I move that the Bill be now read a Second Time.
The existing law relating to patents for inventions is contained in the Industrial and Commercial Property (Protection) Act, 1927, which will be replaced by the Patents Act, 1964, when that Act comes into force.
Section 55 (1) of the 1927 Act precludes protection of chemical products or substances intended for food and medicine, except when those products or substances are produced by the processes described in the complete specification.
However, section 55 (1) contains a proviso that in an action for infringement any substance of the same chemical composition as that to which the patent concerned in the action relates shall, in the absence of proof to the contrary, be deemed to have been produced by the patented process. Accordingly, where the patentee can show that the alleged infringer's substance is of the same chemical composition as the substance to which his patent relates the onus rests on the alleged infringer to prove that his substance was produced by a process other than that claimed in the complete specification of the patent.
The 1964 Act will improve the position of inventors of chemical products or substances intended for food or medicine by extending the protection to the product or substance. Further, by means of a transitional provision an application relating to a chemical invention which is not accepted before the commencement of the Act will proceed under the more liberal provisions of the new Act.
The new Act does not, however, provide for the continuation in force of the proviso to section 55 (1) of the 1927 Act which puts the onus of proof on the alleged infringer of the patent. This means that in an action for infringement of the patent granted under the 1927 Acts, the burden of proof as to the process by which a substance is manufactured may rest on the patentee. The manufacturing interests concerned claim this would present an almost impossible task because of the inherent difficulty of proving what is done within an alleged infringer's factory.
The Pharmaceutical and Allied Industries Adaptation Association has expressed apprehension because of the repeal of the proviso to section 55 (1) of the 1927 Act. There were no representations on the matter when the Patents Bill, 1963, came before the Oireachtas and there is no record of the proviso ever having been invoked since the 1927 Act was enacted, because of the difficulty of proving what is done within the alleged infringer's factory—the process used to produce the substance. The Association, however, regard the proviso as having a deterrent value, and fear that if it is not retained in the 1964 legislation in respect of the existing patents the protection afforded will be seriously diminished and their prospects of expansion adversely affected.
I am satisfied that the industry has cause to be apprehensive about the position—and that the amendment of the Act aimed at continuing the presumptives clause in force should be made. I recommend the principle of the Bill for the approval of the Dáil.