Therapeutic antibodies have become big business. More than 30 antibodies have been approved by the FDA for marketing, including multiple blockbuster biopharmaceuticals. Sterne Kessler helps clients operating in this space to carefully manage intellectual property issues, ensuring they navigate development hurdles and achieve ambitious financial objectives.
Immunotherapy is among the most promising approaches to curing a wide range of diseases — from autoimmune disorders to cancer. However, the IP landscape in therapeutic antibodies is complex and highly competitive. Sterne Kessler's team brings the technical depth and legal acumen necessary to obtain patent protection, defend exclusivities, launch new products with freedom to operate and litigate disputes in any venue.
Strategic issues to consider include:
Freedom to Operate
A patent does not grant the patent holder the affirmative right to practice the patented technology — a patent conveys only the right to exclude others from practicing that technology. It is a real possibility that in making, using or selling patented technology, companies may unwittingly infringe a separate patent of a third party. Growth in the therapeutic antibody market has created a minefield of third-party patents which must be carefully navigated as innovators seek to commercialize proprietary antibody technologies.
Product Lifecycle Management
Many of the therapeutic antibodies launched in recent years are the result of groundbreaking technologies first developed a decade or more ago. As the use of these technologies becomes more common, and their broad applicability becomes increasingly apparent, they are no longer considered groundbreaking — their use becomes more of an industry norm. Consequently, the argument for patentability of the products of these technologies has become more difficult. Companies can address this by adopting a well-planned filing strategy that seeks to time the filings of new patent applications so as to minimize the threat posed by their own prior patents, while at the same time maximizing patent term for potentially blockbuster products. By crafting a careful patent lifecycle management strategy, innovators can continue to obtain patents to new inventions surrounding a valuable antibody product.
Changing Legal Landscape
The legal landscape in which antibody patents are procured and enforced is constantly being reshaped by Congress and the courts. Several recent decisions by the U.S. Supreme Court may affect the patentability of recombinant antibodies, as well as the very right of patent holders to effectively license their technologies or to exclude others from practicing them. Sterne Kessler has the technical depth, legal acumen, and industry experience to help innovators in the therapeutic antibody industry navigate these IP challenges.