Patents – ANDA procedures in Australia
In the US, marketing approval for new drugs is regulated by the Hatch-Waxman Act which strikes a balance between the rights of originators of patented medicines, and the interests of generic manufacturers. Under the Hatch-Waxman procedures, generic manufacturer can file an Abbreviated New Drug Applications (ANDA).
The FDA will approve the ANDA upon satisfaction of certain requirements, particularly, in relation to the 'Orange Book'. Originators may list patents covering their drugs in the Orange Book. If a patent is listed in the Orange Book, the ANDA applicant must certify one of the following:
- that the patent has (or will soon) expire; or
- that the patent is invalid or will not be infringed. Filing such certification provides the patent owner with the right to sue the ANDA applicant for patent infringement.
If the certification is of type (II), the ANDA applicant must give the patentee notice and advise the patentee why it believes the patent is invalid, unenforceable or not infringed. If, within 45 days of giving this notice, the patentee commences patent infringement proceedings, the FDA must delay grant of marketing approval until a court holds that there is no infringement or 30 months have elapsed, whichever is the sooner.
The procedure benefits generic manufacturers by ensuring timely resolution of disputes and benefits originators by ensuring that generic products do not get to market until there is an opportunity for patent infringement proceedings to be decided. ANDA proceedings have been widely used in the US to resolve disputes between originators and generic manufacturers.
The new ANDA proposals will not affect the present Australian arrangements under which generic manufacturers can take steps to obtain marketing approval if a patent extension has been granted for the patented product but before the patent expires. In addition, the current five years of protection for test data submitted by originators with an application for marketing approval will be retained.
PBS listing and pricing procedures
Pharmaceutical Benefit Scheme (PBS) listing is usually essential to the widespread use of a new medicine. The PBS listing procedure has been perceived as a black box. Many new medicines of potential benefit to patients have never been listed. Australia is to make improvements to the transparency and speed of PBS processes and provide more opportunities for companies seeking listing of new medicines on the PBS to have input to the process.
Former Pfizer executive and biotechnology company director, Kevin Fahey, believes that the FTA will mean that multinational pharmaceutical companies will be more likely to invest in Australian R&D if they will receive more return on their new generation drugs.