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 is brought into force by Order.
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 actual processes described in the complete specification.
It would, obviously, be very difficult for a patentee in any infringement action to prove that the alleged infringing substance was made by a particular process. There is, therefore, an important proviso to Section 55 (1) by virtue of which any substance which is of the same chemical composition as one to which a patent concerned in an infringement action relates is deemed to have been made by the patented process unless proof to the contrary is forthcoming. In other words, it is sufficient in such an action for the patentee to show that the alleged infringing substance is of the same chemical composition as that covered by his patent, and so place the onus of proving that it was made by a different process on the defendant.
The new Act, the 1964 Act, following on international trend, introduces protection of chemical products or substances intended for food or medicine and so differs from the 1927 Act which, as I said, precludes protection of the products except where they would be produced by the actual process described in the specification. In addition to this extended protection, the new Act, by means of a transitional provision enables pending applications relating to such products or substances to proceed under its provisions and have the benefit of the wider protection which it affords. Patents granted under the new Act, the 1964 Act, will not, therefore, require the protection given by the proviso to section 55 (1) of the 1927 Act and for that reason the proviso has not been continued into the 1964 Act. It was dropped.
No representations were made at the time of the enactment of the 1964 Act regarding the proviso to section 55 (1) until after the enactment of the new Act. There was nothing on record to show that at any time anybody had found it necessary to avail of the provisions of this proviso. The Pharmaceutical and Allied Industries Adaptation Association has, however, subsequent to the passing of the Act, brought to notice the apprehension of its members at the pending removal from the law of the proviso in the 1927 Act as a result of which, where a patent granted under the 1927 Act is infringed or the subject of an infringement action, the patentee may be burdened with the almost impossible task of proving that the substance concerned was made by the process which he had patented. It is probably impossible for a person so to prove. The association contends that, rather than indicating that it was not necessary, failure to avail of the proviso proved that it had acted as a deterrent and was therefore of value.
I am satisfied that the fears expressed by the Adaptation Association are well founded and that there is a danger that the removal of the presumptive clause will tend to retard or inhibit expansion prospects in the pharmaceutical industry. The amendment of the Act now proposed will continue the clause in force in relation to patents granted under the 1927 Act in the new 1964 Act when that comes into force.
I recommend the principle of the Bill for the approval of the House.