Pharmaceutical Patents in Europe

Abstract

Cases SPC Supplementary Protection Certificates Pharmaceutical patents in Europe1 Industrial applicability Industrial applicability of pharmaceutical product patentsOne of the most basic exercises for a student of organic chemistry is that of using well-known methods of synthesis to manufacture chemical compounds.With a few reactive starting materials and equipment for utilising different reactions, the student will be able to manufacture an almost unlimited number of compounds.It is probable that, from a patent law perspective, one of the compounds could be new, in the sense of having no previously recorded existence.But no one would seriously think that the student had invented anything, because what chemists, like any other engineers, are after is products with practical uses.Short of being a new element, a new chemical entity is hardly useful or particularly interesting in itself.A new chemical entity is only interesting if it has been demonstrated to have features that are sought-after for some reason.Only then is it relevant to view the compound as an invention and possibly to apply for a patent.Research leading to new compounds with pharmaceutical uses mainly involves a series of minor changes to the structure of one or more so-called leading compounds.The changes are evaluated by tests done in vitro or in vivo.If the research is successful, one of the compounds will have an interesting biological effect.That effect may be of value to society, so that the compound meets the requirement of industrial applicability in Art.52 EPC.This test is similar to the American patent law requirement of utility.A new pharmaceutical needs official regulatory approval before it can be sold, but the patent law requirement of industrial applicability will be fulfilled much earlier.Perhaps only a small percentage of all patents for compounds with a pharmaceutical use mentioned in the application later protects a product that is approved for sale.There are a plethora of possible reasons for a patented compound not being used and sold.Apart from the strictly economic considerations, the clinical trials may prove the biological effect to be less in humans than in the earlier pre-clinical trials.It may also be that the compounds cause unacceptable side effects.In this part we shall be considering what consequences knowledge of these kinds of problems may have in the patent law test for industrial applicability.Rule 27(1)(f) EPC provides that the patent description should: "[I]ndicate explicitly, when it is not obvious from the description or nature of the invention, the way in which the invention is capable of exploitation in industry."

Cite this work

No public copy is stored for this record, so only the metadata is cited.

Stored only when both papers are in the corpus — 26 citations exist upstream.

Papers that cite the same references — the relational fallback while embeddings are still backfilling.