Sanofi v Amgen antibody case lands front of queue at UPC

The  Unified Patent Court (UPC) may be less than a week old but it is already set to be the latest stage for the long-running dispute between Sanofi and Amgen concerning antibody patents.

As confirmed by lawyers to WIPR, the German division of French drugmaker Sanofi filed a revocation action against the US pharma company before the court’s central division in Munich citing patent number EP 3 666 797.

It marks a new twist in the global litigation waged between the two companies over antibody patents that wound its way to the US Supreme Court last month.

Commenting on the French company’s early bid at the UPC,  Martyn Fish, partner at HGF welcomed the development as a “sign” of confidence in the court.

“One of the major concerns regarding the court was that the major players in the patent litigation market would avoid it for quite a long time. So this is a positive development: clearly those sort of big, heavyweight players in the litigation market want to use it.”

The move comes after Sanofi  won the closely watched clash at the US highest court in May, after the justices unanimously ruled that antibody patents owned by Amgen were not 'enabled' under the country’s Patent Act.

Low numbers potentially masks true picture

Sanofi’s action may be seen as a favourable nod towards the court, but at the time of writing, the case is only one of two proceedings currently visible on the UPC’s system—the other one, Kaldewei v Bette, concerns a dispute between German bathroom technology manufacturers.

The low number of cases seen four days after the court went live—and a momentous and dramatic build-up to its opening date—is, as Fish points, somewhat unexpected, perhaps even disappointing.

“The low number of visible cases is the one trend that is, so far, certainly surprising,” he says, diplomatically.

“In my network, there's sort of plenty of litigators saying that they’ve filed actions at the UPC. And so, I’d be very surprised if there's not a significant amount of claims filed which we’re just not seeing yet.”

What’s more, lawyers say the dearth of visible cases so far could be yet another example of the technical problems that have plagued the court's case management system over the past six months.

As partners from Hogan Lovells note, noise from the patent market strongly suggests that the court should be seeing considerably more filings—particularly from companies in the telecoms sectors and non-practising entities.

Anna-Katharina Friese-Okoro, partner at the firm, contends that all the signs indicate that many more cases are looming.

“My guess is that there can't be only two cases filed so far, and it does make me wonder whether the CMS is an issue because it has experienced significant problems,” she reflects.

“I want to be as kind as possible,” she adds wryly, before acknowledging that “navigating and accessing the system has been really difficult”.

“We have to match the requirements of the CMS with our own technical requirements. And sometimes just the interface and software simply does not work.”

Her colleague and fellow partner,  Christian Stoll also predicts that a raft of cases will trickle through the system once any teething problems are resolved. Taking a more sanguine approach to the much-publicised technical glitches, he points out that: “We need to give the system a couple of days to really get started. And so, we will probably see many more soon when the system is operating more smoothly.

“There's definitely room for improvement. But basically, these are things that can be modified and improved pretty easily. And I'm confident that the court will listen to the feedback from users and adjust the system.”

Opt-outs escalate

As patent practitioners keep a close watch on revocation and infringement actions, the opt-outs recorded by the court continue to rise: at the time of writing, the number stands at nearly 500,000.

According to Fish, this is likely significantly more than the founders of the UPC “actually anticipated”, as many companies “continue to err on the side of caution” when it comes to the court.

Others, however, counter that the statistics so far paint a far more positive picture.

There was a “lot of doom-mongering from many people”, says  Kevin Cordina, partner at Simmons & Simmons.

“But the number so far falls a long way short of the 800,000 to 1,000,000 being suggested by some which has to be a good thing as it shows trust in the court.”

But while Sanofi’s action may indicate heavyweight interest in the court, it appears that the chemical and pharmaceutical sectors continue to lead the opt-out exodus.

As Cordina explains: “In the pharmaceutical field, companies tend to be much more worried about revocation actions, which would kill off the patents across EU member states. And so that would mean a much much stronger financial risk if they were to expose that patent to the court.”

Opt-outs in the field of pharmaceuticals will likely continue to climb upwards, agrees Friese-Okoro.

“The number is already high, and it's likely to become even higher,” she says, adding that there was “an extremely high jump in applications on Friday—in the region of 18,000”.

“It is a very personal decision to opt out. And many clients may want to wait and see, and then decide,” she explains.

Yet despite the uncertainty and the court’s detractors, Friese-Okoro strikes an optimistic note as the court continues its second working week.

“We're all excited to see what's coming in the next couple of weeks. I hope it's a system which will be adopted by many clients—because it does actually give them quite a lot of advantages.”