In a product claim, the product to be patented is generally defined by its design features. However, it often happens that a product claim contains steps of the manufacturing process. The Japanese Supreme Court has now recently ruled on the admissibility and scope of protection of such claims, forcing a departure from previous practice.
Teva Pharmaceuticals had been granted a patent for pravastatin sodium in Japan. The patent claim was formulated as a product claim which, in addition to information on the composition, also contained steps for manufacturing the product:
“Pravastatin in which the mixing amount of the pravastatin lactone is less than 0.5 wt%, pravastatin sodium contamination of epiprava is less than 0.2% by weight, prepared by a process comprising the following steps:
a) forming a concentrated organic solution of pravastatin;
b) precipitating pravastatin as an ammonium salt thereof;…”
Teva klagte Merck wegen Patentverletzung ein. Das angegriffene Produkt “KH” wies die konstruktiven Merkmale ebenfalls auf, war aber nicht mit dem Schritt a) hergestellt worden.
The Japanese IP High Court dismissed Teva’s Lawsuit. The claim was not infringed because step (a) was not used. If a claim for a product also contains steps for manufacturing the product, it is normally limited to products manufactured by the same process. This limitation of protection only does not apply if circumstances exist which make it impossible to define the product in a way other than by the manufacturing process.
The Japanese Supreme Court overturned this decision and referred it back for reconsideration. It emphasized two points:
Firstly, a product claim protects the product regardless of the manufacturing process. A patent infringement therefore also exists if the attacked product is manufactured in a different way than specified in the protected product claim. The decisive factor is that the attacked product has the same design features as the patented product.
Zweitens: Ein Produktanspruch ist in der Regel unklar, wenn er Merkmale des Herstellungsverfahrens enthält. Normalerweise ist nämlich nicht klar, welche konstruktiven Merkmale aus einem Herstellungsverfahren resultieren. Ein unklarer Anspruch verstösst gegen das Klarheitserfordernis im Patentgesetz und ist daher nichtig. Nur wenn der Patentinhaber nachweisen kann, dass Umstände existieren, die es zum Anmeldezeitpunkt unmöglich oder hochgradig unpraktisch machen, das Produkt nicht mit Schritten des Herstellungsverfahrens zu charakterisieren (product-by-process), ist er zuzulassen. Als Beispiel für “hochgradig unpraktisch” erwähnt der Supreme Court den Fall, dass die strukturellen Merkmale nur mit unerhörtem wirtschaftlichem oder zeitlichem Aufwand ermittelt werden können, was dem praktischen Erfordernis einer zügigen Anmeldung entgegensteht.
The decision extends the protection of all justified product claims with process features, but sets a new and high hurdle for the admissibility of such product-by-process claims. Many product claims granted in the past are likely to be invalid under this ruling due to a lack of clarity.