Anna Edwards-Stuart KC

Call: 2002
Silk: 2024

Anna has an excellent reputation at the IP bar for being a diverse and successful barrister, practising across all areas of intellectual property law ranging from pharmaceutical patents to complex trade mark matters and related contractual disputes as well as damages inquiries and accounts of profits.

Recent patent trials and hearings have concerned pharmaceutical compound and medical use patents (including small molecules, salt forms, antibodies and biosimilars; first and second medical use patents; orphan drug designations), pharmaceutical formulations and dosing regimens (including modified release formulations, preparations for nasal inhalation), medical devices (including advanced wound dressings and auto-injectors), mechanical devices (including coffee machines, food packaging and wind turbines), artificial neuron networks and financial trading systems.

Recent trade mark and passing off trials and hearings have considered the scope of bad faith, the limits of passing off, the use of trade marks as Adwords, and non-traditional marks, and related to subject matter as diverse as medical devices, bandage clothing, branded clothing, energy drinks and the shape of chocolate. Recent design right cases have involved bandage clothing, tablet computers and vacuum cleaners. Recent copying cases have involved fabric and bed linen designs.

Anna has previously been singled out as a “Star of the Future” in the legal press and continues to impress as a proactive advocate with increasing experience acting in several hearings, trials and appeals as sole counsel. She is regularly instructed to act in the Patents Court and general Chancery and Commercial Divisions of the High Court (both at first instance and on appeal), the Court of Appeal, the Supreme Court, the Intellectual Property Enterprise Court, the Trade Mark Registry, the Copyright Tribunal and before the Appointed Person. She has also advised in proceedings before the EPO, the General Court and EUIPO, as well as in various ICC arbitrations and ICANN and Nominet disputes.

Anna has a strong scientific background, having studied in life sciences and biotechnology, and has a doctorate in molecular biology. She is therefore particularly well placed to advise clients in the life sciences field.

During 2019 Anna was appointed Standing Counsel for the Comptroller of Patents, Designs and Trade Marks. Anna was appointed a King’s Counsel (KC) in 2024.

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Recent & Notable Cases

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 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 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...

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, 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)

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)