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
Canadian hydraulic fracturing technology (“fracking”) is at the center of a controversial US case about inter partes review (“IPR”) of patents. The IPR procedure can be a useful defense against patent infringement actions brought by non-practicing entities or “patent trolls.” However, on June 12, the United States Supreme Court agreed to hear the case challenging the constitutionality of the IPR procedure. A SCOTUS decision abolishing or curtailing the IPR procedure, and the ensuing patent troll activity, could have ramifications for Canadian business, including in the fracking industry.… 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
On June 12, 2017, Prothonotary Aylen of the Federal Court issued her decision in Mostar Directional Technologies Inc. v Drill-Tek Corporation et al., 2017 FC 575. Prothonotary Aylen struck the Plaintiff’s claim, holding that the pleading was speculative and failed to provide sufficient material facts for the allegation of patent infringement.
In this case, the Plaintiff alleged that the Defendants infringed Canadian Patent Nos. 2,666,695, 2,544,457, 2,584,671, and 2,634,236 which relate generally to down hole drilling technologies. The Plaintiff’s claim identified the Defendants’ model names and listed the patent claims that were alleged to be infringed. After demanding … 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
On April 4, 2017, the Honorable Justice Birss of the High Court of Justice (Chancery Division) issued his decision in Unwired Planet International v Huawei Technologies,  EWHC 711 (Pat). The decision provides a comprehensive review of the application of Fair, Reasonable and Non-Discriminatory (FRAND) principles to the licensing of Standard Essential Patents (SEPs).… Continue Reading
In a previous blog post, we briefly discussed the LOT Network’s initiative in in the fight against patent assertion entities (PAEs), more commonly known as patent trolls. Since the publication of that post, the LOT Network has overhauled its member agreement and published new information and statistics on how the program is working to protect companies from PAEs We have provided below a brief summary of some of the key changes.… 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 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
On January 4, 2017, the Honourable Justice Locke of the Federal Court of Canada released his decision in Mediatube Corp. et al. v. Bell Canada, 2017 FC 6. This was a patent infringement action in respect of Canadian Patent No. 2,339,477 (the “‘477 Patent”) by the plaintiffs, NorthVu Inc. (patent owner) and MediaTube Corp. (licensee) against Bell Canada (including former Bell Aliant Regional Communications, Limited Partnership, together “Bell”). The plaintiffs alleged that Bell infringed the ‘477 Patent through the delivery of its digital Internet Protocol Television (“IPTV”) services called Fibe TV and FibreOp … 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
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
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
In May 2016, the Allied Security Trust, a non-profit industry group, announced the launch of the Industry Patent Purchase Program, otherwise known as IP3. This new initiative brings together technology industry leaders including Facebook, IBM, Microsoft, and Adobe, to establish a patent marketplace in an effort to create an opportunity for patent owners to both protect their intellectual property, and acquire valuable patents.
The IP3 follows the footsteps of previous initiatives by tech industry leaders, including an initiative spearheaded by Google last year, the Patent Purchase Promotion Program, that invited companies and start-ups to sell their patents to Google.… 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
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