Eli Lilly and Company v. Government of Canada

1. Eli Lilly and Company v. Government of Canada Andrew W. Williams, Ph.D. June 5, 2014

2. Utility Requirement In Canada, section 2 of the patent act provides that an “‘invention’ means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter . . . .”

3. Promise Doctrine • “It means ‘that the invention will not work, either in the sense that it will not operate at all or, more broadly, that it will not do what the specification promises that it will do.’” - ConsolboardInc. v. MacMillianBloedel (Saskatchewan) Ltd.

4. Promise Doctrine • The utility promise must be established “on the basis of either a demonstration or sound prediction.” - Apotex Inc. v. Wellcome Foundation Ltd.

5. Sound Prediction There must be: (1) A factual basis for the prediction (2) An articulable and “sound” line of reasoning form which the desired result can be inferred from the factual basis, and (3) Proper disclosure.

6. Eli Lilly and Company

7. Strattera • 1979 – Development of atomoxetine begins • Early 1980s – Potential to treat depression • 1991 – Use as anti-depressant terminated • 1994 – Possibility raised of new use for ADHD • 1995 – Pilot test at Massachusetts General Hospital • 1996 – Canadian Patent application filed

8. Strattera Novopharm Ltd. v. Eli Lilly and Company The Court found: • The use of atomoxetine to treat ADHD was novel • The use of atomoxetine to treat ADHD was not obvious • But, the use of atomoxetine to treat ADHD did not satisfy the utility requirement

9. Strattera • Promise: Atomoxetine was clinically useful in treating some patients with ADHD, with the implicit promise that it will work in the longer term • Utility not demonstrated by MGH study • MGH study not disclosed in the patent

10. Zyprexa • 1950s – “First Generation” or “Typical” antipsychotics • 1960s – “Second Generation” or “Atypical” antipsychotics • Early1980s – Lilly obtains patent on genus of clozapine-like compounds – Lilly tests flumezapine and ethyl flumezapine • Around 1982 – olanzapine first synthesized • 1989 – olanzapine in clinical trials • 1991 – patent application to olanzapine filed in Canada • 1998 – patent granted

11. Zyprexa Eli Lilly Canada Inc. et al. v. Novopharm Ltd. • Promise: Olanzapine is substantially better in the clinical treatment of schizophrenia (and related conditions) than other known antipsychotics, with a better side-effect profile, and a high level of activity at low doses. • Utility not demonstrated for promise • Sound Prediction – the inventors could not have drawn a reasonable inference of the promise from the factual basis

12. Eli Lilly v. Canada • NAFTA Article 1709(1): “each Party shall make patents available for any inventions, whether products or processes, in all fields of technology, provided that such inventions are new, result from an inventive step and are capable of industrial application.” • NAFTA Article 1709(7): “patents shall be available and patent rights enjoyable without discrimination as to the field of technology . . . .” • NAFTA Article 1709(8): “A Party may revoke a patent only when . . . grounds exist that would have justified a refusal to grant the patent.”

13. www.patentdocs.org

14. Andrew W. Williams, Ph.D.williams@mbhb.com (312) 913-3301

15. THANK YOU! Doc #