Eli Lilly v Janssen Alzheimer Immunotherapy, 25 June 2013, Patents Court, UK, Case No. HC11C03400
The UK High Court has held Janssen Alzheimer Immunotherapy’s patent relating to a pharmaceutical composition comprising an antibody for the treatment of Alzheimer’s Disease to be invalid. The two principal issues before the Court were added matter and insufficiency.
On added matter, the Court rejected the argument that, because claim 1 had been amended to a form that was not limited to antibodies which induced an immune response, matter had been added. First, the Court held that the administration of the claimed antibody would in fact produce an immune response. Second, even if the claim did cover antibodies that did not produce an immune response, it did not disclose such antibodes. There was therefore no added matter. The Court further held that the limitation in the granted claims to antibodies of the human IgG1 isotype was simply a restriction of the scope of the claim, not one that added matter.
However, the Court held the patent to be invalid on two grounds of insufficiency. First of all, a Phase 3 trial had demonstrated that the patent was “classically insufficient”: despite much effort and expediture, the patentee has not succeeded in making an antibody that was suitable for the methods of treatment covered by the claims in issue. The Court further held that it was not possible for a skilled addressee to perform the invention across the whole breadth of the claim without undue burden. The patent did no more than invite the skilled team to perform a major research project.
Had the patent been valid, it would have been infringed by Eli Lilly’s product.
Read the judgment (in English) here.
Head note: Graham Burnett-Hall and Rajesh Sagar