Pharmaceutical

The pharmaceutical industry faces a challenging business environment as competition drives down prices, R&D expenses rise, and government scrutiny deepens. However, companies have many options for navigating these challenges, generally by making deals with others in the field, including mergers and acquisitions, licensing agreements and divestitures, as well as securing patents to protect their IP. Companies may also conduct operational refinements to address risks related to regulatory and compliance concerns.

Attorneys in Saul Ewing’s Life Sciences Practice work together to represent businesses in the pharmaceutical industry across this spectrum, from the early stages of research and development through transactions that help companies establish themselves in the marketplace and reposition to remain competitive to threats ranging from enforcement actions to ANDA litigation.

Patent Support With a Ph.D. Perspective

Our team understands that science drives innovation. Protecting pharmaceutical products that emerge from scientific research is key to maintaining a competitive advantage. Many of our patent attorneys were patent agents and technical specialists who draw on their knowledge acquired during their Ph.D. and post-doctoral training in fields that include molecular biology, organic and pharmaceutical chemistry, and biochemistry to draft, file and prosecute patent applications before the U.S. Patent and Trademark Office and with the assistance of local counsel, in patent offices across the globe. Our team members have vast experience in counseling pharmaceutical companies and conducting due diligence, white space analysis, and freedom-to-operate and patentability determinations. Members of our team have hands-on research experience in the pharmaceutical industry. This direct scientific and industry experience informs our ability to counsel our pharmaceutical clients in a variety of their legal needs. Our team members also have experience with post-grant proceedings before the Patent Trial and Appeals Board of the U.S. Patent and Trademark Office, including inter partes re-examination proceedings and interference proceedings. Our team also has assisted clients with several important inventorship determinations. Keeping in mind that pharmaceutical companies seek worldwide patent protection for their products and processes, our team closely monitors trends, rule changes and pilot programs at the U.S. Patent and Trademark Office and at the World Intellectual Property Organization in order to advise clients on patent prosecution strategy in the U.S. and abroad. Our team also works closely with foreign patent counsel in order to advise clients on filing and prosecuting patent applications worldwide.

Business Counsel to Support Growth and Operations

Our cross-disciplinary team includes business and finance attorneys who guide pharmaceutical companies through the legal aspects of their growth. Our team includes attorneys who have served as outside general counsel to the pharmaceutical industry and worked within the industry developing business case scenarios and advising senior management on the commercial feasibility of potential in-licensing, divestment, acquisitions and co-promotion transactions. We have guided pharmaceutical companies in the sale of products and stock to private-backed companies and private equity groups. We also have experience providing representation in negotiations of contracts for support services, ranging from information technology licensing agreements and regulated systems involved in manufacturing to clinical trial agreements and informed consent documents. Our team is knowledgeable about the special considerations involved in siting labs and other buildings for the industry from our experience assisting a Fortune 500 pharmaceutical company in its acquisition and aggregation of land for the development of several million square feet for its company headquarters and then the later disaggregation, severance, sale and lease-back of parts of various buildings following a downsizing.

Guidance on Compliance and Enforcement

Obtaining regulatory approval to sell pharmaceutical products requires a deep understanding of the highly regulated environment in which the industry operates. We help our clients navigate this maze throughout the product life cycle—from development to promotion—by offering counsel on matters involving labeling, good manufacturing practice (GMP), quality system regulation (QSR), product design, and registration and listing, to name a few. Our experience handling these and other matters involving compliance and enforcement by the FDA, FTC and CPSC is informed by the work of our team that includes members who formerly served as regulatory counsel with the FDA and general counsel for a publicly traded specialty pharmaceutical company, a role that included monitoring government contract and compliance matters. When disputes arise relating to these and other issues, we help our clients prepare for FDA inspections, respond to inspectional observations and warning letters, manage product recalls, and resolve import and export issues. Attorneys with experience in the health care industry provide counsel on compliance with the Sunshine Act and white collar crime and government enforcement attorneys assist with government investigations resulting from enforcement of the Food, Drug and Cosmetics Act; False Claims Act; Anti-Kickback Statute and other laws affecting the pharmaceutical industry.

Litigation Ranging From Patent Protection to Manufacturing Practice Defense

The Life Sciences Practice includes litigators who assist the pharmaceutical industry on disputes ranging from the protection of their patents to the defense of manufacturing practices. Our patent litigation team is nationally recognized for its work on patent infringement matters, particularly cases involving ANDA and the Hatch-Waxman Act. Our patent litigation team members have secured major national trial victories in ANDA cases where hundreds of millions of dollars in sales were at stake and they were ranked fourth, nationally, for the number of cases involving patentee representation between 2015 and the first quarter of 2017, and fourth, nationally, for the number of cases involving ANDA plaintiff representation between 2009 and the first quarter of 2017. Our patent litigation team includes attorneys who have defended pharmaceutical manufacturers in trials and arbitrations and served as national coordinating counsel for pharmaceutical litigation.