Eli Lilly Canada Inc. v Apotex Inc. , 2015 FC 1016 (Gleason, J.)
September 11, 2015
Jamie Mills, Beverley Moore, Chantal Saunders of Borden Ladner Gervais LLP for the Applicant Eli Lilly Canada Inc. and the Respondent Patentee ICOS Corporation
Harry Radomski, Jordan Scopa, Sandon Shogilev of Goodmans LLP for the Respondent Apotex Inc. and the Minister of Health
Result: Application for a prohibition order under the Patented Medicines (Notice of Compliance) Regulations dismissed.
The Federal Court dismissed Eli Lilly Canada Inc’s prohibition application against Apotex relating to its proposed generic version of tadalafil, marketed by Lilly as CIALIS®. Lilly asserted Canadian Patent No. 2,379,948, which claims formulations with a reduced particle size and certain excipients to address tadalafil’s poor water solubility. The Court found Apotex’s allegations of non-infringement and obviousness justified. This decision follows the dismissal, currently under appeal, of a related prohibition proceeding involving similar allegations, but a different generic, ie. Mylan Pharmarceuticals ULC (the “Mylan Decision”, 2015 FC 178).
As a preliminary matter, the Court refused to dismiss the application as being abusive based on the Mylan Decision. The Court held that doing so is a discretionary remedy, with the key issue being which party will be more severely prejudiced. The Court found that this would be Lilly (in particular, if it were ultimately successful in its appeal of the Mylan Decision), as it would lose its ability to have this application heard on the merits.
The Court however found Apotex’s allegation of non-infringement justified. Based on Apotex’s description in its drug submission of the excipients in its product and their functions, the Court held that Apotex’s product did not contain all of the claimed excipients. The Court also rejected the argument that the excipients in Apotex’s formulation did not perform the specified functions, finding the expert evidence on this point speculative, as well as other corresponding arguments.
The Court also found Apotex’s obviousness allegation justified. It first held that Apotex could raise this issue, finding that it had satisfied its evidentiary burden for this allegation. The Court held that Apotex’s Notice of Allegation was not deficient merely because its description of the inventive concept diverged from that later set out by its expert. Determining the inventive concept is a matter of construction and thus need not be raised in the NOA. As such, there was no basis to strike the expert’s evidence and the issue was in play.
The Court found no reason to depart from the inventive concept in the Mylan Decision, which was midway between the parties’ respective constructions. The Court then held that the only difference between the prior art and this inventive concept was the combination of the claimed formulations with tadalafil. Ultimately, the Court found that using tadalafil in free drug form, reducing its particle size and formulating it with specified excipients were obvious steps to try in order to achieve a stable and more rapidly-dissolving formulation of tadalafil.
The Court did however find Apotex’ utility allegations unjustified. The Court noted that the patent made no explicit promises of any sort, mentioning advantages of the claimed formulations only briefly in the disclosure. If any promise was made, it related to certain improved characteristics of the claimed formulations, which invited a comparison with formulations identified in prior art mentioned in the patent.
The Court held that data demonstrating utility need not be referenced in a patent, expressly disagreeing with the Mylan Decision on this issue. The Court held that there is no disclosure requirement for demonstrated utility and that defending a challenge to demonstrated utility usually requires evidence beyond the patent. The Court found that, while Lilly did not test all the claimed formulations, doing so was unnecessary. The testing done sufficiently established the promised utility that formulations without an enteric coating would provide more rapid dissolution and enhanced bioavailability over the prior art formulation which had an enteric coating.
By: Kiernan A. Murphy, Gowling Lafleur Henderson LLP