1st Jul 2022
VERONIQUE BUEHRLEN Q.C. (Sitting as a Deputy High Court Judge)
This is an application dated 18 November 2021 brought by the Defendant for security for costs pursuant to CPR rule 25.13.
The Claimant is a pharmaceutical company whose work includes the development of drugs for the treatment of cancer. The Claimant is a small company owned by 3 individuals, a scientist, a medical doctor and a lawyer. The Claimant has developed a drug known as IP1876B (“the Drug”), which is a form of liquid aspirin, which it hoped and still hopes to licence to pharmaceutical companies. The Defendant is a university, an institution that carries out medical research and a centre of excellence for research into brain cancer.
The Factual Background to the Dispute
The dispute arises out of a written agreement dated 7 July 2016 by which the Claimant hired the Defendant to conduct a Research Programme into the properties of the Drug in the context of the treatment of brain tumours (“the Contract”). The Research Programme was to be undertaken under the direction of Dr Richard Hill, a researcher then employed by the Defendant. The purpose of the Contract, according to the Claimant, was to put itself in a position in which it could demonstrate (such as to a pharmaceutical company) the properties and potential uses of the Drug by reference to a credible and reliable set of research results.
The Claimant’s case is that Dr Hill made a number of false representations in respect of the results of the Research Programme, firstly orally and in text messages and emails sent to the Defendant in August 2018 and secondly in a scientific paper about the methods and results of the Research Programme published in a scientific journal known as Cancer Letters on 28 August 2019 (“the Paper”). The Paper was entitled:
“IP1867B” suppresses the insulin-like growth factor 1 receptor (IGF1R) ablating epidermal growth factor receptor inhibitor resistance in adult high grade gliomas”
In short, the representations were to the effect that the data obtained from the Research Programme showed that the Drug suppressed resistance to Epidermal Growth Factor Receptor (“EGFR”) inhibitors. The significance of this is that a drug that reduced a tumour cell’s ability to develop resistance to EGFR inhibitors would potentially enable much more effective cancer treatment. An associated press release reflects the claim in layman’s terms: “Shrinking brain tumours with liquid aspirin”.
Issues were raised in relation to the Paper following publication and a Corrigendum was issued by Cancer Letters in October 2019. This made two corrections to figures / images set out in the Paper but stated that the corrections did not alter the conclusions of the Paper. I refer to the Paper together with the Corrigendum as “the Cancer Letters Paper”. The Cancer Letters Paper included (i) photographs taken with microscopes of laboratory grown cell cultures to which various drugs (including the Drug) were said to have been applied; and (ii) annotated photographs of “blots” said to have been generated by analysis of various samples. I understand that a “blot” is a little like a Covid-19 lateral flow test. A sample is applied, and marks appear that are indicative of the presence or absence of certain substances in the sample.
In about September 2019, shortly after publication of the Paper, the Defendant commenced an investigation into research misconduct on the part of Dr Hill. A preliminary investigation led to the appointment by the Defendant of a disciplinary panel to undertake a formal investigation. In early 2020 the disciplinary panel found Dr Hill guilty of “research misconduct”. “Research misconduct”, is a term defined in the Defendant’s “Procedure for the Investigation of Allegations of Misconduct in Research”. It comprises any breach of the UK Research Integrity Office’s Code of Practice or of “accepted procedures that seriously deviate[s] from those that are commonly expected within the academic and scientific communities for proposing, conducting or reporting research”. A copy of a draft of the Disciplinary Panel’s report (provided by Dr Hill to the Claimant) includes criticisms of the material set out in the Cancer Letters Paper including findings that the text description did not match the data and issues with the blots presented in the Paper.
By letter dated 11 March 2020, the Defendant informed Cancer Letters that it had investigated allegations that Dr Hill had been engaged in research misconduct in relation to the Cancer Letters Paper and that as a result Dr Hill had been found guilty of research misconduct in relation to research involved in the Cancer Letters Paper.
On 25 March 2021, Cancer Letters issued a Retraction Notice of the Cancer Letters Paper stating that the retraction was “at the request of the Editor-in-Chief due to concerns regarding the legitimacy of images and data presented in the paper”. The Notice stated that the Corrigendum had also been found to contain errors and went on to set out Cancer Letters’ specific concerns.
The Parties’ Respective Cases
In short, it is the Claimant’s case that Dr Hill knowingly misrepresented the results of the Research Programme in breach of the Defendant’s obligations under the Contract and/or did so negligently. It is alleged that: (i) the Defendant failed to exercise reasonable skill and care to ensure the accuracy of the work performed and the information given contrary to clause 11.1 of the Contract; and/or (ii) the Defendant did not uphold the highest standards of business ethics in the performance of its responsibilities or adhere to the general principles of honesty, fairness and integrity in all its dealings contrary to clause 18.1 of the Contract. It is alleged that as a result of the misstatements in the Cancer Letters Paper, Cancer Letters retracted the article, the Research Programme was discredited and rendered worthless, and the reputation of the Drug tarnished by association. In turn, it is alleged that the Claimant has suffered loss and damage including the cost of undertaking a fresh research programme into the properties and efficacy of the Drug and a diminution in the value of the Claimant’s patent in the Drug.