The questions referred from the Court of Appeal in London in two cases – Medeva and Georgetown – concerned the circumstances under which a patent or a product that has won market authorisation can be awarded a supplementary protection certificate (SPC) in a combination therapy.
To give an example, if a company holds patent A and wants to extend the protection for combination therapy A+B it has two options: an SPC for A or one for A+B.
The Georgetown case concerned the first option, and the CJ returned a clear ruling that this was possible, including almost the same language in both the Georgetown ruling and part 6 of the Medeva ruling. Georgetown is, in the words of lawyers close to the case, “very happy about the result”.
The CJ’s ruling on the second option, protecting combination therapy A+B, is less straightforward. Although the ruling makes positive noises about this approach throughout, it concludes in paragraph 28 by saying an SPC cannot be granted for “active ingredients which are not specified in the wording of the claims of the basic patent relied on in support of the SPC application”.
While some lawyers described the ruling as a “beautifully simple” statement of support for SPCs covering combination therapies, others warned that this concluding paragraph is dangerously ambiguous.
“The question just hasn’t been answered. If I were the Court of Appeal I would ask the questions again, because it hasn’t been given any clarity,” said Ravi Srinivasan of JA Kemp, who represented Medeva. “We were afraid that the result would be a lack of certainty, and that has proved to be the case.”
It is unclear which view on SPCs for combination therapies the words “specified in the wording of the claims” support. The German courts in cases there have followed the so-called infringement test, a minimal standard under which if the therapy would infringe a patent, that patent can be used to get an SPC for the therapy. The UK courts have, by contrast, been far more restrictive in cases such as Gilead Sciences and Takeda.
“This is another example of the Court of Justice not understanding patents, and it is one reason people are opposed to the single patent court in Europe,” comments Srinivasan.
There can be only one
A potentially bigger issue for the pharma industry comes in paragraph 41 of the judgment. Here the CJ baldly states that “where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent (see Biogen, paragraph 28)”.
Although Biogen established back in 1997 that there should theoretically only be one SPC granted for any patent, the wording was vague enough for pharma companies to be worked around. Since then several biotech patents have led to many different SPCs being granted on them.
To take one example, PDL Biopharma holds patent EP0451216. Between 1999 and 2009 it had eight SPCs granted based on that patent, including daclizumab, palivizumab, omalizumab and so on.
If it and other companies now find these SPCs to be illegal, it would open them up to challenges for invalidity from generic producers looking to enter those markets.
“This will have a major impact on both current SPCs and patent life cycles in the future,” says Jonathan Radcliffe of Mayer Brown. “Many patents will become less valuable and anyone writing a new patent will be thinking about trying to cover as many products as possible.”
It could also lead to difficult strategic decisions when companies try to establish early on which product to claim an SPC for, given when each gets market authorisation.
Ravi Srinivasan, however, thinks the wording is as unclear as the rest of the judgment. “I don’t think it’s obvious whether the Court is establishing a new test, or whether it is merely emphasising that the Biogen ruling applies. If it’s new, why refer to Biogen at all given how irrelevant it has become commercially?”
Radcliffe disagrees, describing it as the CJ becoming “more up to date, more modern, more realistic” which its approach to the rule of one SPC for one patent.
As with the approach to the possibility of SPCs for combination therapies, and so many other questions referred to the CJ, pharma companies might have to wait for rulings from the Court of Appeal and other courts around Europe to see if this ruling produces more consistency.
