Animal Experiments and Patents Shahnaz Irani Linda Govenlock 11 April 2007

Patents: Basic Facts A standard patent gives the patentee the right to exclude others from exploiting the patented invention including conducting animal experiments A patent application is published 18 months after filing A standard patent has a maximum 20 year term A patent is fundamentally concerned with new and inventive subject matter

Need for experimental data To be granted, a patent application must describe the invention fully. This means there must be sufficient description/examples of the invention For vet/pharma patent applications, the patent specification must generally include results of animal experiments demonstrating drug efficacy/safety/utility

Duplication of data? Patents covering new drug compounds, formulations or indications would generally have original data which was not previously the subject of experimentation Patents can contain comparative experimental data. This could be simply a reference to data published elsewhere. This is not necessarily a duplication of pre-existing experiments.

Delay in publication of data A patent applicant must not publicly disclose their invention-including experimental data-before filing their patent application This delay may result in duplication of experimentation where more than one research group is working on the same invention. This is inevitable Non published data

Data Exclusivity S25A TGA provides that all clinical data provided to obtain regulatory approval of a drug is not available to anyone for 5 years from registration of the drug on the ARTG This includes all Phase l-lll experimental data Phase ll and lll data is rarely included in a patent application Obstructs original/parallel research

Research Exemption Recommendation that an experimental use exemption be introduced into AU Such experimental use includes-determining how an invention works, seeking an improvement of the invention Duplication of experimental data will avoid patent infringement.

Conclusion Duplication of experimentation may be patent infringement Patent applications are published documents Patents per se do not exacerbate needless duplication of animal experiments

Thank you ANY QUESTIONS?