Anna Edwards-Stuart KC

Nador Cott Protection S.A.S. v (1) ASDA Stores Ltd & or [2026] EWHC 553 (Pat)

This is the very first decision of a UK court regarding the infringement of a plant breeders’ right (“PBR”) granted pursuant to the Plant Varieties Act 1997 (“PVA”). The Claimant is the owner of UK PBR No. 28016 for a va...

Emotional Perception AI Limited v. The Comptroller General of Patents, Designs and Trade Marks [2026] UKSC 3

In this landmark decision of the Supreme Court, the Court considered the applicability of the excluded subject matter exceptions under Article 52 EPC to the Artificial Intelligence and other future systems such as quantu...

In this landmark decision of the Supreme Court, the Court considered the applicability of the excluded subject matter exceptions under Article 52 EPC to the Artificial Intelligence and other future systems such as quantum computing.

The Court rejected the Appellant’s primary submission that the “program for computers…as such” exclusion do not apply to artificial intelligence systems. The UKSC upheld the Court of Appeal’s and Comptroller’s decisions that AI did involve a program for a computer and the requirements of the exclusion had to be met. The UKSC also indicated that the same would potentially apply in respect of “mathematical methods” and to other subject-matter, such as quantum computing.

The Court further rejected the Appellant’s next submission, that the UK should take the “Any Hardware” approach simpliciter from the EPO, followed by an unmodified form of the Pozzoli test for obviousness. The UKSC identified that G1/19 from the Enlarged Board of Appeal did not confine its analysis to merely “Any Hardware” plus problem-solution, but rather “Any Hardware+COMVIK”, in which COMVIK involved an intermediate step of removing excluded subject matter from the ’solution’ part of the inventive step analysis. The UKSC held that the UK should nevertheless cease to follow Aerotel, in preference for the EPO Enlarged Board’s approach in G1/19, but utilising Pozzoli instead of problem-solution. The resultant test was new and would need to be worked out by the lower courts and tribunals, starting with the Comptroller General.

The Appellants 3rd and 4th Grounds were rendered moot (they sought to challenge the detailed application of Aerotel to the patent application in suit). No case had been advanced by the Appellant on the basis of AH+Pozzoli with an intermediate step, so much so that the UKSC was unable to consider the application of the new test to the patent application in suit.

For these reasons, the UKSC had no choice but to remit the patent application in suit to the Comptroller General for consideration and application of the new test.

Brian Nicholson KC and Anna Edwards-Stuart KC appeared for the Comptroller-General of Patents Designs and Trade Marks.

The UKSC Judgment can be obtained from here:

[2026] UKSC 3

AstraZeneca v Glenmark, Teva, Viatris & Ors [2025] EWHC 1339 (Pat)

AstraZeneca, the patentee & SPC holder, sought interim relief to prevent generic dapagliflozin being put on the market in the UK. A number of pharmaceutical companies, including Glenmark, Teva and Viatris, were sough...

Merck Serono v Comptroller-General [2025] EWCA Civ 45

By this appeal Merck Serono invited the Court of Appeal to invoke its post-Brexit powers and depart from the CJEU decision in Santen, thereby opening up the possibility for the granting of SPCs for second medical use pat...

SkyKick UK Ltd v Sky Ltd [2024] UKSC 36

This is the highly anticipated decision of the Supreme Court in the Sky v SkyKick saga. The case centred around Sky’s claim of trade mark infringement for the use of the sign ‘Sky’ in relation to cloud migration and clo...

This is the highly anticipated decision of the Supreme Court in the Sky v SkyKick saga. The case centred around Sky’s claim of trade mark infringement for the use of the sign ‘Sky’ in relation to cloud migration and cloud backup services, and SkyKick’s counterclaim for invalidity based on bad faith.

The appeal was heard in June 2023 by Lords Reed, Lloyd-Jones, Kitchin, Hamblen and Burrows. An application made by SkyKick shortly before the judgment was finalised asking for permission to withdraw the appeal was rejected on public policy grounds.

The main judgment was given by Lord Kitchin (with whom the rest of the panel agreed). The court allowed the appeal and reversed the Court of Appeal’s decision on bad faith, and upheld its decision on infringement. Lord Reed gave additional reasons for agreeing with Lord Kitchin’s finding that England and Wales courts retain their pre-Brexit jurisdiction in full in relation to proceedings for infringement or validity of EU trade marks pending on IP Completion Day.

The judgment raised several points of policy with regards to the appropriate limits that need to be placed on applicants when registering a sign for specific goods and services, taking into account the fundamental origin function of trade marks and the need to maintain fair competition on the market. The judgment includes inter alia the following important findings:

It was confirmed that at the time a trade mark application is made the applicant does not need to have a firm or settled intention to use the sign as a trade mark in relation to the goods and services in its specification. However, lack of such use and intention may be evidence in support of an allegation of bad faith where the applicant has no genuine intention to use the grace period to try to establish or even reasonably to explore the viability of a business under the mark, in particular where they nevertheless intend vigorously to enforce the registration against third parties across the full range of the goods and services in respect of which it is registered.
The length of the list of goods and services in the specification, when compared with the size and nature of the applicant’s business, can be taken into account as a factor supporting an allegation of bad faith, as can a failure on behalf of the applicant to provide any satisfactory explanation for the choice of specification.
An applicant’s reputation does not allow them to apply to register the mark for goods and services which they never had any intention to sell or supply.
Applicants should not be permitted to apply to register a mark in respect of distinct categories of goods or services in relation to which they never had an intention to use the mark simply because they chose to use a broad description. A general terminology should be viewed as consisting of several sub-categories, some of which may have been included in bad faith.
As to the proper procedure, the trial judge was entitled in the circumstances of the case to put forward a different limited specification. It would not be fair to require a party seeking a declaration of invalidity to set out with precision the specification to which the trade mark should be restricted without sufficient knowledge of the applicant’s intention.
In the context of infringement, the court agreed with the CoA and reaffirmed the principle that, in considering a specification of goods or services defined by terms which are not clear or precise, the correct approach is to confine the terms used to the substance or core of their possible meanings. Comprising cloud migration within the meaning of “electronic mail services” was therefore an impermissible extension of the core meaning of the expression to an unclear and indeterminate range of services connected to electronic mail in an unspecified way.

Anna Edwards-Stuart KC appeared on behalf of the Comptroller-General of Patents, Designs and Trade Marks as an intervener.

[2024] UKSC 36

Accord, Sandoz and Teva v The Regents of the University of California and Astellas Pharma [2024] EWHC 2524 (Pat)

This case concerned the validity of the first defendant’s patent and SPC which claim the compound enzalutamide (identified as RD162’) and its therapeutic use. This compound is marketed by Astellas under the brand name “...

This case concerned the validity of the first defendant’s patent and SPC which claim the compound enzalutamide (identified as RD162’) and its therapeutic use. This compound is marketed by Astellas under the brand name “Xtandi” for treating both hormone sensitive prostate cancer (“HSPC”) and hormone refractory prostate cancer (“HRPC”). The claimants challenged the validity of the patent on the basis of obviousness over two pieces of prior art, a Poster and Slides, both of which disclosed a molecule identified as RD 162. The only difference between RD162 and RD 162’ lay in the substituents at the bottom right of the central thiohydantoin ring, i.e. a cyclobutyl group and a geminal dimethyl respectively. The claimants also deployed a squeeze argument between obviousness and insufficiency based on implausibility for lack of technical contribution.

The judgment handed down by Mr Justice Mellor includes a detailed consideration of the application of primary expert evidence and the avoidance of hindsight and highlights the potential weakness of obviousness and plausibility arguments not developed in the evidence in chief. The judgment also includes the following points of interest:

a recognition of the fact that the proposition that a seemingly small structural change is tantamount to an obviously immaterial one is not generally appropriate or applicable in medicinal chemistry;
a useful summary of some of the main principles around obviousness, including a discussion of the differences between “immediately obvious” (obvious to develop) and “obvious to do a SAR” (obvious to do routine tests) arguments;
an analysis of the role of motivation, and a reaffirmation of the principle that the skilled person of patent law makes compounds with some specific technical purpose in mind;
an investigation into the extent to which competitive and patenting considerations should influence an obviousness analysis, based on what real-life teams would do. In particular, the Judge held that the normal expectation of the Skilled Team would be that the widest possible patent protection would be in the process of being sought and that would normally indicate that the development of a novel and protectable molecule starting from the prior art would require significant changes;
a synopsis of the legal propositions relating to plausibility as derived from the CoA in Apixaban [2023] EWCA Civ 472; and
an endorsement of the EPO case-law emphasising the absence of a requirement for an invention to be better than the prior art (in addition to it simply being new and non-obvious).

Anna Edwards-Stuart KC appeared for Accord and Sandoz, instructed by Pinsent Masons LLP.

[2024] EWHC 2524 (Pat)

R2 v Intel [2024] EWHC 1974 (Pat)

R2 is the proprietor of European Patent (UK) No. 3 376 653 (the “Patent”), which concerns over voltage spike protection of a switching converter. R2 alleges that Intel infringe the Patent by marketing chips, processors...

Comptroller General of Patents v. Emotional Perception AI Limited [2024] EWCA Civ 825

Brian Nicholson KC and Anna Edwards-Stuart KC represented the Comptroller General of Patents, Designs and Trade Marks (“the Comptroller”) before the Court of Appeal in this important decision concerning the patentability...

JCB v Manitou [2024] EWCA Civ 276

This was an appeal from the decision of the trial judge to revoke JCB’s EP(UK) Patent 2 263 965 for a control system for a telehandler. The control system is designed to stop the telehandler becoming unstable by prevent...

This was an appeal from the decision of the trial judge to revoke JCB’s EP(UK) Patent 2 263 965 for a control system for a telehandler. The control system is designed to stop the telehandler becoming unstable by preventing the telehandler arm from being moved into a position at which it causes the machine to tip about the front axle. The invention of the Patent is to switch the control system off when the machine is moving to prevent false indications of instability and allow the operator to move the telehandler arm at will.

At the trial there were three patents in suit. One was held valid and infringed and two (of which the Patent was one) would have been infringed but were held to be invalid. After the trial the parties settled their differences and the appeal was pursued by JCB unopposed by Manitou solely to restore the validity of the Patent.

The trial judge had held that the invention of the Patent was obvious over a prior disclosure in a Japanese patent application (Aichi) of a mobile work platform of a kind often called a cherrypicker. The control system of Aichi has two operating methods. It switches between them depending on whether the platform is stationary or moving. The trial judge had held that the control system in Aichi if applied to a telehandler would meet the requirements of the claim.

Following the procedure addressed in Halliburton’s Patent [2006] EWCA Civ 185 the Comptroller was directed by the Court to appear to assist the Court.

The Court of Appeal reviewing the evidence on the operation of the Aichi control system and held, contrary to the finding below, that because the Aichi control system remained in operation when the machine is moving it did not meet the requirement of the claim of the Patent that the system be disabled. Consequently, the Court of Appeal reversed the trial judge’s finding that the Patent was invalid.

Michael Silverleaf KC instructed by Baker & McKenzie appeared for the appellant, JCB.

Anna Edwards-Stuart KC instructed by Mills & Reeve appeared for the Comptroller.

Manitou was not represented on the appeal but was represented at the trial by Brian Nicholson KC and Kyra Nezami instructed by Marks & Clark

[2024] EWCA Civ 276

Sandoz Ltd & Teva Pharmaceuticals Industries Ltd v Bristol-Myers Squibb Holdings [2023] EWCA Civ 472

This was the first occasion on which a UK court considered the recent EPO decision in G2/21 on the law of plausibility. Bristol-Myers Squibb (BMS) appealed an order of Meade J revoking European Patent (UK) No. 1 427 415...

This was the first occasion on which a UK court considered the recent EPO decision in G2/21 on the law of plausibility. Bristol-Myers Squibb (BMS) appealed an order of Meade J revoking European Patent (UK) No. 1 427 415 and, with it, the UK Supplementary Protection Certificate No. SPC/GB11/042 (concerning the use of lactam-containing compounds and derivatives thereof, and, in particular, apixaban, as factor Xa inhibitors used to treat thromboembolic disorders) for the reasons given in [2022] EWHC 822 (Pat). The Judge’s decision was made following a trial in which Sandoz and Teva contended that the Patent is invalid because its specification did not make it plausible that apixaban would have any useful factor Xa inhibitory activity.

The appeal was heard by Lord Justices Arnold, Nugee and Warby on 19-20 April 2023. The Court unanimously dismissed the appeal. Lord Justice Arnold’s judgment contains a careful analysis of the most important European and domestic decisions on “plausibility” as a standard for sufficiency and inventive step. The Court applied the plausibility test in Warner-Lambert Co LLC v Generics (UK) Ltd [2018] UKSC 56 and restated the following principles on the subject: (i) the requirement for plausibility applies with equal force to claims to a single chemical compound, and there is no invention in merely identifying a new compound without disclosing its utility; (ii) the correct standard is the one laid down by the majority in Warner-Lambert; (iii) it is not sufficient for the Application to encourage the PSA to carry out simple tests even if such test would indeed show the product is likely to be efficacious – subsequent data cannot substitute sufficient disclosure, as supported by G2/21; (iv) there is no additional requirement for the judge to consider the ‘patent bargain’ as a way to circumvent the plausibility test.

The Court also upheld Meade J’s finding that neither the higher quantity of apixaban made, nor the existence of additional processing steps, nor even the two together are enough, without more, to suggest to the PSA that apixaban was an effective factor Xa inhibitor. The existence of assay test results not specifically linked to apixaban cannot lead to more than speculation.

The Court mostly found that G2/21 was consistent with the UK authority in Warner-Lambert. However, Lord Justice Arnold did express his obiter view that the different results of the majority and the minority judgments in Warner-Lambert evidence the fact that, contrary to G2/21, the “ab initio plausibility” and “ab initio implausibility” tests are, in fact, not the same, and that the Enlarged Board in G2/21 itself seemed to have substantially preferred the former.

Anna Edwards-Stuart appeared as junior counsel for BMS, instructed by Hogan Lovells International LLP and Wilmer Cutler Pickering Hale and Dorr LLP.

[2023] EWCA Civ 472

Siemens v GE [2022] EWHC 3034 (Pat)

Patent validity, construction, obviousness, territoriality Siemens alleged infringement of its patent relating to the location of bearings in wind turbines. GE denied infringement inter alia on the basis that its wind...

Sandoz and Teva v BMS and Pfizer [2022] EWHC 1831 (Pat)

Apixaban, trade name ELIQUIS, is a successful drug for treating thromboembolic disorders. This trial concerned four patents relating to formulations of apixaban (the “Patents”), all from the same family having priority d...

Alcon v Pharmathen [2022] EWCA Civ 845

Patent validity, obviousness This was an appeal of the judgment of Meade J ([2021] EWHC 1026 (Pat)) in which he held that Alcon’s patent for the use of a prostaglandin F2 analogue (fluprostenol isopropyl ester) for t...

Teva v Astellas & Sandoz v Astellas [2022] EWHC 1316 (Pat)

Patent validity, obviousness Teva and Sandoz each sought to revoke a patent of Astellas which claimed the use of mirabegron as a treatment for overactive bladder. By the time of the trial Teva and Sandoz relied on a s...

Sandoz v BMS & Teva v BMS [2022] EWHC 822 (Pat)

Patent validity, insufficiency (lack of plausibility), Agrevo obviousness Apixaban, trade name ELIQUIS, is a successful drug for treating thromboembolic disorders. Sandoz and Teva each alleged that BMS’ patent protect...

Original Beauty Technology Company Ltd & ors v G4K Fashion Ltd & ors [2021] EWHC 3439 (Ch)

This was the damages inquiry in an unregistered design case involving two fashion brands: House of CB (the Claimants) and Oh Polly (the Defendants). A liability trial was heard towards the end of 2020: see [2021] EWHC 2...

This was the damages inquiry in an unregistered design case involving two fashion brands: House of CB (the Claimants) and Oh Polly (the Defendants). A liability trial was heard towards the end of 2020: see [2021] EWHC 294 (Ch).

Oh Polly had sold 15,393 garments which infringed House of CB’s unregistered UK and/or Community design rights. House of CB claimed “standard damages” on two bases: (i) lost profits where Oh Polly’s sales had substituted for sales which would have been made by House of CB; and (ii) “user principle” damages where sales substitution had not taken place. Oh Polly accepted that it was liable to pay “user principle” damages, but not damages for lost profit. House of CB sought c. £275,000 in standard damages, while Oh Polly maintained that only c. £15,000 was due.

The liability trial had determined that House of CB was entitled to additional damages pursuant to §229(2) of the Copyright, Designs and Patents Act 1988. House of CB sought a “top up” award of additional damages to take the total to c. £500,000. Oh Polly’s position was that additional damages should be calculated as an “uplift” on standard damages of 20% (on Oh Polly’s case coming to c. £3,000).

The Court held that House of CB was entitled to standard damages under both heads claimed. It determinexd that 20% of Oh Polly’s infringing sales would have been made by House of CB had the infringing garments not been available, and awarded damages for lost profit accordingly; on the remainder of sales a reasonable royalty was awarded of 10% of Oh Polly’s net sales with a guaranteed minimum royalty of £4,000 per design. Standard damages totalled c. £150,000.

In relation to additional damages, the Court determined that an award of £300,000 was appropriate, having regard to the scale of the infringement and its flagrancy, and the need to punish and deter the Defendants from further infringements. This represents the largest reported UK award of additional damages in a design right (or copyright) case.

Thus total damages of c. £450,000 were awarded to House of CB.

Anna Edwards-Stuart and David Ivison appeared for House of CB. Chris Aikens appeared as sole counsel for Oh Polly.

[2021] EWHC 3439 (Ch)

Teva v Bayer [2021] EWHC 2690

Patent validity, obviousness, claim construction Teva sought to revoke a single claim of Bayer’s patent to clear the way for its generic product. The claim was to the tosylate salt of a known compound (sorafenib). Tev...

Fibrogen v Akebia & Astellas v Akebia [2021] EWCA Civ 1279

Patent validity, insufficiency This was an appeal of the findings of insufficiency and the obviousness of the Family B patents in the judgment of Arnold LJ ([2020] EWHC 866 (Pat)). Birss LJ Arnold LJ had construed...

Renaissance Technologies Plc v Comptroller General of Patents, Designs and Trade Marks [2021] EWHC 2020 (Pat)

Patentability The UKIPO held that the Appellant’s patent application was excluded from being patentable under section 1(2) of the Patents Act 1977 as (1) a method for doing business and (2) a program for a computer, a...

Alcon v Pharmathen [2021] EWHC 1026 (Pat)

Patent validity, obviousness This case began as a claim for patent infringement. The defendants submitted to an interim injunction and the proceedings were stayed pending determination of the validity of the patent at...

Original Beauty Technology & ors v Oh Polly & ors [2021] EWHC 294 (Ch)

This was a dispute between two fashion brands: House of CB and Oh Polly. Both sides sell bodycon and bandage dresses and other garments, styles made famous by celebrities including Kim Kardashian and Jennifer Lopez, eit...

This was a dispute between two fashion brands: House of CB and Oh Polly. Both sides sell bodycon and bandage dresses and other garments, styles made famous by celebrities including Kim Kardashian and Jennifer Lopez, either primarily or exclusively online. House of CB claimed that Oh Polly copied 91 of their garment designs, thereby infringing their unregistered design rights under UK and EU law. There was also a claim for passing off: House of CB claimed that Oh Polly had copied their business model, social media, marketing, packaging and presentation (including using the same models and the same locations for photoshoots) such that consumers would be deceived into thinking that Oh Polly was a sister brand of House of CB.

Proceedings were streamlined such that at this trial, the Court was asked to determine the claims for unregistered design right infringement in respect of 20 out of the 91 garments in issue, in addition to the claim for passing off. The trial took place remotely over seven days. Following closing submissions, an in-person physical inspection of the garments was held at Oh Polly’s solicitors’ offices at which the parties’ counsel had the opportunity to point out similarities and differences to the judge.

Mr David Stone (sitting as a Deputy High Court Judge) held that Oh Polly had infringed unregistered design rights in seven out of the 20 garments in issue and that House of CB were entitled to additional damages as a result of the flagrancy of that infringement. The unregistered design right infringement claims in relation to the remaining 13 garments were dismissed. The claim for passing off was also dismissed, the judge having held that although House of CB had proved its case in relation to goodwill in some of the pleaded indicia, they had not established on the evidence that sufficient members of the relevant public had been deceived into thinking that Oh Polly was a sister brand of House of CB.

Anna Edwards-Stuart and David Ivison appeared for House of CB. Chris Aikens appeared as sole counsel for Oh Polly.

[2021] EWHC 294 (Ch)

Lenovo (Singapore) PTE Ltd v Comptroller General of Patents, Designs and Trade Marks [2020] EWHC 1706 (Pat)

Patentability The UKIPO held that the Appellant’s patent application was excluded from being patentable under section 1(2) of the Patents Act 1977 as (1) a method for doing business and (2) a program for a computer, a...

Akebia Therapeutics Inc v Fibrogen, Inc & Astellas [2020] EWHC 866 (Pat)

A multi-patent action concerning the use of an enzyme inhibitor to treat anaemia and related conditions. The patents in issue fell into two families – Family A & Family B – and included claims to classes of compounds...

Teva UK Ltd v Chiesi Farmacutici SpA [2020] EWHC 1311 (Pat)

Patent infringement, strike out Teva sought to revoke various patents owned by Chiesi relating to inhalers for a combination of beclomethasone and formoterol. Chiesi inferred from this that Teva was seeking to clear t...

Ashley Wilde Group Ltd v BCPL Ltd [2019] EWHC 3166 (IPEC)

Copyright, subsistence, infringement Ashley Wilde manufactured and sold, inter alia, bedlinen for the ‘Kylie Minogue At Home’ including a range called Evangeline. BCPL manufactured and sold, inter alia, bedlinen for t...

Quinn Packaging Ltd v (1) Linpac Packaging Ltd (2) R. Færch Plast A/S [2019] EWHC 2119 (IPEC)

Patent validity, obviousness Quinn sought to revoke two patents, one in the name of Linpac and the other in the name of Færch. The case was unusual in that the co-defendants were unrelated companies, although the subj...

Glaxo Wellcome UK Ltd v Sandoz and Vectura [2019] EWHC 2545 (Ch)

Passing off by use of a similar get up, passing off by equivalence Glaxo sold its salmeterol/fluticasone combination product (under the name Seretide) in a purple inhaler. Following expiry of the relevant patent prote...

Glaxo Group Ltd and ors v Vectura [2018] EWCA Civ 1496

Patents, Arrow relief This was appeal against the judgment of HHJ Hacon striking out Glaxo’s claim for Arrow relief. The appeal was allowed. [2018] EWCA Civ 1496...

Glaxo Group Ltd and ors v Vectura [2018] EWHC 3414 (Pat)

Patent validity, obviousness, insufficiency, infringement, Arrow relief Glaxo sought to revoke five patents in the name of Vectura which related to methods for the manufacture of microparticles (composite active parti...

Victoria Plum Ltd (t/a Victoria Plumb) v Victorian Plumbing Ltd & Ors [2016] EWHC 2911 (Ch)

The parties were competitors in the online bathroom retailing market. They had traded under similar names (Victorian Plumbing/Victoria Plumb)since about 2001. The claimant claimed for infringement of trade mark by the...

Napp Pharmaceutical Holdings Ltd v Dr Reddy’s Laboratories (UK) Ltd and Sandoz Ltd [2016] EWCA Civ 1053

Patent infringement This was an expedited appeal of Arnold J’s decision 2016] EWHC 1517 (Pat) () that Napp’s patent for transdermal patches containing buprenorphine for pain relief was not infringed by Dr Reddy’s and...

Napp Pharmaceutical Holdings Ltd v Dr Reddy’s Laboratories (UK) Ltd and Sandoz Ltd [2016] EWHC 1517 (Pat)

This was a patent infringement action brought against two generic manufacturers seeking to launch buprenorphine pain relief dermal patches. Napp claimed that the generic products fell within the claims of two of their p...

Merck Sharp & Dohme Ltd v Ono Pharmaceutical Co Ltd & Anor [2015] EWHC 2973 (Pat)

In Merck Sharp & Dohme v Ono & BMS [2015] EWHC 2973 (Pat), Birss J held that Ono's patent (under which BMS is the exclusive licensee), with claims to anti-PD-1 antibodies which inhibit the immunosuppressive signa...

In Merck Sharp & Dohme v Ono & BMS [2015] EWHC 2973 (Pat), Birss J held that Ono’s patent (under which BMS is the exclusive licensee), with claims to anti-PD-1 antibodies which inhibit the immunosuppressive signal of PD-1 for cancer treatment, is valid. Merck sought to challenge the validity of the patent, raising a wide variety of attacks on the patent, including added matter, insufficiency, loss of priority, anticipation and obviousness. The case raised a number of points of legal interest including the role of plausibility in priority, novelty and sufficiency.

Merck had admitted that, if the patent were found valid, its proposed dealings in its product for treating melanoma would infringe. Unusually, Ono indicated that if it won its infringement case, it would not seek an injunction in the UK provided an appropriate royalty was paid by Merck, to be agreed or decided by the court.

In concluding that the patent was valid, Birss J held that the mouse models for cancer in the priority document (and the patent) provided support for the claimed invention, such that the Patent was entitled to its priority date. Further, because the skilled person would appreciate that these results would have broad application in treating cancer (because the PD-1 blockade effects the immune system, rather than being directed to an attribute of any particular type of cancer) it was plausible that the invention would be effective for treating a wide variety of cancers and so the claims were sufficient. The Judge also held that the Patent was novel over the mouse models for autoimmune disease contained in the prior art as these did not amount to a ‘disclosure’ of the claimed invention.

The judge applied the ‘obvious to try’ guidance set out by the Court of Appeal in its recent decision in Teva v Leo [2015] EWCA Civ 780, holding that although it would not have been inventive to the skilled person to carry out tests which would have led to the invention, the skilled person would not have had a sufficient expectation that the outcome would be successful to render the claimed invention obvious.

[2015] EWHC 2973 (Pat)

Anna Edwards-Stuart KC

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