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 January 20, 2015, the US Supreme Court rendered its precedent-setting decision in Teva that reversed the Federal Circuit’s practice of reviewing all District Court claim constructions de novo on appeal. Instead the Supreme Court found that some decisions are entitled to deference as a consequence of certain factual findings that require Courts of Appeal to apply a “clear error” standard of review, and consequently, bringing the review of US claims constructions methodology more in line with the Canadian approach.… Continue Reading
On January 7, 2015, Justice de Montigny of the Federal Court released his judgment and reasons in Eli Lilly Canada Inc. v. Mylan Pharmaceuticals ULC, 2015 FC 17, allowing 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. 2,226,784 (the “‘784 Patent”). The patent relates to Lilly’s successful erectile dysfunction (“ED”) drug CIALIS® (tadalafil).
The Court found that Mylan’s allegations of invalidity on the basis of lack of utility and obviousness-type double patenting were unjustified. Justice de Montigny’s reasons signal the Court’s … 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 September 26, 2014, Prime Minister Harper announced that Canada and the European Union have successfully concluded negotiations on a new trade agreement, the Comprehensive Economic and Trade Agreement (CETA) that was five years in the making, and publicly released the consolidated text of the agreement.
CETA is deeper in substance and broader in scope than any other such agreement in Canadian history, significantly affecting all economic areas, including the pharmaceutical sector.
The CETA chapter on intellectual property is of particular interest to the pharmaceutical industry, because it will introduce into Canada for the first time:
- additional (sui generis
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
On July 2, 2014, Mr. Justice Rennie of the Federal Court released his judgment and reasons in Astrazeneca Canada Inc v. Apotex Inc., 2014 FC 638 dismissing AstraZeneca’s action for infringement and granting Apotex’s counterclaim for a declaration that Canadian Patent 2,139,653 (the “‘653 Patent”) is invalid. This patent relates to AstraZeneca’s successful drug NEXIUM® (esomeprazole).
Justice Rennie found the invention of the ‘653 Patent was novel and non-obvious, but nevertheless invalidated the patent for promising an improved therapeutic profile which was not soundly predicted.
While Justice Rennie canvassed a number of legal issues, his … 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
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
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?
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
McCarthy Tétrault is delighted to announce that Euromoney Legal Media Group’s Benchmark Canada named partners Andrew Reddon and Steven Mason as Canada’s Intellectual Property Litigators of the Year – Patents. The award is in recognition of Mr. Reddon and Mr. Mason’s exceptional knowledge of patents and superior trial skills. The pair’s recent successes include their representation of AbbVie in its patent infringement case against Janssen related to AbbVie’s Canadian patent on anti-IL-12 antibodies. This was Canada’s first antibody engineering trial, and the action was the first in Canada dealing with the scope of protection for the new class of … 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
On January 28, 2014, the Government of Canada signalled its intent to transform its intellectual property regimes by tabling five intellectual property law treaties in Parliament. If implemented into domestic law, these treaties would harmonize Canada’s trade-mark, patent and industrial design legislation with its major trading partners. Following a 21-sitting-day waiting period, the Government will be able to introduce legislation to implement these treaties. Such legislation will transform important aspects of the trade-marks practice in Canada, and will lead to significant changes in the industrial designs field as well.
Some key points and concerns about the treaties include the … Continue Reading
On January 24, 2014, the District Court released its reconsideration opinion again dismissing a previously-dismissed proposed antitrust class action against GSK and Teva under the “rule of reason” test set down in the 2012 U.S. Supreme Court’s Actavis decision.
In doing so, the Court made some important statements about Actavis:
- It does not allow scrutiny of all patent settlements with anticompetitive potential.
- It requires scrutiny only of patent settlements that contain “reverse payments”.
- A “reverse payment” must include the exchange of money.
GSK and Teva had settled patent litigation over LAMICTAL (lamotrigine) tablets, which are used to treat epilepsy … Continue Reading
Almost invariably, defendants in a patent lawsuit seek to examine the inventors of the patent or patents in issue. But, what do you do if an inventor resides in Canada? Generally, non-Canadian courts are not able to assert personal jurisdiction over Canadians and, therefore, cannot compel them to give evidence under oath for the purposes of a lawsuit. If a Canadian witness does not willingly provide evidence, commission evidence may be sought via the enforcement of what are called “letters of request”. Essentially, these represent a foreign court’s request that a Canadian court order someone to appear and be examined … Continue Reading
Canada and the United States are close neighbors. About 300,000 people cross the border each day, and bilateral trade amounts to about $1.6 billion in goods daily. It is not surprising that patent, and other intellectual property disputes, often involve some element of cross-border litigation. The Canadian litigation experience is relatively similar to the American experience. There are, however, some important differences that U.S. attorneys involved in such litigation should be aware of.
- Like in the United States, Canada has federal and provincial/state courts. Both can decide patent cases.
- Litigation process and procedure is dictated by the rules of civil