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
On June 8, 2015, the Minister of Industry introduced Bill C-65, with the short title Support for Canadians with Print Disabilities Act. This Bill amends provisions of the Copyright Act dealing with exceptions intended to facilitate access to alternate format works by the visually impaired and other persons with so-called “print disabilities”. These changes are intended to implement (and enable Canada to accede to) the Marrakesh Treaty, as announced in the federal budget. (See pp. 21, 281, 286.)
The proposed amendments broaden the exception in section 32, including by removing the exclusion of large print books … 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
In 2008, the Internet Assigned Numbers Authority (“IANA”), the nonprofit organization overseeing global IP address allocation, began the process of creating and auctioning new top-level domains. Since then, the Internet Corporation for Assigned Names and Numbers (“ICANN”), has confirmed a number of new ‘generic’ top level domains (“gTLD”), including two new “community-based gTLDs” for the financial services community, <.bank> and <.insurance>. “Community-based gTLDs” are top level domain names that are restricted to a specific community. fTLD Registry Services, LLC (“fTLD”), an organization founded and operated by a consortium of banks and insurance … 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 14, 2015, the Federal Court of Appeal released its reasons and judgment in Philip Morris Products S.A. v. Marlboro Canada Limited, 2015 FCA 9. The Court dismissed the appeal, finding that Justice de Montigny of the Federal Court made no reviewable error in awarding the respondents over $1 million in legal costs and disbursements. The award amounted to nearly half of the respondents’ actual costs.… 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
Copyright infringement is normally a factual question – it doesn’t matter whether one intended to copy a substantial part of someone else’s original expression if, in fact, one did so – but there are circumstances where the alleged infringer’s state of mind does matter. Knowledge is relevant to secondary infringement under s. 27 of the Canadian Copyright Act, or to the assessment of statutory damages under s. 38.1, for example. Willful infringement may also be relevant to the applicable limitation period, to the assessment of costs or punitive damages, or to piercing the corporate veil.… Continue Reading
On December 31, 2014, the Canada Gazette published an order proclaiming into force sections 2, 5 and 6, subsection 7(6) and sections 43, 44 and 60 of the Combating Counterfeit Products Act, c. 32, S.C. 2014, as of January 1, 2015. The Act itself received Royal Assent on December 9, 2014.
The principal effect of this order is to bring into force new border enforcement measures intended to combat the importation or exportation of trade-mark or copyright-infringing goods. These measures involve three main features:
- Prohibitions on importation and exportation of infringing copies or goods under the Copyright
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
The Supreme Court granted leave to appeal on September 4, 2014 in another copyright case, Canadian Broadcasting Corporation / Société Radio-Canada v. SODRAC 2003 Inc. The appeal is from the decision of the Federal Court of Appeal which ruled that broadcasters must pay royalties for ephemeral recordings in accordance with the 1990 decision of the Supreme Court in Bishop v. Stevens.
In the Court of Appeal, CBC argued that Bishop v Stevens was no longer good law, having been overruled by a series of decisions of the Court which had, in various circumstances, made references to the … Continue Reading
On July 10, 2014 the Court of Justice of the European Union (the “CJEU”) issued its decision in Apple Inc. v. Deutsches Patent und Markenamt and recognized the possibility to register a three-dimensional representation of the design and layout of a retail store as a Community Trade Mark.
In May 12, 2010, Apple Inc. (“Apple”) filed two applications for marks that are described mainly as the design and layout of a retail store. The United States Patent and Trademark Office (the “USPTO”) granted registration on January 22, 2013. The trademarks are each … Continue Reading
An employee takes a photograph of a customer on the employer’s premises. The employee has a signed employment agreement which states that all materials developed during the term of the contract are property of the employer. The employer obtains a copy of the photograph and uses it in social media. Later, the employee is terminated for cause.
The former employee sues for copyright infringement and, in the case of Mejia v. LaSalle College International Vancouver Inc., 2014 BCSC 1559, wins. (The case also involved wrongful dismissal and defamation claims which were unsuccessful.)… 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