| Popis: |
While the commonly advanced justification for patents on pharmaceuticals--that without a period of monopoly to recoup research and development costs, no company would invest the sums necessary to bring a drug to marke--may hold for new drugs or for old drugs to be used to treat new ailments, that justification is much less sustainable where an old drug is to be used to treat the same ailment but at a different dosage. Under European patent law, patents may not be granted for methods of therapy, apparently to ensure that the physician's freedom to select an appropriate treatment for her patient is not compromised by fear of being accused of patent infringement. Until recently, European patents for drugs could not be infringed by physicians or pharmacists by generic substitution. Now, however, the highest instance of the European Patent Office (EPO), the Enlarged Board of Appeal, is considering the extent to which that position has changed as a result of the 2000 revision of the European Patent Convention (EPC). The revised EPC, although officially intended to keep the legal status quo, actually extends the scope of patent protection for drugs, by introducing purpose-limited product protection in art.54(5). Although the Enlarged Board of Appeal--which currently has the task of interpreting the provisions of the EPC applying to patent protection of novel applications of old drugs--cannot undo the introduction of art.54(5), the authors argue that the Enlarged Board must construe this provision to minimise its potentially negative effects on physicians, veterinarians, nurses and pharmacists, particularly in relation to generic substitution. The authors put forward a concrete proposal for this construction. |
