Industry sources at the Pharmaceutical Patent Term Extension conference in Munich question the practical details of unitary SPCs, including granting procedure, enforcement, and judicial review
The pharmaceutical industry is in clear need of a unitary supplementary protection certificate (SPC), according to panellists at last week’s Pharmaceutical Patent Term Extension conference in Munich.
Speakers from Gedeon Richter, Bracco and the EPO suggested that the confusion surrounding Article 3a of the SPC Regulation could be lifted to a certain extent by creating an SPC that would be enforceable across much of Europe and be granted and managed from one place.
With the assumption that a unitary SPC is necessary and desirable, the panellists said questions remain as to which institution is best equipped to grant them, as well as practical questions of enforcement and judicial review.
“The preferable solution is of course to enact regulation and attach the unitary SPC to and put it under the jurisdiction of the Unified Patent Court. To me the UPC is the easiest solution if it ever comes to life,” said Francesco Macchetta, director of IP at Bracco Imaging in Italy.
“It is the mainstream solution because we all agree in the competency of the UPC with its treaty.”
Imre Gonda, head of IP at Swiss-based Gedeon Richter, said he felt optimistic that the UPC would one day come into being, but questioned what that might mean for SPC holders.
“If the UPC comes into force it doesn’t mean the unitary patent can work centrally because there will still be national patents. There is an unquestionable advantage of interacting with one authority and having one patent,” he said.
The panellists acknowledged that there could be problems with using the UPC as the granting authority for unitary SPCs. Not all countries will be members of the unitary system, and it is anybody’s guess if the UK would join the club after Brexit.
“My own country of Hungary was prevented from joining the UPC, as was Slovakia and the Czech Republic,” said Gonda. “The UPC will not be good place for unitary SPCs for medium and small sized countries.”
How the UPC could grant and enforce unitary SPCs alongside national rights was another question raised by the panellists.
“It is important to keep in mind that the UPC cannot be interested in national rights,” said Gonda. “It can revoke national patents in theory, which will lead to parallel but different procedures, and potentially different outcomes.
“The question is how that will all fit into current regulations,” he added.
Any central authority, whether the UPC or another institution, would run up against the problem of parallel procedures. A patent filed centrally in the UPC could have an identical twin in France or another member country. The question would then arise of which patent is the one in force.
Christopher Bruckner, a European patent attorney of Munich-based Bruckner IP, commented: “One should only have to enforce one patent. In Germany, you can only enforce one. Perhaps it would make some comfortable to have both patents granted, but the important thing is don’t have the same thing twice.”
Panellists asked how an appeal system would work for a unitary SPC. They agreed the natural solution would be to bring any appeals in front of the UPC; but added that while the industry waits for the UPC to free itself from the German courts, using the Court of Justice of the EU (CJEU) could be an alternative.
The panellists suggested looking at the court system of the CJEU, and establishing an IP panel because they are not experienced with IP enforcement.
Without the UPC, appeals for unitary SPCs could float in a legalistic limbo between European national courts, the UK and the CJEU. Finding one central institution to harmonise the system is key to simplifying the granting and appeals process, said the panellists.
There were also several questions posed at the event about what organisation should be put in charge of granting unitary SPCs.
“There is the possibility of entrusting the EPO with granting a unitary SPC. There is the mechanism there but the question remains whether it can be under European law,” said Pierre Treichel, international legal affairs officer at the EPO.
“There is the question of marketing authorisation, and time limits for requesting an SPC.”
Machetta chimed in to say he had a preference for the granting authorisation to pass through a virtual office: “If you build a virtual office with clear guidelines with competency and clear restraints, a granting authority could work.”
Further concerns raised by the panellists were distribution of fees and a common language of issuance. “Imagine we have one fee for this institution, it should be one to simplify the system, and then the question remains how we distribute the fees,” said Treichel.
One further drawback of a unitary SPC discussed on the day was the age-old dilemma of putting all your eggs in one basket. Pharmaceutical companies may see the unitary SPC as a way to save money in operation costs, but also risk having their patents revoked in one central court.
“At the beginning we will opt out of using unitary SPCs as much as possible,” said Gonda at Gedeon Richter. “We will only throw small patents in as a trial to see how it works in practice.”
According to Gonda, testing the waters of the UPC may take five or 10 years and be the work of smaller pharmaceutical companies with fewer blockbuster drugs.
At the moment, discussion of unitary SPCs remains in the realm of armchair patent philosophers. The four panellists at last week’s conference agreed that moving forward the best mechanism for unitary SPCs is the UPC. When either of those become real is anyone’s guess.