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
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
The underlying purpose of the Federal Courts Rules is to ensure the just, most expeditious and least expensive determination of every proceeding. The Federal Court has released notices to the profession help achieve this underlying purpose.… 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 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 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
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
Litigants seeking to invalidate claims of a patent invariably allege that the invention claimed by the asserted patent would have been obvious to a person of ordinary skill in the art. An allegation of obviousness typically relies on a mosaic of prior art combined with the skilled person’s common general knowledge to show that the inventive concept would have been obvious. A recent decision of Justice Heneghan of the Federal Court has clarified the extent to which a party alleging obviousness has to particularize the specific combinations asserted to render the inventive concept obvious.
In Crude Solutions Limited et al … 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
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
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
In 1979, Dr. Robert Butler and his research team filed a Canadian patent application for the oil recovery technology known as Steam Assisted Gravity Drainage (“SAGD”). Over thirty years later, SAGD technology has become a formative oil-recovery process, with over two hundred patent applications filed in Canada relating to SAGD technology.
SAGD operations have increased primarily due to its potential to enhance bitumen recovery. Patent applications have been filed in respect of many aspects of SAGD technology, including the orientation of the wells, the composition of the wells themselves, and the infrastructure that is required to … Continue Reading
In Canada, innovator drug companies can protect their market exclusivity from generic copycats by asserting patents against the generic manufacturer in litigation under the PM(NOC) Regulations. Until now, the consequences of losing PM(NOC) litigation was the potential payment of damages to the generic whose market access was delayed by the litigation. These so-called “section 8 damages” are limited to the actual loss suffered by the generic during that specific period of delay. Public policy is such that the profits earned by the innovator during that period cannot, however, be disgorged pursuant to section 8 of the PM(NOC) Regulations.… 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
Patent disputes are on the rise. 101 patent infringement actions were filed in in the Federal Court in 2013 as compared with 48 patent infringement cases in 2012. As we explained previously, part of that increase is due to an increase in oil and gas patent litigation. This raises the question; what do you do when you discover that your patent has been infringed?
On April 23, we met with in-house counsel and other industry leaders at our new Calgary office to discuss the eleven steps that a patent holder in the oil and gas sector … Continue Reading
We recently posted an article reviewing the year past in oil and gas patent litigation. We analyzed new Federal Court cases and issued decisions and provided commentary on future implications. You can read that article here.
This article continues that analysis by looking backwards in time; specifically to oil and gas patent litigation for the years 2009-2012. What conclusions can be drawn if we look at a 5-year window of time?
The short answer is that 2013 was as busy a year for oil and gas patent litigation as the previous four years combined.
For the 2009-2012 timeframe there … Continue Reading
In 2013 the Federal Court experienced a surge in patent infringement actions. Whereas 48 patent infringement actions were filed in 2012, that number rose to 101 in 2013. Part of that increase came about because of growth in the oil and gas patent infringement sector. Put simply, oil and gas companies were more aggressive at enforcing their patent rights in 2013.
This blog is a review of oil and gas patent litigation in the year 2013. Specifically, we review each of the decided Federal Court cases released during the past calendar year, and provide an overview of the newly … Continue Reading
In recent years major Canadian retailers have been named as defendants in patent infringement lawsuits, including Wal-Mart (T-1841-11), Costco (T-1841-11), Canadian Tire (T-1002-12) and Home Depot (T-1112-13). The common thread linking these and other cases is that the plaintiff is asserting patent rights against a retailer that sells, but does not manufacture, allegedly infringing products in its stores.
Indemnity agreements between retailers and manufacturers who supply product are common. However, such agreements may not provide retailers with sufficient protection. Plaintiffs will often pursue retailers because they are more likely to satisfy a judgment than manufacturers. Sometimes, plaintiffs do not … Continue Reading
In a judgment pronounced on May 10, 2013, Justice O’Reilly of the Federal Court of Canada, granted Apotex’s claim against Pfizer for section 8 damages under Canada’s Patented Medicines (Notice of Compliance) Regulations, SOR/93-133. The sole issue before the Court was whether Apotex had a valid claim to damages. The amount is to be determined in a subsequent proceeding. For the full written decision see: Apotex v. Pfizer Canada Inc., 2013 FC 493.
The section 8 claim arises out of a failed prohibition proceeding. In early 2000, Apotex sought approval for its generic version of ZITHROMAX (azithromycin), … Continue Reading
Patent disputes have proliferated in Alberta. As the economy has levelled-off in recent years, patentees have increasingly sought to enforce patents as part of their business strategy. Threats of patent infringement have proliferated and infringement actions have been filed in all Courts, particularly the Federal Court. Companies in the oil and gas sector must be ready to respond quickly and properly to the threat of patent infringement.
On March 27, we met with in-house counsel and other industry leaders at our Calgary office to discuss effective responses to threats of patent infringement. By taking the 10 steps outlined below, … Continue Reading
The Federal Court of Appeal’s recent decision in Allergan, Inc. et al v. Apotex Inc. et al is the most significant decision on the question of obviousness to be rendered following the Supreme Court of Canada’s landmark decision in Apotex Inc. v. Sanofi‑Synthelabo Canada Inc. The Federal Court of Appeal’s decision is particularly significant for two reasons:
- The Court clarified when recourse to the specification is appropriate to construe the inventive concept of a claim; and
- The Court held that the determination of the inventive concept is a question of law.
Recourse to Specification
In Allergan the Federal Court … Continue Reading