represented clients in the temporary restraining orders and preliminary injunction hearings that arise in the context of launches of products appeals to the Court of Appeals for the Federal Circuit, and post-grant challenges before the Patent Trials & Appeals Board (PTAB).   

Our teams for pharmaceutical industry clients typically blend attorneys and patent agents/technical advisors with undergraduate and graduate degrees in relevant life sciences with experienced trial attorneys who know how to translate complex chemical and biological principles for the benefit of a judge and jury. Moreover, most of our attorneys have represented both branded and generic pharmaceutical companies at various points in their careers. As a result, we provide counsel with a nuanced perspective based on a deep understanding of the strategic and technological options available to our clients and their opponents. Our experience has given us particular insight into a variety of therapeutic areas (e.g., oncology, cardiovascular disease, infectious disease, endocrinology, women’s health, immunology, nephrology, ophthalmology, neurology, and psychiatry) and dosage forms and drug delivery mechanisms (e.g., tablets, capsules, inhalation suspensions, transdermal patches, sublingual films, and injectables). 

Our team members have worked on several drug products that involved patents directed to compound forms of active pharmaceutical ingredients (including polymorphs, isomers, and metabolites), formulations, methods of treatment, methods of manufacture, as well as delivery devices.

This product listing excludes confidential products on which we have been or are currently working on for several of our clients. We have counseled and rendered opinions on patents covering these products and several other products that were eventually not litigated.

Before litigation, we are often asked to provide opinions to support Paragraph IV certification notice letters or detailed statements under the BPCIA or otherwise prior to the filing of litigation. Our team also regularly works with our clients to evaluate their patent portfolios and strengthen them for assertion or defensive use in litigation. 

Pharmaceutical Litigation

Our team includes experienced first-chair trial lawyers who have handled significant pharmaceutical litigation cases across the U.S. We have served as national coordinating counsel and lead counsel in pharmaceutical litigation and have a demonstrated record of success in high-stakes cases. We have prevailed at trial, on summary judgment and at the class certification stage for major international pharmaceutical clients. Our team of attorneys specializes in negotiating resolutions that make business sense, but we are also well-prepared to take cases to trial on the merits if required.

IP Prosecution 

Benesch brings extensive experience to IP prosecution in the pharmaceutical industry, navigating the complex landscape of patent and trademark protection for both large and emerging companies. Understanding the unique challenges posed by pharmaceutical innovation, our IP team focuses on securing patents that protect drug formulations, manufacturing processes, and biotechnology advancements. We ensure that clients' intellectual property rights are safeguarded from development through commercialization, supporting their long-term business goals in a competitive market.

Our team manages large-scale patent portfolios and advises on freedom-to-operate analyses, patent challenges, and litigation risks. With experience in Hatch-Waxman litigation and post-grant proceedings, we are well-positioned to help clients protect their market position and defend against challenges from generic competitors.

Contracting and Licensing

Benesch provides deep experience in contracting and licensing for pharmaceutical clients. Our team works closely with pharmaceutical companies to draft and negotiate a wide range of agreements, including research and development contracts, manufacturing and supply agreements, and product licensing deals. We understand the importance of protecting intellectual property, meeting compliance standards, and supporting long-term business objectives.

Our attorneys are skilled in negotiating licensing arrangements that address key issues such as market exclusivity, royalties, and technology transfer. We work closely with clients to mitigate risks, navigate regulatory hurdles, and ensure their contractual relationships align with the fast-evolving pharmaceutical market. 

Product Liability

Benesch’s attorneys are well-versed in managing complex product liability cases for the pharmaceutical industry. Our team understands the long-lasting implications for our clients and brings a strategic approach to litigation, regulatory compliance, claims prevention, and defense.

Our team has defended pharmaceutical clients in multidistrict litigation (MDL) and state courts, including cases involving alleged false advertising, product mislabeling, product contamination, and recalls. Our attorneys have successfully represented clients across a range of pharmaceutical products, including hormone therapy drugs, diet drugs, and testosterone replacement therapies. We have also represented pharmaceutical companies in consumer class actions related to product labeling and have managed thousands of product liability cases nationwide. 

Government Investigations

Benesch excels in guiding pharmaceutical companies through complex government investigations. Our team regularly represents clients facing investigations initiated by federal agencies such as the FDA, DOJ, and DEA , addressing issues related to regulatory compliance, pricing practices, fraud, and False Claims Act violations. We support clients through every stage of the investigation, from responding to subpoenas and civil investigative demands to negotiating settlements or preparing for litigation when necessary. 

Our experience covers a wide range of enforcement actions, including allegations of off-label marketing, violations of Good Manufacturing Practices (GMP), and compliance with anti-kickback statutes. Our attorneys effectively anticipate government strategies, present compelling arguments, and mitigate legal, financial, and reputational risks while protecting our clients’ business interests.

Mergers and Acquisitions

Benesch has a strong track record representing pharmaceutical companies in high-profile transactions, including acquisitions, mergers, divestitures, joint ventures, and recapitalizations. We guide pharmaceutical clients through every phase of the deal, from initial negotiations and due diligence to finalizing agreements and regulatory approvals. Our team ensures that transactions are structured to achieve strategic objectives while addressing industry-specific considerations such as intellectual property rights, regulatory compliance, and market access.

Our attorneys carefully assess potential risks, evaluate regulator impacts, and identify opportunities for value creation. We work closely with clients to navigate the complexities of antitrust scrutiny, FDA regulations, and other industry-specific issues that may arise during the transaction process.

Transportation & Logistics

Benesch brings extensive experience advising clients through the regulatory landscape, industry relationships, and contract structures within the pharmaceutical sector, including controlled substances. Our team provides counsel on the storage, fulfillment, and transportation of these products nationwide, with a deep understanding of licensure requirements and chain-of-custody best practices to mitigate risk.

The regulatory environment is complex, often involving overlapping federal and state jurisdictions, including agencies like the FDA and DEA. This compliance burden extends to third-party service providers, requiring operational controls such as Standard Operating Procedures. Our team is well-versed in industry practices and risks at the federal and state levels, obviating any learning curve.

Labor and Employment

Benesch represents pharmaceutical companies in a wide range of labor and employment matters, including litigation and counseling. Our team represents clients in disputes such as discrimination claims, wage and hour issues, wrongful discharge, and breach of contract in both federal and state courts. We also have extensive experience prosecuting and defending claims related to non-competition agreements, trade secret rights, and managing arbitrations under employment and collective bargaining agreements.

Additionally, we provide clients guidance under major regulatory frameworks like HIPAA, the Fair Credit Reporting Act (FCRA), and the Americans with Disabilities Act (ADA). Benesch has successfully represented pharmaceutical companies in high-stakes litigation cases, including obtaining injunctive relief in actions against competitors and securing favorable settlements in disputes involving former executives.

Real Estate

Benesch provides a wide breadth and depth of experience in real estate matters within the pharmaceutical industry. Our team represents global and publicly traded pharmaceutical companies in complex transactions, including the acquisition, development, leasing, and disposition of properties used for research, manufacturing, and distribution. Understanding the critical nature of site selection and facility management, we ensure transactions align with regulatory standards and operational needs.

Our attorneys negotiate and structure agreements for laboratory spaces, manufacturing facilities, and office environments, focusing on compliance with industry-specific regulations such as zoning laws, environmental regulations, and health and safety standards. We also support clients in managing real estate portfolios, handling complex lease negotiations, and navigating regulatory approvals.