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
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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
The Federal Court dismissed a motion by Apotex seeking particulars from Allergan's pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
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