Inducing Infringement By Product Monographs & Skill And Judgment In Medical Use Claims: Key Takeaways From The Federal Court's Decision In Hoffman-La Roche Limited V Sandoz Canada Inc.

• Published date: 14 July 2021
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: Bereskin & Parr LLP
• Author: Ms Melanie Szweras, R. Scott MacKendrick and Madelaine Lynch

The recent Federal Court decision Hoffmann-La Roche Limited v Sandoz Canada Inc.¹ concerns Roche's 2,667,654 (654 patent) and 2,709,997 (997 patent) patents related to pirfenidone (ESBRIET) for the treatment of idiopathic pulmonary fibrosis (IPF). It touches on the issues of claim construction of Swiss style use claims, the issue of what amounts to inducement of infringement by a pharmaceutical manufacturer, evidentiary issues of Wayback printouts, and invalidity issues of double patenting, obviousness, and methods of medical treatment.

The 654 patent, "Method of Providing Pirfenidone Therapy to a Patient", claims a dose escalation regimen that minimizes adverse events. The 997 patent, "Pirfenidone Treatment for Patients with Atypical Liver Function", claims a therapeutically effective dose of pirfenidone for patients following pirfenidone-related abnormal liver function. Both patents were issued to InterMune, which was subsequently acquired by Roche in 2014.²

Sandoz is seeking approval for its own pirfenidone capsules and tablets. Roche alleged the Sandoz pirfenidone will infringe and/or induce infringement of the 654 and 997 patents. In response, Sandoz challenged the validity of the 654 and 997 patents on the basis of anticipation (654 patent), double patenting (997 patent), obviousness, unpatentable subject matter (methods of medical treatment), lack of utility, insufficiency of disclosure, overbreadth and/or ambiguity (654 patent).

Admissibility of Wayback Evidence

A law clerk for Sandoz's counsel provided evidence in support of the admissibility of a printout of ClinicalTrials.gov 2006 generated using the Wayback Machine. Justice Manson noted that the Wayback Machine is generally reliable, but Sandoz failed to establish the authenticity of the printout pursuant to s. 31.1 of the Canada Evidence Act and failed to meet the best evidence rule under s. 31.2 of the Canada Evidence Act.

Sandoz was seeking to admit a printout from ClinicalTrials.gov demonstrating an InterMune-sponsored phase III study of pirfenidone in IPF patients. The printout was being relied on to establish the prior art as of October 9, 2006, which would have been beneficial given the 654 patent priority date of December 18, 2006. The law clerk was to provide evidence as to how the information was obtained.

Justice Manson held that since the information on the printout was captured at different points in time the October 9, 2006 date could not be established. Further "it could not be established that the prior art, as contained in the printout, was publicly available at the relevant...