Some would say keeping a software license alive by an injunction is like requiring specific performance of a contract – something courts don’t like to do. However, a recent Ontario decision appears to have done about just that, by relying on its discretion to grant “terms” according to Ontario Rule 37.13(1) in extending an interim injunction for six months, despite the plaintiff failing to justify its request for an interlocutory injunction to trial. … Continue Reading
Ciba Specialty Chemicals Water Treatments Limited v. SNF Inc., 2017 FCA 225, is the Federal Court of Appeal’s latest word on obviousness in patent law. The decision appears to unsettle established approaches to assessing obviousness. For what may be the first time since the Supreme Court’s endorsement of the “inventive concept” approach to evaluating obviousness in 2008, the Federal Court of Appeal by-passed the inventive concept inquiry entirely. The court also held that all dependent claims in the patent were invalid because the independent claim was obvious without reconciling previous Federal Court of Appeal jurisprudence holding that this was … Continue Reading
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
The provisional application of CETA takes effect in Canada today, ushering in a new era for pharmaceutical patent litigation. As part of this implementation, amendments to the Patent Act, the Patent Rules and the PM(NOC) Regulations, as well as the new Certificates of Supplemental Protection (CSP) Regulations, came into force today. See our previous posts on the new PM(NOC) Regulations and CSP Regulations for key details about these new schemes.
The Government of Canada has announced that the amended NOC regulations will come into force on September 21, 2017. These amendments will implement sweeping changes to pharmaceutical patent litigation in Canada pursuant to obligations imposed under CETA. The changes will apply to proceedings commenced in respect of NOAs served on or after September 21, 2017.
In their decision reported as 2017 FCA 161, the Federal Court of Appeal says s. 27(3) of the Patent Act requires the patent to disclose both the invention, and how to make the invention. Further, that a patent will not lack sufficient disclosure where routine experimentation is required of a skilled person. However, disclosure is insufficient if the specification “necessitates the working out of a problem”.
In this case, the patent did not teach a step necessary to synthesize the claimed compound. The issue was whether this gap could be filled by the common general knowledge of the skilled … Continue Reading
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:
- 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