UPC CoA: octrooi Amgen op cholesterolverlagende antilichamen blijft in stand

UPC CoA 25 november 2025, IEF 23924; LS&R 2477; IEFbe 4352; UPC_CoA_528/2024 en UPC_CoA_529/2024 (Amgen tegen Sanofi en Regeneron). In deze zaak tussen Amgen enerzijds en Sanofi en Regeneron anderzijds staat de geldigheid centraal van Europees octrooi EP 3 666 797 voor antilichamen die het eiwit PCSK9 blokkeren en daarmee kunnen worden ingezet bij de behandeling van aandoeningen die samenhangen met een verhoogd cholesterolgehalte. Amgen brengt het cholesterolverlagende geneesmiddel Repatha op de markt, terwijl Sanofi en Regeneron het concurrerende geneesmiddel Praluent aanbieden. De Centrale Divisie München van het UPC had het octrooi in juli 2024 volledig vernietigd wegens gebrek aan inventiviteit. Amgen is tegen deze beslissing in hoger beroep gegaan.

Het Hof van Beroep beoordeelt onder meer de uitleg van de octrooiconclusies, de vraag of sprake is van toegevoegde materie, de nawerkbaarheid en de inventiviteit van de uitvinding. Volgens het Hof moet bij een octrooiconclusie voor een medische toepassing het geclaimde product daadwerkelijk therapeutisch werkzaam zijn. Een willekeurige verlaging van het cholesterolgehalte is daarvoor onvoldoende: de behandeling moet een merkbare verbetering van de medische toestand van de patiënt opleveren. Het Hof verwerpt daarnaast de bezwaren van Sanofi en Regeneron over toegevoegde materie en onvoldoende openbaarmaking van de uitvinding. Bij de beoordeling van de inventiviteit verduidelijkt het Hof dat eerst het objectieve technische probleem moet worden vastgesteld, zonder daarin aanwijzingen voor de geclaimde oplossing op te nemen. Vervolgens moet worden beoordeeld of de gemiddelde vakpersoon, uitgaande van een realistisch vertrekpunt in de stand van de techniek, daadwerkelijk tot de geclaimde oplossing zou zijn gekomen. Daarbij is niet voldoende dat de vakpersoon de oplossing had kunnen ontwikkelen; vereist is dat hij daartoe zou zijn gekomen met een redelijke verwachting van succes. Of zo'n verwachting bestond, hangt onder meer af van de voorspelbaarheid van het onderzoeksresultaat en de technische onzekerheden op de prioriteitsdatum. Volgens het Hof bestond op de prioriteitsdatum onvoldoende zekerheid over de rol van extracellulair PCSK9 bij de regulering van LDL-receptoren. Daardoor kon de gemiddelde vakpersoon niet redelijkerwijs voorspellen of antilichamen die de binding tussen PCSK9 en LDL-receptoren blokkeren, daadwerkelijk een therapeutisch effectieve behandeling zouden opleveren. Dat verschillende farmaceutische ondernemingen destijds al onderzoek deden naar dergelijke antilichamen, betekent volgens het Hof niet dat zij een redelijke verwachting van succes hadden. Ook de omstandigheid dat de vakpersoon in staat was dergelijke antilichamen te ontwikkelen, maakt de geclaimde oplossing niet vanzelfsprekend. Het Hof van Beroep oordeelt daarom dat de uitvinding inventief is en vernietigt de beslissingen van de Centrale Divisie München. De verzoeken van Sanofi en Regeneron tot vernietiging van het octrooi worden afgewezen. Het octrooi van Amgen blijft daarmee in stand. Sanofi en Regeneron moeten ieder € 1.375.000 aan proceskosten uit eerste aanleg aan Amgen vergoeden en dragen daarnaast de proceskosten van het hoger beroep.

Claim interpretation

1. The question of whether conclusions can be drawn from the subject matter of a dependent claim and its features when interpreting the main claim depends on the circumstances of the individual case. If the dependent claim is only adding an additional feature that does not provide a more specific description of the features of the main claim, it generally argues against the possibility of drawing conclusions about the interpretation of the main claim from this dependent claim.

2. When the claims are drafted in ‘medical use-format’, it is an inherent claim feature that the claimed product must be objectively suitable for the claimed use, i.e. be therapeutically effective. This requires that the claimed treatment causes a noticeable improvement of the medical condition of the patient suffering from the disease mentioned in the claim, i.e. the treatment must be meaningful.

3. The fact that the skilled person does not derive any minimum required effect from the claim or the description does not lead to another conclusion, since the feature of therapeutic effect does not follow from the claim language that is to be interpreted, but from the use of the medical use claim format.

Inventive step

10. The approach taken by the Unified Patent Court when establishing inventive step is as follows.

11. It first has to be established what the object of the invention is, i.e. the objective problem. This must be assessed from the perspective of the skilled person (m/f – hereinafter referred to as ’it’), with its common general knowledge, as at the application or priority date (also referred to as the relevant date) of the patent. This must be done by establishing what the invention adds to the state of the art, not by looking at the individual features of the claim, but by comparing the claim as a whole in context of the description and the drawings, thus also considering the inventive concept underlying the invention (the technical teaching), which must be based on the technical effect(s) that the skilled person on the basis of the application understands is (are) achieved with the claimed invention.

12. In order to avoid hindsight, the objective problem should not contain pointers to the claimed solution.

13. The claimed solution is obvious when at the relevant date the skilled person, starting from a realistic starting point in the state of the art in the relevant field of technology, wishing to solve the objective problem, would (and not only: could) have arrived at the claimed solution.

14. The relevant field of technology is the field relevant to the objective problem to be solved as well as any field in which the same or similar problem arises and of which the person skilled in the art of the specific field must be expected to be aware.

15. A starting point is realistic if the teaching thereof would have been of interest to a skilled person who, at the relevant date, wishes to solve the objective problem. This may for instance be the case if the relevant piece of prior art already discloses several features similar to those relevant to the invention as claimed and/or addresses the same or a similar underlying problem as that of the claimed invention. There can be more than one realistic starting point and the claimed invention must be inventive starting from each of them.

16. The skilled person has no inventive skills and no imagination and requires a pointer or motivation that, starting from a realistic starting point, directs it to implement a next step in the direction of the claimed invention. As a general rule, a claimed solution must be considered not inventive / obvious when the skilled person would take the next step prompted by the pointer or as a matter of routine, and arrive at the claimed invention.

17. A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem. This is generally the case when the results of the next step were clearly predictable, or where there was a reasonable expectation of success.

18. The burden of proof that the results were clearly predictable or the skilled person would have reasonably expected success, i.e. that the solution he envisages by taking the next step would solve the objective problem, lies on the party asserting invalidity of the patent.

19. A reasonable expectation of success implies the ability of the skilled person to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within acceptable time limits.

20. Whether there is a reasonable expectation of success depends on the circumstances of the case. The more unexplored a technical field of research, the more difficult it was to make predictions about its successful conclusion and the lower the expectation of success. Envisaged practical or technical difficulties as well as the costs involved in testing whether the desired result will be obtained when taking a next step may also withhold the skilled person from taking that step. On the other hand, the stronger a pointer towards the claimed solution, the lower the threshold for a reasonable expectation of success.

21. When the patentee brings forward and sufficiently substantiates uncertainties and / or practical or technical difficulties, the burden of proof that these would not prevent a skilled person from having a reasonable expectation of success, falls on the party alleging obviousness.

22. The fact that other persons or teams were working contemporaneously on the same project does not necessarily imply that there was a reasonable expectation of success. It may also indicate that it was an interesting area to explore with a mere hope to succeed.