Pharmaceutical Patent

Pharmaceutical inventions have been the subject of special provisions in the past, the likes of which have not been applied to other inventions. Furthermore, pharmaceuticals are the subject of much government regulation outside of the patent system.

October 6, 2016

Pharmaceutical Patentees Could Face More than 100% of Actual Damages under PM(NOC) Regulations

2014 FCA 68 - Innovator pharmaceutical companies should be cautious and think twice about how aggressively they defend their patents as they could potentially face paying more than 100% of actual damages as an award under section 8 of the PM(NOC) Regulations.
October 5, 2016

“More or Less Self-evident” Remains the Standard in the Obvious-to-Try Test

2015 FCA 286 - An attack on the Federal Court’s slight rewording of the obvious-to-try test has proven unsuccessful. The FC referring to a 'fair expectation of success'" was not a reviewable error.
October 3, 2016

FCA Will not Reweigh Expert Evidence to Appeal Patent Invalidity

2015 FCA 191 - The FCA dismissed an appeal wherein Alcon sought to reverse a finding of invalidity against its patent by surreptitiously asking the FCA to reweigh the evidence as a challenge against the Federal Court Judge’s findings of fact and preferred expert evidence.
October 3, 2016

Careful Patent Drafting Saves Novartis’s EXJADE Patent Despite Two Distinct Promises

2016 FCA 230 - The FCA found that the EXJADE patent was drafted so as to make an important distinction between the utilities of the Formula I and Formula II compounds, and thereby held the Formula II claims to a lesser promise, and dismissed Teva’s allegations of inutility.
August 22, 2016

FC Bifurcates Infringement & Validity Issues from Section 8 PM(NOC) Proceeding in Hopes of Settlement

2016 FC 720 - The FC bifurcated the issues of infringement and validity from any other section 8 issue in hopes that bifurcation would likely lead to a settlement of all the issues between the parties.
May 6, 2016

Law Remains Unsettled Regarding Appropriate Date for Assessing Obviousness-type Double Patenting

2015 FC 875 - The FC noted that the law is unsettled when it comes to determining the appropriate date for assessing obvious-type double patenting.
April 22, 2016

Gilead Successfully Invalidates Patent Jeopardizing Its Sovaldi Product

2015 FC 1156 - The FC found that Idenix’s patent was invalid for a lack of utility, demonstrated or soundly predicted, and for insufficient disclosure.
April 11, 2016

FC Dismisses Prohibition Application – Favours Respondent’s “Blinded Expert” Evidence

2015 FC 570 - The FC favoured the respondent’s "blinded expert" evidence in which the experts provided their opinions before knowing what was claimed in the disputed patents.
April 5, 2016

Strike Two: Second Prohibition Application Regarding Mylan’s Proposed Tadalafil Tablets Denied

2015 FC 125 - The existing patent was invalid on the grounds of lack of utility for having made a promise of utility that could not be demonstrated nor soundly predicted, was anticipated by a previous patent of the applicant that claimed an overlapping dosage range, and was also therefore made obvious by the same previous patent.
March 28, 2016

Utility For A Pharmaceutical Patent Must Relate To How It Is Used, Not Simply to Its Properties

PAB 1384 - If a pharmaceutical patent is construed to make a promise, then that promise must relate to how the invention will ultimately be used – not simply to the properties of the pharmaceutical itself.