Dr Lynn Ing

Lynn Ing

Updates

Healthcare & Life Sciences

Update on PMPRB guidelines modernisation
Canada | 26 June 2019

The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.

Infringement based on making and selling under existing NOC struck from action
Canada | 26 June 2019

The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
Canada | 19 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
Canada | 19 December 2018

A Federal Court order has issued on a motion to strike that was brought by Sandoz in four actions relating to the infringement of rituximab patents. The court declined to strike out the claims for damages and an accounting of profits on the basis that, at law, such remedies are unavailable in such an action. The court's treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the Patented Medicines (Notice of Compliance) Regulations.

First judicial consideration of Vanessa's Law: Health Canada must disclose requested clinical trial data
Canada | 05 September 2018

In the first case calling upon a court to interpret and apply the Protecting Canadians from Unsafe Drugs Act (Vanessa's Law), the Federal Court ordered Health Canada to release requested complete copies of all sections of all clinical study reports and all electronic datasets from the clinical trials, including participant level datasets, for Gardasil, Gardasil 9, Cervaris, Tamiflu and Relenza.

New regulations governing post-market oversight of opioids
Canada | 18 July 2018

As part of a federal initiative to address the opioid crisis, the Regulations Amending the Food and Drug Regulations (Opioids) recently came into force, adding post-market oversight of prescription opioids. The minister of health can now impose terms and conditions on the market authorisation for listed opioids. The amendments also introduce a mandatory warning sticker and patient information handout for 'Class A' opioids (as set out in Part A of the List of Opioids).

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Canada | 04 July 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

Promise doctrine struck down and AstraZeneca's NEXIUM patent upheld as useful
Canada | 09 August 2017

The Supreme Court recently delivered an important and highly anticipated decision in AstraZeneca Canada by rejecting the so-called 'promise doctrine' and clarifying the requirement for patent utility in Canada. The unanimous decision represents an important victory for innovators seeking protection in Canada and is especially welcome in the highly litigated area of pharmaceutical patents.

CETA draft regulations on patent linkage and term restoration published for public comment
Canada | 02 August 2017

The government recently published the long-anticipated draft regulations regarding changes to the Patented Medicines (Notice of Compliance) Regulations and proposed Regulations to Implement Certificates of Supplementary Protection to compensate innovators for lost patent term due to regulatory delays. The proposed changes will herald a new environment for pharmaceutical companies, with long-lasting impact.

Apotex's infringement of AstraZeneca's omeprazole formulation patent upheld
Canada | 15 February 2017

The Federal Court of Appeal recently affirmed the validity of AstraZeneca's patent covering its successful product Losec, rejecting Apotex's arguments that the trial judge had adopted a fettered, results-oriented approach and improperly relied on the court of appeal's findings in a Patented Medicines (Notice of Compliance) case regarding the same patent.

Intellectual Property

Update on PMPRB guidelines modernisation
Canada | 01 July 2019

The Patented Medicine Prices Review Board (PMPRB) previously announced that the steering committee on guidelines modernisation would hold its final meeting on 13 May 2019 to discuss both a draft report of its deliberations and the working group's final report. Once the steering committee's report has been finalised and the regulatory amendments have been published in Part II of the Canada Gazette, the PMPRB will release its draft guidelines for public consultation.

Infringement based on making and selling under existing NOC struck from action
Canada | 01 July 2019

The Federal Court has granted in part Pharmascience's motion to strike out portions of Teva's statement of claim under Subsection 6(1) of the Patented Medicines (Notice of Compliance) (PMNOC) Regulations relating to glatiramer acetate (Teva's Copaxone and Pharmascience's Glatect). The court found that it is plain and obvious that Section 6.02 of the PMNOC Regulations prohibits the joinder of a regular infringement action under the Patent Act with an action pursuant to Subsection 6(1).

Court allows Sanofi and Schering to plead that Federal Court ramipril patent invalidity decision was flawed
Canada | 17 December 2018

The Ontario Court of Appeal recently overturned a motion judge's decision denying Sanofi and Schering leave to amend their defences to plead the Supreme Court of Canada's decision in AstraZeneca Canada Inc v Apotex Inc. The present action is one of several novel claims by Apotex seeking damages pursuant to the Ontario Statute of Monopolies and the UK Statute of Monopolies.

Divided success in Sandoz's motion to strike monetary remedies and other novel claims
Canada | 17 December 2018

A Federal Court order has issued on a motion to strike that was brought by Sandoz in four actions relating to the infringement of rituximab patents. The court declined to strike out the claims for damages and an accounting of profits on the basis that, at law, such remedies are unavailable in such an action. The court's treatment of the novel claims by Roche may be of interest to litigants under the current scheme of the Patented Medicines (Notice of Compliance) Regulations.

Apotex not entitled to reopen trial on esomeprazole (Nexium) patent validity
Canada | 18 June 2018

The validity of AstraZeneca's NEXIUM patent has finally been decided by the Supreme Court of Canada, with any doubt about the court's intent resolved by its dismissal of Apotex's motion to raise new grounds of patent invalidity. The court also held that AstraZeneca was entitled to a declaration of infringement and ordered the quantification of AstraZeneca's damages or Apotex's profits.

AstraZeneca and overpromising on grounds other than utility
Canada | 06 November 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.

Federal Court of Appeal applies Supreme Court's utility test to Sprycel patent
Canada | 16 October 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.

Promise doctrine struck down and AstraZeneca's NEXIUM patent upheld as useful
Canada | 14 August 2017

The Supreme Court recently delivered an important and highly anticipated decision in AstraZeneca Canada by rejecting the so-called 'promise doctrine' and clarifying the requirement for patent utility in Canada. The unanimous decision represents an important victory for innovators seeking protection in Canada and is especially welcome in the highly litigated area of pharmaceutical patents.

CETA draft regulations on patent linkage and term restoration published for public comment
Canada | 07 August 2017

The government recently published the long-anticipated draft regulations regarding changes to the Patented Medicines (Notice of Compliance) Regulations and proposed Regulations to Implement Certificates of Supplementary Protection to compensate innovators for lost patent term due to regulatory delays. The proposed changes will herald a new environment for pharmaceutical companies, with long-lasting impact.

Apotex's infringement of AstraZeneca's omeprazole formulation patent upheld
Canada | 13 February 2017

The Federal Court of Appeal recently affirmed the validity of AstraZeneca's patent covering its successful product Losec, rejecting Apotex's arguments that the trial judge had adopted a fettered, results-oriented approach and improperly relied on the court of appeal's findings in a Patented Medicines (Notice of Compliance) case regarding the same patent.

New guidance on diagnostic method claims
Canada | 27 July 2015

The Canadian Intellectual Property Office recently released guidance for the examination of diagnostic method claims in which it has adopted a problem and solution approach. Two types of problem are discussed, along with non-exhaustive factors that may indicate their existence, and potential solutions to data acquisition problems are also provided.

New Patent Office guidance on medical use claims
Canada | 20 April 2015

The Canadian Intellectual Property Office has released revised guidance on examination of medical use claims. The revised guidance supersedes the previous practice notice and follows the Federal Court's decision in AbbVie Biotechnology Ltd v Canada, providing welcome clarification.

Federal Court revisits issue of medical use
Canada | 16 February 2015

The Federal Court recently allowed an appeal of a refusal from the commissioner of patents on the basis that the claims at issue covered a method of medical treatment. The court held that the claims – for use of a known drug, at a specified fixed amount and fixed interval – were patentable. This decision offers further clarification in the area of dosage claims and methods of medical treatment.