The first dispute (35-page / 1.3MB PDF) is between Amgen on the one hand and Sanofi and Regeneron on the other, concerning two products – Amgen’s evolocumab, sold under the brand name Repatha, and Sanofi’s and Regeneron’s alirocumab, sold under the brand name Praluent. Both products are therapeutic monoclonal antibodies used to treat and prevent ailments caused by high cholesterol levels, especially when patients do not respond adequately to changes in diet and treatment with statins.
The second dispute (53-page / 2.5MB PDF) is between Edwards Lifesciences Corporation (Edwards) and Meril Life Sciences group (Meril) in relation to Edwards patents relating to a prosthetic heart valve it manufactures and rival Meril valve products.
The decision in the Amgen v Sanofi and Regeneron case is the first UPC Court of Appeal decision ‘on the merits’, which is where the court hears arguments – and rules – on the substantive legal issues at hand, as opposed to just dealing with preliminary or procedural matters.
Under the holistic approach that the Court of Appeal has endorsed, the first step in assessing whether there has been an inventive step is to determine a ‘realistic starting point’ in the prior art that would have been of interest to the skilled person considering a similar underlying problem as that which the patent claimed to solve.
“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 the context of the specification 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 person skilled in the art, on the basis of the application, understands is (are) achieved with the claimed invention,” the Court of Appeal said.
The UPC Court of Appeal also confirmed that determination of a realistic staring point should not be made with the benefit of hindsight. It said there can be more than one realistic staring point – in those cases “the claimed invention must be inventive starting from each of them”.
“A starting point is realistic if the teaching thereof would have been of interest to a person skilled in the art who, at the effective date, wishes to solve the objective problem,” the court said. “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.”
Once a realistic starting point has been determined, the next step involves assessing whether it would be obvious for the skilled person to arrive at the claimed solution in the patent from that point.
In this regard, the Court of Appeal said: “The claimed solution is obvious when at the effective date the person skilled in the art, starting from a realistic starting point in the state of the art in the relevant field of technology and wishing to solve the objective problem, would (and not only ‘could’) have arrived at the claimed solution”.
The court said this assessment is to be made with a view to the person skilled in the art having “no inventive skills and no imagination” and requiring “a pointer or motivation … that, starting from a realistic starting point, directs them to implement a next step in the direction of the claimed invention”.
It added: “As a general rule, a claimed solution must be considered not inventive/obvious when the person skilled in the art would take the next step, prompted by the pointer or as a matter of routine, and arrive at the claimed invention. For an inventive step to be present, it is not necessary to show improvement of the technical teaching as defined by the patent claims over the prior art. Inventive step may also be found if the patent claims disclose a non-obvious alternative to solutions known in the prior art.”
According to the Court of Appeal, the expectations of the skilled person in taking the ‘next step’ after a realistic starting point has been determined will also be informative of whether a patent’s claims are obvious and lacking an inventive step.
The court said: “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. 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.”
“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. 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,” it added.
The court said that the burden of proof will shift to those claiming obviousness if patent rights holders are able to “sufficiently substantiate” uncertainties and/or practical or technical difficulties relating to the problem that the invention is supposed to solve.
Applying this holistic approach, the UPC Court of Appeal overturned the earlier decision taken by the Munich Central Division of the UPC in the Amgen v Sanofi and Regeneron case, finding that Amgen’s patent is valid.
In the Edwards v Meril case, the Court of Appeal largely rejected appeals by Meril against decisions taken by the Paris Central Division of the UPC and the Munich local division of the UPC respectively, confirming the validity of Edwards’ patents at issue and maintaining, albeit with some amendments, injunctions imposed on Meril regarding the supply of its rival products.
Patent law expert Sarah Taylor of Pinsent Masons said: “The Court of Appeal’s approval of this holistic approach indicates that the UPC is willing to create its own law. That said, it is clearly inspired by the EPO’s approach, and it is interesting that both decisions indicated that, despite the differences in approach between national courts and the EPO, they generally all lead to the same conclusion, supporting the UPC’s broader aim of aligning with EPO case law.”
“Many Court of Appeal decisions to-date have helped to present the UPC as a largely patentee-friendly forum, and while the outcomes in both of these cases were patentee-friendly, this holistic approach offers more flexibility to those challenging patent validity and may result in challengers being drawn more to the UPC. It will be interesting to see if the clarification on the approach to inventive step encourages even more engagement with the UPC, particularly by challengers in the pharmaceuticals space,” she said.
“The Edwards v Meril decision also contains practical considerations for businesses on both sides of a patent disputes, with the Court of Appeal confirming a pragmatic approach to injunctive relief when patient interests are at stake,” added Taylor.
The Court of Appeal confirmed that an exception to the right to injunctive relief may be justified where the infringing embodiment – in this case Meril’s extra large valves – is the sole available treatment. The Munich local division had already acknowledged that Edwards offered no equivalent to these larger valves, but determined that Meril’s extra large product should only be excluded from the scope of the injunction once a team at Edwards had approved their use. The Court of Appeal found that the availability of these products should not depend on Edwards’ approval and amended the relief to carve these products out of the scope of the injunction.