UK SPC ruling pushes patent drafting specificity
Generics and innovator pharma companies welcome December’s SPC decision from a UK court, saying it further clarifies an uncertain regulation, but believe it will introduce prosecution challenges
A court of appeal ruling in Teva v Gilead helps clarify the language in Article 3a of the SPC Regulation and will change the way patent claims are drafted, according to in-house counsel from pharmaceutical companies including Gedeon Richter and Bracco Imaging.
While the judgment is a welcome clarification on the “muddled language” of Article 3a that has beleaguered biologics developers, sources say it means they will need to take care to be more specific when they draft their original claims.
The England and Wales Court of Appeal ruled last month that the combination of tenofovir and emtricitabine in Truvada, an HIV anti-retroviral, did not adequately meet the Court of Justice of the EU’s (CJEU) requirements for a basic patent in force that each component must be expressly named in the original claim.
The ruling widens the gap between supplementary protection certificate (SPC) and UK patent law, according to in-house sources. Under patent law, a second active ingredient can be protected in broader terms alongside a more specific first ingredient. This newest interpretation of Article 3a says that a second active ingredient must be ‘necessarily and specifically’ identified in the claim.
“The first point to be made looking at this case is that the broad phrasing in claims may be risky if you would like to use that patent later on as a basic patent for an SPC,” says Imre Gonda, head of IP at Gedeon Richter in Hungary.
“This development may have an impact on claim drafting in the future, specifically as it relates to an identifiable ingredient. If we knew already the active ingredient at the date of filing, we should be more specific when drafting claims and more specific when drafting the description.
“Terms like ‘other active ingredient’ will not be enough. What’s more, the combination should be unambiguously highlighted in the claims.”
Francesco Macchetta, director of IP at Bracco Imaging in Italy, tells Managing IP he thinks the Court of Appeal issued a good judgment because it made sense of the CJEU’s 2018 ruling on what it means for a combination of active ingredients to relate “necessarily and specifically” to the combination described in the patent.
“This ruling makes my life easier because it provides clarification. The ruling was definitely something reasonable because it didn’t go straight for infringement or provide an essential inventive contribution test,” he says. “What you get is a clearer answer on the interpretation issues around Article 3a.”
While the ruling does make life easier for in-house counsel, the problem is they often don’t know the specifics of the second active ingredient at the time of filing an application that would later be necessary for an SPC.
“The challenge that always faces patentees is a timing pressure to get the patent filed, so they have to balance the wording of the claim when they know there will be a combination product at some point,” says Annsley Merelle Ward, senior associate of IP litigation at Bristows in London.
“This drafting is a really tricky game and the time pressure butts up against where this SPC regulation is going.”
Gonda adds agrees and adds that patent applicants have to do their filing at an early stage before being fully aware of which compounds will ultimately succeed.
“In one application, you have to file a large number of compounds, so you have to be very broad,” he says.
The assistant managing counsel at a European innovator company says that although this specific ruling does not change anything for him, he does see it as another battle won in the SPC war.
“This is, by and large, a very sound judgment,” he says. “Lord Justice Floyd made huge efforts to find a pathway through potentially conflicting CJEU judgments, and finding a way to interpret rulings so they make sense is a hard job.”
How long will it last?
When it comes to SPCs, one concern for in-house counsel is that highly technical questions are thrown in front of courts that do not specialise in IP law. Even though the pharmaceutical industry is awaiting two judgments from the CJEU, the IP manager for a European pharma innovator says he is not expecting much more clarification from them.
“There is a difference between a specialised IP court and a general court. You cannot do anything meaningful if you do not study IP law, which is something the CJEU justices haven’t done. My hope is that the CJEU doesn’t contradict itself,” he says.
The assistant managing counsel reminds Managing IP that getting clarity about Article 3a from the courts can be complicated because the wording is difficult to understand and not every judge has a background in IP.
“This article is a challenge, and though judges are very clever people, this is tough to get your head around. The judges aren’t spending all day doing SPCs. It is a complex area of law and I’m sympathetic with judges who do this.”
He adds that although the recent judgment doesn’t change much in how he sees the law, he thinks this ruling matches what he believes to have been the proper interpretation of SPCs.
“We always wait to see what further clarification we can get from the CJEU to see who is right or wrong,” he adds. “This case is part of the battle in the war of Article 3a and will only change anything if people insist on litigating.”
Merelle Ward says that every SPC decision helps shed light on what is a murky picture of the meaning of the law. “SPC law is like a dirty oil painting undergoing painstaking cleaning. Each reference and decision helps remove some of the dirt to illuminate the picture but there is a great deal still lurking in the shadows and around the edges,” she says.
The new judgment from the UK means innovators are going to have to be more specific without knowing all the details. This is a very tricky exercise and requires a certain amount of crystal ball gazing for those with ambitions for obtaining SPCs.
The hope is that, despite their muddied reputation on IP matters, the European courts will give a ruling in the near future that makes this task a little easier.