Therapeutic antibodies have become big business. More than twenty antibodies have been approved by the FDA for marketing. Annual sales have passed the billion dollar mark. Companies operating in this space must pay careful attention to intellectual property issues, which can dramatically affect potential development and profitability.
Issues to consider include:
A patent does not grant the patentholder 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 you seek to commercialize proprietary antibody technologies.
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 life-cycle management strategy, you can continue to obtain patents to new innovations surrounding a valuable antibody product.
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 to patentholders to effectively license their technologies or to exclude others from practicing them.