New Law Should Bolster Australian Generics Industry

    By Jason Derry --

As discussed by Gareth Dixon and Jacinta Flattery-O'Brien of Shelston IP, a bill has been passed by Australia's Federal Parliament that allows otherwise infringing activities to be carried out for the purposes of obtaining regulatory approval.  The bill allows generic companies to obtain approval for products during the patent term of a drug, so the generic version can be marketed in Australia immediately after the patent expires.  Previously, such activities, known as "springboarding," were only permitted on pharmaceutical product patents that obtained a patent term extension.  The new bill permits springboarding on patents that cover pharmaceutical products, methods of making the products, products related to a pharmaceutical product (e.g., a prodrug or metabolite), and uses of pharmaceutical products.

Jason Derry, Ph.D., who graduated with honors from DePaul University College of Law, is a molecular biologist and founding author of Patent Docs.