Ms Nancy Pei

Nancy Pei

Updates

Healthcare & Life Sciences

Certificate of supplementary protection regime: second anniversary update
Canada | 23 October 2019

The certificate of supplementary protection (CSP) regime recently celebrated its second anniversary. This article looks back on the previous year and provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips, including (among others) that it is important to consider the possibility of a CSP early in the drug development and approval lifecycle.

Innovators commence court challenges regarding recent amendments to Patented Medicines Regulations
Canada | 16 October 2019

The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.

Canada releases final amendments to patented medicines pricing regulations
Canada | 11 September 2019

Health Canada recently announced the final amendments to the Patented Medicines Regulations. The amendments – which represent the first substantive revision to the regulations since their introduction in 1987 – are a significant departure from the existing framework and include new price regulatory factors, updated reference countries and changes in reporting requirements.

Life sciences intellectual property: 2019 mid-year highlights
Canada | 31 July 2019

The first half of 2019 has seen a number of changes to life sciences IP and regulatory law, including the proposed amendments to the Food and Drugs Act. In addition, the Advisory Council on the Implementation of National Pharmacare released its final report, which recommends that Canada implement a universal, single-payer, public pharmacare programme by enacting new legislation and proceeding in a stepwise approach to implementation.

Life sciences intellectual property: 2018 highlights
Canada | 06 February 2019

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.

Certificate of supplementary protection regime: first anniversary update
Canada | 31 October 2018

The certificate of supplementary protection (CSP) regime, which recently celebrated its first anniversary, was a long-awaited complement to the existing forms of protection for pharmaceutical products in Canada. As the regime is still new, companies are reminded to consider applying for a potential CSP for any planned new product in Canada early in the lifecycle planning.

Mid-year life sciences highlights
Canada | 15 August 2018

There have been a number of major highlights in Canadian life sciences law over the past six months, including the consultation on the proposed Regulations Amending the Patented Medicines Regulations. Among other developments, eight certificates of supplementary protection were issued and a number of new biosimilars were approved. Further, the creation of an Advisory Council on the Implementation of National Pharmacare was announced in February 2018.

Life sciences intellectual property: 2017 highlights
Canada | 07 February 2018

With major developments regarding patent linkage, patent term and other substantive patent issues, 2017 was one of the most significant years in history for Canadian life sciences IP and regulatory law. Highlights included the Supreme Court's striking down of the promise doctrine, the Canada-EU Comprehensive Economic and Trade Agreement amendments and the laying of the foundations to overhaul the Patented Medicine Prices Review Board regulations and guidance.

Canada releases proposed amendments to patented medicines pricing regulations
Canada | 10 January 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

New pharmaceutical patent linkage litigation scheme
Canada | 13 December 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.

Health Canada and Federal Court publish guidance on final regulations on patent linkage and term restoration
Canada | 18 October 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 | 27 September 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.

Regulatory and judicial round-up
Canada | 22 February 2017

There have been a number of recent regulatory developments in the healthcare sector, including the Supreme Court's dismissal of Teva's application for leave to appeal the Federal Court of Appeal's venlafaxine decision. Further, the Canadian Intellectual Property Office recently revised the antibody sections of the Manual of Patent Office Practice, and the Canadian Institute for Health Information announced the release of its reports on Canada's health and prescribed drug spending.

Bill C-30 to implement CETA: implications for pharmaceuticals
Canada | 07 December 2016

Following the recent signing of the Comprehensive Economic Trade Agreement (CETA), the minister of international trade tabled Bill C-30. One of the main provisions of the bill specifically relevant to pharmaceuticals is the proposal to amend the Patent Act by adding core certificate of supplementary protection provisions. Although CETA still requires a positive vote in the European Parliament before it can be provisionally applied, the bill could become law as quickly as the end of 2016.

Intellectual Property

Certificate of supplementary protection regime: second anniversary update
Canada | 04 November 2019

The certificate of supplementary protection (CSP) regime recently celebrated its second anniversary. This article looks back on the previous year and provides an updated summary of approvals, rejections and pending applications, as well as further reminders and tips, including (among others) that it is important to consider the possibility of a CSP early in the drug development and approval lifecycle.

Innovators commence court challenges regarding recent amendments to Patented Medicines Regulations
Canada | 14 October 2019

The recent amendments to the Patented Medicines Regulations have been the subject of two court challenges launched by groups of innovative pharmaceutical companies – one in the Quebec Superior Court and the other in the Federal Court. The applicants before the Quebec court brought a constitutional challenge to the Patented Medicine Prices Review Board provisions of the Patent Act and the regulations, while the applicants before the Federal Court challenged the validity of the amending regulations.

Canada releases final amendments to patented medicines pricing regulations
Canada | 09 September 2019

Health Canada recently announced the final amendments to the Patented Medicines Regulations. These amendments represent the first substantive revision to the regulations since their introduction in 1987 and are a significant departure from the existing framework. The amendments include new price regulatory factors, updated reference countries and changes in reporting requirements.

Life sciences intellectual property: 2019 mid-year highlights
Canada | 29 July 2019

Although the amendments to the Patented Medicines Regulations did not come into force as expected, a number of life sciences IP and regulatory law developments took place in the first half of 2019. For example, there were two Patented Medicines (Notice of Compliance) Regulations decisions on the merits, as well as a pair of appeal decisions. In addition, the Competition Bureau released its IP Enforcement Guidelines and Bill C-100 was published to implement the United States-Mexico-Canada Agreement.

Life sciences intellectual property: 2018 highlights
Canada | 04 February 2019

There have been a number of key developments in Canadian life sciences IP and regulatory law over the past 12 months, including a consultation on the different approaches to the naming of biological drugs. Among other developments, four biosimilars were approved, the Canadian Agency for Drugs and Technologies in Health announced revisions to its biosimilar and administrative review process and significant proposed amendments to the Patent Rules were released.

Certificate of supplementary protection regime: first anniversary update
Canada | 29 October 2018

The first anniversary of the certificate of supplementary protection (CSP) regime was 21 September 2018. CSPs, which provide an additional patent-like protection term, are intended to partly compensate innovators for the time invested in researching and obtaining regulatory approval in Canada. This article looks back on the previous year, recaps how the regime works and provides an update on the CSPs granted and rejected to date.

New patent term extension framework
Canada | 28 May 2018

The amendments to the Patent Act and the enactment of the Certificate of Supplementary Protection (CSP) Regulations flowing from the Canada-EU Comprehensive Economic and Trade Agreement introduced a new framework in Canada for the issuance of CSPs. CSPs provide an additional patent-like protection term and are intended to partly compensate innovators for the time required to research and obtain regulatory approval in Canada.

Canada releases proposed amendments to patented medicines pricing regulations
Canada | 15 January 2018

The governor in council recently published the proposed Regulations Amending the Patented Medicines Regulations. The proposed regulations represent a significant overhaul of the Patented Medicines Regulations and are estimated by Health Canada to result in savings of C$12.6 billion net present value over 10 years. While the regulations have yet to be adopted, companies should be factoring these potential changes into their business planning now.

Bill C-30 receives royal assent
Canada | 26 June 2017

Bill C-30 was passed by the Senate in May 2017. It implements the Canada-EU Comprehensive Economic and Trade Agreement. The bill recently received royal assent and became an act. However, apart from certain coordinating amendments, the act will not come into force until there is an order in council.

Bill C-30 ushers in changes to Canadian pharma patent regulations
Canada | 12 June 2017

The Senate recently passed Bill C-30 without amendment. The bill will implement the Canada-EU Comprehensive Economic and Trade Agreement and includes a number of IP law provisions – the most notable relating to the protection of pharmaceuticals. The provisions will come into force only once changes to the related regulations are registered.

Bill C-30 to implement CETA: implications for pharmaceuticals
Canada | 28 November 2016

Following the recent signing of the Comprehensive Economic Trade Agreement (CETA), the minister of international trade tabled Bill C-30. One of the main provisions of the bill specifically relevant to pharmaceuticals is the proposal to amend the Patent Act by adding core certificate of supplementary protection provisions. Although CETA still requires a positive vote in the European Parliament before it can be provisionally applied, the bill could become law as quickly as the end of 2016.

Life sciences IP update: 2015 highlights
Canada | 25 January 2016

This update highlights developments in Canadian life sciences IP and regulatory law in 2015, including the Federal Court's order for Apotex to pay Eli Lilly over C$100 million in damages for infringing sales of cefaclor and publication of the Regulations Amending the Patented Medicines (Notice of Compliance) Regulations to address court decisions that were inconsistent with the policy intent of the original regulations.

The year in review: 2014 highlights in pharmaceutical IP news
Canada | 19 January 2015

This update examines the key developments in Canadian pharmaceutical IP and regulatory law in 2014, including the approval of the first antibody SEBs; the reversal in part of the first two decisions quantifying Section 8 damages; heightened matching requirement for patent listing; a Competition Bureau white paper on patent litigation settlements; and the release of the text of CETA.

Patent term restoration for pharmaceutical and biologic patents
Canada | 17 November 2014

The text of CETA was recently released. Chapter 22 in particular includes provisions specifically affecting pharmaceuticals and biologics in three areas: patent term restoration, innovator's right of appeal under the Patented Medicines (Notice of Compliance) Regulations and data protection.

Text of CETA finalised – finally!
Canada | 26 August 2014

The Canadian government has announced that the text of the Comprehensive Economic and Trade Agreement between Canada and Europe has been finalised after many months of silence on the historic trade deal. Significant changes are expected to IP protection, including for geographical indications, pharmaceuticals and biologics.

Subsequent-entry biologic patent litigation commences
Canada | 09 July 2012

The first proceeding under the Patented Medicines (Notice of Compliance) Regulations for a subsequent-entry biologic was recently commenced. Amgen Canada Inc and Amgen Inc commenced the proceeding against Teva Pharmaceutical Industries Ltd, Teva Canada Innovation and the minister of health regarding Teva's proposed filgrastim product.

Supreme Court Upholds Selection Patent
Canada | 24 November 2008

In a unanimous decision in Apotex Inc v Sanofi-Synthelabo Canada Inc, the Supreme Court of Canada has upheld the validity of a patent claiming a single isomer despite the granting of an earlier patent claiming a broad genus which included the isomer, its mirror-image enantiomer and the mixture of the two (ie, the racemate).

Food and Drug Amendments Enhance Pharma Protection
Canada | 06 August 2007

Recent amendments to the Food and Drug Regulations have significantly enhanced the data protection available to the innovative pharmaceutical industry in Canada. The amendments prohibit the issuance of a notice of compliance (NOC) to a manufacturer that makes a direct or indirect comparison to an "innovative drug" until eight years after issuance of the innovator's first NOC for the innovative drug.

Federal Court Upholds Minister's Interpretation of Apotex Decision
Canada | 11 June 2007

The minister of health interpreted the Supreme Court's decision in Apotex Inc v AstraZeneca Canada Inc. Following the interpretation, several judicial review applications were commenced. However, on March 20 2007 the Federal Court dismissed all the judicial review applications, rendering a single set of reasons for all the applications.

Case Law Round-Up: Pharmaceutical Patents
Canada | 05 February 2007

The Federal Court of Canada has granted an application by Pfizer for an order of prohibition, finding that Novopharm's allegations that the atorvastatin calcium patent is invalid on the basis of anticipation, obviousness and double patenting were unjustified.

Ontario Flat 50 Pricing Rule Upheld
Canada | 30 January 2007

The Ontario Divisional Court has dismissed an application by Apotex for the judicial review of the amended regulations under the Ontario Drug Benefit Act and the Drug Interchangeability and Dispensing Fee Act. The amended regulations lowered the permissible price of generic products from 70% of the drug benefit price of the original product to 50%.

Pricing Board Asserts Jurisdiction During Laid-Open Period
Canada | 22 January 2007

The Patented Medicine Prices Review Board has held that the term 'for the time being' in the definition of 'patentee' under Section 79 of the Patent Act includes the laid-open period. This means that, once the patent issues, the board has jurisdiction to prevent excessive pricing during the laid-open period.

New Developments for Pharmaceutical Products
Canada | 08 January 2007

Health Canada has released revised Form IV: Patent List and Form V: Declaration re: Patent List Documents in light of sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations and the data protection provision of the Food and Drug Regulations.

Recent Decisions Relating to Pharmaceutical Patents
Canada | 04 December 2006

The Federal Court of Appeal has affirmed a lower court's decision that the patent covering lisinopril, which is marketed as Zestril by AstraZeneca and Prinivil by Merck, is valid. The attack on the patent's validity was based on the propriety of the filing of a voluntary divisional application for several compounds, including lisinopril.

Supreme Court Finds Apo-Omeprazole NOC Valid
Canada | 20 November 2006

The Supreme Court of Canada has issued its decision in Apotex Inc v AstraZeneca Canada Inc (2006 SCC 49), allowing Apotex's appeal of a Federal Court of Appeal decision that had quashed its notice of compliance for Apo-Omeprazole. The case turned on the interpretation of the Patented Medicines (Notice of Compliance) Regulations, specifically Section 5(1).

Amendments to Linkage and Data Protection Regulations
Canada | 30 October 2006

Sweeping amendments to the Patented Medicines (Notice of Compliance) Regulations and the data protection provision of the Food and Drug Regulations introduce a 'frozen' Patent Register under the amended regulations, combined with more restrictive patent listing requirements, a six-year no-filing period for generic submissions and an eight-year period of market exclusivity for innovative drugs.

Court Summarily Dismisses Prohibition Proceeding
Canada | 20 March 2006

In a decision relating to the medicine fenofibrate, a prothonotary summarily dismissed a prohibition proceeding pursuant to Section 6(5)(b) of the Patented Medicines (Notice of Compliance) Regulations, which allows dismissal "on the ground that the application is redundant, scandalous, frivolous or vexatious or otherwise an abuse of process".

Case Law Update
Canada | 06 March 2006

In a recent decision, the Federal Court of Appeal dismissed an appeal against a lower court ruling that prevented a generic from raising an allegation of invalidity after having unsuccessfully raised an allegation of non-infringement in respect of the same drug and the same patent.

Supreme Court of Canada Grants Apotex Leave to Appeal
Canada | 14 November 2005

The Supreme Court has granted Apotex leave to appeal a Federal Court of Appeal decision in AstraZeneca v Apotex which quashed its notice of compliance for Apo-Omeprazole capsules. The Federal Court of Appeal's decision turned on the interpretation of the 'marketed' requirement in Section 5(1) of the Patented Medicines (Notice of Compliance) Regulations.

Case Law Update
Canada | 26 September 2005

A judge has dismissed a company's application for a judicial review of the minister of health's decision that its patent was ineligible for listing on the Patent Register. The judge found that the patent related to a drug delivery system and not a particular medicine or use of a medicine, and therefore held that the minister's decision was correct.

Supreme Court Finds Biolyse is not Caught by Linkage Regulations
Canada | 13 June 2005

The Supreme Court of Canada has ruled that Biolyse's submission to Health Canada for approval to sell its prescription drug paclitaxel falls outside the scope of the Patented Medicines (Notice of Compliance) Regulations. Therefore, Biolyse needed only to comply with the Food and Drug Regulations to obtain a notice of compliance.

Legislation to Allow Exports of Patented Pharmaceuticals
Canada | 20 September 2004

Parliament has approved Bill C9, An Act to Amend the Patent Act and the Food and Drugs Act (the Jean Chrétien Pledge to Africa Act), making Canada the first country to implement the August 30 2003 decision of the World Trade Organization General Council, implementing Paragraph 6 of the Doha Declaration.

Proposals to Permit Exports of Patented Medicines to Developing Countries
Canada | 15 March 2004

The Canadian government has introduced proposed changes to the Patent Act and the Food and Drugs Act with the aim of facilitating access to pharmaceutical products, in order to address public health problems such as HIV/AIDS, tuberculosis, malaria and other epidemics afflicting developing and least-developed countries.

Appeal Court Overrules on Product-Specific Patent List Requirements
Canada | 10 February 2003

In a significant decision, Eli Lilly Canada v The Minister of Health, the Federal Court of Appeal determined that a patent can be listed on the Patent Register maintained pursuant to the Patented Medicines (Notice of Compliance) Regulations even if the patentee’s commercial formulation does not make use of the patented invention.