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.

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January 3, 2017

FC Rules PM(NOC) Prohibition Application Not An Abuse of Process

2015 FC 1016 - In this decision, the FC permitted the applicant to proceed with its prohibition application, despite a previous decision finding that the patent in question was invalid.

November 23, 2016

FC Invalidates Selection Patent as Obvious in View of Genus Patent

2015 FC 247 - The Federal Court reminds us that a selection patent will typically require something more than routine testing to justify the reclaiming of a particular compound within a previously known class of compounds.

October 21, 2016

FCA Clarifies Test for Obviousness-Type Double-Patenting

2016 FCA 119 - The FCA dismissed the appeal, which alleged that Canadian Patent No. 2,226,784 was invalid on the basis of obviousness-type double-patenting and for lack of utility due to no sound prediction. As a result, the ‘784 patent was upheld.

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.

November 30, 2015

FCA: Generic pharmaceuticals also subject to price regulation

2015 FCA 249 - The Federal Court of Appeal clearly stated that the price regulation provisions apply not only to literal patent holders, but also to exclusive licensees of patents.

October 7, 2015

Relitigating Conceded Claims is an Abuse of PM(NOC) Proceedings

Gilead Sciences, Inc v Canada (Health), 2015 FC 610 - Gilead's assertion that its patent is valid would be relitigating old issues and an abuse of PM(NOC) proceedings.

September 16, 2015

FC Finds Novartis Patent Promises a Mechanism of Action, not a Treatment

Novartis Pharmaceuticals Canada Inc v Teva Canada Limited, 2015 FC 770 - Novartis was able to uphold its patent against allegations of invalidity from Teva, but not without the Federal Court making a number of razor thin distinctions between what the patent promised and what it did not.

September 15, 2015

FCA Rejects “Exact Matching” Requirement in PM(NOC) Regulations

Eli Lilly Canada Inc v Canada (Attorney General), 2015 FCA 166 - The FCA rejected the notion adopted by the Federal Court that a higher level of specificity is required to adhere to the Regulations than is required for an element to be claimed as a matter of claim construction, bringing the law in line with Industry Canada proposed amendments.

September 9, 2015

The Word “will” can Indicate a Patent Promise, not an Expectation

AstraZeneca Canada Inc v Apotex Inc, 2015 FCA 158 - The FCA acknowledged that the word “will” often refers to an expectation or goal rather than a promise, but still held that the FC did not err in finding that a promise was made when reading the patent as a whole from the eyes of a skilled reader.

September 2, 2015

In Situ Reaction Cannot Avoid AstraZeneca’s Product Claim

AstraZeneca Canada Inc v Apotex Inc, 2015 FC 322 - Claim 1 was worded general enough to capture Apotex’s subcoating layer even though Apotex’s subcoating layer was generated by an in situ chemical reaction, a process that the patentee had not contemplated.

May 21, 2015

FCA Upholds Gilead Product Specificity Requirement

ViiV Healthcare ULC v Teva Canada Limited, 2015 FCA 93 - The FCA confirmed that paragraph 4(2)(a) of the Patented Medicines (Notice of Compliance Regulations) requires that a patent listed on the register requires an “exacting threshold of specificity” between what is claimed in the patent and what has been approved in the Notice of Compliance. However, proposed amendments to the PM(NOC) Regulations would reverse this holding.