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:
- Clinical Trials
- Crisis Management and Recalls
- Direct-to-Consumer Communications
- Distribution, Co-Promotion, Co-Marketing and Joint Venture Agreements
- Formulary Listings and Challenges to Listings
- Freedom of Information
- Genetic Testing
- Good Manufacturing Practices
- Informed Consent
- Labeling, Advertising, and Promotion
- Licensing
- Non-Competition and Proprietary Rights Agreements
- Patent and Trade-mark Litigation, including Litigation under the Patented Medicines (Notice of Compliance) Regulations
- Patent and Trade-mark Preparation, Prosecution and Maintenance
- Patentability, Validity, Infringement, and Freedom to Operate Searches and Opinions
- Patented Medicine Prices Review Board
- Privacy and Personal Information
- Product Liability and Class Actions
- Public Law Advocacy
- Regulatory Approvals
- Regulatory Change Analysis
- Research and Collaborative Research Agreements
- Website Issues
Client Work
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.
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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.
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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.
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Tranzyme Pharma Completes Second Tranche of Financing
Tranzyme, Inc. and Tranzyme Pharma Inc. received US$10 million on the closing of this second tranche.
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Three Biopharmaceutical Companies Complete Rounds of Private Equity Financing
Ogilvy Renault represented Tranzyme Pharma, Enobia Pharma, and Topigen Pharmaceuticals.
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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.
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Kendle International Inc. Acquires DecisionLine Clinical Research Corporation
Represented Kendle in its acquisition of DecisionLine through a wholly owned Canadian subsidiary.
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Inmar, Inc. Acquires USF Processors
Acted as Canadian counsel
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Acted as Counsel to Tranzyme Pharma, Leading Biopharmaceutical Company
In connection with its US$32 million financing
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Æterna Zentaris Offers Subordinate Voting Shares of Atrium Biotechnologies Inc.
Acted for the Quebec City-based biopharmaceutical company in its $55 million secondary offering
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UCB SA Take-Over Bid to Acquire German-based Schwarz Pharma Aktiengesellschaft
Acted as Canadian counsel to the Belgium-based biopharmaceutical company
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Events
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.
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Biomedex 2008
Jacques Lemieux moderates the Ogilvy Renault-sponsored Success Stories workshop, featuring panelists from Biolactis, Biosyntech Canada inc., and Variation Biotechnologies Inc.
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Publications
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.
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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.
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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...
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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 ...
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"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.
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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 ...
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Canada Seeks Uniformity with New Organic Products Regulations
From Update Magazine January/February 2007, Issue 1. Reprinted with permission from FDLI.
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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.
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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.
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General Information - Trade marks
Overview; registering a trade-mark; common law trade-marks; licenses; trade-mark use; maintaining valid trade-marks.
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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.
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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).
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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.
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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.
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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).
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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.
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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."
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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.
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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.).
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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.
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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.
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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).
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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.
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"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.
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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.
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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")
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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.
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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.....
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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.
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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.
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Media Highlights
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.
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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.
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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.
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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.
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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 ...
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Contacts

Penny S. Bonner
416.216.6629
pbonner@ogilvyrenault.com
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Martha A. Healey
613.780.8638
mhealey@ogilvyrenault.com
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Judith M. Robinson
514.847.4608
jrobinson@ogilvyrenault.com
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