United Kingdom Patent Decisions 2016
United Kingdom Patent Decisions 2016
Julia Powles 0
0 J. Powles (&) Postdoctoral Researcher Faculty of Law and Computer Laboratory, University of Cambridge , Cambridge , UK
This report highlights the main UK patent cases from 2016, including the interpretation of ''plausibility'' and ''obvious to try'', obviousness, experimental use, numerical limits, infringement, stays, and a case to watch on ''Arrow declarations''.
Arrow declaration; Patent law; Plausibility; Experimental use; Obvious to try; Obviousness
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Shionogi & Co Ltd [2016] EWHC 2989 (Pat); Meter-Tech LLC v. British Gas Trading
Ltd [2016] EWHC 2278 (Pat); Napp Pharmaceutical Holdings Ltd v. Dr Reddy’s
Laboratories (UK) Ltd [2016] EWHC 1517 (Pat); [2016] EWCA Civ 1053; Richter
Gedeon Vegyeszeti Gyar RT v. Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 410;
Schlumberger Holdings Ltd v. Electromagnetic Geoservices AS [2010] R.P.C. 33;
Warner-Lambert Co LLC v. Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 1006.
Alongside the constant political intrigue over Britain’s participation in the
unitary patent and Unified Patent Court, domestic patent jurisprudence continued at
pace throughout 2016. Ten of the more notable judgments of the year are extracted
in this report.
As in 2015, litigation over Warner-Lambert’s second medical use patent for
pregabalin (branded Lyrica) generated significant decisions, in the UK and
interna
tionally. In October 2016, the Court of Appeal1 upheld Arnold J’s September 2015
decision2 that claims to the use of pregabalin for treating pain and, in the alternative,
neuropathic pain, failed for insufficiency because they were not plausible across their
breadth.3 This finding invalidated core claims in Warner-Lambert’s infringement case
against generics manufacturer Actavis. Given that an application to amend the claims
post-trial was unsuccessful, there was no definitive ruling on infringement.
Delivering the Court of Appeal’s judgment, Floyd LJ addressed the ‘‘plausibility’’
requirement that has acquired increasing prominence across sufficiency, industrial
applicability and obviousness assessments, stating that it is a ‘‘low, threshold test …
designed to prohibit speculative claiming’’.4 It requires proof that a claim is more than
merely speculative, but it should not be conflated with the test of ‘‘obvious to try’’. In
dicta, Floyd LJ also reconfirmed his view on construction of ‘‘Swiss form claims’’,
dismissing Arnold J’s differing interpretation in earlier stages of the litigation.5 Floyd
LJ held that what is required is that the manufacturer knows or is able to foresee that
there will be intentional use of the drug for the new medical indication. Generics
manufacturers carry the (onerous) burden of taking ‘‘all reasonable steps in their
power’’ to prevent the product from being used for the patented purpose.
Soon after the Lyrica case, the Court of Appeal issued its decision in Idenix
Pharmaceuticals Inc v. Gilead Sciences Inc.6 Plausibility was also at issue, in the
context of obviousness as well as sufficiency. The Court held that a claim to a class
of billions of compounds with anti-Flaviviridae activity was obvious, due to lack of
evidence making such a technical contribution plausible.
In the domain of obviousness, the ‘‘obvious to try’’ test arose in Hospira UK Ltd
v. Genentech Inc,7 concerning formulation patents of the breast cancer drug
1 Warner-Lambert Co LLC v. Generics (UK) Ltd (t/a Mylan) [2016] EWCA Civ 1006.
2 Generics (UK) Ltd (t/a Mylan) v. Warner-Lambert Co LLC [2016] R.P.C. 3.
3 Contra Apotex Pty Ltd v. Warner-Lambert Co LLC (No 2) [2016] FCA 1238 (where the evidence led to
4 See similar GlaxoSmithKline UK Ltd v. Wyeth Holdings LLC [2016] EWHC 1045 (Ch).
5 See 47 IIC 189 (2016); doi:10.1007/s40319-016-0457-x. 6 [2016] EWCA Civ 1089.
trastuzumab (branded Herceptin). The Court of Appeal affirmed the first instance
decision8 that the formulations claimed were obvious to any skilled team
motivated to produce a stable dry formulation, embarking on a standard screening
programme, and using standard products. It was not necessary to show that the
team knew, or ‘‘would’’ necessarily have arrived at, the precise formulation
claimed. Floyd LJ stated that such a requirement would be a ‘‘wholly unrealistic’’
straightjacket on the law on obviousness, in a situation where there were a range of
obvious possibilities, all of which could be arrived at without inventive effort. By
contrast with Hospira v. Genentech, a case involving a compound that would not
have been expected, and was therefore not obvious, was Actavis Group PTC EHF
v. ICOS Corp (tadalafil).9
A short decision on obviousness was Richter Gedeon Vegyeszeti Gyar RT v.
Generics (UK) Ltd (t/a Mylan),10 Sir Robin Jacob’s final decision in his post
retirement capacity as occasional sitting judge. The question was whether a dosage
patent for an oral contraceptive was invalidated by prior art reporting the trial of a
1.5 g dose. Such a dose wa (...truncated)