These proceedings raise, for the first time in the courts of the United Kingdom, the question how the concepts of sufficiency and infringement are to be applied to a patent relating to a specified medical use of a known pharmaceutical compound. Four issues arose: (i) the construction of the claims (in particular, Claim 3 as to neuropathic pain); (ii) the sufficiency of the disclosure in the specification; (iii) amendment and abuse of process; and (iv) the test for infringement of a patent in relation to manufacturing for a limited use.
Held: The appeal failed, but the cross-appeal was granted (Lord Mance and Lord Hodge dissenting in part on whether there was sufficient disclosure in the specification for Claims 1 and 3).
On issue (i) and (iii), the Court confirmed (1) the view of both courts that Claim 1 extended to all pain and Claim 3 to all neuropathic pain, whether peripheral or central, and (2) Arnold J’s decision rejecting Warner-Lambert’s application to amend the Patent to narrow it.
On issue (ii), the disclosure in the specification supports the claims in relation to inflammatory pain, but not neuropathic pain, whether peripheral or central. Claims 1 and 3 therefore fail for insufficiency. This required the patentee to show that the specification disclosed scientifically why the implied assertion of efficacy in the patent claim may well be true. More than a bare assertion or mere possibility of therapeutic efficiency is required, though a priori reasoning (not necessarily only experimental data) may suffice. This respects the principle that the patentee cannot claim a monopoly of new use for an existing compound without real disclosure.
On issue (iv), if Claims 1 and 3 had been valid, they would not have been infringed by Actavis.
Lord Sumption and Lord Reed considered that the intention of the alleged infringer, whether subjective or objective, is irrelevant and that the sole criterion of infringement was whether 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 – the ‘outward presentation’ test. On the facts, it was not disputed that Lecaent was sold with labels and patient information to the effect that it was for the treatment of seizure disorders and general anxiety disorder.
Lord Mance agreed that the test depends on the objective appearance and characteristics of the product as it is
prepared, presented and put on the market, but considered that in rare cases the context may make it obvious that
these are not to be taken at face value.
Lord Briggs and Lord Hodge preferred the view of Arnold J that the test is whether the alleged infringer
subjectively intended to target the patent-protected market (Arnold J found they had not so intended).
Lord Mance, Lord Sumption, Lord Reed, Lord Hodge, Lord Briggs
[2018] UKSC 56, [2019] 3 All ER 95, [2019] Bus LR 360, (2019) 165 BMLR 14, UKSC 2017/0078, UKSC 2017/0069, UKSC 2016/0197
Bailii, Bailii Summary, SC, SC Summary, SC Summary Video, SC 2018 Feb 12 am Video, SC 2018 Feb 12 pm Video, SC 2018 Feb 13 am Video, SC 2018 Feb 13 pm Video, SC 2018 Feb 14 am Video, SC 2018 Feb 14 pm Video, SC 2018 Feb 15 am Video, SC 2018 Feb 15 pm Video
Patents Act 1977 60
England and Wales
Citing:
Cited – Liardet And Adams v Johnson And Another 5-Jul-1780
Lord Mansfield said: ‘The condition of giving encouragement is this: that you must specify upon record your invention in such a way as shall teach an artist, when your term is out, to make it – and to make it as well by your directions: for then at . .
Appeal from (CA) – Warner-Lambert Company Llc v Generics (UK) Ltd (T/A Mylan) and Others CA 13-Oct-2016
The court was asked: ‘Firstly, did Arnold J correctly hold certain claims of the patent in suit invalid for insufficiency; and, if so, should he have held more claims invalid on that ground? Secondly, was he correct in holding the patentee’s . .
At First Instance (Patents Court) – Generics (UK) Ltd (T/A Mylan) v Warner-Lambert Company Llc PatC 10-Sep-2015
The defendant marketed its patented drug for the treatment of epilepsy, generalised anxiety disorder and neuropathic pain under the protection of a European patent. The claimants now challenged the renewal of the patent for obviousness.
Held: . .
Cited – EXXON/Fuel Oils EPO 1994
The EPO Technical Board of Appeal observed that it was: ‘the general legal principle that the extent of the patent monopoly, as defined by the claims should correspond to the technical contribution to the article in order for it to be supported, or . .
Cited – EISAI/Second Medical Indication EPO 1985
(Enlarged Board of Appeal of the European Patent Office) it was: ‘legitimate in principle to allow claims directed to the use of a substance or composition for the manufacture of a medicament for a specified new and inventive therapeutic . .
Cited – Biogen Plc v Medeva Plc HL 31-Oct-1996
The claim patented sought to protect a genetic molecule rather than a whole mouse namely that the molecule would, if inserted into a suitable host cell, cause the cell to make antigens of the Hepatitis B virus. A recombinant method of making the . .
Cited – John Wyeth and Brother Ltd’s Application PatC 1985
. .
Cited – AGREVO ECFI 1992
A product claim was made for a patent for a class of chemical compounds alleged to be useful as herbicides. There was nothing in the description to justify the assertion that all the compounds in the class would have herbicidal properties. The Board . .
Cited – BRISTOL-MYERS SQUIBB/Dasatinib EPO 1-Feb-2017
. .
Cited – Re Prendergast’s Applications ChD 2000
The applicant attempted to patent the use of two known pharmaceuticals to treat the folowing: ‘battle fatigue, combat stress reaction, post-traumatic stress disorder in civilian and military emergency situations, neurological symptoms associated . .
Cited – JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE/Growth differentiation factor-9 ECJ 2004
the hypothetical problem calling for solution was whether a claimed polynucleotide was a member of the TGF-beta superfamily. The only evidence to support the contention that it was, consisted of material published after the priority date. The patent . .
Cited – SALK INSTITUTE FOR BIOLOGICAL STUDIES/AP-I complex EPO 27-Oct-2004
The Board considered the approach to sufficiency in a patent claim, observing: ‘Where a therapeutic application is claimed in the form allowed by the Enlarged Board of Appeal in its decision G 5/83 (OJ EPO 1985, 64), ie in the form of the use of a . .
Cited – IPSEN/Pancreatic cells EPO 29-Jun-2011
The patent claim was for a compound for extending the functional life of pancreatic islet cells. The patent comprised no experimental data supporting the drug’s claimed therapeutic effect, but it did contain a technical explanation of its effect and . .
Cited – Conor Medsystems Inc v Angiotech Pharmaceuticals Inc and others HL 9-Jul-2008
The respondents had applied for and obtained an order to revoke the appellant’s patent of a stent for obvousness. Though the parties had settled, the public law element required the intervention of the Comptroller General. The House was asked about . .
Cited – Regeneron Pharmaceuticals Inc v Genentech Inc CA 21-Feb-2013
Kitchin LJ said: ‘be possible to make a reasonable prediction the invention will work with substantially everything falling within the scope of the claim or, put another way, the assertion that the invention will work across the scope of the claim . .
Cited – Merrell Dow Pharmaceuticals Inc and Another v H N Norton and Co Ltd; Same v Penn Etc HL 26-Oct-1995
A patent for a substance which had been produced naturally before the application of the process was invalid. The patent was invalidated after the discovery that the effect was produced naturally from an acid metabolite. Patent infringement does not . .
Cited – Parkinson v Simon CA 1894
The Court will construe claims so as to give a different meaning to different claims, otherwise some will not be effective. Lord Esher MR said: ‘I have always thought that the value of the expert evidence in such cases as this is, that they can . .
Cited – Nokia Gmbh v IPCom Gmbh and Co Kg CA 20-Jan-2011
The respondent’s two patents at issue had been found invalid, but that if valid, that the appellant’s mobile phones woud have infrige the patents.
Held: Jacob LJ said that ‘It is not normally procedurally fair to subject the other side to . .
Cited – Catnic Components Ltd and Another v Hill and Smith Ltd HL 1982
The plaintiffs had been established as market leaders with their patented construction, had ample production capacity and stocks, but had never granted any licence under their patent. The patent was for a novel type of galvanised steel lintel, which . .
Cited – Nikken Kosakusho Works and Another v Pioneer Trading Company and Another CA 29-Jun-2005
The Court drew a sharp distinction between (a) pre-trial patent amendments, (b) post-trial patent amendments to delete claims which had been found invalid, and (c) post-trial patent amendments designed to set up a new claim which had not been . .
Cited – Kirin-Amgen Inc v Roche Diagnostics Gmbh PatC 11-Apr-2001
. .
Cited – BASF AG v Smithkline Beecham Plc CA 25-Jun-2003
Sedley LJ said: ‘Because the law has historically been suspicious of monopolies for well-known reasons of public policy, there is no useful analogy between a patent and a deed or a written contract. The latter two will have been drafted for a . .
Cited – Menashe Business Mercantile Limited, Julian Menashe v William Hill Organization Limited CA 28-Nov-2002
Claim for exclusive licence under a patent . .
Cited – Bourgoin SA v Minister of Agriculture Fisheries and Food CA 1985
The plaintiffs were French producers of turkeys. They alleged that the Minister revoked their licence to import turkeys into this country by a decision that was ultra vires and motivated by a desire to assist British turkey producers, and that this . .
Cited – Grimme Maschinenfabrik Gmbh and Co Kg v Derek Scott (T/A Scotts Potato Machinery) CA 15-Oct-2010
. .
Cited – Douglas and others v Hello! Ltd and others; similar HL 2-May-2007
In Douglas, the claimants said that the defendants had interfered with their contract to provide exclusive photographs of their wedding to a competing magazine, by arranging for a third party to infiltrate and take and sell unauthorised photographs. . .
Cited – Bourgoin SA v Minister of Agriculture Fisheries and Food 1985
The Minister had revoked the plaintiffs’ licence in order to protect English turkey producers against competition from French turkey producers, knowing that this was in breach of the UK’s obligations under article 30 of the EEC treaty, that the act . .
Cited by:
Cited – Actavis Group Ptc EHF and Others v Icos Corporation and Another SC 27-Mar-2019
The court considered: ‘the application of the test of obviousness under section 3 of the Patents Act 1977 to a dosage patent. In summary, a patent, whose validity is not challenged, identified a compound as an efficacious treatment but did not . .
Lists of cited by and citing cases may be incomplete.
Intellectual Property
Updated: 23 January 2022; Ref: scu.628675