Our Biotech and Pharmaceutical Group

For clients looking for a strategic partner in the pharmaceutical and biotech sector, Borden Ladner Gervais LLP (BLG) has one of the largest and most comprehensive practices in Canada. Our lawyers and registered patent and trademark agents work within cross-disciplinary teams to understand and assist you as you balance marketing, regulatory and intellectual property concerns with successful financing and business strategies. Also, a well versed litigation team is available to act on your behalf in a wide variety of matters relevant to this sector, including intellectual property disputes, products liability litigation, contract and licensing disputes, administrative proceedings and class actions. Regardless of the issue, the Biotech and Pharmaceutical Group works with you, as part of your team, to achieve your goals.

BLG truly speaks your language. Our team includes many individuals whom hold PhDs or Master's degrees in the life sciences, and bring an in-depth understanding to the science on which your business is built. Many of our professionals also have years of experience in relevant industry positions, which provides us with a genuine comprehension of this sector — both where it's been and where it's heading. In addition, we continue to maintain close involvement within the biotech and pharmaceutical community, and have partnered with numerous leading members in the area to create or support central organizations where members can come together, share knowledge and gain valuable insights.

Clients can expect to find a team of professionals at BLG that is entrepreneurial and business minded. Our Biotech and Pharmaceutical Group has extensive experience assisting clients in structuring and documenting standard and unique business structures including mergers, divestitures, acquisitions, joint ventures and partnerships. With such a diversified practice, you can look to BLG to act as your trusted and well-connected advisor.

At BLG, we are also leaders in the food and drug regulatory community in Canada, and assist clients in navigating through the highly complex environment of federal and provincial regulations. The Firm provides strategic advice under the Patented Medicines (Notice of Compliance) Regulations, and consult on drug reimbursement strategies for dealing with provincial formularies and the Patented Medicines Prices Review Board. We also assist clients in all aspects of the legislative process, including helping clients conceive and implement effective advocacy strategies to achieve their public policy objectives, including changes to statutes and regulations.

Within our group are experienced professionals who are able to help in protecting your valuable intellectual property assets. In addition to our extensive experience drafting and prosecuting patents on behalf of our clients, our professionals can also assist in the due diligence review for mergers and acquisitions, provide competitive review for potential acquisitions, perform freedom to operate analysis to assist in your research and development planning, and provide validity and infringement opinions as these concerns arise. Our Competition and Marketing Law, Labour and Employment and Tax Groups also regularly serve clients of the Biotech and Pharmaceutical Group.

Always at the forefront of the industry, professionals in the Biotech and Pharmaceutical Group have been consistently featured in the top international legal ranking publications, including the 2010 editions of The Best Lawyers in Canada©, Chambers Global – Guide to the World's Leading Business Lawyers and the Lexpert®/American Lawyer Guide to the Leading 500 Lawyers in Canada.

At BLG, we're serious about your success. You come to the table looking for the best Biotech and Pharmaceutical team and we strive to exceed your expectations.

OUR SERVICES

Included in the range of services and advice provided are:

Structuring and negotiating product development and collaboration agreements between domestic and international parties licensing arrangements and strategic alliances.
Assisting in the preparation and documentation of agreement related to third party manufacturing of active pharmaceutical ingredients.
Structuring and negotiating licensing arrangements, joint ventures and strategic alliances involving pharmaceutical manufacturers.
Reviewing and negotiating clinical trial agreements on behalf of health sector participants.
Assisting in the negotiation of product listing agreement with provincial health authorities.
Advising on regulatory compliance with the requirements of Health Canada including clinical trials, new drug submissions, Notices of Compliance and Drug Identification Numbers, marketing including product recalls and detentions; advertising clearances; and packaging and labeling advice.
Providing advice on provincial pharmaceutical requirements including payments of rebates, incentives and professional allowances.
Ensuring compliance with federal and provincial privacy and document retention law requirements including undertaking compliance reviews and drafting compliance programs and related materials.
Assistance in dealings with the Patented Medicines Prices Review Board, including interpretation of Excessive Price Guidelines, negotiations of Voluntary Compliance Undertakings and administrative proceedings before the Board.
Advising on the application of codes of conduct and the rules governing health professionals.
Advising on private and public merger and other acquisition transactions including conducting due diligence in respect of various forms of commercial transactions.
Assistance in venture capital, institutions investment and public market financing transactions, acting either on behalf of investors or the investee companies.
Public policy including issuing of advice on government relations, regulatory affairs and strategic communications.
Protecting intellectual property, including preparing and prosecuting patent and trademark applications, obtaining patents and trademarks, copyright protection, and preparing, prosecuting and obtaining plant breeders' rights.
Advising on intellectual property portfolios and management, including advising on issues relating to the Health Canada Patent Lists.
Analyzing and monitoring competitors' intellectual property.
Providing freedom to operate, validity and infringement analysis and opinions.

OUR EXPERIENCE

Drug Manufacturers

Our lawyers provide legal and strategic advice to our drug manufacturing clients, from the preclinical development stage through the most beneficial approval pathways and the myriad of post marketing obligations. With the assistance of our intellectual property, corporate and licensing, health, and litigation colleagues, we provide integrated, practical advice for successful product development and marketing including product recalls and detentions; clinical trial agreements; advertising clearances; and packaging and labeling advice as well as in dealings with provincial ministries of health responsible for provincial formularies and intergovernmental bodies such as the Canadian Agency for Drugs and Technologies in Health (CADTH ) and federal bodies such as Health Canada and the Patented Medicines Prices Review Board (PMPRB). We also advise on the application of industry codes of conduct and the rules governing health professionals.

Clients include large international diversified pharmaceutical companies, leading biotechnology companies and smaller specialty pharmaceutical organizations. We advise on products that range from traditional new drugs to biotechnology products, including controlled substances, tissue and cellular therapies, and innovative combination products.

Medical Devices Companies

BLG's medical device clients range in size from small startups to established industry leaders. Our clients rely on us for help obtaining Heath Canada clearance and approval to market products; complying with the Health Canada's post market requirements, and defending themselves against enforcement actions. We also assist with contracts, mergers and acquisitions, and financings, including corporate-commercial due diligence, contract manufacturing, contract services, and research and co-development agreements.

Diagnostic Companies

In addition to providing traditional corporate and commercial advice to this rapidly expanding field, our professionals understand the complexities behind the latest technologies used to identify biomarkers for disease and/or response to treatment. We understand that these technologies can result in stand alone products and/or companion diagnostics for new medicines and work to help ensure effective patent protection for these products. We also continue to monitor the ever evolving changes in the legal framework relevant to these technologies as regulators struggle to deal with the challenges that these technologies pose.

Emerging Life Science Companies

Our lawyers have substantial experience in dealing with early and emerging innovative organizations, and entrepreneurs with compelling new ideas and technology. BLG has been at the forefront of helping the industry to develop and implement new financing mechanisms, from private investors to institutional sources as well as the public market. Our relationship with leading members of the domestic and international venture capital community is seen as a great strength as is the extensive experience of a number of the senior members of the practice with all aspects of the legal requirements of emerging biotech companies, including negotiating licensing transactions with universities and other research institutes, financing transactions with institutional and venture investors.

Natural Health Products

The Firm acts for a number of international manufacturers of natural health products and provides advice on regulatory matters ranging from regulatory approvals, and labeling issues related to nutritional supplements, traditional herbal medicines, and natural health products, including issues related to licensing of establishments. Firm lawyers advise and represents clients interacting with Health Canada on issues such as manufacturing and processing, including good manufacturing practices, safety or efficacy concerns, quality control issues, requests for recall and clinical trials.

Bio-Ag Sector

With broad regulatory and legislative experience our group advises companies and in all segments of the food chain, from farm to table as well as industrial applications arising from bio-products. Mandates include assisting in regulatory compliance; including helping them prepare for and manage a product recall; or advising on product manufacturing, labeling and marketing considerations.

Bio-Fuels / Cleantech

Lawyers are involved in representing the emerging subset of the biotechnology sector involved in cleantech applications. Cleantech encompasses a broad range of products, services, and processes designed to reduce or eliminate environmental impacts. Cleantech is also increasingly understood to include any technology that promotes the more efficient use and re-use of the earth's resources in industrial production and consumption and include alternative energy projects, wastewater treatment, and resource-efficient industrial processes, many of which rely on the application of biotechnology processes. The Firm is involved in providing legal advice on all aspects of the business, from IP protection to financing to regulatory compliance.