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
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
On April 27th, 2015 Google announced the launch of its Patent Purchase Promotion. The “experiment,” as Google calls it, allows patent owners, or those otherwise authorized to sell a patent, to set a price for their patent and offer it for sale to Google. The Promotion is Google’s attempt to “remove friction from the patent market” and “help improve the patent landscape and make the patent system work better for everyone.” By offering to buy patents direct, Google is attempting to provide an alternative to the lure of selling one’s patent to a non-practicing entity, more commonly … 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
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