LES 2015: ‘Much unrest’ in molecular diagnostics area, argues Roche

There is “clearly a lot of unrest” in the patent law on molecular diagnostics, according to the head of licensing at Roche Diagnostics.

Monte Wetzel, who was speaking today, October 28, at the LES 2015 Annual Meeting in New York, argued that there are no clear guidelines on what is patent eligible.

When the law is unclear, “you’re kind of stuck”, he added.

It follows the Ariosa Diagnostics v Sequenom decision from the US Court of Appeals for the Federal Circuit in June this year.

A three-judge panel at the court affirmed that a patent owned by molecular technology company Sequenom that protects a non-invasive method of testing a mother’s blood for genetic traits in her foetus is invalid.

Sequenom’s lawyers have said it creates an “existential threat” to patent protection for an array of meritorious inventions.

Melissa Hunter-Ensor, partner at law firm Saul Ewing, had earlier described the ruling as troubling and urged attendees “not to lose sight of the fact that the US is fairly isolated in the world” on its view of what is patentable in this area.

During the panel discussion, a member of the audience who identified herself as being from the medical research centre the National Institutes of Health asked Wetzel whether he was bothered by rulings including Ariosa, since Roche might have to take out fewer licences when developing diagnostics.

Answering with “bring it on”, Wetzel  said that following recent cases, Roche looks “very carefully” at patent claims and what it needs for a freedom to operate.

“We’re an ethical company, so if we think there is a reason to take a licence to patents, we do that,” he added.

The LES 2015 Annual Meeting, taking place at the Marriott Marquis hotel, finishes today.