Over the past few years the pan-European and parallel national patent litigation based on Eli Lilly’s pemetrexed patent has attracted considerable attention, as it has resulted in a number of diverse land mark decisions in relation to the doctrine of equivalence, as evidenced by the various posts on the Kluwer Patent Blog.
By way of reminder, Lilly’s patent claims a vitamin B12 regime mitigating the toxic side effects of the anti-cancer drug pemetrexed, which in the course of prosecution had been limited to its disodium salt.
Generic competitors have filed declaratory actions for non-infringement with respect to pemetrexed products, other than the disodium salt.
In the UK the Supreme Court in its judgment of 12 July 2017 ( UKSC 48) ruled that the Lilly patent is not limited to the disodium salt of pemetrexed, and that Actavis’ diacid form and other salts of pemetrexed, representing immaterial variants of the claimed invention, directly infringe the patent.
In other jurisdictions, including Germany (Federal Supreme Court X ZR 29/15 of 14 June 2016), Switzerland (Federal Supreme Court 4A_208/2017 of 20 October 2017) and Italy (Court of Milan Case No. 45209/2017 of 15 October 2018), the courts also acknowledged infringement under the doctrine of equivalence.
In the UK cross-border case, the claimant Actavis was irrevocably bound to its undertaking not to challenge the validity of the Lilly patent.
The Lilly patent had survived EPO opposition proceedings, but in Germany its validity was again challenged by third party generics.
On 17 July 2018 the Federal Patent Court handed down its decision in the joined cases 3 Ni 23/16 and 3 Ni 19/17 (an English translation of the decision can be found here). The court sided with the generics and revoked the patent for lack of inventive step. Thus, the court held that the technical problem underlying the invention was overt and that one of skill in the art, taking into account his expert knowledge would have had ample pointers and motivation to arrive at the invention, in view of the well documented biochemical processes involved.
The court also emphasized that their conclusion should not be viewed as being in contradiction with the decision of the opposition division, as here other prior art had been considered.
Dr. Alexa von Uexküll and Oswin Ridderbusch, both partners at the IP-specialized law firm Vossius & Partner, are the editors of the new handbook “European SPCs Unravelled: A Practitioner’s Guide to Supplementary Protection Certificates in Europe” published by Wolters Kluwer.
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The whole hype created by the various pemetrexed decisions in various jurisdictions will die sooner or later, and especially the one from the UK Supreme Court.
The biggest lesson to be learned from the case is that there should not be a premium for slapdash drafting, allowing the applicant/proprietor to reap profit from an invention he might have broadly thought off in theory, but for which no plausibility was given at filing date.
It is good that another view on the patent has been given by the German Federal Patent Court (GFPC-DPatG). It is to be seen whether this decision will be upheld by the German Federal Court (GFC-BGH), as it would be surprising that the proprietor would not fight such an outcome. All the efforts put into the claim that other salts of pemetrexed have an equivalent effect of that of pemetrexed disodium would then have been in vain.
It is interesting to see that to decide on lack of inventive step, the GFPC did not rely exclusively on the documents brought forward by the nullity claimant (NIKn), but also took into consideration documents brought forward by the proprietor (HLNKn).
Not only was there a promising starting point for the combined use of pemetrexed disodium and vitamin B 12, but also for the longest known antifolate, i.e. methotrexate, albeit in the treatment of rheumatoid arthritis, but in which the deleterious effects of methotrexate exist as well. The GFPC concludes that there was no prejudice against the use of vitamin B12 to treat the serious side effects of pemetrexed treatment.
In the case before the EPO, the parties were different than before the GFPC, one opponent, TEVA, and one intervener, Actavis, but since the appeal was withdrawn, no decision was given by a Board of Appeal. The angle of attack by the opponent was totally different. Only one of the documents cited in the procedure before the EPO, D27, was used in the action before the GFPC under the name NIK 8. No wonder thus that the conclusion were totally different.
It is interesting to note that the GFPC considered that it did not need expert advice, as its own members have the technical expertise needed to decide on inventive step. The positive side of the presence of technical judges in patent matters as foreseen by the UPC, should it ever come to life, has to be seen in this light.
Last but not least, bifurcation has sometimes its good sides….
That the pemetrexed story will continue, also in countries were non-infringement declarations have been refused is more or less sure. Too much attention has been given to the whole story, to assume that the last word on this topic has been said.
When attacking alleged infringers, the proprietor might not feel as comfortable as he could have felt after his success in claiming that equivalents also fall under his claim. If the patent is revoked for lack of inventive step, then equivalents will not help much. There might sometimes be justice, even in the patent world….
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