Wednesday, 11 February 2015

From hepatitis B virus antigens to wine and canapés: Biogen v Medeva revisited

The "Biogen v Medeva 20 Years On" event, organised by London-based law firm Rouse last year and cruelly postponed on account of a strike call by one of the London Underground unions, was finally held last week.  Rouseniks Mary Smillie and Catriona Smith bring us this report on one of the most influential pieces of British patent litigation to have emerged in recent decades:
Rouse invited the main protagonists in the landmark House of Lords case of Biogen v Medeva for a reunion at the Crisis London Skylight Café near Spitalfields, before an invited audience. This now famous case on a patent for hepatitis B virus antigens led to the well-known speech of Lord Hoffmann in the House of Lords and the concept of 'Biogen Insufficiency'. The event was chaired by Rouse's Diana Sternfeld who acted for Medeva. The panel was made up of those involved on the commercial side from Biogen's licensee SmithKline Beecham Biologicals (Bill Tyrrell) and Medeva (Peter Cozens) and those who ran the case for Biogen (Jim Haley, Leslie McDonell, Simon Thorley QC and Andrew Waugh QC) and for Medeva (Peter Prescott QC, Adrian Speck QC and John Ilett). We also had the experience of Medeva's expert witness, Jeff Almond and comments from The Rt Hon Professor Sir Robin Jacob and Martin Howe QC.

It was an evening of nostalgia, shared wisdom, anecdotes and fun. We remembered those who are no longer with us, notably Sir Hugh Laddie, who acted for Biogen, and the inventor, Sir Ken Murray.

The story started with the founding of Biogen in 1978 by scientists around the globe working in their home labs. Ken Murray took the lead working on the production of antigens to the hepatitis B virus, using DNA technology, at the University of Edinburgh. The patent claimed priority from 1978 and was granted in 1990. It was licensed to SmithKline Beecham Biologicals, who had developed a recombinant hepatitis B vaccine called Engerix-B which came onto the market in the late 1980s. Although SmithKline Beecham Biologicals thought Biogen's patents were initially dubious, and had (unsuccessfully) opposed the narrower patent (EP0013828 'Recombinant DNA, hosts transformed with it and polypeptides produced by the hosts') at the European Patent Office, they changed track when Medeva came along with results to indicate they had a vaccine which worked in patients who did not respond to Engerix-B. SmithKline Biologicals then lined up with Biogen to fight Medeva in the Patents Court and beyond.

The leading counsel, Hugh Laddie and Peter Prescott, were described as being at the 'height of their game'. Andrew Waugh, then a junior, recalled his anxiety at having to prepare to explain the 'smudgeograms' (the name given by Peter Prescott to auto radiographs showing experimental results) to the House of Lords without the benefit of overhead projectors or a whiteboard. Adrian Speck reflected that it was his first case and that it was a high point of his career.

The case was difficult, as witnessed by the time it took in the Court of Appeal (18 days) and the Lords (14 days) partly because of the nature of the science. While genetic engineering was a fast developing field, there had been a voluntary moratorium on further work by scientists because of concern about the safety of genetically modified bacteria in use. This meant that, while ideas were there and developing at speed, research had halted, leaving the theoretical methods available to reach desired end-points undeveloped. The skills of the expert witnesses in the case were praised and some details of the difficulties of undertaking the research were shared by Jim Haley, who still has the original court transcripts. Examples included the difficulties of working on microscopic cells through clumsy glove boxes.

Jim Haley pointed to an analogy given by Lord Hoffman to the invention by the Wright brothers: 'The idea of making HBV antigens by recombinant DNA technology was shared by everyone at the Geneva meeting of Biogen in February 1978 and no doubt by others working in the field, just as the idea of flying in an heavier-than-air machine had existed for centuries before the Wright brothers. The problem which required invention was to find a way of doing it.'

The analogy had resonated with Mr Haley, as his firm at the time (Fish & Neave of New York) had successfully defended a patent for the Wright brothers at an early point in their history.

This was the first time the House of Lords had considered the validity of a product made by genetic engineering, yet the issue decided in Biogen v Medeva is still a live issue today. As Robin Jacob commented, the width of a claim, and what is meant by enabling an invention across the width of that claim, is still a challenge. The Biogen insufficiency test works for a patent claiming a chemical class; you have to be able to make all the chemicals in that class. In other cases the test will not work, and in yet others, Biogen Insufficiency will ride again. Robin Jacob concluded that Sir Hugh put up a great fight, and duly lost. The panel concurred that Biogen had won at first instance because of Sir Hugh's closing speech.

The case was heard before judgment transcripts were made available in advance. When Diana Sternfeld heard the opening words of Aldous J's judgment, that 'The patent is valid and infringed' she needed 30 seconds to compose herself before speaking to the clients sitting in the public gallery. She left the courtroom and bumped into Hugh Laddie, also on the other side of the double doors, who said to her 'now, that is a turn up for the books'.

The idea of sides getting together after the end of such litigation to debate the issues was much praised, preferably before 20 years have elapsed. The two sides commented repeatedly that meeting each other face to face in a friendly environment was an occasion to be celebrated after such a hard fought case.

The evening was rounded off by wine and canapés and lively conversation.

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