Patents covering an antibody are often claimed by the antibody’s function (the residues where it binds to the antigen) rather than its structure (amino-acid sequence). This tactic can successfully cast a very wide net of patent protection over potentially millions of different antibodies. In doing so, even if the patent holder’s own antibodies never make it out of the laboratory, the patents can nevertheless corner the market on intellectual property covering a new class of inhibitors. The risk of this strategy, however, is that extremely broad patent scope can simultaneously doom a patent’s validity for not being sufficiently enabled or lacking written description. As an example, a recent decision from the District of Delaware, MorphoSys AG v. Janssen Biotech, Inc., No. 16-221 (LPS) (Dkt. 471) (Jan. 25, 2019), invalidated broad antibody patents for not being sufficiently enabled, as well as coming near to invalidating the same patents for lacking written description. The case is important to the growing body of patents covering biologic drugs because it delineates more precisely when functionally-claimed antibody patents can survive enablement and written description challenges.
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