Pharmaceutical

Intellectual Property Litigation and Counseling

We work hand in glove with FDA regulatory counsel to ensure that litigation positions and strategies are consistent with regulatory filings and reporting obligations. We have aided clients in the preparation of Citizens’ Petitions and reviewed proposed product labeling for overlap with key patent limitations and compliance with statutory requirements. We also work with clients on evaluating patents for Orange Book listing and de-listing.

Hatch-Waxman litigation presents unique regulatory and commercial complexities. Benesch attorneys have extensive experience representing both branded and generic pharmaceutical companies in Hatch-Waxman litigation and related opinion matters.  

Our trial-savvy team has litigated and tried pharmaceutical patent cases in key jurisdictions like the District of Delaware and District of New Jersey, and has litigated additional cases in the Southern District of New York, District of Nevada and Northern District of West Virginia. We have represented clients in preliminary injunction hearings that arise in the context of at-risk launches of generic 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 with undergraduate and graduate degrees in relevant life sciences with experienced trial attorneys who know how to translate complex biological and chemical principles for the benefit of a jury or judge. Moreover, many of our attorneys have represented both brand 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, women’s health contraceptives and hormone replacement therapies, psoriatic and rheumatoid arthritis, neurological disorders) and dosage forms and drug delivery mechanisms (e.g., transdermal patches, oral transmucosal films, and injectables). 

Our team members have worked on a number of drug products that included Orange Book-listed or related patents directed to compound forms of active pharmaceutical ingredients (including polymorphs), formulations, solutions, methods of treatment, methods of manufacture, and delivery devices. 

While our team members have represented clients in Hatch-Waxman matters for over 20 years, recent exemplary products include:

This product listing excludes confidential products on which we are currently working for a number of our clients, including branded pharmaceutical companies. 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 the filing of litigation. Our team also regularly works with our branded clients to evaluate their patent portfolios and strengthen them for assertion in litigation.   

Representative Experience

• Represented the manufacturer of blockbuster opioid dependence treatment Suboxone^®Film in multiple patent trials in the District of Delaware against generic competitors as well as related appeals and inter partes review proceedings. Obtained a bench trial verdict of infringement and validity of patent relating to oral transmucosal thin film, which was upheld on appeal.  
• Represented a client in Hatch-Waxman patent litigation in a first to file (FTF) opportunity related to a methylphenidate transdermal patch sold by Noven as Daytrana®. Obtained partial summary judgment rulings of non-infringement and invalidity due to inadequate written description. The parties’ settlement permitted the client to launch its product three years before expiration of the patent-in-suit.
• Represented Sandoz Inc. in a patent litigation regarding a biosimilar version of Amgen’s drug Neulasta®. The litigation was successfully terminated when Sandoz obtained an order dismissing Amgen’s related declaratory judgment.
• Argued an appeal before the Federal Circuit on behalf of appellee seeking reversal of summary judgment of non-infringement based on prosecution history estoppel in a Hatch-Waxman ANDA litigation.
• Represented a leading manufacturer of women’s health products in multiple litigations relating to extended regimen oral contraceptives and a hormone replacement therapy.
• Obtained summary judgment of noninfringement and unenforceability based on inequitable conduct on behalf of the filer of an ANDA for a generic version of DDAVP^®tablets (desmopressin acetate). The summary judgment was affirmed on appeal.
• Forced a covenant not to sue and a unilateral motion to dismiss in a case involving formulation patents for a dronabinol oral solution (Syndros) that led to the possibility of an entry date prior to expiration of the Orange Book-listed patents.
• Secured a favorable claim construction for a patent relating to a cyclodextrin carrier for a melphalan injectable (Evomela) that led to a successful settlement.
• Represented plaintiffs in multiple Hatch-Waxman litigations for patents relating to a GC-C receptor agonist (Linzess^®). Obtained favorable settlements for clients.*
• Secured a covenant not to sue of a polymorph patent relating to a form of apremilast (Otezla) that created an opportunity for an early entry date prior to expiration of certain patents.
• Represented a pharmaceutical company in ANDA litigations before district and appellate courts and the PTAB involving patents for the treatment of ulcerative colitis.*
• Represented a pharmaceutical client in an inventorship proceeding, resulting in a finding that the opposing party’s alleged inventor did not invent the claimed subject matter.*
• Represented a pharmaceutical company in ANDA litigation involving a drug for treating prostate cancer.*
• Obtained an order from the appellate court vacating and remanding a district court’s determination on summary judgment that a pharmaceutical client was equitably estopped from seeking to correct inventorship of certain patents.*
• Represented a client in a qui tam action involving pharmaceutical patents before district and appellate courts.*

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.

Representative Experience

• Lead counsel for major life science manufacturer in an 18,000-plaintiff mass tort coordinated proceeding in LA County Superior Court. Through trials and aggressive motion practice over a period of 4+ years, eliminated 90% of case inventory, the balance of which was the subject of a settlement matrix.
• Lead counsel for major pharmaceutical manufacturer in multiple state attorneys general actions alleging unfair trade practices.
• In a major pharmaceutical multi-state litigation, responsible for preparing company defense against allegations of failure to warn and off-label promotion. Handled major department heads in regulatory, medical affairs and marketing. Developed and handled lead regulatory experts in individual failure to warn trials, MDL proceedings, state coordinated proceedings and state attorney general cases. Also handled Daubert hearings seeking to disqualify plaintiffs’ experts in these disciplines.
• Counsel for generic pharmaceutical manufacturer/distributor in Metformin MDL class action proceeding, currently pending in Northern District of New Jersey.
• Represented developer of neuropathic pain medication in international arbitration of breach of contract and fraud action against manufacturer/distributor over worldwide marketing and distribution of product.
• Co-national coordinating counsel in Propulsid litigation.
• Regional coordinating counsel in PPA litigation.
• Regional coordinating counsel in Diet Drug litigation.
• In a published opinion, obtained summary judgment in the Central District of California on behalf of major life sciences manufacturer in product liability failure to warn case. Thompson v. Janssen Pharmaceuticals Inc.*
• Defended Abbott Laboratories, Inc. in a multimillion-dollar suit involving complex contract law and collective bargaining pension withdrawal liability issues.
• Successfully moved to disqualify opposing counsel from representing a pharmaceutical client in several appeals for a conflict of interest.*
• Represented a Fortune 500 pharmaceutical manufacturer in MDL and multiple state jurisdictions in a product liability class action matter.*
• Defended a pharmaceutical distributor in MDL 2804, National Prescription Opiate Litigation, which was hailed as the largest and most complex litigation in U.S. history.*
• Defended pharmaceutical companies in defense of consumer class actions concerning product labeling.
• Defended pharmaceutical clients and supplement manufacturers/retailers in various multidistrict litigation encompassing hundreds of cases involving personal injury and some including suicidal ideation/suicide, osteonecrosis of the jaw and birth defects.*
• Represented a pharmaceutical manufacturer in multidistrict and multistate litigation alleging false advertising of pain medication.*
• Represented a major pharmaceutical manufacturer in cases alleging product mislabeling and contaminated Heparin, tracking contaminated products from both the labeling side and the supply chain side.*
• Defended a pharmaceutical laboratory when it was sued more than 35 times related to product recalls.*

*Matter completed prior to joining Benesch.