The Dutch courts are on a roll this year in clarifying the scope of protection of Swiss-form claims. Earlier this month, Attorney-General Wissink delivered his opinion in the long-running ribavirin case involving Merck Sharp & Dohme and Teva, concerning a Swiss-form claim for the use of ribavirin (a known substance) for treating a specific selection of patients with chronic hepatitis C (a so-called sub-group indication (“SG-I”) patent). This opinion comes on the back of two earlier decisions this year by the District Court of the Hague and the Dutch Supreme Court in the also long-running case of Sun v Novartis, concerning a Swiss-form claim for the use of zoledronic acid (a known substance) for the treatment of osteoporosis, the new indication which is different from the known condition (a so-called classical second medical indication (“2M-I”) patent).
Scope of protection of a 2M-I patent and an SG-I patent
In 2015, the Hague Court of Appeal in zoledronic acid had accepted that the scope of protection of a 2M-I patent may extend to the substance being marketed by a third party, even if it was not specifically stated that it was meant for the new use (Sun had carved-out the osteoporosis indication from its generic zoledronic acid product’s SmPC and package leaflet). The Court of Appeal in ribavirin, however, aimed to delineate the scope of protection of an SG-I patent in such a way that it does not include the existing use of the substance for treatment of the group, but only its use for the sub-group defined in the SG-I patent. With this in mind, it restricted the scope of protection of an SG-I patent to the situation in which it is “specifically” indicated by a third party that the substance is intended for the sub-group.
In the A-G’s opinion, this general limitation is too restrictive. He submits that the proper scope of protection of an SG-I patent cannot be answered in the abstract, but will have to be determined by interpreting the patent. The A-G does not in any event believe that the scope of protection based on “specific use” should be restricted to cases in which a third party specifically indicates that the substance is meant for the sub-group, since it is conceivable that the generic product could be used specifically for the sub-group without the producer/trader indicating (on the SmPC or package leaflet) that the substances is meant for that group. Otherwise, the producer/trader would be allowed to achieve the benefits of the patent via the back door, and the patent owner of an SG-I patent would simply be left with no reasonable protection.
Scope of protection of Swiss-form claims generally and the question of infringement
The A-G is of the view that the element of “manufacturing” in Swiss-form claims is based on a fiction; it is an empty phrase: it is there but it does not really relate to the invention to be protected. The “manufacturing” element is as such meaningless and, in determining the scope of protection, the A-G opines that one should aim for a convergence of both Swiss-form claims (which are no longer granted) and EPC 2000 claims.
Viewed this way, the patent owner will be protected in situations where such protection is justified, one such situation being when the producer/trader of a generic product knows or with a sufficient degree of certainty can foresee that its medicinal product will, notwithstanding a carve-out in an SmPC or package leaflet, be used for the patented indication but does not take adequate measures to counter such use. The A-G submits that this is the “normative starting point” on which the recent rulings of the Dutch courts in Sun v Novartis were based, which in turn were strongly influenced by the English Court of Appeal’s formulation of the test of infringement of 2M-I claims in the pregabalin litigation concerning Warner-Lambert and Actavis.
Applying this to the infringement provisions of the Patents Act, the A-G’s view is that, proceeding from the process (by which lip service is paid to the wording of the claim), one could argue that the producer directly infringes the patent in the aforementioned situation through dealings in a product obtained directly by means of the patented process. In that situation the producer manufactures a product that will foreseeably be used for the patented indication, meaning that in the absence of adequate precautionary measures to prevent this, this could also be deemed to be intended by the producer. If one entirely ignores the process, the application of the statutory provision where the invention is a product comes into view, although the A-G submits that this is not necessary since the option of proceeding via dealings in a product obtained directly by means of the patented process is available.
Assuming that the process is fiction, then looking at the situation from the viewpoint of the statutory provision concerning indirect infringement, what matters is not whether other parties will use the process further down the chain, but whether these other parties intend the product to be used for the patented indication, or it is obvious to a reasonable person in the circumstances. This view of not requiring a “downstream act of manufacture” again appears to be adopted from the English Court of Appeal’s judgment in the pregabalin litigation.
Regardless of the route by which infringement is found, the A-G is careful to state that a distinction must at the end of the day be made between the production of the generic product for the patent-free indication and the production for the patented indication, by examining which part of the production will foreseeably be used for the patented indication.
It seems that the A-G has adopted a common sense pragmatic stance on infringement and the generic party’s responsibility to prevent its product being used for the patented indication (even when it is a an SG-I). It will be interesting to see if the A-G’s opinion is adopted by the Dutch Supreme Court in its decision, which is expected later this year.