About
There are many challenges facing the pharmaceutical industry today. It is absolutely critical to keep up-to-date with the rapid pace of complex legal and regulatory developments in pharma patents to maintain a competitive edge. Millions of dollars are at stake. Brand name companies stand to lose if their pharma patents are inadequately protected. Generics want to benefit from early market entry of non-infringing drugs, challenging potentially invalid patents. Competition between generics and brand names is heating up and the stakes are high.
This
Canadian Institute publication on
Pharma
Patents will arm you with cutting-edge strategies and practical legal skills to help you to meet the challenges of the complex world of pharma patents. You'll learn from experienced industry lawyers, in-house counsel and pharma executives on important topics including:
- The latest proposed amendments to the critical PM (NOC) Regulations
- Effect of proposed pricing changes and increased data protection
- Crucial legal developments in patent filings: what you need to know
- Key developments in United States patent law and their effect on Canadian companies
Contents & Contributors
AMENDMENTS TO THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS – STATUS UPDATE
Douglas Clark, Industry Canada
UPDATE ON PROPOSED AMENDMENTS TO THE PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS AND THE FOOD AND DRUG REGULATIONS
Edward Hore, Hazzard & Hore
THE BIOLYSE DECISION: IMPLICATION OF A NEW INTERPRETATIVE APPROACH TO THE NOC REGULATIONS
Barbara J. Murchie, Bennett Jones LLP
Paul Taylor, Bennett Jones LLP
CRITICAL DEVELOPMENTS IN PHARMA PATENT CASE LAW THIS YEAR
Ken Clark, Gowling Lafleur Henderson LLP
Neil Belmore, Gowling Lafleur Henderson LLP
Taren Wilkins, Gowling Lafleur Henderson LLP
Roger Tam, Gowling Lafleur Henderson LLP
RECENT JURISPRUDENCE UNDER THE NOC REGULATIONS
Gunars A. Gaikis, Smart & Biggar
Junyi Chen, Smart & Biggar
PHARMA PATENTS FORUM: THE GENERICS VIEW
Jim Keon, Canadian Generic Pharmaceutical Association
PROVINCIAL FORMULARIES AND PHARMA PATENTS
Julia Brown, Janssen Ortho Inc.
Megan Evans, Cassels Brock & Blackwell LLP
PROPOSED CHANGES TO PRICING: UPDATE ON PMPRB PRICE CONTROLS
Barbara L. Ouellet, Patented Medicine Prices Review Board
RECENT U.S. PATENT DEVELOPMENTS: WHAT THEY MEAN FOR CANADIAN PHARMA
James Leeds, Eli Lilly & Company
RECENT U.S. PATENT DEVELOPMENTS: A CANADIAN PERSPECTIVE
Ildiko Mehes, Novopharm
RECENT U.S. PATENT DEVELOPMENTS: A CANADIAN PERSPECTIVE
Shonagh McVean, Gilbert's LLP
RECENT U.S. PATENT DEVELOPMENTS: WHAT THEY MEAN FOR CANADIAN PHARMA
James F. Haley, Jr., Ropes & Gray
WHEN THE ELEPHANT CATCHES COLD: CANADIAN DRUG SUPPLY REGULATION IN THE FACE OF U.S. INTERNET DEMAND AND POTENTIAL U.S. BULK IMPORT LEGISLATION
John A. Terry, Torys LLP
DRUG IMPORTATION: OPENING THE FLOODGATES FOR FAKE DRUGS?
Timothy H. Gilbert, Gilbert's LLP
INTERNATIONAL PRESCRIPTION SERVICES: AN EVOLVING LANDSCAPE
John A. Myers, Taylor McCaffrey LLP
PM (NOC) REGULATIONS & PATENT LIST ELIGIBILITY: THE MEANING OF "CLAIM FOR THE MEDICINE ITSELF"
Jason C. Markwell, Ogilvy Renault
MIXIMIZING YOUR PHARMA PATENT PROTECTION
Yoon Kang, Smart & Biggar
Nancy P. Pei, Smart & Biggar
Publication Details