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 identify an optimal dosage regime. A pharmaceutical company, which had acquired the patent, conducted extensive research into ascertaining the optimal dosage of the compound. It discovered a dose which not only was safe and effective but also, unexpectedly, could be administered in a new and beneficial manner, because of both the half-life of the compound and its minimal side effects at that dose. A number of generic drug manufacturers challenge the validity of the dosage patent on the basis that it involves no inventive step.’
Held: The appeal was dismissed.
The trial judge’s findings of what would have been the sequence of the tests, which did not depend upon hindsight, included the finding, justified on the evidence, that the team, having found a therapeutic plateau, would be very likely to test lower doses and so come upon the dosage regime which is the subject matter of the patent. The Court of Appeal was entitled to treat the judge’s failure to appreciate the logical consequences of the finding – that it was very likely that the skilled team would continue the testing – as an error of principle which allowed an appellate court to carry out its own evaluation. As such, the Court of Appeal was entitled to interfere with the trial judge’s assessment of obviousness and to hold that the patent was invalid for lacking an inventive step and to grant the declaration sought in the counterclaim.
Judges:
Lady Hale, President
Lord Kerr
Lord Sumption
Lord Hodge
Lord Briggs
Citations:
[2019] UKSC 15, [2019] Bus LR 1318, [2019] RPC 9, (2019) 167 BMLR 1, [2020] 1 All ER 213, UKSC 2017/0214
Links:
Bailii, Bailii Sumary, SC, SC Summary, SC Video Summary, SC 18 Nov 19 am Video, SC 2018 Nov 19 pm Video, SC 2018 Nov 20 am Video
Statutes:
Jurisdiction:
England and Wales
Citing:
At First Instance – Actavis and Others v Eli Lilly and Company PatC 10-Aug-2016
Patents relating to tadalafil . .
At CA – Actavis Group Ptc EHF and Another v Teva UK Ltd and Others CA 1-Nov-2017
These appeals are concerned with the validity and infringement of a patent concerning tadalafil. . .
Cited – Gale’s Application CA 1991
The applicant had devised a new and better algorithm for finding square roots. Having embodied the method in a read only chip which could be installed within a computer which could then apply the algorithm, he sought to patent it.
Held: . .
Cited – Warner-Lambert Company Llc v Generics (UK) Ltd (T/A Mylan) and Another SC 14-Nov-2018
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 . .
Cited – Eli Lilly v Actavis UK Ltd and Others SC 12-Jul-2017
The issue raised on this appeal and cross-appeal is whether three products manufactured by Actavis would infringe a patent whose proprietor is Lilly, namely European Patent (UK) No 1 313 508, and its corresponding designations in France, Italy and . .
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 – MedImmune Ltd v Novartis Pharmaceuticals UK Ltd CA 10-Oct-2012
Held: The court must answer a relatively simple question of fact: was it obvious to the skilled but unimaginative addressee to make a product or carry out a process falling within the claim . .
Cited – Human Genome Sciences Inc v Eli Lilly and Company SC 2-Nov-2011
The court considered an appeal against the declaration of invalidity of a biomedical patent for a new human protein on the grounds that it was not susceptible of industrial application.
Held: The patentee’s appeal succeeded. The court had to . .
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 – MedImmune Ltd v Novartis Pharmaceuticals UK Ltd CA 10-Oct-2012
Held: The court must answer a relatively simple question of fact: was it obvious to the skilled but unimaginative addressee to make a product or carry out a process falling within the claim . .
Cited – MedImmune Ltd v Novartis Pharmaceuticals UK Ltd CA 10-Oct-2012
Held: The court must answer a relatively simple question of fact: was it obvious to the skilled but unimaginative addressee to make a product or carry out a process falling within the claim . .
Cited – Novo Nordisk A/S v DSM NV; DSM NV’s Patent PatC 21-Dec-2000
Patent revocation action . .
Cited – Gedeon Richter Plc v Bayer Schering Pharma Ag PatC 17-Mar-2011
Where the pattern of the research programme which the notional skilled person would undertake can clearly be foreseen, it may be legitimate to take a step by step analysis. Floyd J said: ‘I think that the guiding principle must be that one has to . .
Cited – Bessant and others v South Cone Incorporated; in re REEF Trade Mark CA 28-May-2002
The Reef pop group applied to register ‘REEF’ for Classes 25 and 26 – e.g. T-shirts, badges, etc. South Cone opposed them as registered proprietors of ‘Reef Brazil’ for the footwear which also was included in Class 25. South’s reputation was . .
Cited – Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly and Company Ltd CA 18-Dec-2009
Appeal from dismissal of application for revocation of patent. . .
Cited – Dr Reddy’s Laboratories (UK) Ltd v Eli Lilly and Company Ltd CA 18-Dec-2009
Appeal from dismissal of application for revocation of patent. . .
Cited – Generics (UK) Ltd v Daiichi Pharmaceutical Co Ltd and Another CA 2-Jul-2009
validity of patent.
Held: No formula should distract the court from the statutory question. . .
Cited – Bessant and others v South Cone Incorporated; in re REEF Trade Mark CA 28-May-2002
The Reef pop group applied to register ‘REEF’ for Classes 25 and 26 – e.g. T-shirts, badges, etc. South Cone opposed them as registered proprietors of ‘Reef Brazil’ for the footwear which also was included in Class 25. South’s reputation was . .
Cited – Assicurazioni Generali Spa v Arab Insurance Group (BSC) CA 13-Nov-2002
Rehearing/Review – Little Difference on Appeal
The appellant asked the Court to reverse a decision on the facts reached in the lower court.
Held: The appeal failed (Majority decision). The court’s approach should be the same whether the case was dealt with as a rehearing or as a review. . .
Cited – Generics (UK) Ltd and others v H Lundbeck A/S HL 25-Feb-2009
Patent properly granted
The House considered the patentability of a chemical product, citalopram made up of two enantiomers, as opposed to the process of its creation, questioning whether it could be new or was insufficient within the 1977 Act.
Held: The appeal . .
Cited – Buchanan v Alba Diagnostics Limited HL 5-Feb-2004
The original inventor obtained a patent for a brake fluid protection system. A loan was raised against the patent, assigning also the future developments of the idea. The loan was called in, and then assigned to the defenders, who took the idea . .
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 – Pozzoli Spa v BDMO Sa and Another CA 22-Jun-2007
The patentee had invented a method for storing CDs. The patentee sought leave to appeal a finding that its patent was invalid, and if successful, to appeal a finding that the defendant’s apparatus was not infringing.
Held: The application for . .
Cited – Datec Electronics Holdings Ltd and others v United Parcels Services Ltd HL 16-May-2007
The defendants had taken on the delivery of a quantity of the claimant’s computers. The equipment reached one depot, but then was lost or stolen. The parties disputed whether the Convention rules applied. UPS said that the claimant had agreed that . .
Cited – Synthon Bv v Smithkline Beecham Plc HL 20-Oct-2005
Synthon filed an international application for a patent. Before it was published, SB filed a similar application in the UK patents registry. Synthon had applied for the UK patent granted to SB to be revoked. Jacob J had found that the reader of the . .
Cited by:
Cited – Regeneron Pharmaceuticals Inc v Kymab Ltd SC 24-Jun-2020
SC Kymab Ltd (‘Kymab’) alleges that the relevant patents are invalid for insufficiency because they did not enable the ordinary skilled person to work the claimed invention across the breadth of the claims. The . .
Cited – Shanks v Unilever Plc and Others SC 23-Oct-2019
The claimant appealed from refusal of statutory compensation under the 1977 Act. He had invented a form of pump which was used by his employers, the respondents in the management of diabetes management.
Held: The appeal succeeded: ‘the correct . .
Lists of cited by and citing cases may be incomplete.
Intellectual Property
Updated: 24 April 2022; Ref: scu.635121