By 2022, monoclonal antibody therapy revenue is predicted to reach $140 billion. For pharmaceutical companies and research universities, protecting proprietary antibodies is critical for capturing a piece of this profitable market. A broad claim over an entire genus of antibodies makes for the most valuable patent protection. However, these types of broad claims are increasingly difficult to achieve due to the exponential growth of relevant prior art.
Antibody patent applications must also meet all other criteria, including the “written description” requirement as outlined in 35 U.S.C. 112. As the Life Sciences Intellectual Property Review explains, “the majority of patent examiners and supervisory patent examiners at USPTO have begun taking the position that any functional antigen-based antibody claim lacks written description…”
With these challenges in mind, entities must weigh the need to file first against the need for data that satisfies the written description requirement and demonstrates nonobviousness. Applications that can not only describe antibodies by their function but by their epitope as well result in the broadest claims. “[A] claim supported by extensive testing might significantly improve the chances of validity and, at the same time, sizably expand the scope of protection around important commercial products.” Collecting the necessary data for a genus-encompassing claim requires physically making and testing antibodies representative of the genus—which takes time.
Pursuing multiple patents for the same antibody offers an alternative approach to valuable protection. Antibodies serve “as diagnostics, as imaging agents, as therapeutics at the margins of tumor environment, and the list goes on and on and on.” The application of antibodies in medicine continues to grow. “[D]ifferent types of patent claims (e.g., directed to compositions of matter, formulations and/or dosage regimens, and/or methods of use) offers a strategy for building multiple, reinforcing layers of patent protection.”