The UK High Court recently revoked Janssen's Patent covering the use of amyloid-β antibodies in Alzheimer's disease for lack of sufficiency (Eli Lilly and Company v. Janssen Alzheimer Immunotherapy). Almost simultaneously, in parallel proceedings at the EPO, the Opposition Division came to the same conclusion in respect of the entire European Patent.
The decisions demonstrate a similar approach by the UK High Court and the EPO in the field of antibody technology, when considering the requirement that a patent must disclose the invention in sufficient detail to be carried out by a person skilled in the field.
The disputed Patent had claims directed to compositions containing antibodies to amyloid- β (Aβ) of isotype human IgG1 which were for use in preventing or treating diseases characterized by amyloid deposit.
In the UK High Court, Arnold J carried out a two-stage enquiry into sufficiency, considering i) whether the teaching of the Patent made it plausible that the invention would work across the scope of the claim, and then ii) whether later evidence established that the invention could not be performed across the scope of the claim without undue burden.
The Patent suggested selecting an antibody to an epitope at the N-terminal end of Aβ, but Arnold J held that it was not plausible from the Patent that any antibody to Aβ of the IgG1 isotype would be effective. He then went on to consider the effort required to develop an effective antibody following on from the Patent. Later disclosures, including results from unsuccessful clinical trials involving bapineuzumab (Janssen's clinical candidate) provided evidence that not all Aβ antibodies were efficacious. Although the judge held that such antibodies fell outside the claims (because they were not useful in preventing Alzheimer's disease), there was an undue burden for the skilled person to produce an effective antibody.
The EPO Opposition Division took a similar approach to the question of sufficiency, holding that whilst it was not required for every anti-Aβ IgG1 antibody to have therapeutic effect, the patent did have to enable the skilled person to provide anti-Aβ IgG1 antibodies that have therapeutic effect without undue burden. The Opposition Division also focused on the later-published evidence that several antibodies were not effective – only one antibody covered by the Patent could be deemed to credibly work (solanezumab – Lilly's clinical candidate), but there were no teachings in the Patent as to why this was so. Solanezumab works through a different mechanism (binding of soluble Aβ to prevent deposition) to that taught by the Patent.
Also of note is the approach of the different authorities to added matter (it is not permissible to add new information to a patent specification after filing). Amended claims covering antibodies having the combination of features of being isotype human IgG1 and being directed to Aβ13-28 were not allowed by the Opposition Division, consistent with the usual strict approach to added matter taken by the EPO in recent years. They also held that deletion of the requirement that the antibody "induce an immunogenic response against Aβ in a patient" was impermissible, taking the view that new information was being provided (that it was not necessary for the antibody to induce an immune response), and that the claim scope had been extended to encompass antibodies such as solanezumab. Interestingly, the UK High Court came to a different view on that point (albeit in respect of the granted claims rather than the amended claims before the EPO), holding that deletion of the requirement for induction of an immune response did not add matter.
The decisions highlight the willingness of the EPO and UK Courts to take into account new information published after the filing date of a Patent as evidence in certain circumstances when considering challenges to sufficiency of disclosure. Both decisions are appealable, but if the decision by the EPO Opposition Division to revoke the European Patent is upheld, any further UK Court proceedings will become redundant.
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