Print Increase Font Size

Expertise

Life Sciences

The rapid evolution of life sciences industries continues to raise important legal, ethical and scientific issues. At Ogilvy Renault, our seasoned lawyers, patent agents and trade-mark agents provide legal and technical advice to a diverse clientele in the life sciences sector, including universities, research centres, hospitals, venture capitalists, multinational corporations and start-up and mid-size companies.

Our life sciences practitioners have in-depth knowledge of the industries they serve and a clear understanding of the business goals of companies at every stage of their growth. We can meet all of a company's legal needs through every step of a product's life cycle. We also anticipate and analyze emerging issues to assist life sciences companies in meeting the challenges of critical change.

Team

Our life sciences team of over 65 practitioners, many with advanced science degrees and industry experience, is renowned for its depth of expertise in this field.

We represent clients in the biologics and biopharmaceuticals, prescription and over-the-counter pharmaceuticals (human and veterinary), natural health products, nutraceuticals, medical devices, foods, cosmetics, and agriculture sectors of the life sciences industry.

Services

Our Life Sciences practice spans the firm's four major practice areas of Intellectual Property, Business, Litigation, and Employment and Labour. Our services include:

Client Work
Kiacta Sàrl to Acquire and License Kiacta(TM) from Bellus Health

Counsel to Celtic Therapeutics Holdings, L.P. and Kiacta Sàrl in connection with the acquisition and license from Bellus Health of the worldwide rights related to the Phase III investigational product candidate Kiacta(TM)(eprodisate).  More

CTI Life Science Fund Completes First Tranche of Investment in Zymeworks

Counsel to CTI Life Science Fund in the context of a multi-tranche private placement of $3.2M principal amount secured convertible debentures of Zymeworks Inc.  More

Sanofi-aventis to Acquire Canderm Pharma

Counsel to Sanofi-aventis Canada Inc. in connection with its purchase of the assets of Canderm Pharma Inc.  More

OMERS and Dutch pension fund, ABP, Establish €200 Million Fund for Canadian and Dutch Start-Ups

Counsel to OMERS, a Canadian pension fund, in connection with a unique joint venture with Dutch pension fund, ABP, to establish an investment program to deploy €200 million in Canada and the Netherlands over the first five years to invest in knowledge eco  More

Valeant and Biovail Agree to Merge

Canadian counsel to multinational specialty pharmaceutical company Valeant Pharmaceuticals in its announced $US3.2 billion merger with Biovail, Canada's largest publicly traded pharmaceutical company.  More

Labopharm Establishes Joint Venture with Gruppo Angelini for the Commercialization of OLEPTRO(TM)

Counsel to Labopharm Inc. in connection with the establishment of a joint venture with Gruppo Angelini for the commercialization of its once-daily trazodone drug.  More

Labopharm and Angelini to Establish Joint Venture to Commercialize OLEPTRO(TM) in the United States

Counsel to Labopharm in establishing a joint venture with Angelini to commercialize antidepressant OLEPTRO(TM)in the US.  More

Aeterna Zentaris Completes US$15 Million Registered Direct Offering of Common Shares and Warrants

Counsel to Aeterna Zentaris Inc. in the issuance in the United States of an aggregate amount of US$15 million of units comprised of common shares and common share purchase warrants by way of registered direct offering.  More

Trillium Therapeutics and Biogen Idec Enter into Global Licensing Agreement

Counsel to Trillium Therapeutics in regards to a definitive license agreement with Biogen Idec, granting Biogen exclusive worldwide rights to one of Trillium's development programs.  More

Valeant Canada Limited Acquires Laboratoire Dr Renaud

Counsel to Valeant Canada Limited and Valeant Pharmaceuticals North America in connection with the $23 million acquisition of Laboratoire Dr Renaud and Renaud Skin Care Laboratories.  More

OPMEDIC Group Completes $4 Million Underwritten Private Placement and Secondary Offering

Counsel to OPMEDIC Group Inc. and the selling shareholders in an underwritten private placement of $2.1 million of new common shares and a concurrent underwritten secondary offering private placement of approximately $1.9 million of common shares sold by  More

Pfizer Wins Order Preventing Genericization of its Ophthalmic Drug XALATAN®

Counsel to Pfizer in successfully preventing genericization before Canadian patent expiry of its best-selling glaucoma treatment XALATAN® (latanoprost) by Pharmascience Inc.  More

Warner Chilcott Acquires Procter & Gamble's Worldwide Pharmaceutical Business for US$3.1 Billion

Canadian counsel to Warner Chilcott plc in its acquisition and financing of Procter & Gamble's worldwide pharmaceuticals business for US$3.1 billion  More

Strategic Collaboration between Haemacure and Angiotech

Counsel to Haemacure Corporation in connection with a strategic collaboration providing Angiotech with certain license, distribution and supply rights related to Haemacure's all-human fibrin sealant and thrombin products  More

Baylis Medical Company Acquires Fralex Therapeutics

Counsel to Baylis Medical Company Inc., a leading supplier of high-technology cardiology, pain management, and radiology products, in connection with its acquisition of Fralex Therapeutics Inc., a medical technology company.  More

Kimberly-Clark Acquires Baylis RF Pain Management System from Baylis Medical Company

Counsel to Baylis Medical Company Inc., a leading supplier of high-technology cardiology, pain management, and radiology products, in connection with the sale of its worldwide pain management business to Kimberly-Clark Corporation  More

CTI Life Science Fund Completes Private Placement

Counsel to CTI Life Science Fund, L.P. in the context of a private placement of a $1.25M principal amount secured convertible debenture of Zymeworks Inc., the first of a two-tranche investment totalling $2.5M.  More

Aeterna Zentaris Completes Second Registered Direct Offering of Common Shares and Warrants

Counsel to Aeterna Zentaris Inc. in the issuance in the United States of an aggregate amount of US$5.5 million of units comprised of common shares and common share purchase warrants by way of registered direct offering.  More

Enobia Pharma Raises US$50 Million in Series C Multi-Tranche Private Equity Financing

Counsel to Enobia Pharma in the context of a US$50 Million Series C multi-tranche private equity financing.  More

License, Development and Supply Agreement between Bioniche Life Sciences, Bioniche Urology and Endo Pharmaceuticals

Counsel to Bioniche Life Sciences and Bioniche Urology in connection with the US license, development and supply agreement with Endo Pharmaceuticals for Bioniche's lead drug candidate UrocidinT, a Mycobacterial cell wall-DNA complex which Bioniche Life Sc  More

Aeterna Zentaris' Registered Direct Offering of Common Shares and Warrants

Counsel to Aeterna Zentaris Inc. in the issuance, in the United States, of units comprised of common shares and common share purchase warrants by way of registered direct offering, for gross proceeds of US$10 million.  More

Merck Frosst Wins Federal Court Appeal Decision Against Apotex Under Section 8 of the PM(NOC) Regulations

Counsel to Merck Frosst in connection with its successful appeal of the first trial decision under Section 8 of the Patented Medicines (Notice of Compliance) Regulations.  More

Enobia Completes Third Tranche of its $40.1M Private Financing

Counsel to Enobia Pharma, a biopharmaceutical company developing therapeutics for the treatment of severe orphan disorders affecting the bone, for the third tranche of its private financing.  More

Federal Court Declares Servier's Patent Valid and Infringed

Represented Servier Canada in its perindopril patent infringement claim against Apotex, resulting in the dismissal of Apotex's invalidity counterclaim and the issuance of a permanent injunction.  More

Valeant Canada is Granted Commercialization Rights in Canada to Xyrem® by Jazz Pharmaceuticals

Successfully represented Valeant Canada in acquiring Canadian commercialization rights for Xyrem® (sodium oxybate) in oral solution from Jazz Pharmaceuticals. Xyrem® is used in the treatment of narcolepsy.  More

Merck Successfully Defends Patent for Lisinopril

Represented Merck in a successful patent case in which the Federal Court of Appeal maintained a trial judgment that found Merck's patent for the medicine Lisinopril to be valid and infringed by Apotex Inc.  More

Æterna Zentaris Inc. Sells Rights Related to Miltefosine to Paladin Labs

Represented Æterna Zentaris in its $9.125 M definitive purchase and sale agreement with Paladin Labs.  More

Tranzyme Pharma Completes Second Tranche of Financing

Tranzyme, Inc. and Tranzyme Pharma Inc. received US$10 million on the closing of this second tranche.  More

Three Biopharmaceutical Companies Complete Rounds of Private Equity Financing

Ogilvy Renault represented Tranzyme Pharma, Enobia Pharma, and Topigen Pharmaceuticals.  More

Atrium Sells Active Ingredients and Specialty Chemicals Division to AXA Private Equity

Represented Atrium Innovations in the sale of its Active Ingredients and Specialty Chemicals division to AXA Private Equity for total proceeds of US$166,400,000.  More

Kendle International Inc. Acquires DecisionLine Clinical Research Corporation

Represented Kendle in its acquisition of DecisionLine through a wholly owned Canadian subsidiary.  More

Inmar, Inc. Acquires USF Processors

Acted as Canadian counsel  More

Acted as Counsel to Tranzyme Pharma, Leading Biopharmaceutical Company

In connection with its US$32 million financing  More

Æterna Zentaris Offers Subordinate Voting Shares of Atrium Biotechnologies Inc.

Acted for the Quebec City-based biopharmaceutical company in its $55 million secondary offering  More

UCB SA Take-Over Bid to Acquire German-based Schwarz Pharma Aktiengesellschaft

Acted as Canadian counsel to the Belgium-based biopharmaceutical company  More

Events
Canadian Pharmaceutical Pricing and Reimbursement Conference

Penny Bonner is a panellist at this conference.  More

BioContact Québec 2010

Pierre Soulard will sit on a panel addressing innovative funding and partnership opportunities.  More

ACCT (Alliance for Commercialization of Canadian Technology) 2010 Directors Forum

Jay Lefton is a speaker at this conference.  More

Legal Matters Seminar Series - The New (Gene Patent) Economy: What the Myriad Decision Means for Your Business and Health

Join Ogilvy Renault's Joan Van Zant and Jeremy Grushcow as they provide insights on the BRCA gene case, the situation it has created and what the prospects are for gene technology from the patenting and commercialization perspectives.  More

BioFinance 2010

Jeremy Grushcow is the moderator of the session ''Alternative Financing Panel'' and Joan Van Zant is a panelist for the session ''Patents - Maximizing Market Exclusively''.  More

McMaster University - DeGroote School of Business

Jason Markwell and Jill Daley will give a lecture on intellectual property law in the pharmaceutical industry.  More

Pharma Patents: Cutting Edge Legal Analysis to Strengthen Your Pharma Patent Strategy

Nadine D'Aguiar and Jason Markwell will speak on topics that will help companies bolster their pharma patent strategy.  More

Canadian Science Policy Conference

Ogilvy Renault is a community sponsor of the conference and Jeremy Grushcow will be moderating one of the panels.  More

Growing Your Business

Jeremy Grushcow and Christopher Hunter present a session on Licensing and Strategic Partnerships in the Life Sciences sector.  More

IP Strategies for Medical Devices

Christopher Hunter and Christine Wong lead this seminar on intellectual property and medical devices as part of the MaRS Best Practices series.  More

Biomedex 2008

Jacques Lemieux moderates the Ogilvy Renault-sponsored Success Stories workshop, featuring panelists from Biolactis, Biosyntech Canada inc., and Variation Biotechnologies Inc.  More

Publications
Federal Court Denies Prohibition Order and Finds Patent Obvious [GLUCONORM® (repaglinide)]

On July 15, 2010, the Federal Court dismissed an application by Novo Nordisk Canada Inc. and Dr. Karl Thomae GmbH for an order prohibiting the Minister of Health from issuing a notice of compliance to Cobalt Pharmaceuticals Inc. in respect of...  More

Exemptions for Unlicensed Natural Health Products

Canada's Natural Health Products Regulations have been in force since 2004. However, there are an estimated 11,700 natural health product licence applications pending with Health Canada.  More

Court of Appeal holds that ''Invalid Selection Patent'' is not an independent basis to invalidate a patent (ZYPREXA®)

On July 21, 2010, the Federal Court of Appeal set aside the trial decision of Justice O'Reilly and held that Canadian Patent No. 2,041,113 is not invalid for ''invalid selection'', obviousness, double patenting, inutility or insufficiency.  More

Federal court confirms that a notice of allegation is not a confidential document

On June 21, 2010, Mr. Justice Crampton of the Federal Court dismissed an appeal by Novopharm Limited and affirmed the prothonotary's finding that a notice of allegation is not a confidential document under Canadian law.  More

Federal Court finds patent obvious and not soundly predicted

On June 30, 2010, the Federal Court dismissed AstraZeneca's application for an order prohibiting the Minister of Health from issuing a Notice of Compliance to Apotex in respect of its generic version of esomeprazole (NEXIUM) until after the expiry of...  More

Federal Court of Appeal holds that Patent Dedication to be assessed as of date of hearing, not earlier

On June 22, 2010, the Federal Court of Appeal granted Abbott's cross-appeal and dismissed Sandoz's appeal stemming from a decision of the Federal Court.  More

Federal Court holds PM(NOC) Findings Not Necessarily Irrelevant in Subsequent Patent Actions [VIAGRA® (sildenafil citrate)]

On June 11, 2010, Prothonotary Aalto of the Federal Court dismissed a motion by Apotex seeking to strike allegations of res judicata, issue estoppel, collateral estoppel, comity and abuse of process from Pfizer's Statement of Defence in an impeachment act  More

Federal Court of Appeal: Section 8 damages do not arise if a prohibition order is set aside after an impeachment action [NAPROXYN SR® (naproxen)]

On June 10, 2010, the Federal Court of Appeal dismissed Apotex Inc.'s appeal from the decision of Hughes J., who had dismissed Apotex's damages action under section 8 of the NOC Regulations in respect of the drug NAPROXYN SR.  More

Ontario slashes the price of generic drugs and abolishes the payment of professional allowances to pharmacies

On June 7, 2010, the Government of Ontario adopted Regulations that will reduce the price of generic drugs in the province and abolish the payment of professional allowances to pharmacies.  More

Natural Health Products Update

The commercial and legal concerns caused by the delay between an application being made for a natural health product licence and the issuance of that licence (a delay of years in some cases) may now be resolved by the newly-proposed Natural Health...  More

Federal Court upholds XALATAN® patent and grants prohibition order to Pfizer [XALATAN® (latanoprost)]

On April 26, 2010, the Federal Court granted Pfizer Canada Inc. and Pharmacia Aktieblolag's application for an order prohibiting the Minister of Health from issuing a notice of compliance to Apotex Inc. in respect of a generic...  More

Federal Court holds that Notice of Allegation is not a confidential document

On April 14, 2010, Prothonotary Milczynski of the Federal Court dismissed a motion by Novopharm Limited ("Novopharm") for an Order designating its notice of allegation as ''confidential information'' under the terms of a Protective Order.  More

Supreme Court of Canada Grants Leave to Appeal in a Case Concerning the Jurisdiction of the PMPRB [THALOMID® (thalidomide)]

On April 22, 2010, the Supreme Court of Canada granted Celgene Corporation's application for leave to appeal the decision of a majority of the Federal Court of Appeal regarding the jurisdiction of the Patented Medicine Prices Review Board...  More

Canada's Patented Medicines Prices Review Board Extends Jurisdiction into the United States

A recent decision of the Canadian Federal Court of Appeal in Canada (Attorney General) v. Celgene Corporation appears to have extended the jurisdiction of theCanadian Patented Medicines Prices Review Board to includesales from patentees in the...  More

Health Canada releases Statistical Data for the PM(NOC) Regulations and Data Protection

Health Canada recently issued its annual report pertaining to the administration of the Patented Medicines (Notice of Compliance) Regulations and the data protection provisions of the Food and Drug Regulations.  More

Supreme Court Denies Leave to Apotex re: COVERSYL® Patent

On March 25, 2010, the Supreme Court of Canada denied Apotex Inc.'s application for leave to appeal from a decision of the Federal Court of Appeal in which it was held that Servier's Canadian Patent was valid and infringed by Apotex Inc.'s use...  More

Patent Listing - Important Issues That You Should Consider

For some practitioners, questions related to patent listing are just another item on the post-allowance checklist. If that sounds familiar, you may be surprised to hear that in many cases waiting until after allowance might be too late.  More

Court Denies Motion for Mareva Injunction in a Section 8 Damages Action

On March 2, 2010, the Federal Court denied a motion brought by Novopharm Limited seeking a Mareva injunction enjoining Eli Lilly Canada Inc. from transferring its revenues to its parent company, Eli Lilly and Company.  More

Health Canada Releases Finalized Guidance Document For Subsequent Entry Biologics

On March 8, 2010, Health Canada released the finalized version of its Guidance Document on the approval of Subsequent Entry Biologics. The finalized Guidance Document follows the original and revised draft Guidance Documents, released on January...  More

Court Holds That Innovators Have No Duty Of Care To Consumers Of Generic Drugs

A proposed class action was commenced against Pfizer Canada Inc. et al. for alleged negligence relating to the manufacture and sale of Neurontin (gabapentin).  More

Pharmaceutical Pricing and Reimbursement in Canada: An Overview for Innovative Drug Manufacturers

Navigating through the labyrinth of pricing regimes poses a significant challenge to drug manufacturers in Canada.  More

Supreme Court Of Canada Denies Leave To Apotex. Liability Under Section 8 Of The Noc Regulations Is Now Clarified.

On January 28, 2010, the Supreme Court of Canada denied Apotex's application for leave to appeal from the first appellate decision concerning the scope of liability under section 8 of the Patented (Notice of Compliance) Medicines Regulations...  More

Federal Court Confirms That Deputy Judges Over the Age of 75 Are Permissible

On January 26, 2010, the Federal Court ruled that persons older than 75 years of age are permitted to sit as Deputy Judges of the Federal Court and the Federal Court of Appeal.  More

Federal Court Denies Prohibition Order - Patents Not Infringed [Desloratidine (Aerius®)]

On December 22, 2009, the Federal Court dismissed an application for an Order preventing the Minister of Health from issuing a notice of compliance to Pharmascience Inc. in respect of a generic version of Schering-Plough's desloratidine drug ...  More

Country Q&A - Canada 2009/2010

Written by Penny S. Bonner, Martha A. Healey, Judith Robinson and Teresa J. Walsh, this section of PLC's Cross-border Handbook on Life Sciences examines pertinent life sciences topics as they relate to Canada.  More

Federal Court Of Appeal Extends The Jurisdiction Of The PMPRB To Include Sales From The U.S.A. [Thalomid (Thalidomide)]

On December 23, 2009, the Federal Court of Appeal allowed the Attorney General's appeal from the decision of Campbell J. and restored the order of the Patented Medicine Prices Review Board.  More

Federal Court Rejects All Allegations of Invalidity and Grants Prohibition Order to Pfizer [XALATAN® (latanoprost)]

On December 18, 2009, the Federal Court granted an application by Pfizer Canada Inc. and Pharmacia Aktieblolag for an order prohibiting the Minister of Health from issuing a notice of compliance to Pharmascience Inc. in respect...  More

Federal Court Upholds Commissioner's Decision To Refuse To Grant A Patent On The Ground Of Obviousness Double Patenting

On December 8, 2009, the Federal Court dismissed an appeal by Bayer of a decision of the Commissioner of Patents refusing to grant a patent for Patent Application No. 508,336 on the basis of obviousness double patenting.  More

Federal Court Holds That Formulation Patents Must Claim All Medicinal Ingredients In Order To Be Eligible For Listing [Yaz (Drospirenone/Ethinyl Estradiol)]

On November 17, 2009, Justice Russell of the Federal Court dismissed Bayer Inc.'s application for judicial review of the Minister of Health's decision that Canadian Patent No. 2,194,979 was ineligible for listing on the Patent...  More

Federal Court of Canada Sets Aside 'Unreasonable' Decision of the PMPRB

On November 12, 2009, Hughes J. of the Federal Court allowed the judicial review applications of Teva Neuroscience G.P.-S.E.N.C. and sent the decisions back to the Patented Medicines Prices Review Board for...  More

Federal Court Considers a Patent Disclaimer Filed After the Receipt of a Notice of Allegation

On October 22, 2009, Justice Zinn of the Federal Court dismissed sanofi-aventis Canada Inc.'s application for an order of prohibition. In doing so, Justice Zinn considered several issues relating to disclaimers including: the date at which...  More

Federal Court Finds That Generic Manufacturer is Estopped From Re-litigating Patent Validity in Regard to a Related Product

On October 19, 2009 Justice Martineau of the Federal Court held that Apotex's notice of allegation (''NOA'') in respect of Canadian Patent No. 2,041,113 (the ''Patent'') and the drug ZYPREXA was null, void and of no effect, as Apotex had previously...  More

Federal Court Invalidates Selection Patent for Zyprexa (Olanzapine)

On October 1, 2009, Justice O'Reilly of the Federal Court held that Canadian Patent No. 2,041,113 was an invalid selection patent on the basis that the advantages of olanzapine in comparison to a previously disclosed genus and other...  More

Importation of Product Made by a Patented Process is an Act of Infringement

On October 1, 2009, after twelve years of litigation and a six-month trial, Justice Gauthier of the Federal Court held that Apotex Inc. had infringed eight Canadian patents pertaining to the drug CECLOR® (cefaclor) by using Lilly's patented...  More

Data Protection: Generics Appeal The Federal Court Decision Upholding Canada's Data Protection Regulations

On September 11, 2009 Apotex Inc. filed a Notice of Appeal with the Federal Court of Appeal to set aside the decision of Mr. Justice Mandamin dated July 17, 2009, which upheld the validity of section C.08.004.1 of the data protection provisions in the...  More

Focus on Innovation: Life at MaRS

Innovation and research are fundamental to a thriving economy. Ogilvy Renault is proud to support MaRS and to be actively involved with innovation in Canada.  More

Federal Court Grants Prohibition Order: Allegations Regarding Oxycontin® Patent Not Justified

On July 17, 2009, the Federal Court (Harrington J) allowed an application by Purdue Pharma under section 6 of the Patented Medicines (Notice of Compliance) Regulations and prohibited the Minister of Health from issuing a Notice of Compliance...  More

Federal Court Finds Norvasc® Patent to be Invalid

On July 8, 2009, the Federal Court granted ratiopharm inc. a declaration under section 60(1) of the Patent Act that Canadian Patent No. 1,321,393 is invalid.  More

Federal Court of Canada Upholds Data Protection Regulations

On July 17, 2009, Mandamin J. of the Federal Court of Canada dismissed the judicial review applications of the Canadian Generic Pharmaceutical Association and Apotex Inc. and upheld the constitutional validity of the Food and Drug Regulations.  More

Federal Court finds certain claims of ACE inhibitor patent invalid on the basis of no sound prediction and, alternatively, for obviousness.

On June 29, 2009 Justice Snider of the Federal Court of Canada found that claims 1, 2, 3, 6 and 12 of Canadian Patent No. 1,341,206 in relation to the drug ALTACE® (ramipril) were infringed by Apotex Inc. and Novopharm Ltd.  More

Federal Court Sets Aside PMPRB Decision That Required Patentees to Report Payments Made to Third Parties

Federal Court sets aside PMPRB decision that required patentees to report payments made to third parties  More

Federal Court of Appeal Clarifies Abuse of Process Doctrine in NOC Cases

On June 22, 2009, the Federal Court of Appeal allowed Apotex Inc.'s appeal from the decision of Shore J., who had granted Janssen-Ortho Inc.'s application for a prohibition order in respect of the drug LEVAQUIN and Canadian Patent No. 1,304,080.  More

Federal Court of Appeal Upholds Validity and Infringement of Coversyl® Patent

On June 30, 2009, the Federal Court of Appeal upheld the decision of Snider J. who had found Canadian Patent No. 1,341,196 valid and infringed by Apotex Inc.'s use, sale and export of its Apo-perindopril product.  More

Adverse Drug Reaction Reporting Requirements

The Canadian government recently announced an amendment to the adverse drug reporting requirements.  More

Federal Court Grants Prohibition Order Rejecting Allegations Of Obviousness, Inutility And Insufficiency

Federal Court grants order of prohibition preventing the Minister of Health from issuing notice of compliance to Novopharm in respect of a generic version of Pfizer's sildenafil drug until the expiry of Canadian Patent No. 2,163,446.  More

Federal Court Of Appeal Holds That Section 8 Liability Is Confined To Damages And Excludes Future Losses

At long last, on June 4, 2009, the Federal Court of Appeal rendered its first substantive judgment on section 8 of the Patented Medicines (Notice of Compliance) Regulations (the "Regulations").  More

Federal Court of Appeal holds that underlying data supporting a sound prediction of utility must be disclosed in the patent

On March 25, 2009, the Federal Court of Appeal dismissed an appeal of Justice Hughes' decision dismissing Eli Lilly's application for an order of prohibition.  More

Health Canada Issues Finalized Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations

The Guidance Document is substantially similar to the draft circulated in 2007, but also seeks to clarify the eligibility of innovative drugs, including combination drugs, the marketing status of innovative drugs, as well as the general review process.  More

Health Canada Issues Revised Guidance Document on the Patented Medicines (Notice of Compliance) Regulations

The Revised Guidance on the PM(NOC) Regulations focuses primarily on the 2008 amendments to the PM(NOC) Regulations, SOR/2008-211, which clarify the status of patent lists submitted prior to June 17, 2006.  More

Health Canada issues revised draft Guidance Document for Subsequent Entry Biologics

The Federal Court granted an order of prohibition preventing the Minister of Health from issuing a notice of compliance to Genpharm, Apotex and Cobalt in respect of a generic version of Lundbeck's escitalopram drug until the expiry of the patent.  More

Federal Court grants prohibition orders: Applies recent SCC tests for anticipation and obviousness

The Federal Court granted an order of prohibition preventing the Minister of Health from issuing a notice of compliance to Genpharm, Apotex and Cobalt in respect of a generic version of Lundbeck's escitalopram drug until the expiry of the patent.  More

Country Q&A - Canada 2008 / 2009

Written by Penny S. Bonner, Martha A. Healey, Judith Robinson and Teresa J. Walsh, this section of PLC's Cross-border Handbook on Life Sciences examines pertinent life sciences topics as they relate to Canada.  More

Passage of Genetic Information Nondiscrimination Act (GINA) in the U.S. Opens the Door for Personalized Medicine

On May 21, President Bush signed the Genetic Information Nondiscrimination Act (GINA). GINA prohibits discrimination by insurance companies or employers on the basis of "genetic information" about an individual or his or her family members.  More

Country Q&A - Canada 2007/2008

This document provides answers to some of the top questions regarding regulation, manufacturing, marketing and other topics in the field of life sciences.  More

Ontario Superior Court Certifies Class Action Against Health Canada

On September 5, 2007, the Ontario Superior Court of Justice released its decision in Taylor v. Canada (Health),[1] certifying a class action that alleges that Health Canada was negligent in that it failed to exercise its powers and responsibilities...  More

Federal Court of Appeal Ups the Ante for Patentees Litigating under the PM(NOC) Regulations

In Sanofi-Aventis Canada Inc. v. Novopharm Limited 2007 FCA 163 the Federal Court of Appeal has decided that a patentee who unsuccessfully challenges an allegation made by a generic drug manufacturer under the PM(NOC) Regulations cannot re-litigate ...  More

"A More Sinister Complexion": The Critical Need for Thorough and Robust Privacy Compliance Procedures and Plans

Personal information stored on stolen devices can be used for purposes such as fraud and identity theft - problems that have reached epidemic proportions throughout North America.  More

The Doctrine of Inequitable Conduct May Have Arrived in Canada

In a startling decision released on January 24, 2007, a judge of the Federal Court has deemed a patent to be abandoned based on the patentee's failure to disclose in good faith all appropriate facts in its patent application, and respond in good faith ...  More

Canada Seeks Uniformity with New Organic Products Regulations

From Update Magazine January/February 2007, Issue 1. Reprinted with permission from FDLI.  More

Drug Name Confusion: Health Canada's "Look-alike, Sound-alike" Drug Name Review Policy

It has now been one year since Health Canada released a new policy to review drug and other health product names as part of its pre-market regulatory approval process.  More

Country Q&A - Canada 2006/2007

This document provides answers to some of the top questions regarding regulation, manufacturing, marketing, and other topics in the field of life sciences.  More

General Information - Trade marks

Overview; registering a trade-mark; common law trade-marks; licenses; trade-mark use; maintaining valid trade-marks.  More

Governing Green: Canada Introduces Organic Products Regulations

The organic products industry in Canada has been growing at a rate of 15-20% annually for the past 10 years and is now the fastest growth sector in agriculture.  More

Update - Regulating Drug Prices in Ontario - A Hasty Attempt to Resolve Intricate Issues

This bulletin updates our commentary of April 2006 in which we described proposed changes to the Drug Interchangeability and Dispensing Fee Act (DIDFA) and the Ontario Drug Benefit Act (ODBA).  More

Does It Matter Whether the Best Is REALLY the Best? Advertising Claims in Canada

From Update Magazine July/August, Issue 4. Reprinted with permission from FDLI.  More

Federal Government proposes important changes to the PM(NOC) Regulations and to the data protection provisions of the Food and Drug Regulations

The Government of Canada will publish in the Saturday, June 17, 2006 Canada Gazette the attached draft regulations amending the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations.  More

A Short-Sighted Approach to Reducing Drug Costs in Ontario

On April 13, 2006, the Ontario Ministry of Health and Long-Term Care proposed sweeping amendments to the Drug Interchangeability and Dispensing Fee Act (DIDFA) and the Ontario Drug Benefit Act (ODBA).  More

Substance Over Form: Federal Court of Appeal Overturns Disclosure Exemption

Last year the Federal Court (trial division) restricted disclosure under the Access to Information Act of confidential information submitted by a pharmaceutical company in connection with a New Drug Submission.  More

Canada's New Law Permitting Compulsory Licences for Export of Pharmaceuticals Comes into Force

In July 2004, we distributed an information bulletin entitled "Canada Amends Patent Law to Allow Compulsory Licences for Export of Pharmaceuticals."  More

In the Kitchens of the Nation

On November 23, 2004, the Canadian Government passed a motion to promote the development of replacements to processed trans fats.  More

Canadian Diet Drug Litigation Settled

The Supreme Court of Ontario has recently approved the settlement of the Canadian diet drug class action (Wilson et al. v. Servier et al.).  More

Proposed Regulations Governing Compulsory Licences for Export of Drugs and Devices

Canada has become the first country in the world to implement the August 30, 2003 decision of the General Council of the World Trade Organization (WTO), allowing compulsory licences for the export of pharmaceutical products (drugs and devices).  More

Federal Court Strengthens the Confidentiality of Information Held by Health Canada

In its recent decision Merck Frosst Canada & Co. v. Canada (Minister of Health), 2004 FC 959, the Federal Court restricted the disclosure of confidential information submitted by pharmaceutical companies to Health Canada as part of New Drug Submissions.  More

Country Q & A - Canada

This document provides answers to some of the top questions regarding regulation, manufacturing, marketing, and other topics in the field of life sciences.  More

"But I Didn't Know": Monsanto v. Schmeiser and Knowledge of Patent Infringement

The recent ruling of the Supreme Court of Canada in Monsanto v. Schmeiser (2004 SCC 34), a patent infringement case, received much attention in the general media.  More

Canada Amends Patent Law to Allow Compulsory Licences for Export of Pharmaceuticals

Canada was the first country in the world to implement the August 30, 2003 decision of the General Council of the World Trade Organization (WTO), allowing compulsory licences for the export of pharmaceuticals to address public health problems.  More

Commentary on the New Nutrition Regulations

Food labelling has been under scrutiny and debate both in Canada and in the United States. Labelling guidelines in Canada, never harmonized with those of the United States, now appear somewhat more consistent with them.  More

Commentary on New Natural Health Products Regulations

Marking an end to well over five years of discussion, debate, consultation and legislative drafting, on June 18, 2003, the Canadian government published new Natural Health Product Regulations[1] (the "NHP Regulations")  More

Supreme Court Revisits Doctrine of Sound Prediction in Patent Law

The Supreme Court of Canada has just ruled that when applying for a patent, inventors must either have demonstrated, or be able to soundly predict, that their invention will have the promised utility.  More

The Mouse That Won't Roar - For Now

With the December 5, 2002 release of a 5 4 majority decision in Harvard College v. Canada (Commissioner of Patents)1, a sharply divided Supreme Court of Canada brought to an end that case's 17 year odyssey through the Canadian patent examination and.....  More

Natural Health Products Regulations: A Vague New Vision

Natural health products - neither food nor drug but something new entirely? Bringing an end to years of speculation and debate, Health Canada has finally published proposed Natural Health Products Regulations.  More

Does Your Food, Drug, Medical Device or Cosmetic Pose a Risk to the Environment?

Effective September 13, 2001, products regulated under the Canadian Food and Drugs Act are subject to the New Substances Notification Regulations under the Canadian Environmental Protection Act, 1999.  More

Media Highlights
Man on a (Trade) Mission-Ogilvy Renault's Jay Lefton in Israel

Ogilvy Renault senior partner Jay Lefton will join an Ontario life sciences mission to Israel and the West Bank on May 23-27, 2010.  More

Patent Pursuit Imperiled By Purse Strings?

The trend of dropped patent applications following the economic downturn is especially prevalent among life sciences firms. Ian Clarke comments in the Ottawa Business Journal.  More

Tentative Steps Into The Blogosphere

Jeremy Grushcow, co-founder of the Cross-Border Biotech Blog, talks to the Globe and Mail about the evolution of blogging about the law.  More

Horizon Issues: Life Sciences

Life sciences companies have one thing in common: the need to keep a constant eye on what's happening in multiple federal arenas, writes Jeremy Grushcow in Counsel to Counsel.  More

Health Canada Approves First Subsequent Entry Biologic Drug

Kristin Wall writes in the Lawyers Weekly about the human growth hormone Omnitrope, the first biologic drug to be approved in Canada as a subsequent entry biologic.  More

2009 National Champions: Ogilvy Renault's Life Sciences Team Earns Top Honour

Ogilvy Renault's Life Sciences team has been named the only law firm in Canada as a national champion in Practical Law Company's (PLC) Life Sciences Super Leagues 2009.  More

L'industrie réclame des mesures d'urgence

Gino Martel and Marie-Hélène Rochon talk to Les Affaires about the financial crisis' impact on the biotechnology sector.  More

Supreme Court Ruling on PLAVIX Favours Patentees: Ogilvy Renault

Ogilvy Renault LLP successfully represented Canada's Research-Based Pharmaceutical Companies (Rx&D) before the Supreme Court of Canada, which dismissed a challenge by Apotex against Sanofi-Aventis's patent for the drug PLAVIX.  More

Canada High Court Delivers Good News to Patent Owners

Patrick Kierans talks to Managing Intellectual Property about the Plavix case before the Supreme Court of Canada, and the impact the Court's decision has on patent owners.  More

Supreme Court Strengthens Drug Patent Protection

Patrick Kierans, a senior partner in the Intellectual Property Group, is featured in The Globe and Mail, where he discusses the Supreme Court of Canada's patent case regarding the drug Plavix.  More

Projet de loi C-51

Julie Dallaire is quoted in La Presse, where she explains why provisions in the Food and Drug Act could be revised.  More

The International Who's Who of Life Sciences Lawyers, 2008

Five Ogilvy Renault lawyers, the most of any Canadian firm, are ranked in The International Who's Who of Life Sciences Lawyers 2008. The lawyers recognized are Judith Robinson, Patrick Kierans, Penny Bonner, Brian Gray and William McNamara.  More

Super Results for Ogilvy Renault's Life Sciences Team

Ogilvy Renault was recently recognized by UK-based Practical Law Company (PLC) as the only Canadian firm in the 2008 Life Sciences Regulatory Super League. It is the second consecutive year the firm ranks in the two-year-old category.  More

Life Sciences Expert Penny Bonner Addresses Bioethics in National Magazine

Senior partner and life sciences lawyer Penny Bonner spoke with National, a publication from the Canadian Bar Association, on the future of her field in the legal landscape.  More

Ogilvy Renault's M&A, Corporate Finance and Technology Practices strengthened by addition of Jay Lefton

Ogilvy Renault LLP is pleased to announce that Jay A. Lefton will be joining the firm as a partner in its Business Law Group in Toronto, July 1, 2007.  More

Ogilvy Renault Remains The Only Canadian Law Firm In The Life Sciences Regulatory Super League

Ogilvy Renault LLP is proud to remain the only Canadian law firm in the Life Sciences Regulatory Super League, according to Practical Law Company's Cross-border Super League results.  More

Practical Law Company's Cross-Border Super League, 2005

Ogilvy Renault LLP is proud to remain the only Canadian law firm in the Life Sciences Regulatory Super League, according to Practical Law Company's Cross-border Super League results.  More

Ogilvy Renault Stands out as Leading Intellectual Property Practice

Ogilvy Renault, one of Canada's most prominent law firms, has been chosen as Leading intellectual property practice and as Leading life sciences practice in the 2001/2 edition of Global Counsel 3000 , a reputable British publication that is ...  More