Case No. 645 Novartis AG vs Saudi Generic Company Registration of pharmaceutical generic product with drugs department does not exempt generics from liability of patent infringement.

In the subject case, the Plaintiff Novartis AG filed patent infringement case against local generic company on the basis of GCC Patent for its drug exjade. The case was filed before Patent Dispute Committee, having original jurisdiction to adjudicate the case.

The stance of plaintiff was that the defendant has started commercial exploitation of infringing product chelaton in Saudi Arabia, which is exclusively reserved for plaintiff under GCC Patent law, enforceable in Saudi Arabia. The plaintiff relied upon the rights granted under GCC Patent law, and enforcement provisions as provided under national Saudi patent law.

The defendant argued that its product is registered with Saudi Food and Drugs Authority (SFDA) and as such the defendant has been granted right to make commercial exploitation of the registered drug by a government body.

The issue before committee as framed in the case was, whether drugs registration provides exemption to such registrant from liability of infringement under patent law.

The plaintiff argued that since the two laws are distinct and addresses different subject matters, therefore registration under SFDA laws does not remove potential liability under patent law. The plaintiff further argued that establishing safety and efficacy under SFDA laws is nowhere mentioned as an exception or exemption to liability under patent law, therefore the infringement established as per evidence brought forward by plaintiff makes the defendant liable for patent infringement.

In its judgement, the committee ruled that once a patent is granted by issuing authority, any further exploitation by any entity without authorization is an infringement under GCC patent law and this is irrespective of registration with SFDA. Permanent injunction was issued ordering defendant not to make commercial exploitation of infringing product.