The demand for generic pharmaceuticals is growing rapidly, and the companies that can overcome barriers and bring products to market quickly are best positioned to benefit. Effective legal strategies can help businesses navigate the regulatory thicket of the U.S. Food and Drug Administration (FDA). Whether it is District Court litigation, inter partes review or a work-around, the Husch Blackwell team can help find the best strategy to achieve your goals.
Our firm has one of the premier Abbreviated New Drug Application (ANDA)/generic drug patent litigation practices in the country. Clients benefit from our experience and understanding of FDA regulations involving marketing approval for generic drugs under the Hatch-Waxman Act, a necessity in crafting comprehensive patent litigation strategies. Our team has extensive experience at the trial and appellate levels litigating Hatch-Waxman statutory patent infringement and other actions involving prescription pharmaceutical drugs. We combine in-depth legal and scientific knowledge to obtain favorable rulings for our clients.
Husch Blackwell clients also have been among the first to benefit from inter partes review (IPR). Part of the America Invents Act (AIA), IPR is a tool that can be used to challenge a patent’s validity more quickly and cheaply, all to the advantage of our clients.
Our team of professionals includes six scientists whose real-world experience gives them unique insight that, when coupled with the experience of our litigators, guides clients in safely navigating existing patents. Our interdisciplinary approach allows us to formulate the team that best matches the needs of the client.
Our proven record of success includes helping clients bring to market generic competitors for many major brand-name drugs, including:
Our attorneys are active members and leaders in a variety of healthcare, life sciences and pharmaceutical industry associations, including the Biotechnology Industry Organization (BIO) and the Generic Pharmaceuticals Association (GPhA). This participation helps us remain current on emerging legal matters and provides opportunities to interact with industry leaders.