Smart & Biggar/Fetherstonhaugh updates

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • December 18 2017

The Federal Court recently found that the Patented Medicine Prices Review Board's assessment that a patent pertained to Galderma Canada's Differin was unreasonable, as it had failed to consider the entire patent. As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.

Recent developments in Alexion cases
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • December 18 2017

The Federal Court of Appeal recently heard Alexion's appeal of a decision striking out its constitutional challenge to the price regulation scheme and confiscatory powers found in the Patent Act. A decision is under reserve. Alexion also has a pending judicial review of the Patented Medicine Prices Review Board's decision that it sold Soliris (eculizumab) at excessive prices.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • December 13 2017

The Federal Court recently found that the Patented Medicine Prices Review Board's assessment that a patent pertained to Galderma Canada's Differin was unreasonable, as it had failed to consider the entire patent. As a result, the court quashed the board's decision requiring Galderma to file pricing information for Differin.

New pharmaceutical patent linkage litigation scheme
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • December 13 2017

The recent amendments to the Patented Medicines (Notice of Compliance) Regulations introduced a new scheme for pharmaceutical patent linkage litigation in Canada regarding generic challenges. The scheme is now much closer to the US Hatch-Waxman scheme, but with a number of key differences.

Court rejects Apotex's application for judicial review of omeprazole magnesium tablet submission
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 29 2017

The Federal Court recently rejected Apotex's application for judicial review regarding Health Canada's review of its omeprazole magnesium tablet regulatory submission. Apotex had applied for reconsideration, which was cancelled due to disagreement on an eligible question to pose to the reconsideration panel. Apotex had focused the question solely on safety and efficacy, while the minister of health had required that the question consider bioequivalence.

Patented Medicine Prices Review Board update
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 27 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Court declares that administrative errors during application cannot void issued patent
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 27 2017

The Federal Court of Appeal recently ruled that Pfizer's failure to pay the correct issue fee did not render its patent void. In the context of a Section 8 case, Apotex had brought a partial summary judgment motion to have Pfizer's patent declared void for failure to comply with the Patent Act. The court cited the general principle that "pre-patent issuance defects in the administrative process for applying for a patent cannot be relied upon by an alleged infringer to render a patent void".

Ontario bill proposes mandatory disclosure of financial relationships
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 22 2017

The Ontario legislature recently introduced Bill 160, which – if passed – will enact the Health Sector Payment Transparency Act 2017. The act will require the disclosure of financial relationships between healthcare professionals and pharmaceutical or medical device manufacturers and the reporting of various information. More details, such as the manner and frequency of reporting, will be prescribed by regulation.

Patented Medicine Prices Review Board update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 22 2017

The Patented Medicine Prices Review Board recently announced the release of a hearing panel's decision regarding the pricing of a breakthrough drug and the publication of a report which compares lists of drugs covered by the public drug plans to determine the extent of overlap in drug coverage. Further, in response to an unopposed request filed by the board to do so, a hearing panel discontinued an excessive pricing proceeding relating to Apotex's Apo-Salvent CFC Free.

Health Canada update
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 15 2017

Health Canada recently issued a notice of intent soliciting comments on possible changes to the Food and Drug Regulations relating to pharmaceutical equivalence and an updated notice on its interim policy regarding the interpretation of a medicinal ingredient. In addition, it recently solicited online comments regarding proposed pre-market transparency initiatives for human prescription drugs.

Government issues statement of intended actions to implement CETA
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 15 2017

Global Affairs Canada recently published its statement of intended actions regarding the implementation of the Canada-EU Comprehensive Economic and Trade Agreement, which has been provisionally applied since September 21 2017. The document summarises the Canadian government's position on its obligations and how it intends to implement the treaty. A number of the document's chapters are relevant to the pharmaceutical industry.

Idenix seeks leave to appeal from Supreme Court in SOVALDI dispute
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 13 2017

The Federal Court of Appeal recently affirmed a trial decision relating to two competing patents concerning Gilead's SOVALDI (sofosbuvir). The Court of Appeal upheld the validity of Gilead's Patent 2,527,657 and declared Idenix's Patent 2,490,191 invalid on the basis of insufficiency of disclosure and inutility. Idenix has applied to the Supreme Court for leave to appeal.

Pfizer obtains prohibition orders for polymorphic form patent
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • November 08 2017

The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.

AstraZeneca and overpromising on grounds other than utility
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 06 2017

The Supreme Court recently dismissed Apotex's motion to amend its judgment in AstraZeneca Canada Inc v Apotex Inc. Apotex had asked that the case be remanded to the Federal Court to determine whether overpromising has rendered the 653 Patent invalid. Two recent Federal Court decisions also illustrate attempts to raise overpromising as a ground of invalidity outside the promised utility doctrine rejected in AstraZeneca.

Pfizer obtains prohibition orders for polymorphic form patent
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • November 06 2017

The Federal Court recently granted prohibition orders preventing Apotex and Teva from marketing their generic o-desmethyl-venlafaxine products (based on Pfizer's Pristiq) until the expiry of Patent 2,436,668. The court held that Apotex's allegations regarding non-infringement and invalidity on the basis of obviousness, inutility, anticipation double patenting and overpromising and Teva's allegations of invalidity on the basis of obviousness and inutility were not justified.

New challenges and opportunities for pharmaceutical trademarks
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • October 23 2017

In Canada, trademarks for pharmaceutical preparations and related products have faced numerous challenges, some of which are unique to the industry. In addition, a number of important changes and new opportunities will be introduced by upcoming amendments to the trademark law, which are expected to come into force in 2019.

Supreme Court leave sought for decision refusing natural health product licence
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • October 18 2017

In May 2017 the Federal Court of Appeal set aside the order of mandamus compelling the minister of health to grant a licence to The Winning Combination Inc for its natural health product, Resolve, and remitted the matter back to the minister for redetermination. The Winning Combination recently applied to the Supreme Court for leave.

Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration
Smart & Biggar/Fetherstonhaugh
  • Healthcare & Life Sciences
  • Canada
  • October 18 2017

The government recently published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement. Health Canada has since published guidance regarding the application process under the new regulations. In addition, the Federal Court has published a practice notice regarding actions brought under the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations 2017.

Federal Court of Appeal applies Supreme Court's utility test to Sprycel patent
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • October 16 2017

The Federal Court of Appeal – in its first decision to consider the Supreme Court's landmark decision in AstraZeneca Canada Inc v Apotex Inc on the utility requirement – recently overturned a finding of inutility made under the promise doctrine, with practical guidance for the requirement of a scintilla of utility. Following the Supreme Court's decision, the Federal Court of Appeal reversed the Federal Court's decision, noting that the Supreme Court had unanimously abolished the promise doctrine.

Protecting your brand at the border: new reporting mechanism for dangerous counterfeit goods
Smart & Biggar/Fetherstonhaugh
  • Intellectual Property
  • Canada
  • October 09 2017

The Canada Border Services Agency, the federal organisation responsible for policing Canada's borders, recently issued a customs notice to advise the public and rights holders that its Border Watch hotline now accepts information and tips on dangerous counterfeit or pirated goods that are destined for Canada. This hotline is yet another tool available to rights holders that wish to protect their brands in Canada.

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