Case review: Biogen v Medeva, 20 years on

It may be hard to imagine Napoleon and the Duke of Wellington sitting down to reminisce after the Battle of Waterloo, and it’s perhaps just as hard to imagine warring legal parties doing so after a long and hard-fought battle. But that is what happened in February when the parties involved in the landmark patent case Biogen v Medeva met to reminisce about their involvement in the case before an invited audience.

The Biogen v Medeva litigation began in 1992 when biotechnology company Biogen brought proceedings against Medeva at the Patents Court (part of the English High Court) for the alleged infringement of a patent for a hepatitis B virus vaccine using recombinant DNA technology. The patent could be construed in such a way that it could in effect block all other ways of achieving the same result via different routes.

At the time, DNA technology was in its infancy and Biogen was one of the leaders in the field. The company was founded in 1978 in Switzerland by a group of the world’s most accomplished biologists, one of whom proceeded to develop the technology for the hepatitis B vaccine in question.

The now famous litigation that followed was complex (largely due to the science involved), hard-fought and lengthy. Following a trial at the Patents Court in which Biogen’s patent was held valid, the English Court of Appeal, which overturned the decision, took 18 days to hear the case from start to finish; the subsequent appeal in the House of Lords (now the Supreme Court), which upheld the appeal court’s ruling in 1996, took 14.

Lord Hoffman’s well-known judgment, which introduced the concept of what is now known as ‘Biogen insufficiency’, was the first time the House of Lords had considered the patentability of genetically engineered products. Hoffman’s judgment held the patent to be insufficient, saying: “The Wright brothers showed that heavier than air flight was possible, but that did not entitle them to a monopoly of heavier than air flying machines.”

Lord Hoffman said: “Care is needed not to stifle further research and healthy competition by allowing the first person who has found a way of achieving an obviously desirable goal to monopolise every other way of doing so.”

Two members of the discussion panel shared the lessons they had learned, some of which are recapped here.

Andrew Waugh (now QC but a junior counsel at the time) worked closely with Biogen’s leading counsel, the late Hugh Laddie, for many years over the course of the case and the appeals.

Lessons learned

Waugh learned four lessons from the case:

If you plan to share cross-examination notes, do it early and don’t engage in a noisy debate outside the courtroom on the morning of the trial

Jim Haley, a US lawyer representing Biogen and assisting the English lawyers, and Laddie were heard having a momentous row on the other side of the double doors outside the Patents Court in the Thomas More building. Haley had asked for the cross-examination notes the previous day, and had spent all night re-writing them with red ink. At the time, Laddie was cross-examining Medeva’s expert, professor Jeffrey Almond, and did not take kindly to having his cross-examination plans queried at the last minute.

Don’t misjudge the humour of the court

One of Biogen’s witnesses was Lydia Villa-Komaroff. In a book about the race between Harvard and Stamford Universities to clone human insulin, Peter Prescott, Medeva’s lead counsel, had found a story about Lydia’s grandfather, who had been spared from a death sentence by the Mexican revolutionary Pancho Villa simply because he had the same name.

At the start of Villa-Komaroff’s cross-examination Prescott checked the story with her and then commented that had that not been the case, he would have been spared a lot of trouble. Although the Patents Court laughed, the joke was not appreciated by Judge Aldous.

In order to be successful in biotechnology cases, lose at first instance

Looking back at all of the landmark biotechnology patent cases since Biogen, all first instance judgments have been overturned on appeal. In addition to Biogen v Medeva, other cases that were overturned include Kirin-Amgen v TKT, Conor v Angiotech, Lundbeck v Generics and Eli Lilly v Human Genome Sciences. The only survivor, which predated Biogen, was Genentech v Wellcome Foundation.

In summary, where the law is new and the facts are difficult, lose at first instance: the prospects of winning on appeal are much better.

Parties in landmark cases should get back together to debate it sooner rather than later

The experience of meeting all parties in a court case is invaluable, but 20 years after the case is too late. The parties should get back together sooner. This happened in the Novartis (CIBA) v Johnson & Johnson litigation surrounding contact lenses.

The litigation was multi-jurisdictional—in Ireland, France, Australia, and the US, as well as England. The sides in each jurisdiction gathered for a meeting in Basle to consider what they had learned from the litigation, which could be used next time.

“Where the law is new and the facts are difficult, lose at first instance: the prospects of winning on appeal are much better.”

Professor Jeffrey Almond, who at the time of the case was professor of microbiology at the University of Reading after 15 years in the vaccines business with Sanofi, is now a visiting professor at University of Oxford. He spoke about the case from the point of view of the expert.

Four interesting points occurred to Almond when reflecting on this case:

The legal approach is different from the scientific approach

The scientific question at the heart of the case was whether a hepatitis B surface antigen had been expressed. That question could have been answered by further experiments but, as the expert adviser, Almond’s job was to answer the question to the best of his ability on the basis of the information available to him; he could not ask for more tests. At the time of the case, Almond was also on the committee advising the government on the mad cow disease (BSE) crisis.

One of the questions being asked of the committee was whether the newly emerging ‘variant CJD’ was caused by BSE jumping from cows to humans. The scientists on the committee lacked the evidence to make a sound scientific conclusion and were initially reluctant to provide an answer. However, after his new legal experience, Almond insisted that they needed to make a judgment based on the partial evidence they had, just as Almond had been asked to do for the court case.

The drama of the courtroom

Almond found the drama in the courtroom fascinating and gave a number of examples why. In a casual discussion, Alan Kingsman (Biogen’s expert) had told Almond just before the hearing that much of his report had been written by the lawyers on Biogen’s team. In cross-examination, Prescott pointed to a particular passage of the report and asked whether it was Kingsman’s own testimony or “something a lawyer has written for you”. The resulting glare Kingsman gave Almond could have killed.

When it was Almond’s turn to be cross-examined he too was ambushed by Laddie and the dreaded “bundle X”. The bundle contained Almond’s CV, which listed that he had attended a course about cloning DNA around the priority date of the patent. Almond was asked how he could say he was “an expert at that time” if he was attending starter courses.

The forensic rigour, including the study of the “smudgeograms”

The “smudgeograms” was a nickname given by Prescott to autoradiographs that Biogen said demonstrated the expression of hepatitis B surface antigen. The plates showed black smudges on the films which, Biogen said, showed where the radioactive label had bound to the expressed surface antigen.

The smudgeograms required some interpretation for the court to understand. Almond was not at all convinced that they showed what they claimed to show, particularly as some smudges appeared to be artefacts, whose position depended on the orientation of the lid of the light-proof box used for the exposure of the filters to the photographic film. This was difficult material to explain to the judges on all levels but Almond was impressed by their desire to understand and interpret.

The entertainment

The entertainment factor came from different directions. One which Almond particularly enjoyed came about when answering a series of questions in his cross-examination about a lazy post-doctoral student in his laboratory. After referring to the post-doc as a “laddie”, Laddie himself replied: “I think I would prefer it if you do not refer to your lazy colleague as a laddie.”

Contributors:

Jeffrey Almond is a visiting professor at the University of Oxford.

Andrew Waugh QC is a member of intellectual property chambers, 3 New Square.

Diana Sternfeld is partner and head of patent litigation at intellectual property law firm, Rouse Legal.

Mary Smillie is an associate at Rouse Legal.