Innovate Pharmaceuticals Ltd v University of Portsmouth Higher Education Corporation
Jurisdiction | England & Wales |
Judge | Mr Roger ter Haar |
Judgment Date | 12 January 2024 |
Neutral Citation | [2024] EWHC 35 (TCC) |
Year | 2024 |
Court | King's Bench Division (Technology and Construction Court) |
Docket Number | Case No: HT-2021-000478 |
[2024] EWHC 35 (TCC)
Mr Roger ter Haar KC
Sitting as a Deputy High Court Judge
Case No: HT-2021-000478
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
TECHNOLOGY AND CONSTRUCTION COURT (KBD)
Royal Courts of Justice
Rolls Building
London, EC4A 1NL
Thomas Roe KC and Katharine Bailey (instructed by JMW Solicitors LLP) for the Claimant
Clare Dixon KC, Nicholas Zweck and William Birch (instructed by Eversheds Sutherland (International) LLP) for the Defendant.
Hearing dates: 4, 5, 9, 10,11,12, 16, 17, 18, 19 October, 29, 30 November 2023
Approved Judgment
This judgment was handed down remotely at 10.30am on 12 January 2024 by circulation to the parties or their representatives by e-mail and by release to the National Archives.
Mr Roger ter Haar QC:
In this action the Claimant (“Innovate”) claims damages from the Defendant (“UoP”) arising out of a Research Agreement between those parties. The claim is highly unusual turning as it does upon an academic research paper published in a well-respected scientific journal which paper is alleged to have been infected by errors which were said to be at least careless, but for reasons which are important to limitation of liability clauses in the contract, are also said to have been the product of dishonesty.
The Claimant
Innovate was incorporated on 9 September 2014. Since February 2017 Innovate has been owned by:
(1) Simon Cohen, a podiatrist with a history of working for pharmaceutical companies and a full-time employee of Innovate;
(2) Dr Michael James Stuart, a Doctor and the sole director of Innovate; and
(3) Jan Cohen, a lawyer and Mr Simon Cohen's brother. Where in this judgment I refer to “Mr Cohen”, I am referring to Mr Simon Cohen rather than Mr Jan Cohen.
Innovate holds the patent to a formulation of liquid aspirin known as IP1867B or Glioprin. The formulation is made up of 2.5% aspirin, 1% saccharin and 96.5% triacetin, which is a commonly used excipient in cosmetic and pharmaceutical formulations as a solvent. In this judgment, IP1867B is referred to as “the Drug”.
Innovate was incorporated by the shareholders as the vehicle through which they would seek to develop and commercially exploit the Drug. I set out in somewhat more detail below the evidence, which I accept, as to the development of the Drug.
The University and the Brain Tumour Centre of Excellence
The University of Portsmouth traces its roots back to the 19 th century. In 2010 UoP established a “Brain Tumour Research Centre of Excellence” led by Professor Geoffrey Pilkington, Professor of Cellular and Molecular Neuro-oncology. By the time of the events with which this Court is concerned, Dr Richard Hill was the Group Leader of the Novel Therapeutics Unit at the Centre.
The Centre was funded, in part, by, and derived its name from, a charity called Brain Tumour Research (“BTR”). BTR was co-founded by Sue Farrington-Smith MBE when she lost her niece to brain cancer. Professor Pilkington's evidence was that in the early 2000s Ms Farrington-Smith reached out to him as an individual with a high profile in the area of brain cancer and they developed a close working relationship. He encouraged her and the charity she founded to establish a number of research centres, dedicated to finding treatment for brain tumours. In 2010 the Brain Tumour Research Centre of Excellence was the first of these centres to receive an endowment. Imperial College London, Queen Mary University of London and the University of Plymouth were subsequently granted endowments and have BTR Centres of Excellence.
Professor Pilkington's evidence was that BTR aspired to provide each Centre of Excellence with funding of £1 million a year, but during the time that he was Head of the Centre at Portsmouth the UoP did not receive this level of funding: BTR's ability to fund the Centres was dependent on its fundraising and was inherently uncertain. The UoP team applied for grant funding from various bodies and charities to support the Centre's work and supplement the BTR endowment. Some of the Centre's costs were funded by the UoP. A small amount of funding also came from industry collaborations.
Types of testing
This section of this judgment and that which follows are principally based upon the evidence of the Defendant's liability expert, Professor Martin Bushell, but I do not understand any part of the contents of these two sections to be controversial.
This case concerns the reporting of testing of the Drug. Three types of studies are used to test new or repurposed drugs: in vitro studies, in vivo studies and clinical trials or studies.
In vitro studies are carried out on biological cells that have been removed from their normal biological context (e.g. through a biopsy), and can be considered to be “test-tube experiments”.
In vivo studies are carried out on biological cells in their normal biological context, so are tests on whole, living organisms or cells, usually animals – in vivo studies can therefore be considered to be “animal testing”.
Studies involving humans are usually referred to as clinical trials or studies rather than as in vivo studies.
There was put in evidence before me a document entitled “Guidelines for phase 1 clinical trials 2012 edition” 1 which says under the heading “Developing a new medicine”:
The pharmaceutical industry is the main sponsor of medicines research in the UK. Sponsors have to demonstrate the safety, quality and efficacy of a potential new medicine – called an investigational medicinal product (IMP) – through a series of rigorous trials in humans in order to obtain a licence, so that doctors can give the medicine to patients.
However, before an IMP can be given to humans, sponsors must first test it thoroughly in animals. The main aim of these pre-clinical studies are:
• to find out the effects of the IMP on body systems (pharmacodynamics)
• to study the blood levels of the IMP, and how it is absorbed, distributed, metabolised and eliminated after dosing (pharmacokinetics)
• to find out if a range of doses of the IMP, up to many times higher than those intended for use in humans, are toxic to animals and if so, to identify the target organs and the margin of safety in terms of (a) the no-observed-adverse-effect dose level (NOAEL) relative to body weight and (b) IMP exposure – the concentration of IMP in the bloodstream over 24 hours (toxicokinetics), and
• to make a formulation of the IMP, such as a capsule or injection, suitable for early studies in humans.
After the pre-clinical studies, there are four phases of trials in humans, which in practice often overlap. Phases 1 to 3 are done before a licence is granted and Phase 4 is done after authorisation to market the drug. The phases are different in terms of the number and types of subject studied, and the questions asked. The numbers in the table are indicative only and can vary.
Phase
Number and type of subject
Questions
1
50–200
healthy subjects (usually) or patients who are not expected to benefit from the IMP
• Is the IMP safe in humans?
• What does the body do to the IMP? (pharmacokinetics)
• What does the IMP do to the body? (pharmacodynamics)
• Might the IMP work in patients?
2
100–400
patients with the target disease
• Is the IMP safe in patients?
• Does the IMP seem to work in patients? (efficacy)
3
1000–5000
patients with the target disease
• Is the IMP really safe in patients?
• Does the IMP really work in patients?
4
many thousands or millions
patients with the target disease
• Just how safe is the new medicine? (pharmacovigilance)
Does the medicine work in the real world? (real world data collected to demonstrate value)
• How does the new medicine compare with similar medic [sic]
Phases are also often subdivided. For instance, small-scale, exploratory efficacy studies in a limited number of patients may be referred to as ‘Phase 2a’. In contrast, slightly larger trials that test the efficacy of a compound at different doses (‘dose-range finding’ studies) might be designated ‘Phase 2b’.
Key Scientific Terms that feature in the Proceedings
Glioblastoma Multiforme or “GBM”
The most common form of brain tumour is a Glioma. Gliomas can be grouped according to how quickly they are likely to grow, with grade 1 being the slowest and grade 4 the fastest. Grade 4 gliomas are also known as Glioblastoma Multiforme (“GBM”). Treatment for the disease may involve surgery, radiotherapy and/or chemotherapy. Temozolomide (“TMZ”) is a chemotherapeutic commonly used in the treatment of GBM. Although treatment is effective in some situations, the clinical prognosis for GBM sufferers is generally poor and additional treatments are required.
In order for a drug to be effective in the treatment of GBM, it would need to be established that:
(1) it could penetrate the barrier between the blood and the brain (in which the GBM is situated), which barrier is known as the blood-brain barrier;
(2) (a) it could shrink GBM and do so in a manner comparable with or better than existing GBM treatments, and, (b) if it could shrink GBM, the mechanisms that allowed it to do so would need to be understood;
(3) it was relatively well tolerated by bodily cells other than those contained in the GBM; and
(4) it does not give rise to unacceptable side effects.
IGFR and EGFR
The terms IGFR (also IGF1 and IGF1R) and EGFR are of significance in this case.
Cells, including cancer cells, have receptors on their surface. Protein molecules can interact with those receptors, the effect of which interactions can be to cause the cell to behave in a certain way.
Epidermal Growth Factor Receptor (“EGFR”) stimulates tumour...
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