Ms Urszula Wojtyra

Urszula Wojtyra

Updates

Healthcare & Life Sciences

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Canada | June 06 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

New use patent valid and infringed by biosimilar
Canada | May 02 2018

The Federal Court recently upheld the validity of Kennedy Trust's patent covering a use of infliximab (Janssen's Remicade) and granted Kennedy's counterclaim that Hospira's biosimilar Inflectra had infringed the patent. This is the third patent infringement action decision relating to a biologic and the second on the merits relating to a biosimilar.

Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
Canada | April 11 2018

In 2016 the Federal Court found that Apotex and Cobalt had infringed Bayer's valid patent for an oral contraceptive composition. The Federal Court subsequently held that Bayer was entitled to elect between damages and an accounting of Apotex's profits. In so holding, the court disagreed with Apotex's argument that it, rather than Bayer, should be entitled to elect whether Bayer should be limited to recovering Apotex's profits. The Federal Court of Appeal recently dismissed Apotex's appeal of the latter decision.

Stakeholder consultation on naming of biologic drugs, including biosimilars
Canada | March 14 2018

Health Canada and the Institute for Safe Medication Practices Canada recently opened their consultation on different approaches to the naming of biologic drugs, including biosimilars. The consultation aims to gain insight into stakeholder views on the practical impacts of different approaches to the naming of biologic drugs and biosimilars throughout the medication use process, including prescribing, dispensing and adverse drug reaction reporting.

Ontario Bill 160 receives royal assent
Canada | February 14 2018

Ontario Bill 160, the Strengthening Quality and Accountability for Patients Act 2017, enacts or amends 10 statutes, including the Health Sector Payment Transparency Act 2017. The act will require payors – including manufacturers of pharmaceutical or medical devices – to report financial relationships with healthcare professionals and organisations, as well as other prescribed recipients.

Supreme Court dismisses Apotex's leave application
Canada | January 31 2018

​In April 2017 the Federal Court of Appeal overturned the Federal Court's conclusion that Apotex had failed to mitigate the loss that it incurred as a result of Health Canada's tortious conduct in considering Apotex's Apo-Trazodone drug submission. The Federal Court of Appeal otherwise dismissed the parties' appeals relating to Apotex's claims in negligence, misfeasance in a public office and contract. The Supreme Court recently dismissed Apotex's leave application.

Biosimilars update
Canada | January 24 2018

There were a number of developments concerning biosimilars in 2017. For example, Health Canada held a workshop and issued a report which notes that it intends to consult with stakeholders about the impact of the naming of biosimilars on prescribing, dispensing and pharmacovigilance needs. In addition, the Comprehensive Economic and Trade Agreement amendments have had an effect on biologics and numerous patent litigations involved biosimilars.

Recent developments in Alexion cases
Canada | December 20 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
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.

Updates from Health Canada
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.

Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration
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.

Publication of final regulations on patent linkage and term restoration relating to CETA
Canada | September 27 2017

The government recently published the final pharmaceutical regulations resulting from the Comprehensive Economic and Trade Agreement. According to an order in council, the new regulations will come into force on September 21 2017. The amended regulations mark a significant change to the environment for pharmaceutical companies in Canada, with long-lasting consequences for innovators in terms of exclusivity and drug product lifecycle management.

Recent Health Canada updates
Canada | August 16 2017

Recent Health Canada developments include new plain language labelling regulations for non-prescription drugs, proposed amendments to the Food and Drug Regulations, new regulations permitting the import of drugs to meet an urgent public health need and a consultation on changes to generic drug equivalence.

Competition Bureau report questions restrictions on healthcare advertising
Canada | November 16 2016

The Competition Bureau recently announced the release of its report on advertising restrictions in healthcare services. The bureau found that most regulators of these services tend to restrict advertising in some form, but that there is insufficient evidence to assess whether these restrictions are achieving their policy objectives.

Intellectual Property

Apotex fails to establish that it would have obtained non-infringing product from foreign suppliers
Canada | May 28 2018

Servier and its related company ADIR were recently successful in another chapter of the patent litigation concerning perindopril when the Federal Court again dismissed the non-infringing alternative defence of Apotex Inc and Apotex Pharmachem Inc (collectively, Apotex). The court found that Apotex would not have called on foreign third parties to manufacture perindopril to supply its affiliates in the United Kingdom and Australia and thus reaffirmed the quantum of profits from its original judgment.

New use patent valid and infringed by biosimilar
Canada | May 07 2018

The Federal Court recently upheld the validity of Kennedy Trust's patent covering a use of infliximab (Janssen's Remicade) and granted Kennedy's counterclaim that Hospira's biosimilar Inflectra had infringed the patent. This is the third patent infringement action decision relating to a biologic and the second on the merits relating to a biosimilar.

Federal Court of Appeal confirms patent infringer not entitled to dictate appropriate remedy
Canada | April 09 2018

In 2016 the Federal Court found that Apotex and Cobalt had infringed Bayer's valid patent for an oral contraceptive composition. The Federal Court subsequently held that Bayer was entitled to elect between damages and an accounting of Apotex's profits. In so holding, the court disagreed with Apotex's argument that it, rather than Bayer, should be entitled to elect whether Bayer should be limited to recovering Apotex's profits. The Federal Court of Appeal recently dismissed Apotex's appeal of the latter decision.

Biosimilars update
Canada | January 29 2018

There were a number of developments concerning biosimilars in 2017. For example, new certificates of supplementary protection now apply to biologics and numerous patent litigations involved biosimilars. In addition, Health Canada held a workshop and issued a report which notes that it intends to consult with stakeholders about the impact of the naming of biosimilars on prescribing, dispensing and pharmacovigilance needs.

Federal Court finds PMPRB unreasonable in determining that patent pertains to medicine
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
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.

AstraZeneca succeeds in omeprazole patent infringement profits case
Canada | October 02 2017

The Federal Court recently issued its public judgment and reasons concerning the financial compensation to be paid to AstraZeneca as a result of Apotex's infringement of the omeprazole formulation patent. AstraZeneca sought an account of Apotex's profits after the court found that the omeprazole formulation patent was valid and had been infringed during the liability phase. The remaining issues were decided in AstraZeneca's favour.

Federal Court issues decision in biologic patent infringement action
Canada | February 17 2014

The Federal Court recently rendered a decision in a biologic patent infringement action, finding AbbVie Corporation's patent valid and infringed by Janssen Inc's antibody drug Stelara (ustekinumab) used in the treatment of psoriasis. AbbVie does not market and does not have a notice of compliance for a drug containing ustekinumab for the treatment of psoriasis.

Federal Court upholds Lundbeck's escitalopram patent
Canada | April 22 2013

The Federal Court has dismissed an action brought by Apotex to impeach the patent claiming escitalopram (Lundbeck's Cipralex), declaring the patent to be valid and infringed by Apotex and Apotex Pharmachem, and granting certain remedies to Lundbeck. Escitalopram is the S-enantiomer of citalopram, a previously known compound.

Federal Court of Appeal upholds decision denying data protection for DEXILANT
Canada | March 04 2013

In a split decision, the majority of the Federal Court of Appeal dismissed Takeda's appeal and affirmed the minister of health's refusal to list DEXILANT (dexlansoprazole) on the Register of Innovative Drugs. The dissenting judge would have allowed the appeal, quashed the minister's decision and remitted the matter back to the minister for redetermination in accordance with the dissenting reasons.

Federal Court of Appeal provides further clarity on approach to inventive concept
Canada | December 17 2012

The Federal Court of Appeal recently dismissed a pharmaceutical company's appeal of a Federal Court decision granting an order prohibiting the minister from issuing a notice of compliance to it for its ophthalmic drug combining brimonidine and timolol. In doing so, the Federal Court of Appeal re-analysed the allegation of obviousness and commented on the doctrine of judicial comity.