Sandoz AG & Ors v Biogen MA Inc [2024] EWHC 2567 (Pat)
On 11 October 2024, Mr Justice Mellor handed down a lengthy decision holding EP(UK) 3 575 792 (the “Patent”) invalid for insufficiency and added matter and not infringed. The Judge also declined Sandoz’s request, made in view of a pending divisional, for a declaration in respect of the PCT application from which the Patent derived (PCT).
Claim 1 of the Patent was to a method of evaluating a patient’s risk of developing PML, a potentially fatal neurological condition. The method comprised the use of a test to determine whether a patient was high risk which was said to be the case if a patient’s sample had an index value of greater than 1.5. The index value is a measure of a patient’s antibody titer to a virus called JCV. Pre-priority, prior infection with JCV was a known risk factor for developing PML in certain immunosuppressed individuals, including in individuals undergoing treatment with Biogen’s multiple sclerosis medicine, Tysabri (natalizumab). Biogen had its own anti-JCV antibody test, STRATIFY JCV DxSelect, that was said to implement the teaching of the Patent and they brought an infringement claim following the development of Sandoz’s own test (‘Sandoz Test’) for use with its biosimilar natalizumab product, Tyruko.
Some of the most interesting points to emerge from the decision are outlined below. The decision also addressed obviousness, added matter, excluded subject matter and technical infringement (both on a normal basis and applying the doctrine of equivalents).
Insufficiency
For the Patent to be sufficient, Mellor J held that the skilled team (in this case a neurologist, a virologist and an immunoassay development scientist) would have needed to be able to produce a test that can identify an individual as being at a high risk of developing PML at an index value of 1.5 that uses the same anti-JCV antibody titer as in the test disclosed in the Patent. Mellor J held that the skilled team would have been unable to do so, and that even if by chance they had been able to, they would not
have known this. A key issue was that the index value was calculated by reference to a claimed but undisclosed cut-off calibrator. Mellor J held that although it may be difficult for a patentee to describe a calibrator in words, that does not excuse them from the requirement to make an enabling disclosure.
Although Biogen had described them as burdensome, there were options available to meet the requirement such as depositing a calibrator and making it available on request. Sandoz also supported its case with secondary evidence of insufficiency. It explained that it was only able to develop the Sandoz Test because it had access to post-priority samples and results that had been tested using STRATIFY JCV DxSelect and, even then, it took them 18 months to develop it. The Judge therefore held the Patent to be insufficient for classical insufficiency and uncertainty insufficiency. The Patent was also bad for breadth of claim insufficiency as the claimed method did not work for individuals who had received prior immunosuppressant treatment.
Declaratory relief
Sandoz sought a declaration that the PCT did not disclose a JCV test clearly and completely enough for the skilled person to be able to determine whether a patient was at a high risk of developing PML at an index value of 1.5 or at any other index value disclosed in the PCT. The justification for seeking the declaration was that Biogen intended to assert a pending divisional if and/or when it granted.
However, having considered the authorities on Arrow declarations, Mellor J held that granting such a declaration would usurp the function of the EPO regarding the grant of the pending divisional or any future divisional that might derive from the PCT.
Infringement
Amongst other non-infringement arguments, Sandoz advanced a territorial defence, with which Mellor J agreed, holding that none of the steps of the allegedly infringing method were carried out in the UK.
Even though patient samples were taken in the UK, they were prepared for testing, tested and assigned an index value outside the UK. The index value would be sent to the clinician in the UK and they could then go on to make their own assessment. However, this assessment was not part of the claimed method. This follows earlier decisions of English courts on territoriality, including Menasche v William Hill, RIM v Motorola and Illumina v Premaitha.
A copy of the judgment can be read here.