28 October 2013Big Pharma

Arnold clears conflict of interest in SPC trial

Mr Justice Arnold has refused to recuse himself from a patent trial after he was accused of being conflicted by an expert witness.

Generic company Resolution Chemicals is trying to revoke a supplementary protection certificate for escitalopram (anxiety medicine) that is held by pharmaceutical company Lundbeck. Resolution says the underlying patent is invalid.

Arnold is set to hear an eight-day trial at the England & Wales High Court, starting on the “earliest possible” date after November 11, 2013, according to court documents.

But last month Lundbeck asked Arnold to recuse himself because his past connection with a witness, organic chemist Jack Baldwin, gave rise to a possibility of bias. Baldwin taught at Oxford University when Arnold studied natural sciences there.

In an order published on October 22, Arnold considered whether the “fair-minded and informed observer” would conclude that there was a real possibility of him being “subconsciously biased” when assessing Baldwin's evidence, due to their association.

He assessed several factors, including the nature and extent of their connection.

“Prof Baldwin supervised, but not closely, a research project lasting less than a year which I conducted as a compulsory part of my degree course. This research led to the publication of a short paper in the joint names of Prof Baldwin, Dr Ziegler and myself; but I was not involved in writing or submitting the paper and most of the work it reported was carried out by Dr Ziegler.”

He added that while Baldwin once had “some measure of authority over me” 30 years ago, now, as “a judge assessing a witness, I would have a considerable measure of authority over Prof Baldwin”.

Arnold said after giving “anxious consideration” to questions about his impartiality, he was in “no doubt that the fair-minded and informed observer would not conclude” that there was a real possibility of bias.

It is very rare for parties to ask a judge to recuse themselves in patent cases.

Asked whether he thought Lundbeck had a legitimate grievance, Suleman Ali, attorney at law firm K2 in London, said it was not unreasonable for the company to make the request.

“In UK patent cases experts are very important, and will often determine how the case is decided. The judge has to decide between the expert of one side, versus the expert of the other side. Even though the case should be decided based on what the expert says, rather than who they are, inevitably the judge has to make a decision about their credibility, and so knowing the expert in some capacity may influence that.”

Having been faced with the “unenviable task” of deciding whether or not to recuse himself, said Nicole Jadeja, senior associate at IP law firm Rouse, Arnold made the right call.

She added: “It is interesting to note, that, as Mr Arnold comments, judges often know the barristers on one, or both, sides and also the instructing solicitors. They may even have worked with these people in the past. Fundamentally, we have to have confidence in our judges.”

The case, which will now proceed to trial, will be an interesting one to watch, Jadeja said.

“Lundbeck’s patent has already been litigated in the English courts all the way to the House of Lords (where it was held valid) and has also been held valid in Australia, Belgium, Canada, France, Germany, Hungary and the US.

“Lundbeck is probably frustrated at having another fight,” she said.

Lawyers for Olswang LLP and Wragge & Co LLP, which are representing Resolution and Lundbeck respectively in the case, did not respond to a request for comment.

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