On July 15, 2017, the Canadian government published (link) its proposed amendments to the NOC Regulations. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. There will be a 15-day comment period, after which, the amendments will be published in final form. The finalized amendments are expected to be in force around late September 2017. These revamped NOC Regulations will apply to Notices of Allegation (“NOAs”) served on or after the date the revamped NOC Regulations come into force.
Overall, the revamped NOC Regulations… Continue Reading
On June 30, 2017, the Supreme Court of Canada, released a landmark patent decision (2017 SCC 36) abolishing Canada’s so-called ‘Promise Doctrine’ by finding it “unsound”, “not good law” and “incongruent with the both the words and scheme of the Patent Act.”… Continue Reading
In Teva v. Pfizer Canada, 2017 FC 526, the Federal Court reaffirmed and reissued a judgment awarding Teva a section 8 damages award in excess of $125 million relating to the drug EFFEXOR XR® (venlafaxine). This decision offers insight into the legal limits on what inferences can be drawn about a generic’s ability to source sufficient drug supply in the but-for damages world.
The key issue at this redetermination was whether Teva would have had and could have had access to sufficient quantities of venlafaxine at the relevant time to support its notional sales in … Continue Reading
Canada’s sweeping trade deal with the European Union is expected to be implemented early next year. As reported previously, the government of Canada has tabled Bill C-30 to ratify CETA, which proposes significant changes to the Patent Act and the PM(NOC) regime, as well as geographic indications under the Trade-marks Act.
Bill C-30 will receive Royal Assent, and become law in Canada, once it passes through both the House of Commons and the Senate.
On December 13, 2013, Bill C-30 passed a second reading in the House of Commons by a comfortable margin of 266 to 39. Bill C-30 … Continue Reading
In a recent decision, the Federal Court dismissed a motion by Apotex seeking particulars from (or to strike paragraphs from) Allergan’s pleading relating to the prior art, inventive concept, promised utility and sound prediction of utility of the patents at issue.
In this case, Allergan Inc. (“Allergan”) brought an infringement action against Apotex and AA Pharma in respect of two patents relating to Allergan’s drug ALPHAGAN P. Apotex filed a statement of defence and counterclaim, seeking to impeach Allergan’s patents. In its defence to counterclaim, Allergan denied Apotex’s invalidity allegations.… Continue Reading
In this decision (2016 ONSC 4966), the Ontario Court dismissed Apotex’s claim for damages under s. 8 of the NOC Regulations in the face of a motion to strike. Apotex’s other relatively esoteric claims were, however, left for another day. These claims include alleged false and misleading statements under s. 7 of the Canadian Trade-Marks Act, unjust enrichment, nuisance, and conspiracy. Pfizer failed to establish that these claims were doomed to fail. The high standard applicable on these motions was not met.
Apotex pursues Pfizer in the Ontario Court for alleged losses relating to Apotex’s delay in … Continue Reading
On March 31, 2016, the Competition Bureau (Bureau) released revised Intellectual Property Enforcement Guidelines (IPEGs). These IPEGs reflect incremental changes to the draft version released for consultation last year. Most notably the new IPEGs provide further guidance on (i) pharmaceutical patent litigation settlements, (ii) product switching (also known as “product hopping”), (iii) collaborative standard setting and standard essential patents, and (iv) patent assertion entities.… Continue Reading
The question of whether a “fair expectation of success” is the correct legal standard applicable to an obvious to try analysis was finally laid to rest in the Federal Court of Appeal’s recent important decision of Eli Lilly v Mylan (2015 FCA 286). A unanimous panel held that a “fair expectation of success” was not the correct standard. Instead, the higher “more or less self-evident” test articulated by the Supreme Court of Canada in Sanofi-Synthelabo (2008 SCC 61) was reaffirmed as the correct legal standard. The higher standard for obviousness makes it more difficult to invalidate … Continue Reading
In a decision released on June 3, 2015 (2015 FCA 137), a unanimous Federal Court of Appeal (“FCA”) dismissed Apotex’s appeal of Justice O’Reilly’s order prohibiting the Minister of Health from issuing a NOC to Apotex to market its generic version of LUMIGAN RC® until the expiry of Canadian Patent No. 2,585,691 (the “‘691 Patent”).
Significantly, on the issue of sound prediction the FCA held that the elements of sound prediction need not be disclosed in a patent if they would be self-evident to the skilled person. The Federal Court of Appeal has previously stated this … Continue Reading
On October 30, 2014, the Supreme Court of Canada granted leave to Sanofi-Aventis’ (“Sanofi”) application for leave to appeal a decision of the Federal Court of Appeal (2014 FCA 68). By granting leave to Sanofi, the Supreme Court will now consider for the first time the correct interpretation of, and the correct legal framework applicable to quantifying section 8 damages under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).
The PM(NOC) Regulations strike a balance between the interests of innovative pharmaceutical companies and generic manufacturers, by requiring generic manufacturers to address innovators’ patents before receiving … Continue Reading
On September 26, 2014, Prime Minister Harper announced that Canada and the European Union have successfully concluded negotiations on a new trade agreement, the Comprehensive Economic and Trade Agreement (CETA) that was five years in the making, and publicly released the consolidated text of the agreement.
CETA is deeper in substance and broader in scope than any other such agreement in Canadian history, significantly affecting all economic areas, including the pharmaceutical sector.
The CETA chapter on intellectual property is of particular interest to the pharmaceutical industry, because it will introduce into Canada for the first time:
… Continue Reading
On July 2, 2014, Mr. Justice Rennie of the Federal Court released his judgment and reasons in Astrazeneca Canada Inc v. Apotex Inc., 2014 FC 638 dismissing AstraZeneca’s action for infringement and granting Apotex’s counterclaim for a declaration that Canadian Patent 2,139,653 (the “‘653 Patent”) is invalid. This patent relates to AstraZeneca’s successful drug NEXIUM® (esomeprazole).
Justice Rennie found the invention of the ‘653 Patent was novel and non-obvious, but nevertheless invalidated the patent for promising an improved therapeutic profile which was not soundly predicted.
While Justice Rennie canvassed a number of legal issues, his … Continue Reading
In a pair of simultaneously released decisions on June 13, 2014, Justice O’Reilly allowed Allergan’s applications (the “Applications”) prohibiting the Minister of Health from issuing NOCs to Cobalt (now “Actavis”) (2014 FC 566) and Apotex (2014 FC 567) to market their generic versions of LUMIGAN RC® until the expiry of Canadian Patent 2,585,691 (the “‘691 Patent”) in 2026.
Allergan was represented by Andrew Reddon, Steven Mason, Steven Tanner and Sanjaya Mendis of McCarthy Tétrault LLP.
Allergan originally marketed a 0.03% bimatoprost (“Bp”) containing formulation for treating glaucoma called LUMIGAN, … Continue Reading
As discussed in the November 9, 2012 post, Supreme Court Invalidates Pfizer’s Blockbuster VIAGRA® Patent, the Supreme Court of Canada struck down Pfizer’s blockbuster VIAGRA® patent (the “‘446 Patent”) on the basis of insufficient disclosure: see Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60.
In a curious twist, the SCC declared the ‘446 Patent “void”, despite the case being brought under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”). However, on June 4, 2013, the SCC granted Pfizer’s rare Rule 76/81 Motion, varying this controversial aspect of its … Continue Reading
Canada’s top court has struck down Pfizer Inc.’s lucrative patent on VIAGRA, paving the way for generic entry into the Canadian marketplace shortly.
In Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60, the Supreme Court of Canada unanimously (7-0) declared Pfizer’s patent for its blockbuster VIAGRA drug invalid on the basis of insufficient disclosure.
Background – the ‘466 Patent
Pfizer research scientists initially investigated “sildenafil citrate” (VIAGRA’s active compound) for use as a cardiovascular drug. However, upon discovering sildenafil’s peculiar effect on rats, scientists began to suspect that the compound might be useful in treating erectile dysfunction … Continue Reading