Eli Lilly Canada Inc. v. Novopharm Limited , 2011 FC 1288 (November 10, 2011)
Les principes analysés dans la présente décision:
The following summarizes my understanding of the proper approach to determining the issues of utility and sufficiency in respect of selection patents generally, and the ‘113 patent in particular:
1. Review the patent to determine whether it sets out a specific promise of a substantial advantage over the genus compounds and, if it does, identify it.
2. In construing the patent, refer explicitly to the expert evidence to determine whether a skilled person would interpret the stated advantage(s) as being truly advantageous; only those advantages regarded as truly advantageous can form part of the patent’s promise.
3. The‘113 patent contains a sufficient factual basis for a sound prediction of its promise – studies in rodents, an open-label clinical trial with 8 patients, and healthy volunteer studies involving 20 persons.
4. The real issue in respect of sound prediction is whether there is an articulable line of reasoning from the factual basis set out in the ‘113 patent to the patent’s promise; that is, whether there exists a prima facie reasonable inference linking the factual basis to the promise.
5. To decide whether a selection patent discloses the invention sufficiently, one must determine whether it identifies the compound, its advantages and how it works; this is distinct from determining whether the patent meets the disclosure requirements for sound prediction (which is not in issue here).