Eli Lilly Canada Inc. v. Mylan Pharmaceuticals UCL, 2015 FC 178 (Justice de Montigny)
February 23, 2015
Jamie Mills, Beverley Moore and Ryan Steeves for Eli Lilly Canada
Tim Gilbert, Maxwell Morgan, Zarya Cynader for Mylan Pharmaceuticals.
Lilly sought an order prohibiting the Minister of Health from issuing NOC for its patent directed to a reduced particle size of the drug tadalafil. The Application was dismissed on the basis that Lilly failed to meet its burden on both infringement and obviousness.
Infringement
In the infringement analysis, Justice de Montigny considered two essential elements.
The first was a requirement that the range of pharmaceutical formulation be “about 1% to about 5%”. On the facts, the Court found Lilly’s evidence about the formulation of Mylan-tadalafil to be based on speculation and insufficient to meet Lilly’s burden.
The second essential element considered was that “at least 90% of the particles in the compound have particle sizes less than 40 microns”. The key dispute between the parties was when this measurement should occur. Ultimately the Court concluded under a purposive construction that the key point in time to effect this measurement was before the particles were combined with excipients. On this construction there was insufficient evidence to discharge Lilly’s burden.
Obviousness
As a preliminary evidence matter, Lilly took issue with Mylan’s expert using prior art not cited in Mylan’s NOA to inform his opinion on the applicable common general knowledge. Justice de Montigny dismissed this concern in part as Lilly did not refer to case law to support its allegation that every single document upon which a party intends to rely must be disclosed in NOA.
The PM(NOC) Regulations require a party to disclose the legal and factual basis for an allegation. The Regulations are silent as to documents.
Justice de Montigny went on to conclude that a document should be excluded when it is not listed in NOA but provides a source for a new factual basis or allegation. Where, however, non-included documents provide no new or improper factual basis, those documents may still be relied on.
The underlying purpose of this approach is to prevent surprise so that a patentee may know with some certainty the legal and factual allegations levelled against it.
In the substantive obviousness analysis, the inventive step was found to be the improved dissolution and stability of tadalafil, achieved in part by reducing its particle size.
Justice de Montigny applied the “obvious to try” factors in his analysis.
Lilly argued that the time taken to develop the original tadalafil formulation (some 6 years) suggested a high degree of complexity which should militate towards a finding of non-obviousness. This argument was dismissed as the skilled person in the present case would have at their disposal more modern common general knowledge and the situations were not analogous.
Based on the skilled person and the common general knowledge, Justice de Montigny ultimately concluded that reducing the particle size of tadalafil was an “obvious route to try” as a skilled person would have a fair expectation of success. Given the state of the prior art, there were a finite number of ways to achieve the aims of the patent, including reducing the particle size. That there were other complicating factors, such as the selection of proper excipients, was not enough to overcome this finding as those complicating factors would require only routine trial and error to overcome.
By: David Potter, Gowling Lafleur Henderson LLP