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The law and big pharma: a special kind of science

The law and big pharma: a special kind of science

Shaun McVicar

With Australia still buzzing from National Science Week celebrations, a Melbourne-based litigator speaks about some of the important ways that science works with intellectual property law in the court room.

In a conversation with one of Australia’s leading intellectual property (IP) disputes litigators, Lawyers Weekly asked about how important the role of expert scientific evidence was in some legal matters.  

Shaun McVicar (pictured) is a partner with the Herbert Smith Freehills IP disputes practice and also holds the position of co-leader of pharmaceuticals at the global firm.

Last year the Melbourne-based lawyer represented the major pharmaceuticals drug company Gilead Sciences Ltd (Gilead) in the Federal Court of Australia, with relevant court battles also taking place in the UK and US for corresponding patents in those jurisdictions.

The Australian court ruled in favour of HSF’s client in March 2016 to invalidate a patent that would have restricted the ability of the big pharma to take a drug for the treatment of hepatitis C to market.

The matter was subsequently appealed and is still awaiting a decision from a full bench of the Federal Court to be handed down.

According to Mr McVicar, IP patent disputes involving big pharmaceutical clients very often rely on an understanding of complex chemistry.

“Expert evidence is always critical to pharmaceutical patent cases. There’s very rarely any what you call lay evidence or fact evidence, except in the context of an interlocutory injunction,” he said.

Mr McVicar explained that in the case of Gilead’s claim to being able to put its product named SOVALDI to market, an expert scientific report had to show a complete overview of the science as it was known by a common or an ordinary practitioner, and in the relevant area at the time that patent was registered.

Specifically, the contested patent required an understanding of a highly specialised form of chemistry known as carbohydrate chemistry, he said.

A total of about nine people were called by both sides as expert science witnesses for the hearing last year.

HSF even sent two lawyers of its own to work alongside a scientist based in a university in New Zealand, where they stayed for at least six weeks to help draft evidence which would ultimately be submitted to the court. That on-site work involved watching and learning from the expert in his office technical scientific evidence about the Markush structure of a molecule that was critical to the case.

“The scientific evidence in this case – and typically, this is what we see – is that we had to get from the expert, without him having seen the patent in question, a thorough understanding of what was known in the field of chemistry at the time the patent was filed; effectively common general knowledge,” Mr McVicar said.

“We needed to extract from him, without leading him in any way, a complete overview of what the known science was at the time (what we call a priority date) of the patent,” he said.

When dealing with important technical experts to assist with the drafting of evidence, the IP lawyer suggested that having a lawyer with a background in science present was very useful.

“I would never sit down with an important expert to try and take their scientific evidence without having at least one well-versed, science-qualified lawyer with me to work with the expert.”

Mr McVicar also noted that the rise of pharmaceutical patent litigation over the past decade has shown the benefits of being a lawyer with dual qualifications in either chemistry, biology or physiology.

“The science is relatively complex. It’s not so difficult to get your head around the small molecule chemistry, which involves the synthesis of normal molecules, but as we move into the world of biological pharmaceuticals, which are essentially all protein-based, the complexity is amplified,” Mr McVicar said.

“And the complexity of the drugs is immense and very hard to categorise,” he added.

Nicola Gollan, a graduate lawyer with a science degree majoring in physiology, works with Mr McVicar at HSF. Prior to joining the firm, she worked as an associate to a judge. Ms Gollan said that in her own experience, she found that understanding certain concepts in medical patents was made easier because of the general science knowledge that she brought to the table.

“Obviously all patents are very specific, so you obviously have to learn on the job as well, but it does help having a science background to give you that background knowledge,” she said.

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