In AstraZeneca v Apotex, 2017 FC 726, the Federal Court issued its damages decision concerning Apotex’s infringement of a patent pertaining to AstraZeneca’s LOSEC (omeprazole) drug. This decision offers insight in the factual hurdles a generic must overcome to establish an ex post facto non-infringing alternative (NIA), and confirms that s. 8 damages are not available during a period in which a generic would be infringing a patent, as there is no compensable loss.… Continue Reading
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
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
In a rare case where drug samples were given under consent in an NOC proceeding Novartis sought, but was denied, to use these samples in a related litigation in Portugal (2016 FC 1091).
Samples are rarely provided in NOC proceedings. Nevertheless, production may be compelled if samples were provided to the Minister as part of the drug submission (Patented Medicines (Notice of Compliance) Regulations (SOR/93-133), s. 6(7)). This was not the situation in this case where Mylan consented to producing the samples, subject to the existing protective order.… Continue Reading
Changes are coming swiftly, as the federal government moves to implement the Comprehensive Economic and Trade Agreement (“CETA”) just days after it was signed by Prime Minister Trudeau in Brussels at the end of October 2016.
These changes will significantly impact biologic/pharma patents in two major ways. First, they will implement, for the first time, a Canadianized version of patent-term restoration. Second, they will revamp the current framework for linkage between patents and the approval of biosimilar/generic drugs in Canada by giving innovators the right of appeal, by changing the nature of the PM(NOC) proceedings to a more U.S.-style approach, … Continue Reading
In Teva Canada v. Novartis Canada 2016 FCA 230, the Federal Court of Appeal confirms that in assessing the utility of a patented invention, different patent claims can have different promised utilities.
This decision was made in Teva’s appeal from the Federal Court’s judgment (2015 FC 770) in which the Minister of Health was prohibited from granting an NOC to Teva in respect of its generic version of Novartis’ EXJADE® (deferasirox).
The only issue on appeal was whether the lower court erred in law in its construction of the so-called “promise of the patent”.… Continue Reading
Gilead’s Canadian Patent 2,261,619 (the “619 Patent”)—the compound patent for tenofovir disoproxil fumarate (“TDF”)—is no stranger to Canadian courts. Adding to its litigious history, the Federal Court recently dismissed each of Apotex’s claims in an application under Canada’s NOC Regulations to find—for a second time—allegations relating to the 619 Patent’s validity unjustified.… Continue Reading
On May 4, 2016, the Federal Court of Appeal upheld a summary motion ruling that Gilead’s ‘619 Patent is ineligible for listing against the combo-product, TRUVADA(R) (decision published as Gilead Science, Inc. v. Apotex Inc., 2016 FCA 140).
Canada’s PM(NOC) Regulations allow innovative drug manufacturers to list patents on the public Patent Register pertaining to their drug products. This provides a public notice function to potential copycat generic manufacturers of all listed patents that must be addressed or, else the patent expired, before obtaining marketing authorization from the Canadian Minster of Health to market and sell a generic … Continue Reading
On June 12, 2015, at the urgent request of Horizon Pharma PLC (“Horizon”), the Federal Court of Canada granted a rare interlocutory stay preventing the Minister of Health (the “Minister”) from issuing a Notice of Compliance (“NOC”) to Horizon in respect of its own glycerol phenylbutyrate drug RAVICTI that will be used to treat Urea Cycle Disorders (“UCDs”). Horizon sought the stay to prevent generic competitors from using the information in its regulatory submission while Horizon challenged the Minister’s decision to deny RAVICTI data protection. The Minister did not oppose Horizon’s motion.
While this case raises a fairly unique issue, … Continue Reading
Industry Canada has sponsored proposed amendments to the Patented Medicines (Notice of Compliance) Regulations (the “PM(NOC) Regulations”) that broadens the eligibility to list patents on the Patent Register. These amendments are a direct response to the “perfect match” doctrine recently endorsed by Canadian courts. They reaffirm Health Canada’s long-standing practice regarding patent listing. In so doing, Industry Canada is seeking to restore the balance between innovators and their generic competitors as intended by the PM(NOC) Regulations.… Continue Reading
The Federal Court of Appeal has affirmed the stringent product specificity requirements for listing a patent against a drug for purposes of the PM(NOC) Regulations in its recent decision in ViiV Healthcare ULC et al. v. Teva Canada Limited et al., 2015 FCA 93.
In this proceeding, Teva and Apotex brought motions under the PM(NOC) Regulations arguing that a patent listed against ViiV’s KIVEXA drug was not eligible for purposes of paragraph 4(2)(a) of the Regulations. KIVEXA is a combination drug that contains two medicinal ingredients. The patent at issue explicitly claims one of these ingredients.… Continue Reading
The relevance of expert evidence in establishing indirect infringement of a pharmaceutical in Canada has been questioned. It is unclear what “facts” a product monograph is to contain that will amount to “instructions” to infringe a patent or how a party is to prove that such “facts” amount to “instructions” or how those “instructions” would be understood. What is clear is that “speculation” will not suffice.
On March 26, 2015, the Federal Court released its decision in Bayer Inc. v. Pharmaceutical Partners of Canada Inc., 2015 FC 388, granting PPC’s motion to strike portions of an application brought … Continue Reading
In reasons dated February 26, 2015, Justice Barnes dismissed Janssen’s application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Teva for the compound bortezomib until the expiry of Canadian Letters Patent 2,203,936 (the ‘936 Patent). The ‘936 Patent relates to bortezomib and its use to treat cancer.
The fatal finding for the ‘936 Patent was its characterization by the Court as a selection patent. Justice Barnes held that bortezomib falls within a genus of compounds claimed by an earlier patent, all of which are said to be highly potent in the treatment of … Continue Reading
On February 23, 2015, the Federal Court released its judgment in the latest of three PM(NOC) proceedings relating to Eli Lilly’s CIALIS (tadalafil) patents. The previous two decisions were discussed in snIP/ITs posted on January 26, 2015 and March 30, 2015.
In the latest decision, Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 178, Justice de Montigny found that Mylan’s allegations of non-infringement and obviousness were justified, and dismissed Lilly’s application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan until expiry of Canadian Patent No 2,379,948 (the … Continue Reading
On February 2, 2015 Justice de Montigny of the Federal Court released his judgment and reasons in Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 125, dismissing Lilly’s application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Mylan until the expiry of Canadian Patent No. 2,371,684 (the “‘684 Patent”). The ‘684 Patent claims a dosage form of tadalafil and its use to treat erectile dysfunction (“ED”). This decision is the second in a series of three prohibition applications by Lilly relating to its tadalafil patents.
The use of tadalafil … Continue Reading
“Asking a court to prohibit a notice of compliance after it has issued is like asking someone to close the barn door after the horses have escaped.”
With this analogy, the Federal Court of Appeal in Janssen Inc. v. Teva Canada Limited, 2015 FCA 36 has confirmed that an appeal from an order dismissing a prohibition application under the PM(NOC) Regulations becomes moot once the generic notice of compliance is issued. The Court dismissed Janssen’s appeal noting that it does not serve judicial economy to hear moot appeals.
In fact, the FCA has only exercised its discretion to hear … 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 June 4, 2014 Justice Roger Hughes of the Federal Court released his public reasons for dismissing Bayer’s prohibition application against Apotex in respect of its generic YAZ tablets on the basis that Apotex’s non-infringement allegation was justified. His confidential judgment was issued on May 7, 2014 and Apotex received its NOC the very next day. The term of Bayer’s patent was not set to expire until August 31, 2020. For the full written decision see: Bayer Inc. et al. v. Apotex Inc. et al. 2014 FC 436.
Although not determinative, this decision addresses the somewhat contentious issue of … Continue Reading
On January 15, 2013, the Honourable Justice Michael G. Quigley of the Ontario Superior Court granted summary judgment to Abbott and Takeda, denying Apotex’s claim for disgorgement of profits on the basis of unjust enrichment.
The case involved a claim for damages arising from Abbott’s invocation of the Patented Medicines (Notice of Compliance) Regulations. The PM(NOC) proceedings were ultimately discontinued by Abbott and Apotex thereafter brought an action, in the Ontario Court, for (a) damages under section 8 of the PM(NOC) Regulations; and (b) disgorgement of Abbott’s profits on the basis of unjust enrichment.
In the Federal Court, … Continue Reading
On Friday, November 23, 2012 the Federal Court of Appeal released its decision in A-312-12 dismissing Apotex’s appeal of Justice Hughes’ order dated June 18, 2012 granting Allergan’s application for a prohibition order in respect of the drug COMBIGAN. This decision, and related litigation involving COMBIGAN, clearly demonstrates why innovators need a right of appeal when unsuccessful in applications they bring pursuant to section 6 of the PM(NOC) Regulations.
Facts and Issues
COMBIGAN is an ophthalmic drug marketed in Canada by Allergan. It is useful for lowering pressure in the eye and treating glaucoma.
The first generic to seek … Continue Reading
The Federal Court of Appeal has clarified that there must be a “high threshold of consistency” between the content of a new drug submission and a patent’s claims in order for the patent to be listed on the patent register pursuant to section 4(2)(a) of the PM(NOC) Regulations.
This decision, Gilead Sciences Canada Inc. v. The Minister of Health and The Attorney General of Canada, 2012 FCA 254 (Gilead), presents additional challenges for innovative pharmaceutical companies seeking to protect new innovations by listing patents on the patent register.
The Facts of Gilead
On October 4, 2010, Gilead filed a … Continue Reading