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.
Calgary | Montréal
| Ottawa | Toronto | Vancouver | Waterloo Region
Borden Ladner
Gervais LLP is an Ontario Limited Liability Partnership.
Lawyers |
Patent & Trade-mark Agents
blg.com
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.
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 5: Biopolymers: DNA, RNA, and Proteins
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
Chapter 11: Patented Medicines (Notice of Compliance) Regulations
Chapter 12: Patented Medicine Prices Review Board
Chapter 13: Subsequent Entry Biologics
Chapter 14: Infringement, Validity, and Post-Grant Modifications
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.
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 in patent procurement in chemical and mechanical technologies including oil and gas (upstream and downstream, including oil sands extraction), carbon capture and sequestration, chemistry, material science, metallurgy, clean tech, and medical devices. He also provides opinions as to patentability, validity, and infringement, and offers counsel in global patent strategy and portfolio management.
Chris
Watson
Chris Watson (cwatson@blg.com) is a lawyer, patent, and trade-mark agent in the Toronto office. Chris received his LL.B. from the University of Windsor in 2001 and was called to the Ontario Bar in 2002. Prior to law school, Chris obtained a B.A.Sc. in Civil Engineering at the University of Waterloo in 1998. Chris's patent practice focuses on drafting and prosecuting patent applications for chemical manufacturing processes and related equipment, various green technologies, and medical and surgical devices.
David
Wood
David Wood (dwood@blg.com) is a lawyer in the Calgary office. He was admitted to the Alberta Bar in 2009. David is now training to become a patent agent. David completed his Ph.D. (Biochemistry) and LL.B. at the University of Saskatchewan in 2005 and 2008, respectively. David's doctoral research focused on characterization of an interaction between DNA and metal ions. David has experience in drafting and prosecuting patent applications, preparing validity and infringement opinions, assisting with patent and trade-mark litigation, and advising securities counsel on transactions involving patents and patent applications. David's experience is in technical fields including oil and gas, particularly heavy oil and bitumen, chemistry, biotechnology, and pharmaceuticals.
OTHER CONTRIBUTORS
The authors would like to thank Andrea Pitts, Benjamin Reingold, and Ryan Steeves for their contributions to this edition.
Contributors to previous editions include David Barrans, Susan Beaubien, Katherine Britt, Andrew Hicks, Ravinder Jain, Jean-François Jutras, Kevin LaRoche, Jennifer Ledwell, Martin Marcus, John Paxton, Juila Pomeroy, and Sorhab Sabet.
GENERAL PATENT PRACTICE IN CANADA
OVERVIEW OF THE CANADIAN PATENT SYSTEM
1.1 CANADIAN PATENT LAW
Canadian patent law is established under Canadian legislation and case law. In particular, Canadian patent law is established under the Patent Act[1] and Patent Rules,[2] as well as other legislation as discussed in subsequent chapters in this book. Also, the Canadian Intellectual Property Office (CIPO) has published a Manual of Patent Office Practice (MOPOP) which establishes procedures and practices relating to the filing and prosecution of patent applications filed with CIPO (Canadian applications).[3] MOPOP is a guide, and should not be relied on as an authority.
Canadian applications are published 18 months after the earlier of the filing date of the Canadian application or the earliest claim date (see below).[4] The maximum term for patents issuing from Canadian applications is 20 years from the filing date.[5] Maintenance fees are payable on an annual basis for all Canadian applications, beginning on the second anniversary of the filing date, and on all patents issuing therefrom (Canadian patents).[6] Failure to pay maintenance fees may result in a loss of rights.[7]
The issues in this chapter will be discussed in detail in subsequent chapters.
1.2 CLAIM DATE
Each claim in a Canadian application has a claim date. By default, the claim date is the filing date of the Canadian application.[8] However, in accordance with Canada's membership in the Paris Convention, NAFTA, and the WTO, the Patent Act provides conditions under which a claim date may be earlier than the filing date of the Canadian application.[9] A claim in an application for a Canadian patent is considered to have a claim date earlier than the Canadian filing date where the following conditions are met: a patent application was previously filed in a country that is a member of one of the above agreements,[10] the previously filed application discloses the subject matter of the claim, the Canadian application is filed within one year after the filing date of the previously-filed application, and the applicant requests priority on the basis of the previously filed application.[11] Where these conditions are met, the claim date is the filing date of the previously filed application, and is commonly referred to as the "priority date."[12] Thus, in effect, s. 28.1 of the Patent Act allows one or more claims of a Canadian application to have a claim date that is up to one year prior to the filing date of the Canadian application.
An applicant may request priority on the basis of multiple previously filed applications in respect of a single Canadian application, provided that the above conditions are met for each previously filed application.[13] Claims in the Canadian application may have different claim dates from each other. The claim date of a given claim in the Canadian application will be determined by which of the previously filed applications discloses the subject matter of the claim, and is not necessarily the earliest filing date of the previously filed applications.[14] The claim dates of different claims may be significant when assessing novelty and inventiveness of the claimed subject matter in view of a disclosure that occurred following the earliest filing date of the previously filed applications but prior to the Canadian filing date.
1.3 PATENTABILITY REQUIREMENTS
1.3.1 Definition of Invention
In Canada, "invention" means "any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter."[15]
In assessing whether subject matter falls within the meaning of invention under this definition, the criteria established by the Canadian courts and the Patent Act, are as follows:[16]
a. whether the subject matter relates to a useful art as distinct from a fine art where the result produced is solely the exercise of personal skill, mental reasoning or judgment, or has only intellectual meaning or aesthetic appeal;
b. whether the subject matter is operable, controllable, and reproducible by the means described by the inventor so that the desired result will inevitably follow whenever the subject matter is put into practice;
c. whether the subject matter has practical application in industry, trade, or commerce; and
d. whether the subject matter is more than a mere scientific principle or abstract theorem.
The terms "art," "process," "machine," "manufacture," and "composition of matter" are not defined in the Patent Act or Patent Rules. However, court decisions provide some clarification on patentable subject matter. For example, methods of medical treatment are, in a strict sense, outside of the definition of invention and are not patentable in Canada.[17] However, a medical device and its method of operation may be patentable. Higher life forms, including plants and animals, are not patentable subject matter.[18] However, claims to a plant cell may be enforceable against an infringer possessing an entire plant.[19] Further discussions as to the patentability of subject matter within the biotechnology and chemical arts, as well as acceptable claim formats, are provided in later chapters.
1.3.2 Novelty Requirements
The Patent Act has novelty requirements for subject matter to be claimed in a patent. The subject matter of a claim must not have been disclosed such that it was made available to the public prior to the claim date.[20] A one-year grace period is allowed for subject matter disclosed to the public by the applicant or someone obtaining knowledge directly or indirectly from the applicant.[21] The one-year grace period extends back from the Canadian filing date.[22] It does not extend back from the claim date where the claim date is earlier than the filing date.[23] Therefore, when a public disclosure is made by a soon-to-be applicant, a patent application must be filed with CIPO within one year of the disclosure in order for a claim to the subject matter to be novel in view of the disclosure. If the Canadian application is filed after the one-year grace period has expired, the disclosure is applicable as prior art against the Canadian application.
For patent applications filed under the Patent Cooperation Treaty (PCT), the PCT international filing date is deemed to be the Canadian filing date.[24] The applicable grace period extends back from the PCT international filing date and not the date of the application's national phase entry into Canada.
While the requirement for novelty is imposed by the Patent Act, the test for whether a given public disclosure or a Canadian application with an earlier claim date is anticipatory of subject matter is defined by case law. Disclosure of subject matter in a way described in s. 28.2 precludes claiming the subject matter only where the disclosure both discloses and enables the subject matter.[25]
1.3.3 Inventive Ingenuity/Non-Obviousness
The Canadian patent system has inventiveness requirements for subject matter to be claimed in a patent. Section 28.3 of the Patent Act requires that the subject matter not have been obvious on the claim date to a person skilled in the art to which it pertains. As with the provisions of the Patent Act requiring novelty, a one-year grace period extending back from the filing date applies to disclosures by the applicant or someone obtaining knowledge directly or indirectly from the applicant.[26]
While requirements for inventiveness are imposed by the Patent Act, the test for whether subject matter is obvious in view of a given public disclosure or combination of disclosures is defined by case law. The test for obviousness has four steps. First, the applicable person skilled in the art and the relevant common general knowledge of such person on the claim date are identified. Second, the inventive concept of the claim in question is identified. Third, the differences between the state of the art and the inventive concept are identified. Fourth, the question of whether the differences would have been obvious to the person skilled in the art on the claim date is answered.[27] In technical fields where advances are won by experimentation, the question of whether the subject matter of a claim is "obvious to try" may be considered at the fourth stage of the obviousness analysis.
1.3.4 Utility Requirements
To be an invention within the meaning of section 2 of the Patent Act, subject matter must possess utility. This can be either demonstrated or soundly predicted as of the Canadian filing date.[28] If relying on a sound prediction, the patent must disclose both the factual basis underlying the prediction and the sound line of reasoning to the prediction.[29]
Utility is generally assessed on a claim-by-claim basis. However, if the invention does not work for the purpose set out in the Canadian patent, then the lack of utility for that specified purpose invalidates the patent as a whole.[30] A Canadian patent cannot be granted for something that is inoperable for the purpose for which it was designed. A patentee must bear this in mind when considering the scope of the claims to be submitted in a patent application to avoid claiming any subject matter that does not work for the purpose set out in the specification. Any such claim may be deemed invalid. There is, however, no obligation on the patentee to claim the utility of the invention.[31]
1.3.5 Sufficiency of Disclosure
Section 27(3) of the Patent Act provides that the specification of an invention must correctly and fully describe the invention and its operation or use in such full, clear, concise, and exact terms as to enable any person skilled in the art or science to which it pertains to make, construct, or use it.
The skilled person must be able to understand how the subject matter of the patent is to be made or performed by reading the specification. The specification must set out the invention in sufficient detail to allow the skilled person to put it into practice. Where insufficient information is provided in the specification, the claims may be found unpatentable or invalid.[32]
1.3.6 Ambiguity
Section 27(4) of the Patent Act requires that the specification end with a claim or claims defining distinctly and in explicit terms the subject matter of the invention for which an exclusive privilege or property is claimed. In Minerals Separation North American Corp. v. Noranda Mines Ltd.,[33] the Exchequer Court held that, to be valid, claims must be free from avoidable ambiguity or obscurity.
1.3.7 Scope of Invention
Section 84 of the Patent Rules requires that claims be clear, concise, and fully supported by the description independently of any document referred to in the description.
1.4 UNITY-OF-INVENTION REQUIREMENTS
A patent is granted for one invention only, although a patent will not be found invalid solely on the basis that it includes more than one invention.[34]Section 36 of the Patent Rules states that an application does not claim more than one invention if the subject matter defined by the claims is so linked as to form a "single general inventive concept."
1.5 UNTRUE MATERIAL ALLEGATIONS, OMISSIONS, AND ADDITIONS
Section 53(1) of the Patent Act provides two bases under which an issued Canadian patent may be void. First, where a material allegation in the petition is untrue. Second, where the the specification and drawings contain more or less than is necessary for obtaining the patent, and the omission or addition is wilfully made for the purpose of misleading.[35]
While intention to mislead is difficult to prove, applicants for Canadian patents are strongly encouraged to make efforts to ensure that the correct inventors are named in the petition to reduce the possibility that a s. 53(1) challenge will be brought against an issued patent. Similarly, the disclosure should be reviewed prior to filing by the applicant and a patent agent to ensure that nothing relevant to the scope of the claims is omitted and that no unnecessary additions are present.
1.6 GOOD-FAITH PROSECUTION
By operation of the Patent Act, pending Canadian applications are deemed abandoned where an applicant does not respond in good faith to a requisition of the examiner within a defined time period.[36] The time period is typically six months, but may be less. The Federal Court of Appeal has held that once a patent issues, it can not be invalidated pursuant to s. 73(1)(a).[37]
[1] R.S.C. 1985, c. P-4 [Patent Act].
[2] S.O.R./96-423 [Patent Rules].
[3] Manual of Patent Office Practice, online: The Canadian Intellectual Property Office <http://www.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00720.html> [MOPOP].
[4] Patent Act, supra note 1, s. 10.
[5] Patent Act, ibid., s. 44.
[6] Patent Act, ibid., s. 27.1; Patent Rules, supra note 2, s. 99, Sch. II.
[7] Patent Act, supra note 1, s. 73(1)(c); but see s. 73(3). For further discussion, see Chapter 2, Procedural Requirements, section 2.5.
[8] Patent Act, supra note 1, s. 28.1(1).
[9] Patent Act, ibid., ss. 28.1(1)(a)-(c).
[10] At least one of the applicants must be a resident or citizen of a country that is a signatory to one of these agreements.
[11] Patent Act, supra note 1, s. 28.1(2).
[12] Ibid.; "priority date" was previously a term defined in the Patent Act. The definition was repealed but the term remains in common use.
[13] Patent Act, supra note 1, s. 28.4(1).
[14] Patent Act, ibid., s. 28.1(1)(a), s. 28.4(4)(a).
[15] Patent Act, ibid., s. 2.
[16] Tennessee Eastman Co. et al. v. Canada (Commissioner of Patents) (1970), 62 C.P.R. 117 (Can. Ex. Ct.), aff'd [1974] S.C.R. 111, 8 C.P.R. (2d) 202 (S.C.C.) [Tennessee Eastman]; Re N.V. Organon Application No. 003,389 (1973), 15 C.P.R. (2d) 253 (P.A.B.); Patent Act, supra note 1, s. 27(8).
[17] Tennessee Eastman, ibid. (S.C.C.). For further discussion, see Chapter 8, Medical Treatments and Medical Uses.
[18] Harvard College v. Canada (Commissioner of Patents), 2002 SCC 76, 21 C.P.R. (4th) 417. For further discussion, see Chapter 7, Living Matter (Life Forms).
[19] Monsanto Canada Inc. v. Schmeiser, 2004 SCC 34, 31 C.P.R. (4th) 161.
[20] Patent Act, supra note 1, ss. 28.2(1)(a)-(b).
[21] Patent Act, ibid., s. 28.2(1)(a).
[22] Ibid.
[23] Ibid.
[24] Patent Rules, supra note 2, s. 64.
[25] Sanofi-Synthelabo Canada Inc. v. Apotex Inc., 2008 SCC 61, 69 C.P.R. (4th) 251 [Sanofi].
[26] Patent Act, supra note 1, s. 28.3.
[27] Sanofi, supra note 25.
[28] Apotex Inc. v. Wellcome Foundation Ltd., 2002 SCC 77, 21 C.P.R. (4th) 499.
[29] Ibid.
[30] TRW Inc. v. Walbar of Canada Inc. (1991), 50 F.T.R. 160, 39 C.P.R. (3d) 176 (F.C.A.).
[31] Eli Lilly & Co. v. Apotex Inc., 2009 FC 991, 80 C.P.R. (4th) 1, aff'd 2010 FCA 240, 90 C.P.R. (4th) 327.
[32] Minerals Separation North American Corp. v. Noranda Mines Ltd., [1950] S.C.R. 36, 12 C.P.R. 99 (S.C.C.).
[33] Minerals Separation North American Corp. v. Noranda Mines Ltd. (1947), Ex. C.R. 306, 12 C.P.R. 99 at 102 (Ex. Ct. Can.).
[34] Patent Act, supra note 1, s. 36(1). For further discussion of invention requirements in the context of divisional applications, see Chapter 2, supra note 7, section 2.2.
[35] Patent Act, supra note 1, s. 53(1).
[36] Patent Act, supra note 1, s. 73(1)(a).
[37] Weatherford Canada Ltd. v. Corlac Inc., 2011 FCA 228, 2011 CarswellNat 2835, rev'g 2010 FC 602, 84 C.P.R. (4th) 237.
PROCEDURAL REQUIREMENTS
2.1 FILING REQUIREMENTS
The Canadian Patent Act requires the filing of a minimum of documents to obtain a filing date for a patent application. For all applications filed after October 1, 1996, the minimum requirements include:[1]
a. a written statement in either English or French that a patent is being sought;
b. a document in either English or French that, on its face, describes the invention;
c. the name of the applicant;
d. the address of the applicant or the applicant's patent agent; and
e. the application fee.
The document describing the invention corresponds to the specification but it need not include claims. At filing, the Patent Office does not examine the document to determine the merits of the invention. It makes only a cursory review of the document's form rather than its substance. The inventor or inventors need not be identified at the time of filing to meet the minimum requirements. When only the minimum requirements are met, the application is termed "incomplete." An incomplete application does not need to be converted to a "regular" patent application. Rather, additional documents simply have to be filed with the Patent Office within 15 months from the earlier of the earliest claimed priority date and the Canadian filing date. The documents required to complete the application are as follows:[2]
a. a petition;
b. a statement that the applicant is the inventor, or a declaration that the applicant is the legal representative of the inventor ("legal representative" is defined in s. 2 of the Patent Act as including "heirs, executors, administrators, guardians, curators, tutors, assigns and all other persons claiming through or under applicants for patents and patentees of inventions");
c. an abstract of the invention;
d. claim(s) to the invention;
e. any drawing mentioned in the description;
f. a biological deposit number, if applicable; and
g. a sequence listing, if applicable.
Patent Cooperation Treaty (PCT) applications entering the national phase in Canada are governed by slightly different rules. On entering the national phase, an applicant for a PCT application must provide the Patent Office with a copy of the international application, if it has not been published by the World Intellectual Property Organization (WIPO); a translation of the application into either English or French, if necessary; and payment of the prescribed national entry fee.[3] As an alternative to providing the declaration that the applicant is the legal representative of the inventor, the applicant may submit a declaration as to the applicant's entitlement, as at the filing date, to apply for and be granted a patent, in accordance with rule 4.17 of the Regulations under the PCT.[4] The applicant is also required to pay any outstanding maintenance fees.[5] The deadline to enter the national phase in Canada and satisfy these requirements for a PCT application is 30 months after the priority date. The applicant may, however, be given an additional 12-month period to enter the national phase by paying an additional late-entry fee, thereby effectively extending the deadline for entering the national phase in Canada to a total of 42 months.[6]
New subject matter cannot be added to the application at any time after the application is filed. New subject matter includes anything that is not reasonably inferable from the original specification or drawings.[7] New features in the invention, further data, further developments, or a more precise description of the invention are all considered to be new subject matter.
Any new subject matter may be included in a new Canadian application, which may claim priority from the earlier-filed Canadian application if it is filed within one year of the earlier-filed Canadian application.[8] These provisions allow an applicant to claim "internal" priority. This practice gives an applicant the opportunity to file an incomplete patent application as early as possible after an invention has been made, in order to obtain the earliest possible filing date for the disclosed subject matter. Further improvements, alterations, or additional data are included in the later-filed patent application, which then requests priority over the previously filed application. This practice allows the applicant to retain an early claim date for the subject matter disclosed in the first application while receiving a later claim date for the new subject matter. The applicant has the option of proceeding with both applications, or abandoning the first application and proceeding with only the second application. There is no limit to the number of priority claims that may be made. This practice of claiming internal priority is similar to the U.S. continuation-in-part practice with the exception that, in Canada, there is a time limit of 12 months from the first-filed application. Once the 12-month period from the first-filed application has expired, internal priority may no longer be claimed. For the later-filed application, the patent term is calculated as 20 years from the filing date of the later-filed application.
2.2 DIVISIONAL APPLICATIONS AND UNITY OF INVENTION
In Canada, a divisional application may be filed at any time before the parent application issues to patent.[9] The parent application can, itself, be a divisional application. That is, in the case of an application that is divided more than once, the first divisional application may be a parent to a subsequent divisional application. Thus, the issuance of the original, or "parent," application does not prevent further divisional applications from being filed, provided that there is at least one divisional application still pending in the Patent Office that describes all of the inventions. An application may be divided voluntarily by the applicant or at the insistence of the Patent Office.[10]
If the Patent Office raises a unity-of-invention objection and requires division, Canadian case law supports the proposition that because the division was required by the patent examiner, it does not constitute double patenting.[11] That is, any attack on such patents for double patenting will fail because the division was made at the request of the Patent Office. However, when an applicant initiates the filing of a divisional application without previously receiving a unity objection, a double-patenting attack is available, and has previously been successful in the courts.[12] Accordingly, it is unadvisable for an applicant to initiate the filing of a divisional application for subject matter that has not been clearly delineated as a separate invention in a unity objection. Such an application is often referred to as an applicant-initiated divisional or voluntary divisional application.
Unity-of-invention requirements in Canada are quite broad and merely require a single general inventive concept. Various types of claims may be included in the same application without offending unity-of-invention requirements. CIPO considers the following combinations of claim categories to be acceptable within the same application:[13]
a. a product and a process for making the product;
b. a product and a use of the product;
c. a product, a process for making the product, and a use of the product;
d. a process and an apparatus specially adapted to carry out the process;
e. a product, a process for making the product, and an apparatus specially adapted to carry out the process; or
f. a product, a process for making the product, an apparatus specially adapted to carry out the process, and a use of the product.
According to MOPOP, a Canadian application may include claims to a final product and claims to an intermediate product used in the preparation of the final product, but only when there is sufficient structural similarity between the two so that it can be reasonably assumed that the intermediate product was designed to prepare the final product. In order for such claims to be considered part of the same invention, the final product should be manufactured directly from the intermediate product. The intermediate product may have the same use as the final product, but it must not have other uses.[14]
2.3 REQUESTS FOR EXAMINATION
Patent applications are not automatically examined by the Canadian Patent Office. The applicant is required to file a request for examination and pay the prescribed fee.[15] Examination must be requested before the expiry of five years from the Canadian filing date.[16] For divisional applications, examination must be requested at the same deadline as for the parent application or, if that deadline has passed, then within six months after the date on which the divisional application is actually filed.[17] If examination is not requested by the deadline, the application will be considered abandoned.[18] An application abandoned for this reason may be reinstated within one year of the date of abandonment by the filing of a request for reinstatement and payment of a prescribed reinstatement fee, as well as by the filing of the request for examination and payment of the examination fee.[19]
2.4 ACCELERATING EXAMINATION
There are currently three options for accelerating examination in Canada.
2.4.1 Special Order
An applicant may request expedited examination by stating that failure to advance the application is likely to prejudice the applicant's rights, and by paying the prescribed fee.[20] Unless publication has already occurred, the applicant must also request early publication.[21]
2.4.2 Patent Prosecution Highway
The Patent Prosecution Highway (PPH) program provides an alternative option for accelerating examination in Canada based on claims allowed or issued by another patent office. Currently, the Canadian Patent Office has established a PPH program with the patent offices of the United States, Japan, Korea, Germany, Spain, Denmark, Finland, and the Canadian Receiving Office of the PCT. Allowance can often be obtained within 12 months of making the request. While the basic premise of the bilateral agreements is the same, the specific requirements differ. Currently, there are no government fees.
2.4.3 Green Technology
In addition, if the application relates to "technology the commercialization of which would help to resolve or mitigate environmental impacts or to conserve the natural environment and resources," expedited examination is also available without a government fee.[22]
2.5 MAINTENANCE FEES
For all applications filed after October 1, 1989, the applicant must pay annual maintenance fees in order to maintain the application in good standing. The first maintenance fee is due for payment on the second anniversary of the filing date and is payable every year thereafter until the patent expires. Maintenance fees may be paid up to one year after the due date with the additional payment of a late payment fee.[23]
For applications that were filed before October 1, 1989, but that issue to patent after this date, transitional provisions apply requiring maintenance fees to be paid on such patents.[24] These patents have a term of 17 years from the date of issue. Maintenance fees are payable annually from the date of issuance until the date the patent expires. Again, these fees may be paid up to one year after the due date with an additional late payment fee.
If an outstanding maintenance fee and the additional late payment fee are not paid to the Patent Office within that one-year grace period, the patent will lapse. A lapsed patent may not be revived.
2.6 ABANDONMENT/REINSTATEMENT
Under the Canadian Patent Act, with few exceptions, a patent application is deemed to be abandoned if the applicant does not reply in good faith to any requisition made by the Patent Office.[25] For example, an application is considered abandoned if a timely response is not filed to an Examiner's Office Action. An application is also considered abandoned if examination is not requested within the prescribed time limit, if the application is not completed within the prescribed time limit, or if the final fee is not paid within the time limit.
An abandoned application is automatically reinstated if appropriate steps are taken within one year of abandonment. To reinstate an application, the applicant must take the action that it had previously failed to take and for which the application became abandoned, make a request for reinstatement, and pay the prescribed fee for reinstatement as well as any other outstanding fees.[26] These steps must be taken with respect to each failure for which the application became abandoned. Therefore, if examination is not requested within the prescribed time limit, the application becomes abandoned. If, subsequently, the applicant does not pay the required maintenance fee, the application is also deemed abandoned for failure to pay maintenance fees. As a result, to fully reinstate the application, the applicant must:
a. request examination,
b. pay the examination fee,
c. request reinstatement from the failure to pay the examination fee,
d. pay a first reinstatement fee,
e. pay the outstanding maintenance fee,
f. request reinstatement from the failure to pay the maintenance fee, and
g. pay a second reinstatement fee.
Automatic reinstatements for abandonment apply only to applications filed after October 1, 1989; they do not apply to the few remaining applications filed before this date that are still pending.[27]
The deadline for reinstating an application is before the expiry of the 12-month period after the date on which the application becomes abandoned as a result of the failure to take action. Where the applicant fails to take action on more than one count, dates of abandonment run from each failure to take action, and not simply from the earliest.
2.7 CORRECTION OF CLERICAL ERRORS
Section 8 of the Patent Act allows for the correction of clerical errors in any instrument of record in the Patent Office.[28] The courts have defined "clerical error" as an error that arises in the mechanical process of writing or transcribing.[29] A correction of a clerical error under s. 8 is at the discretion of the Commissioner of Patents.[30] Even if a clerical error is found to have occurred, the Commissioner may refuse to exercise his discretion to correct the error. The Commissioner has refused to exercise his discretion in cases where the correction had the potential to prejudice third parties and where there was a substantial delay in requesting the correction.[31]
[1] Patent Rules, S.O.R./96-423, s. 27.1(1) [Patent Rules].
[2] Ibid., ss. 37, 94, 104.
[3] Ibid., s. 58(1).
[4] Ibid., s. 37(2).
[5] Ibid., s. 59(2).
[6] Ibid., s. 58(3).
[7] Patent Act, R.S.C. 1985, c. P-4, s. 38.2 [Patent Act].
[8] Ibid., s. 28.1.
[9] Ibid., s. 36.
[10] Ibid., ss. 36(2)-36(2.1).
[11] Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd., [1981] 1 S.C.R. 504, 56 C.P.R. (2d) 145.
[12] GlaxoSmithKline Inc. et al. v. Apotex Inc. et al. (2003), 234 F.T.R. 251, 27 C.P.R. (4th) 114 (F.C.T.D.).
[13] Manual of Patent Office Practice, online: The Canadian Intellectual Property Office <http://www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00720.html>, s. 14.02 [MOPOP].
[14] Ibid., s. 14.03.03.
[15] Patent Rules, supra note 1, s. 96(1).
[16] Ibid.
[17] Ibid., ss. 96(2), 150(2).
[18] Patent Act, supra note 7, s. 73(1)(d).
[19] Ibid., s. 73(3).
[20] Patent Rules, supra note 1, s. 28(1).
[21] Ibid., s. 28(2)
[22] Ibid., s. 28(1).
[23] Patent Act, supra note 7, s. 46. See Patent Rules, supra note 1, ss. 99-102, 154-158, Sch. II.
[24] Patent Act, supra note 7, s. 78.2. See Patent Rules, supra note 1, s. 182, Sch. II.
[25] Patent Act, supra note 7, s. 73(1).
[26] Ibid., s. 73(3).
[27] Patent Rules, supra note 1, s. 26.
[28] Patent Act, supra note 7, s. 8.
[29] Bayer Aktiengesellschaft v. Commissioner of Patents (1980), 53 C.P.R. (2d) 70 at 73 (F.C.T.D.).
[30] Ibid. at 74.
[31] Dow Chemical Co. v. Canada (Attorney General), 2007 FC 1236, 63 C.P.R. (4th) 89.
BIOTECHNOLOGY-SPECIFIC PROCEDURAL REQUIREMENTS
3.1 SEQUENCE LISTINGS
Sequence listings are required for all patent applications filed after October 1, 1996 that disclose an unbranched nucleotide sequence of 10 or more nucleotides or an unbranched amino acid sequence of four or more contiguous residues, other than a sequence identified as forming a part of the prior art.[1] It is not necessary that the sequence be claimed, only that it be included in the application and not be identified as prior art.
Sequence listings are not statutorily required for Canadian patent applications filed before October 1, 1996. However, the Patent Office has found it useful to allow them. No formal requirements apply, but the requirements for applications filed after October 1, 1996 are often followed in such cases.
Significant amendments to the Patent Rules relating to Canadian sequence listing requirements came into force on June 2, 2007. One of the main effects of these amendments was to harmonize the Canadian format for sequence listings with the Patent Cooperation Treaty (PCT) sequence listing standard by referencing the latter in the Patent Rules. Thus, the Canadian standard will automatically change whenever the PCT standard changes. The amended Patent Rules also harmonize the due dates for filing a sequence listing in an application that is a PCT national entry with the requirements for an application that is a non-PCT patent application. Under transitional provisions, for any applications filed before June 2, 2007, applicants may substitute the sequence listing requirements prescribed under the "old" Patent Rules — that is, as they read immediately before June 2, 2007 — for the current sequence listing requirements. The old Patent Rules for sequence listings will be discussed separately, later in the chapter.
3.1.1 Current Formal Requirements
Under the current Patent Rules, if an application contains disclosure of a nucleotide or amino acid sequence other than a sequence identified as forming a part of the prior art, the description shall contain, in respect of that sequence, a sequence listing in electronic form.[2] Both the sequence listing and the electronic form must comply with the PCT sequence listing standard. Accordingly, the electronic form of the sequence listing must be in ASCII text format (such as a text or ".txt" file) and may be submitted on an electronic medium, such as a computer CD. Suitable electronic mediums include a CD, a DVD, or any format as set forth in Annex F of the Administrative Instructions under the Patent Cooperation Treaty.[3] If an application originally filed without a sequence listing is amended to include a sequence listing, the applicant must file a statement to the effect that the sequence listing does not go beyond the disclosure in the application as filed.[4] If a sequence listing initially filed in paper form or in an electronic form that does not comply with the PCT sequence listing standard is subsequently replaced by a sequence listing in an electronic form that does comply with that standard, the applicant must file a statement to the effect that the replacement listing does not go beyond the disclosure in the application as filed.[5]
Where a sequence listing is required, it is treated as a completion requirement and must be filed within certain time limits to avoid paying a completion fee:
a. With respect to a non-PCT application, the time limit is 15 months after the filing date of the application or, if a request for priority has been made in respect of the application, 15 months after the earliest filing date of any previously regularly filed application on which the request for priority is based.[6]
b. For PCT cases entering the national phase in Canada, the time limit is three months after the date of national entry.[7]
If the sequence listing is not filed within the required time limit, the Patent Office will issue a letter requisitioning the applicant to comply with the sequence listing requirements and to pay a completion fee.[8] Failure to respond to that requisition will result in abandonment of the application.
The sequence listing requires several items of information and follows a prescribed format. The PCT standard for the presentation of nucleotide and amino acid sequence listings is set forth in Annex C of the PCT Administrative Instructions.[9] The current PCT standard is also sometimes referred to as "World Intellectual Property Organization (WIPO) Standard ST.25."
The United States Patent and Trademark Office (USPTO) offers a computer program, PatentIn, for use in preparing sequence listings. The software for this program can be downloaded by the public at no charge from the USPTO website.[10]
The formal requirements of the sequence listing can be briefly summarized as follows. Sequence listings must include the numerical data element headings and the respective information, if applicable and when available to the applicant, as set forth in Annex C, Appendix 1 of the PCT Administrative Instructions.[11] Amino acid and nucleotide sequences are identified in a standard format. The term "amino acids" refers to those L-amino acids commonly found in naturally occurring proteins and such amino acids when they have been modified.[12] "Nucleotides" refer to those nucleotides that can be represented using the symbols set out at the end of this chapter in Appendix A, table 3, and such nucleotides when they have been modified — for example, by the addition of methyl or thiol groups. Modified nucleotides may be identified using the symbols set out at the end of this chapter in Appendix A, Table 4.[13]
Amino acids are listed in the amino to carboxy direction from left to right, and the amino and carboxy groups are not represented in the sequence. The amino acids are represented using the symbols set out in Appendix A, Table 1. Modified, non-natural, or otherwise unusual amino acids are listed in the sequence as "Xaa" with further information given elsewhere in the sequence listing. Modified amino acids may be defined using the symbols set out in Appendix A, Table 2. Amino acid sequences are listed with a maximum of 16 amino acids per line with a space between each amino acid. Amino acids corresponding to the codons in the coding parts of a nucleotide sequence are indicated immediately under the corresponding codons. Where a codon is split by an intron, the amino acid symbol is indicated below the portion of the codon containing two nucleotides. The enumeration of amino acids in a sequence starts at the first amino acid at the amino terminal as number 1 and is marked under the sequence of every fifth amino acid. Where a mature protein has been identified, the amino acids are enumerated starting at the first amino acid of the mature protein with number 1. The amino acids preceding the mature protein, when present, have negative numbers counting backward starting with the amino acid next to number 1. A sequence that is made up of one or more non-contiguous segments of a larger sequence or segments from different sequences is presented as a separate sequence. A sequence having gaps is numbered as a plurality of separate sequences with separate sequence identifier numbers. For example, an amino acid sequence that contains a blank or internal terminator symbols (such as "Ter," "*," or ".") may not be represented as a single amino acid sequence, but shall be presented as separate amino acid sequences.[14]
Nucleotide sequences are presented only by a single strand in the 5' to 3' direction from left to right. Modified nucleotides are listed in the sequence as "N" with further information given elsewhere in the sequence listing. Modified nucleotides may be identified using the symbols set out in Appendix A, table 4. Nucleotides in a nucleotide sequence are listed in groups of 10 bases except in the coding parts of the sequence. Leftover bases, fewer than 10 in number at the end of non-coding parts of the sequence, are grouped together and separated from adjacent groups by a space. The nucleotides of the coding parts of a sequence are listed as triplets. A nucleotide sequence is listed with a maximum of 16 codons or 60 nucleotides per line, with a space between each codon or group of 10 nucleotides. Nucleotides in a sequence are enumerated starting at the first nucleotide in the sequence with number 1. The enumeration is continuous throughout the whole nucleotide sequence in the direction 5' to 3' and shall be marked in the right margin, the line containing the one-letter codes for the nucleotides, and giving the number of the last nucleotide of that line. These enumeration methods for both amino acids and nucleotides apply to circular nucleotide and amino acid sequences with the exception that any nucleotide or amino acid may be designated as the first nucleotide or amino acid.
3.1.2 Formal Requirements for Applications Filed Before June 2, 2007
Under transitional provisions, for any PCT or non-PCT application filed before June 2, 2007, applicants may substitute the sequence listing requirements set forth in the old Patent Rules — that is, the Patent Rules as they read immediately prior to June 2, 2007 — for the requirements set forth in the current Patent Rules (discussed above).
In accordance with the old Rules, where sequence listings are required for non-PCT applications, they must be filed within the following time limits: the later of 12 months after the Canadian filing date and 3 months after a request from the Patent Office — this request is normally received within 15 months from the earliest-claimed priority date. There is no deadline for providing a sequence listing for PCT cases, unless the Patent Office issues a specific request setting a deadline. If the sequence listing is not filed within the prescribed time limits, the application becomes abandoned.
Download this book for your ebook reader.
(Pages 1-33 show above.)