New Judgment: Warner-Lambert LLC v Generics (UK) Ltd t/a Mylan & Anor [2018] UKSC 56
14 Wednesday Nov 2018
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On appeal from: [2016] EWCA Civ 1006
This appeal considered whether (and what) role plausibility should play in the statutory test for sufficiency, and whether a patent should be held insufficient for lack of plausibility even though it is in fact enabled across the whole scope of the claim. It also considered, if a plausibility test is appropriate, provided there is basis to support the claim across part of its scope, whether later evidence can be used to fill the gap; the correct approach to (and the use of expert evidence in) the construction of patent claims; and whether a post-trial application to amend an invalid patent claim to limit it to a part found to be plausible is an abuse of process.
The Supreme Court dismissed the appeal and allowed the cross-appeal. This was because the majority of the Court held that the disclosure in the specification supported the claims in relation to inflammatory pain, but not neuropathic pain, whether peripheral or central, and therefore Claims 1 and 3 failed for insufficiency. This approach requires the patentee to demonstrate that the specification discloses some scientific reason why the implied assertion of efficacy in the patent claim may well be true, and as such more than a bare assertion or mere possibility of therapeutic efficiency is required. The majority of the Court held that the test of patent infringement is whether, objectively, the product as it emerges from the manufacturing process, including any labelling or accompanying leaflet, is presented as suitable for the uses which enjoy patent protection.
For judgment, please download: [2018] UKSC 56
For Court’s Press Summary, please download: Court’s Press Summary
For a non-PDF version of the judgment, please visit: BAILII
To watch the hearing, please visit: Supreme Court Website (12 Feb 2018 morning session) (12 Feb 2018 afternoon session) (13 Feb 2018 morning session) (13 Feb 2018 afternoon session) (14 Feb 2018 morning session) (14 Feb 2018 afternoon session) (15 Feb 2018 morning session) (15 Feb 2018 afternoon session)