In Napp Pharmaceutical Holdings Ltd v Ratiopharm GmbH; Napp Pharmaceutical Holdings Ltd v Sandoz Ltd [2009] EWCA Civ 252, on appeal from an English High Court ruling that two patents for a controlled release tablet were valid but not infringed, the Court of Appeal has determined that both patents were valid and infringed. The Court considered whether the product fell outside the scope of the claims on the proper construction of those claims and also whether or not the patentees had added matter to the patent during its prosecution.

DECISION

Regarding infringement, the Court held that the trial judge had erred in finding that the phrase “spheronising agent” was limited to non water soluble materials that were incorporated to give plasticity in a spheronisation process. According to Jacob LJ, HPMC (an ingredient of the tablet product that was alleged to infringe the patents) fell within the definition of a spheronising agent as set out in the patents, which stated that “the spheronising agent may be any pharmaceutically acceptable material that, together with the active ingredient can be spheronised to form spheroids”. The Court held that the fact that HPMC also acted as a binder was irrelevant.

The Court also held that a tablet, which otherwise infringed the patent, did not fall outside the claims by addition of extra active ingredient on the surface of the tablet. There was nothing in the claim language that excluded a tablet that had all the characteristics of the claim, but with the additional feature of external application of the active ingredient. There was also no commercial or technical reason for thinking that the patentee would have wanted to limit his claim in this way.

Regarding added matter, the Court upheld the trial judge’s finding that the skilled person would understand from the patent that acrylic resins were suitable materials for achieving pH-independent release, but the combined effect of the disclosure and the disclaimer (relating to such acrylic resins) inserted during prosecution was that such materials were not claimed. The skilled person would not derive from the disclosure any technical teaching about pH-dependent acrylic resins.

COMMENT

Interestingly, the German courts in Dusseldorf have come to a different conclusion regarding the German parts of the patents, finding that the relevant product does not infringe. A determination of validity of one of the patents is pending in Germany.