Life Sciences and Chemical Patent Practice in Canada: A Practical Guide (Third Edition)

Life Sciences and Chemical Patent Practice in Canada: A Practical Guide

Third Edition

Smashwords Edition

2011

Borden Ladner Gervais LLP

Canada

Life Sciences and Chemical Patent Practice in Canada: A Practical Guide

(Third Edition)

Copyright © 2011 Borden Ladner Gervais LLP

All rights reserved. Although this is a free book, it remains the copyrighted property of the authors, and may not be reproduced, stored in a retrieval system, copied, or transmitted in any form without prior written permission of the authors. If you found this book to be useful, please encourage others to download a copy.

Published in 2011 by Borden Ladner Gervais LLP

ISBN 978-0-9730750-8-3

First edition, February 2002.

Revised first edition, September 2003.

Second edition, October 2008.

The information in this publication is of a general nature, and should not be regarded as legal, accounting, or other professional advice. Intellectual Property law is complex and developing rapidly, and must be considered in the circumstances of each individual transaction, case, or issue. If legal or other expert advice or assistance is required, the services of a competent professional should be sought.

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About the Cover

Charis Tsevis

The Maple Leaf Design was created by Charis Tsevis, who is based in Athens, Greece. He serves global clients and he frequently contributes to prominent publications with articles on design theory, aesthetics, and cyberculture. His work has been awarded at Epica, NPSA, and Ed-Awards in the United States and Europe. Charis Tsevis has studied design and advertising in Athens and Milan and he now teaches Typography and Editorial Design at AKTO College.

CONTENTS

Foreword

Authors and Contributors

Part I: General Patent Practice in Canada

Chapter 1: Overview of the Canadian Patent System

Chapter 2: Procedural Requirements

Chapter 3: Biotechnology-Specific Procedural Requirements

Part II: Life Sciences and Chemical Subject Matter

Chapter 4: Chemical Compounds

Chapter 5: Biopolymers: DNA, RNA, and Proteins

Chapter 6: Antibodies

Chapter 7: Living Matter (Life Forms)

Chapter 8: Medical Treatments and Medical Uses

Chapter 9: Bioinformatics, Diagnostic Technologies, and Biomarkers

Chapter 10: Plant Breeders' Rights

Part III: Regulatory Issues

Chapter 11: Patented Medicines (Notice of Compliance) Regulations

Chapter 12: Patented Medicine Prices Review Board

Chapter 13: Subsequent Entry Biologics

Part IV: Patent Challenges

Chapter 14: Infringement, Validity, and Post-Grant Modifications

FOREWORD

Almost a decade has elapsed since the first edition of this book was printed. Initially, our aim was to assist our clients in navigating the then largely uncharted territory of life sciences and chemistry patent practice in Canada.

Ten years on, the lay of the land is clearer in many respects: we have definitive decisions from the courts in certain technologies, such as the exclusion of higher life forms from patentability. The Canadian Patent Office has also devoted an entire chapter in its Manual of Patent Office Practice (MOPOP) to biotechnology inventions.

At the same time, the need for a practical guide has never been greater. Most legal precedents for inventions in the life sciences and chemistry concern patent applications filed in the 1980s and early 1990s: a time of great technological change, to be sure, but one in which not even a single bacterial genome had been fully sequenced. The practice guidance provided within MOPOP on the basis of precedent necessarily suffers from a technological lag when applied to today's inventions. This lag often leaves inventors and their advocates to fend for themselves amidst sometimes contradictory guidance. We aspire to highlight best practices for life sciences and chemical inventions in Canada in a way that may not be embedded in Patent Office policy. As far as we are aware, there is no comparable text available in Canada.

Earlier editions of this book were, in some instances, the first exposure to intellectual property for our own junior colleagues and patent agent trainees, some of whom have become contributors to this edition.

Now in its third edition, our book is directed toward patent agents/attorneys and lawyers, agent trainees, in-house patent counsel, technology transfer officers, and inventors specializing in the life sciences and chemistry. We aim to outline the features of Canadian patent practice that are most relevant to our clients and associates in Canada and around the world.

This book comprises four parts:

Part I outlines general patent practice in Canada. An overview of the Canadian patent system is provided, together with highlights of the procedural requirements for patent procurement in Canada. Requirements specific to inventions in the life sciences and chemistry are featured.

Part II deals with specific subject matter areas, including chemical compounds, antibodies, and life forms, to name just a few. Within each category, exemplary claim formats are provided.

Part III is devoted to regulatory issues, including the Patented Medicines (Notice of Compliance) Regulations, the Patented Medicine Prices Review Board, and Subsequent Entry Biologics.

Part IV deals with challenges to issued patents. Claim construction, infringement, and validity are discussed, as are third-party challenges to patents and pending applications in the Patent Office.

We update this publication regularly. As always, we would appreciate any feedback from you, the reader, with a view to improving future editions. We hope that you will find this updated edition to possess sufficient disclosure and adequate utility.

AUTHORS AND CONTRIBUTORS

Timothy Bailey

Timothy Bailey (tbailey@blg.com) is lawyer and associate in the Toronto office. Tim completed a B.Sc. and Ph.D. in Physiology at The University of Western Ontario. His doctoral research focused on examining the influence of mechanical ventilation on the pulmonary surfactant system using a number of in vivo, ex vivo, biochemical, biophysical, and imaging techniques. Tim is a graduate of the Faculty of Law at the University of Alberta. Tim was admitted to the Alberta Bar in 2009 and the Ontario Bar in 2011.

Graeme Boocock

Graeme Boocock (gboocock@blg.com) is a technical advisor and associate in the Ottawa office. He received an B.Sc. (Honours) with High Distinction in Molecular Genetics and Molecular Biology from the University of Toronto (1999). He went on to complete a Ph.D. in Molecular and Medical Genetics (2006) at U of T, during which time he was based at the Hospital for Sick Children. His doctoral research culminated in discovery of the gene that is mutated in Shwachman-Diamond syndrome, a rare p releukemic disease of childhood. He then worked for three years as post-doctoral fellow in protein engineering at the MRC Laboratory of Molecular Biology in Cambridge (U.K.). Graeme specializes in biotechnology and life sciences inventions.

Daniel Brinza

Daniel Brinza (dbrinza@blg.com) is an associate in the Toronto office. He is a graduate of the University of Toronto Law School, and was admitted to the Ontario Bar in 2008. Prior to attending law school, Daniel worked for six years as a process development engineer with a large Canadian pharmaceutical company. In addition to regulatory and research and development work in the pharma field, his past experience encompasses environmental applications, systems engineering, as well as legal research pertaining to health law, renewable energy, and biotechnology issues. Daniel has an undergraduate degree in Chemical Engineering and a Master of Applied Sciences from the University of Ottawa. Daniel is fluent in Romanian and reads French and Russian.

Alaka Chatterjee

Alaka Chatterjee (achatterjee@blg.com) is a partner in the Vancouver office. She received her Ph.D. in Biochemistry from Tufts University, Boston, in 1996 and pursued post-doctoral studies in cell cycle regulation at a Boston-area biotechnology company and in insulin-mediated cell signalling at the Joslin Diabetes Center, Harvard Medical School. Alaka has been called to the British Columbia and Massachusetts bars and is a registered patent agent in Canada and the United States. She specializes in preparing and prosecuting patent applications in the biotechnology, biomedical, pharmaceutical, agriculture, forestry, and mining sectors and advises clients on international patent portfolio management and strategies, as well as on patentability, infringement, validity, and freedom to operate issues.

Christine Collard

Christine J. Collard (ccollard@blg.com) is a partner in the Ottawa office. She graduated with B.Sc. and LL.B. degrees from the University of New Brunswick and was called to the Ontario Bar in 1995. She was registered as a trade-mark agent in 1995 and as a Canadian patent agent in 1997. Christine specializes in protecting technology in the areas of oil and gas, mining, pharmaceuticals, life sciences, medical devices, and industrial chemicals. Christine's practice also includes intellectual property litigation including freedom to operate, validity, and infringement matters.

David Conn

David Conn (dconn@blg.com) is a partner in the Ottawa office. He graduated from the University of Edinburgh with a B.Sc. (Honours) in Genetics and an M.B.A. from Dalhousie University. He went on to complete his Ph.D. in Genetics at Imperial College at the University of London. He was registered as a Canadian patent agent in 1986. David specializes in chemical and biotechnology related subject matter.

Kirsten Crain

Kirsten Crain (kcrain@blg.com) is a partner in the Ottawa office. Kirsten graduated from the Faculty of Law at McGill University with an LL.B. in 1999 (Dean's Honours List). Prior to law school, Kirsten obtained a B.A. in Economics from McGill University and an M.Sc. from the London School of Economics. Kirsten was called to the Ontario Bar in 2001. Kirsten's practice is focused on complex commercial cases, health sector litigation, pharmaceutical regulatory proceedings before the Patented Medicine Prices Review Board, and intellectual property litigation.

Joachim Fritz

Joachim Fritz (jfritz@blg.com) is a partner in the Ottawa office. Joachim received a Qualifying Diploma in Sciences from the University of Ulm (Germany). He graduated from the University of Ottawa with a B.Sc. (Honours) in Biology magna cum laude. He was registered as a Canadian patent agent in 1992. Joachim is multilingual and provides services in English, French, and German. He is the National Leader of the Intellectual Property and Technology Group.

Steven Kennedy

Steven Kennedy (skennedy@blg.com) is a lawyer and registered trade-mark agent in the Ottawa office. He was called to the Ontario Bar in 2009 after graduating cum laude from the University of Ottawa Faculty of Law (Common Law Section) with a Law & Technology option. At law school, Steven worked as a senior editor with the Ottawa Law Review and served on the executive committee. He received a B.Sc. in Physics (with Distinction) from McGill University in 2004. His practice focuses on trade-mark prosecution as well as commercial and intellectual property litigation, with an emphasis on patent and trade-mark disputes.

Kathleen Marsman

Kathleen Marsman (kmarsman@blg.com) is a patent agent in the Ottawa office. She received a B.Sc. in Biochemistry (Honours) from the University of Waterloo, and holds M.Sc. and Ph.D. degrees in Nutrition and Metabolism from the University of Alberta. Kathleen became registered as a Canadian patent agent in 1999 and as a U.S. patent agent in 2001. Kathleen specializes in drafting and prosecuting patent applications, and advising on patent strategy, patent infringement and validity, and freedom-to-operate in all areas of the life sciences, with emphasis on biotechnology and pharmaceutical inventions. Her client base includes university and institutional technology transfer offices, as well as biotechnology and pharmaceutical companies.

Barbara McIsaac

Barbara McIsaac (bmcisaac@blg.com) is counsel in the Ottawa office, where she advises private sector clients, governments, and government agencies on issues relating to public procurements, Charter and human rights issues, legislative mandates, jurisdiction, and the conduct of investigations. Barbara is recognized as one of the leading Canadian practitioners in the areas of procurement law and privacy and access to information law and is co-author of The Law of Privacy in Canada (Carswell, 2000). She also advises on general regulatory compliance issues including matters relating to compliance with the Patented Medicine Prices Review Board. She served as senior counsel to the Somalia Inquiry and senior counsel for the Government of Canada for the Arar Inquiry. Barbara received her LL.B. from Queen's University in 1973 and was called to the Ontario Bar in 1975. She was appointed Queen's Counsel in 1989.

Jamie Mills

Jamie Mills (jmills@blg.com) is a partner in the Ottawa office. Jamie practises in all areas of IP law, including the prosecution and litigation of patents, trade-marks, and copyrights, with a primary focus on defending the patent rights of the innovative pharmaceutical and biopharmaceutical industry. In this regard, he has appeared as an advocate before the Federal Courts in Canada, the Ontario courts, the Patent Appeal Board, and the Trade-marks Opposition Board. He has also appeared numerous times on behalf of the industry and individual pharmaceutical and biopharmaceutical companies before government agencies and politicians, including committees of the Canadian Parliament. Jamie also has significant experience in providing advice to the industry in respect of pharmaceutical regulatory matters, Internet pharmacy, the listing of patents on the Patent Register, data protection in Canada, and Canada's pricing regime for pharmaceuticals administered by the Patented Medicine Prices Review Board.

Beverley Moore

Beverley Moore (bmoore@blg.com) is an associate in the Ottawa office. Beverley specializes in the area of intellectual property, with an emphasis on patent litigation and applications under the PMNOC Regulations. Beverley regularly advises clients on regulatory issues such as patent listing, portfolio management, and the Register of Innovative Drugs. Beverley has appeared before the Federal Court and Federal Court of Appeal on behalf of innovative pharmaceutical companies in patent infringement actions, applications under the NOC Regulations, damages proceedings under the PMNOC Regulations, and judicial reviews of decisions of the Minister of Health. She is also a frequent writer and speaker in areas of patent law, the PMNOC Regulations, regulatory issues, and issues surrounding Subsequent Entry Biologics.

David Nauman

David Nauman (dnauman@blg.com) is a patent agent in the Ottawa office. He received a B.Sc. in Chemical Engineering in 1997 from the Massachusetts Institute of Technology and a Ph.D. in Organic Chemistry from the University of California, Berkeley. After his doctoral studies, he worked at the Children's Hospital of Eastern Ontario Research Institute and at a start-up biotech company in Ottawa. David specializes in drafting and prosecuting patent applications and advising on patent infringement and validity issues in the fields of chemistry, pharmaceuticals, molecular biology, and biotechnology.

J. Erin Pisko

J. Erin Pisko (episko@blg.com) is a patent agent and partner in the Vancouver office. Erin received a B.Sc. in Civil Engineering with a concentration in Environmental Engineering from Carleton University in 1995 and an M.Sc. in Engineering from the University of Calgary in 1998. Erin's research was focused in the areas of environmental engineering and biochemical engineering. She has spent eight years working in-house at several Vancouver-based biotech companies both developing and managing intellectual property portfolios. Erin is a Canadian patent agent and is registered as a U.S. patent agent to act on behalf of Canadian residents. She specializes in drafting and prosecuting patent applications, and advising on patent infringement and validity issues in life sciences, clean-tech, mining, and forestry-related technologies.

Scott Pundsack

Scott Pundsack (spundsack@blg.com) is a partner in the Toronto office. He was admitted to the Ontario Bar in 1997 and has practised exclusively in the field of intellectual property since 1995. Scott is a registered patent and trade-mark agent, with a background in civil engineering. He won the Maybee Award for the highest mark in the Canadian patent agents' exam in his year of qualification. Scott is also a U.S. citizen and has passed the U.S. patent exam, qualifying him to represent international clients in U.S. patent and design cases (including re-issue and re-examination applications and appeals).

Jennifer Raoul

Jennifer Raoul (jraoul@blg.com) is a patent agent in the Ottawa office. She received her Ph.D. in Pharmacology from Dalhousie University in 2004. During her graduate studies, Jennifer conducted a research rotation at a leading pharmaceutical company. She specializes in drafting and prosecuting patent applications in the areas of pharmaceuticals, biotechnology, therapeutics, and diagnostics. She advises clients on infringement and validity issues, freedom to operate, IP due diligence, global IP protection strategies, and portfolio management. Jennifer also advises clients on patent issues pertaining to Canada's regulatory regimes affecting patented medicines in Canada.

Chantal Saunders

Chantal Saunders (csaunders@blg.com) is a partner in the Ottawa office. Chantal specializes in the area of intellectual property, with an emphasis on patent litigation and particularly pharmaceutical litigation under the PMNOC Regulations. Her practice also involves copyright and trade-mark infringement litigation, and Access to Information Act matters. She has appeared before the Federal Courts on patent and copyright matters. Chantal also advises clients with respect to data protection, and issues arising in respect of the Patent Register and the Patented Medicine Prices Review Board.

Gail Silver

Gail Silver (gsilver@blg.com) is a partner and patent agent in the Ottawa office. She received her Ph.D. in Bioinorganic Chemistry from the University of California, San Diego in 1993 and then pursued post-doctoral studies at the Muséum National d'Histoire Naturelle in Paris on gene therapy. Gail specializes in drafting and prosecuting patent applications in the fields of chemistry, pharmacology, medical polymers, and biotechnology, and advises on patent infringement and validity issues. Gail is a member of the Intellectual Property Institute of Canada and serves on its Joint Liaison Committee for patents.

Mhairi Skinner

Mhairi Skinner (mskinner@blg.com) is a technical advisor and associate in the Ottawa office. She obtained a B.Sc. (Honours) from the University of Guelph in 1994. She pursued her graduate studies at the University of Guelph and received her Ph.D. in Molecular Biology and Genetics in 1999. Following graduate school, Mhairi co-founded a biotechnology company in the area of cancer therapeutics. She worked as an editor at Nature Publishing Group, as a consultant to the National Institute of Health (National Cancer Institute), and as an adjunct professor at the University of Guelph.

Andrew Sojonky

Andrew Sojonky (asojonky@blg.com) is a partner and patent agent in the Ottawa office. He graduated with honours in Materials and Metallurgical Engineering from Queen's University. Andrew specializes