Animal Experiments and Patents

1. Animal Experiments and Patents Shahnaz Irani Linda Govenlock 11 April 2007

2. 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

3. 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

4. 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.

5. 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

6. 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

7. 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.

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

9. Thank you • ANY QUESTIONS?