On June 25, 2013, the England and Wales High Court rendered its decision in Eli Lilly & Company v. Janssen Alzheimer Immunotherapy,  EWHC 1737. This ruling demonstrates the danger in drafting patents to include only broad claims without subordinate, narrow claims, which are more likely to survive a validity challenge like the one Eli Lilly Company (“Lilly”) successfully raised in this case. That is not to say broad claims should be eliminated altogether. However, as this ruling demonstrates, in drafting a patent it is extremely important to include a series of narrow claims that are well-supported by the disclosure.
The case concerned a Janssen Alzheimer Immunotherapy (“JAI”) patent relating to antibodies for use in the prevention or treatment of certain diseases characterized by amyloid deposit, including Alzheimer’s disease. Lilly sued JAI for the revocation of its patent and for a declaration that Lilly’s Phase III antibody, solanezumab, would not infringe.
In the end, the court rejected Lilly’s contention that the patent lacked novelty and was obvious. However, the court found that the patent was invalid on the ground of insufficiency. Interestingly, if the patent were not invalid, the court concluded that Lilly would infringe.
The court’s insufficiency conclusion demonstrates the importance of including in patents narrow, well-supported claims.
Under U.K. law, as in Canada, a patentee need not demonstrate in the patent itself that the invention works in every case (i.e., across the entire scope of the claim). In Canada, patentees can rely on the doctrine of sound prediction when such utility is not demonstrated. In the U.K., the court examines whether the patent disclosure makes it “plausible” or “credible” that the invention will work across the scope of the claim.
In arriving at insufficiency conclusion, the court construed the broad independent claim of the JAI patent as covering any antibody to ß-amyloid peptide. The court found that utility across the breadth of that claim had not been demonstrated. Further, that the patent disclosure only made “plausible” something less than the entire scope of the claim – the disclosure only made it plausible that a suitable antibody to ß-amyloid peptide would be effective to prevent and/or treat a disease characterized by amyloid deposit; not any antibody.
Given the ruling, it seems that more narrowly drafted claims directed at the suitable antibodies supported by the disclosure would have survived Lilly’s validity challenge.