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Wakefield filed for a patent on vaccine products before unleashing MMR crisis

This page is material from the award-winning investigation by Brian Deer for The Sunday Times of London, the UK’s Channel 4 TV network and BMJ, the British Medical Journal, which exposed vaccine research fraudster Andrew Wakefield | Investigation summary

In a video and at a press conference in February 1998, called - the Royal Free said - to launch the Lancet article, Andrew Wakefield advised parents to demand that the component shots be given separately. What parents weren't told, however, was that Wakefield and the hospital's medical school had already filed the first of what would become a string of extraordinary patent applications

(1) 05.06.97: Wakefield lodges a product patent claim

Below is a London patent office report on the claim filed on 5 June 1997 - almost nine months before the press conference - in the name of the Royal Free hospital medical school and the Neuroimmuno Therapeutics Research Foundation. The foundation is the private company of controversial immunologist Professor H Hugh Fudenberg of Spartanburg, South Carolina. Giving evidence to the UK General Medical Council in August 2007, the former dean of the medical school, Professor Arie Zuckerman, said the Royal Free had no knowledge of the application, and that he was "absolutely shocked" to discover that Wakefield had lodged it.

The patent title is "Pharmaceutical composition for treatment of IBD and RBD". IBD means inflammatory bowel disease. RBD is sometimes described in later documents as "regressive behavioural disease" and sometimes as "regressive behavioural disorder", or autism. This document is the patent office notification, not the claims supplied by Wakefield and Royal Free to the office. The first Wakefield MMR patent application, describing an allegedly safer single measles vaccine - a potential competitor to MMR - is available in full at this website.

(2) 02.02.98: Wakefield tells Free of vaccine idea

Nearly four weeks before the press conference, and as the hospital was preparing the video to distribute to broadcasters, Wakefield filed an ethics committee application to test a product based on the plans in the first patent submission. It makes clear that the idea of a possible vaccine was already in Wakefield's mind.

(3) 28.02.98: Wakefield launches MMR vaccine scare

Without disclosing their ambitions for products which could only find a market if MMR's reputation was damaged, Andrew Wakefield and the Royal Free medical school called a press conference, backed by an elaborate 20-minute video news release, to announce a low-grade Lancet paper, peppered with errors and omissions, which has since been substantially retracted. The press conference triggered an unwarranted global scare over Wakefield's unsubstantiated claims and recommendations, which purported to link MMR with autism and advised parents to ask for single vaccines instead of the three-in-one MMR.

(4) 04.06.98: Wakefield files anti-MMR claim in full

Under patent law, applicants have twelve months before they must publish the full characterisation of their invention, which must correspond with the initial claim. The full Royal Free/Neuroimmuno Therapeutics patent is filed on 4 June 1998 - just three months after the press conference - with Andrew Jeremy Wakefield and Hugh Fudenberg (misspelt as "Fundenberg") named as the inventors of a new kind of single measles vaccine, plus apparently revolutionary treatments for a disease and a disorder they allege to be caused by MMR.

The patent title is "Pharmaceutical composition for treatment of MMR virus mediated disease comprising a transfer factor obtained from the dialysis of virus-specific lymphocytes". It states: "Such a composition may be used as a measles virus vaccine and for the treatment of inflammatory bowel disease and regressive behavioural disorder." Talk of cures for autism is found elsewhere in patent documents. The key date on the document is the "priority" date (32), which dates the claim for a vaccine and treatments to the beginning of June 1997.

There is a large volume of patent documents, with minor variations, including those registered in various jurisdictions,including the United States, the European Union, Canada, Australia and worldwide, at different dates. Applications continued in the medical school's name until Wakefield left its employment in December 2001, when all rights were transfered to him. For space reasons, only the title page and claims section of this UK document are republished below, with other extracts republished at this website.

(5) 14.11.04: Royal Free issues statement on patents

In response to Brian Deer's inquiries, the medical school issued the following statement:

"Universities in the UK are the owners of any intellectual property rights (IPR) derived from work performed by their staff and have an obligation to ensure that intellectual property of potential commercial value is properly assessed and if necessary protected and exploited.

"After Dr Wakefield initiated patents in 1997, through a wholly-owned commercial subsidiary of the medical school, these avenues were appropriately explored.  When expert advice within the school indicated that the scientific basis and commercial exploitability were poorly sustained, the school’s claim on the IPR was relinquished, and all the school’s rights to IPR deriving from his work were assigned to Dr Wakefield when he left the school.

"Any implication that the school had a vested interest in supporting an attack on MMR and raising public concerns about its safety, because it had commercial interests in the development of a rival vaccine and in a treatment for inflammatory bowel disease and autism, is ill-founded and wrong.

"The school never attacked, nor supported any attack, on MMR.  In all its actions it consistently supported the continued use of MMR, including the repeated release of press statements dissociating itself from Dr Wakefield’s comments and publications, urging all parents to protect their children with MMR and explicitly stating that the Lancet paper did not provide virological evidence of associations between inflammatory bowel disease, behavioural disorders and MMR vaccine."

In a statement published on the worldwide web after Brian Deer's revelations in the Channel 4 documentary, Wakefield asserted that the vaccine claims, revealed above, were "an afterthought". He said "my genuine concerns about the safety of MMR are wholly unrelated to any desire or opportunity to develop a competing vaccine". The full first application is here

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