The High Court has ordered Bristol Myers Squibb and its co-plaintiffs and Merck companies to provide specified documents in their dispute over a patent covering immunopotentiating compositions, while refusing other parts of their discovery requests.
The ruling by Ms Justice Costello concerns discovery ahead of a trial split into two modules. The first is to address the patent’s validity and all aspects of the alleged infringement. Any damages claim and other issues were left for a second module, if required. The judgment decides discovery applications; it does not determine whether the patent is valid or has been infringed.
The plaintiffs allege that the manufacture and supply in Ireland of KEYTRUDA, which contains the anti-PD-1 antibody pembrolizumab, infringes their patent. The defendants deny the infringement allegations and counterclaim for revocation, arguing, among other grounds, that the patent lacks novelty or inventive step and is insufficient. The defendants admit that KEYTRUDA is made in Ireland by two of their companies and is supplied here for compassionate use on a named-patient basis without charge. Those admissions do not resolve the wider allegations against each defendant.
The judge ordered the defendants to update their US discovery for Category 1 to include publicly available third-party documents about KEYTRUDA’s mode of action. They are not required to include marketing materials in that update. For Category 2, the judge ordered discovery of documents about arrangements between the defendants and third parties concerning manufacture, supply, importation or stocking of KEYTRUDA or pembrolizumab in Ireland. The defendants may redact confidential material in those documents that does not relate to the category. The judgment says a confidentiality club will be required for this material.
For Category 3, concerning the prior art hBAT and CT-011, the judge refused to require searches using the generic term “BAT”, finding that this would likely produce many irrelevant results. She ordered the defendants to provide an affidavit setting out the technical difficulty with that search.
The plaintiffs must update their US discovery for Category 30, covering queries from patent licensees or potential licensees about pleaded validity issues and responses to them. The judge refused the defendants’ request to extend Category 33, concerning analysis or reverse engineering of the product, beyond the US discovery cut-off. She concluded that the additional discovery was not necessary for a fair trial and would add expense.
The judgment records that the US discovery process covered material up to 4 September 2014. The case was issued in December 2015. The ruling leaves the substantive patent and infringement questions for trial.