1. Anticipation in Canada since Sanofi February 15, 2012 Don Cameron Donald M. Cameron

2. 2 What’s a patentable invention need to be? New Useful Inventive – An invention of the court: 1890: it’s an “invention”, so it must be “inventive” 1936: SCC required “a degree of ingenuity” to be present – Now in the New Patent Act, s. 28.3

3. NEW – NOVELTY/ANTICIPATION

4. Current Patent Act 28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed 28.2 – (a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject- matter became available to the public in Canada or elsewhere; – (b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere; 4

5. What Sanofi said Enabling disclosure 5

6. What Sanofi said 6

7. 7

8. Enablement: The “IKEA” threshold 8

9. Cases since Sanofi Merck v. Apotex (2010) Prior art: fermentation process with yeast – did it produce lovostatin? No disclosure: – Not inevitable that claimed product would be produced – No evidence process was actually used before key date 9 disclose enable

10. Cases since Sanofi Sloan Kettering (P.A.B.) Claim was for an antibody No disclosure: BTW: No enablement: – starting material: you couldn’t buy it, you’d have to make it – To make it would take: “hopeful yet prolonged and arduous experimentation” 10 disclose enable

11. Cases since Sanofi AstraZeneca v. Apotex esomeprazole, a stereoisomer of enalapril Prior art said it separated optically pure compounds Apotex: slight change in process produced esmeprazole AstraZeneca: no it didn’t Court: result not consistent 11 disclose enable

12. Cases since Sanofi Easton v. Bauer Hockey skate boot: a one-piece rear quarter Used in test league, but in public rink Disclosed but not enabled – You’d have to dismantle the skate to reproduce it 12 disclose enable

13. Conclusions since Sanofi Mechanical: – “The Caramilk bar test” – If you can see it, you can figure it out – Observing isn’t “experimenting” 13 disclose enable

14. Conclusions since Sanofi Chem/Pharma: – “The Coca-cola test” – Can’t figure out how they made it. 14 disclose enable

15. Thank You Don Cameron DCameron@bereskinparr.com Bereskin & Parr LLP