In a final judgment issued on June 18 2015 and served on the parties on July 14, the Supreme Court revoked a previous decision of the Burgos Court of Appeal and declared the invalidity of Richter Gedeon's patent EP1448207 ('EP'207'), which claimed a single dose of 1.5 milligrams (mg) of levonorgestrel and its use as an emergency contraceptive. This appears to be the first time that the Supreme Court has revoked a European patent by reversing a previous appeal decision.
EP'207 claimed a single dose of 1.5 mg of levonorgestrel and its use as an emergency contraceptive (the so-called 'morning-after pill').
In June 2011 León Farma (Chemo Group) filed a revocation action against EP'207. León Farma argued as follows:
- Before the priority date of the patent (November 27 2001), the emergency contraception regime consisted of two doses of 0.75 mg of levonorgestrel, with a 12-hour interval between the first and second dose. This interval caused compliance problems. For instance, many women delayed taking the first tablet so that they would not have to take the second tablet at an inconvenient time, such as in the middle of the night.
- The patent solved that problem by providing a single dose of 1.5 mg.
- However, before the priority date of the patent, the World Health Organisation (WHO) had already published (in its technical annual reports for 1998, 1999 and 2000) details of a multinational, randomised double-blind clinical trial to analyse the efficacy of a single dose of 1.5 mg of levonorgestrel, with the aim of solving the compliance problems presented by the 12-hour interval associated with the double dose of 0.75 mg. The WHO reports specified that the clinical phase of this study had already been completed.
In light of the above, León Farma alleged that the patent was invalid due to lack of novelty (claims 1 and 2) and lack of inventive step (claims 1 to 3).
Richter Gedeon defended the validity of its patent on the grounds that the results from the WHO's clinical trial had not been published before the priority date. According to Richter Gedeon, without those successful results, at the priority date an expert could not have predicted whether the single dose would work satisfactorily.
The Burgos Commercial Court 1 upheld Richter Gedeon's defence and dismissed the invalidity action (March 27 2013). The Burgos Court of Appeal confirmed that decision (September 2 2013).
León Farma then filed an extraordinary appeal before the Supreme Court.
The Supreme Court upheld the extraordinary appeal filed by León Farma, thus revoking the appeal decision and declaring the invalidity of Richter Gedeon's patent due to lack of inventive step.
The Supreme Court confirmed, in line with León Farma's allegations, that the appeal decision contained several mistakes regarding the assessment of inventive step based on the European Patent Office's problem and solution approach. In particular, the Supreme Court confirmed that to show that a patent lacks inventive step, it suffices to show that the skilled person had a "reasonable expectation of success"; it is not necessary to show that he or she was certain that the alleged invention would work.
According to the Supreme Court, the fact that the WHO had published details of its clinical trial involving the same subject matter (a single dose of 1.5 mg of levonorgestrel) in order to solve the same problem (deficient compliance associated with the 12-hour interval) made clear that there was already a reasonable expectation of success before the priority date. Therefore, the patent lacked inventive step.
This decision is final and cannot be further appealed.
For further information on this topic please contact Ana-Laura Morales at Grau & Angulo by telephone (+34 93 202 34 56) or email ([email protected]). The Grau & Angulo website can be accessed at www.gba-ip.com.
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