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?