Kamleh Nicola’s practice focuses on intellectual property litigation, with an emphasis on all aspects of patent and trademark disputes, especially in the field of pharmaceuticals. Ms. Nicola has successfully navigated cases through to resolution in a manner that maximizes benefits to her clients. She has the ability to efficiently manage the complexities of litigation without losing sight of the overall case strategy, especially where the case is being litigated in multiple jurisdictions around the globe. In those instances where a case is litigated in multiple jurisdictions, Ms. Nicola works collaboratively with counsel and client contacts in those jurisdictions to ensure consistency in strategic approach.

Practice Focus

Ms. Nicola also advises clients on the regulatory aspects of pharmaceuticals and medical devices, including strategic advice relating to product approval and launch, marketing, labelling and pricing. Ms. Nicola works with her clients to minimize risk and navigate the often complex Canadian regulatory regime.

Representative Legal Matters

Representative Pharmaceutical Litigation Matters

Ms. Nicola has represented:

• Pfizer in the Federal Court in patent impeachment proceedings versus ratiopharm related to amlodipine besylate (Norvasc®); in the Federal Court of Appeal in proceedings pursuant to the Patented Medicines (Notice of Compliance) Regulations versus Novopharm related to celecoxib (Celebrex®); in the Federal Court and Federal Court of Appeal in proceedings pursuant to the Patented Medicines (Notice of Compliance) Regulations versus ratiopharm, Apotex, Cobalt and Pharmascience related to amlodipine besylate (Norvasc®); and in the Federal Court in proceedings pursuant to the Patented Medicines (Notice of Compliance) Regulations versus Mayne Pharma related to epirubicin hydrochloride (Pharmorubicin®).
• Various Canadian and North American pharmaceutical and biologics companies involved in patent litigation and proceedings pursuant to the Patented Medicines (Notice of Compliance) Regulations.
• A Canadian pharmaceutical company in the settlement of a multijurisdictional patent proceeding.
• A global integrated information solutions company in a complex trademark opposition proceeding.
• Various consumer goods and cosmetic companies in trademark infringement and passing off proceedings.

Other Representative Matters

Ms. Nicola has advised:

• Pharmaceutical, medical device and biologic companies on localizing policies and procedures to ensure compliance with regulatory requirements; conflict of interest situations involving healthcare professionals; and PMPRB jurisdictional matters, as well as negotiations relating to Voluntary Compliance Undertakings.
• The Canadian affiliate of global biopharmaceutical company in preparation of comprehensive pre-launch risk assessment for a new product.
• A global healthcare and pharmaceutical gas company on the regulatory aspects of an asset purchase.
• Global and North American pharmaceutical and biologics companies in various matters involving licensing disputes and the Patented Medicine Prices Review Board.

Professional Associations and Memberships

• Canadian Bar Association - Executive Committee, National IP Section
• Canadian Bar Association - Court Practice Committee, National IP Section
• International Trademark Association (INTA) - Member
• Intellectual Property Institute of Canada - Fellow
• The Advocates' Society - Member
• Canadian Bar Association - Professional Development Committee, National IP Section - Past Chair

Admission

Ontario~Canada (1992)

Education

University of Windsor  (LL.B.) (1990)
Dalhousie University  (B.S.C.) (1986)