Patent decision
- BL number
- O/0772/23
- Concerning rights in
- GB1812182.2
- Hearing Officer
- Dr L Cullen
- Decision date
- 11 August 2023
- Person(s) or Company(s) involved
- Hugh Robert Wotherspoon
- Provisions discussed
- Patents Act 1977; sections 1(1)(b), 14(3), 14(5)(c)
- Keywords
- Inventive step, Sufficiency, Support
- Related Decisions
- None
Summary
The application relates to the second medical use of a known anti-IL-1b antibody, canakinumab, to prevent or reduce the risk of an event of acute pancreatitis (AP) in a patient who has had an earlier event or bout of AP. The application itself provides some detail of the reduction of increased IL-1b levels by canakinumab, and some prior art disclosures of its use to treat gout and type 2 diabetes mellitus, as well as the effects of canakinumab on levels of the clinical marker of inflammation, human C-reactive protein (CRP). None of the experimental data provided demonstrates the use of canakinumab to reduce IL-1b levels in an AP patient.
The Hearing Officer (HO), applying the principles for plausibility of second medical use claims set out in Warner-Lambert Company LLC v Generics (UK) Ltd (t.a. Mylan) & Anor. [2018] UKSC 56, considered whether there was enough a priori reasoning in the prior art and in common general knowledge (CGK) of the skilled team that would render the invention plausible given the lack of experimental evidence in the application as filed. The HO also considered if the requirements for support for second medical use claims set out by the High Court in Prendergast’s Applications {2000} RPC 446 were met.
In the absence of experimental evidence, the CGK of the skilled person, supplemented by prior art provided by the applicant in the application and during the proceedings, was used to determine whether it would have been plausible, from the application as filed, that the anti- IL-1b antibody could be used to prevent or reduce the risk of a subsequent attack of AP. Whilst the HO concluded that it may be plausible that the antibody could treat an ongoing attack of AP because IL-1b levels would be increased once an attack had started, there was insufficient evidence that would make it plausible that the anti-IL-1b antibody could prevent or reduce the risk of an attack of AP before it had started, when IL-1b are unlikely to be increased. Therefore the application did not meet the requirements of section 14(3) or section 14(5)(c) of the Act.
When considering whether the invention was obvious, the HO was mindful of the ‘squeeze’ between sufficiency and inventive step that can occur when the basis for the patent relies upon common general knowledge and the prior art (particularly US 9,683,038 in this case). Nevertheless, following Windsurfing/ Pozzoli, he concluded that the team skilled in the art with the requisite common general knowledge and familiar with the cited prior art would consider it obvious to try to use the anti-IL-1b antibody to prevent or reduce the risk of AP, and would do so with a reasonable expectation of success. However, the HO noted that if the experimentation required to arrive at the invention went beyond the routine, then the skilled person reading US 9,683,038 would not consider applying the teachings therein to AP, and furthermore would not do so after reading the present application. This would again render the application insufficient for lack of plausibility, demonstrating that in the present case there is a squeeze between plausibility for insufficiency and obviousness. He concluded that application also did not meet the requirements of section 1(1)(c) of the Act.
Full decision O/0772/23 
441Kb
