As a part of its obligations under CETA, Canada plans to introduce patent term restoration for up to two years when research or regulatory delays have consumed part of the 20-year term of a pharmaceutical patent. Patent term restoration will occur via the grant of a so-called certificate of supplementary protection (“CSP”).
On July 15, 2017, the government of Canada published its proposed Certificate of Supplementary Protection Regulations (“CSP Regulations”) which, in conjunction with amendments to the Patent Act, will create the framework for the issuance of CSPs which will be administered by Canada’s Minister … 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
In a recent appeal (2017 FCA 25) relating to the issue of costs following a patent infringement trial, the Federal Court of Appeal commented that lump sum awards have found increasing favour with courts, and for good reason as they save the parties time and money. Lump sum costs awards further the objective of the Federal Courts Rules of securing “the just, most expeditious and least expensive determination” of proceedings (Rule 3). When a court can award costs on a lump sum basis, granular analyses are avoided and the costs hearing does not become an exercise in accounting. … Continue Reading
In a recent decision (Apotex Inc. v. ADIR, 2017 FCA 23), the Federal Court of Appeal determined that the Federal Court erred in law by rejecting the relevance at law of any available non-infringing product and failed to adequately consider the evidence adduced as to the ability and willingness of three suppliers to provide non-infringing product. According to the Court of Appeal:
… Continue Reading
- To the extent the Federal Court rejected the relevance of non-infringing perindopril because the defendant sold perindopril, this conclusion was inconsistent with Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34 where the Roundup Ready
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
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
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
This case (Apotex v. Canada (Health), 2016 FC 673) involves a very unique set of circumstances. An underlying Health Canada decision was found to have been made for an improper purpose and carried out unfairly. This decision was apparently perpetuated in identical form in a subsequent decision without an evidentiary or lawful basis to do so and the subsequent decision was, therefore, found to be unlawful as well.… Continue Reading
Last year we wrote about a trilogy of Federal Court decisions relating to Eli Lilly’s erectile dysfunction (ED) drug CIALIS® (tadalafil). While Lilly was successful in obtaining a prohibition order in the first proceeding, its latter two applications were dismissed. Mylan appealed the first order, and the Federal Court of Appeal (FCA) recently released its decision in Mylan Pharmaceuticals ULC v. Eli Lilly Canada Inc., 2016 FCA 119 dismissing Mylan’s appeal.
The FCA’s decision affirms the view that obviousness and obviousness-type double patenting validity challenges require distinct analyses, and that a patent’s disclosure cannot be referenced to vary the … Continue Reading
A recent decision of the Federal Court in Allergan Inc. v. Apotex Inc. et al. (2016 FC 344), relating to the drug Gatifloxacin, appears to have regressed the issue of expert “blinding” in patent cases. Expert “blinding” is a relatively recent trend in patent litigation where a litigant intentionally “blinds” its expert witness to certain issues and materials in an effort to afford their opinions a higher degree of credibility. In the Gatifloxacin decision, the Court appears to have endorsed expert “blinding” in patent cases as not only de rigueur but, perhaps necessary; while other recent decisions of … Continue Reading
In The Winning Combination Inc. v. Canada (2016 FC 381), the Federal Court found that Health Canada demonstrated bias, prejudgment and prevented The Winning Combination (“TWC”) from fully and fairly participating in the licensing process. Accordingly, the Court quashed Health Canada’s decisions and awarded TWC full costs.
This was a judicial review of a series of related Health Canada decisions regarding the TWC product Resolve, a smoking cession aid. There is a long history associated with this dispute, involving a convoluted set of decisions by Health Products and Food Branch Inspectorate (“HPFBI”) and the Natural and Non-Prescription Health Products … Continue Reading
On April 14, 2016, the Supreme Court of Canada denied Apotex’s final attempt at obtaining leave to appeal in the storied patent battle between Merck and Apotex over Merck’s lovastatin patent.
The case began in 1997 when Apotex launched its generic lovastatin product. At the liability trial in 2010, Justice Judith Snider of the Federal Court found Merck’s lovastatin patent to be valid and infringed (2010 FC 1265). The judgment included reference to DNA evidence establishing that Apotex had infringed through its operations in Winnipeg. The Judge also found that Apotex’s joint venture partner fabricated batch records and … Continue Reading
In reasons dated March 21, 2016, the Federal Court of Canada upheld a decision that allowed a patent infringement action involving tenofovir (an anti-HIV drug) to continue on the basis of allegations of a likely future (quia timet) infringement. The Court was satisfied that there was a “strong possibility of infringement” in circumstances where regulatory approval, and future market presence, of the generic copycat was “sufficiently likely” even though not inevitable that the generic would receive marketing authorization.… Continue Reading
NPEs, otherwise known as non-practicing entities, or pejoratively referred to by some as “patent trolls”, have seen a significant negative impact on their business model south of the border. NPEs are analogous to private equity businesses–their business model is to acquire undervalued patent assets and turn around and sell or license them to others, which often leads to expensive patent litigation. If their assets are depreciating in value, the model becomes significantly less attractive. This is exactly what is happening in the US.
Recent US Supreme Court decisions including Alice, which restricted the scope of patent-eligible subject matter, and … Continue Reading
The online sale of a software licence constitutes a “use” in relation to a good for the purposes of Canadian trademarks. This was the recent holding of the Federal Court of Canada in Specialty Software v Bewatec, 2016 FC 223. This decision strengthens trademark protection for software in Canada and demonstrates that courts will adapt legal concepts to modern technology. Here, the traditional model of purchasing software on tangible media, such as a CD-ROM, is simply outdated. Software as a service (SaaS) offerings have greatly increased in recent years with the explosion of cloud computing, which essentially provides … 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
Canadian patents have utility requirements. A claimed invention must have some level of utility. A ‘mere scintilla’ of utility is all that the Patent Act requires. However, where a patent contains an explicit promise of a specific result, the case-law has developed a requirement that this so-called ‘promised utility’ be demonstrated or soundly predicted as of the Canadian filing date of the patent application.
There has been much controversy over this ‘promise doctrine’ as well as the ‘heightened disclosure requirement’ that has been applied in the case of a sound prediction. The controversy includes a NAFTA challenge by Eli Lilly … 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 Judgment released July 23, 2015, the Federal Court of Appeal upheld the Federal Court’s award of more than C$180 million in damages and interest for Apotex’s infringement of Merck’s Canadian lovastatin patent. In this decision, the Federal Court of Appeal reversed the Trial Judge and held that the availability of a non-infringing alternative (“NIA”) is relevant under Canadian law but held that Apotex could not have and would not have deployed it.… 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