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From Discovery to Dollars An IP handbook for researchers with bright ideas version 2

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From Discovery to Dollars An IP handbook for researchers with bright ideas version 2

Suite 200, 2386 East Mall University of British Columbia Vancouver, British Columbia, Canada, V6T 1Z3 tel: 604-222-3600 fax: 604-222-3606 www.prionetcanada.ca

Š 2012 Borden Ladner Gervais LLP All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form or by any means without the prior written permission of the copyright holder.

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Table of Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

What is a patent and what does it do? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

What criteria must my invention meet to be patentable? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2

What do I need to understand about patent laws? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

How and where do I file patent applications? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

How do I get the ball rolling for a Canadian patent application? . . . . . . . . . . . . . . . . . . . . . . 12

How do I determine if I am an inventor? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Do I have to test every possible embodiment of my invention? . . . . . . . . . . . . . . . . . . . . . . . 14

How many inventions may I claim in one patent? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

What if I have too many inventions in one patent? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

What else do I need to do to complete the application? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

When should I file my patent application? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

When will the Patent Office examine my application? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

What fees do I pay and when? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

What happens if I forget deadlines and payments? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

There’s a mistake in my application. Am I in trouble? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

New data isn’t in the application. How do I deal with that? . . . . . . . . . . . . . . . . . . . . . . . . . . 23

My invention relates to medicines. Are they treated differently? . . . . . . . . . . . . . . . . . . . . . 23

How do I ensure that my record-keeping will support my invention? . . . . . . . . . . . . . . . . . . 24

What could somebody do to challenge my patent? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25

What are the purchaser’s rights to a patented article? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

What about improvements to my patented invention? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Does my invention have to show a patent mark? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

My patent has been infringed! What can I do? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28


Table of Contents (continued) Commercialization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

What is it all about? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Licences . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

What is a licence agreement? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

Is a licence the same thing as a contract? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30

As the licensor, does the invention still belong to me? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Are there different types of licences? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Can I restrict a licence? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

My licence has been breached! What can I do? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

Can I simply sell my IP? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

What is an assignment (or purchase and sale) agreement? . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

What should I watch out for? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32

What if I can’t pinpoint the value of my invention? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

I’m not ready to sell or license my IP. What else can I do? . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

What is a research and development agreement? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33

What should I include in my research and development agreement? . . . . . . . . . . . . . . . . . . . . . 33

What is an option agreement? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

What kind of preconditions could there be? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34


Table of Contents (continued) Commercialization (continued)

Are there other commercialization issues that I should know about? . . . . . . . . . . . . . . . . . 35

What are Notice of Compliance (NOC) Regulations? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

What happens if my patent relates to a medicine? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

What other protection does my new drug have? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

What types of patents are most likely to be listed on the Patent Register? . . . . . . . . . . . . . . . . . 36

What is the Patented Medicine Price Review Board’s (PMPRB) role? . . . . . . . . . . . . . . . . . . . . . 37

What does Canada’s Food and Drugs Act do? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

How do I know if my invention fits the “New Drug” category? . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Do I need a product licence and/or a facility licence for a new drug? . . . . . . . . . . . . . . . . . . . . . 38

How does the Act handle the new medical device I invented? . . . . . . . . . . . . . . . . . . . . . . . . . . 40

Do I need a product licence or a facility licence for a new medical device? . . . . . . . . . . . . . . . . 40

What are my responsibilities to the consumer? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Can I commercialize my invention through a spin-off company? . . . . . . . . . . . . . . . . . . . . . 42

What is a spin-off company? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

How do I know if the time is right to launch a spin-off company? . . . . . . . . . . . . . . . . . . . . . . . 42

Am I better off launching a spin-off company

or licensing my invention to an existing company? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Where can I find money to support my spin-off company? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

Conclusion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 Contributing authors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46


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What is intellectual property?

Intellectual property (IP) refers to creations, such as inventions, literary and artistic works, symbols, names, images and designs used in commerce. IP is divided into two categories: • industrial property, which includes inventions (patents), trademarks, industrial designs and geographic indications of source; and •

copyright, which includes literary works, such as novels, poems and plays; films; musical works; artistic works, such as drawings, paintings, photographs and sculptures; and architectural designs. Rights related to copyright include those of performing artists in their performances, producers of sound recordings and broadcasters of radio and television programs.

Source: World Intellectual Property Organization


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Innovation phases

Idea creation

Exploitation

Technology development

IP protection

Although there are many types of IP protection, this handbook focuses on patent protection due to the nature of the majority of PrioNet Canada’s research. Additional information related to other forms of IP protection, such as copyright or trademarks, can be found on the accompanying CD.


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Introduction At PrioNet Canada, we encourage our scientific members to think like entrepreneurs and to leave a legacy of research results that may become commercially useful. To do this successfully, we must be aware of the various issues that surround identifying and protecting our ideas.   We developed this intellectual property (IP) handbook with the basis written by experts in IP law from Borden Ladner Gervais LLP. Whether the handbook serves as an introduction to IP protection and commercialization or simply to reinforce current knowledge, we hope it helps you commercialize your products, technologies and services that will benefit Canada and other countries.   Together with our partners and researchers, we have made great strides towards eradicating prion diseases and creating value for Canadian and international economies.

DISCLAIMER: This handbook is intended to provide general information on protecting and commercializing intellectual property. It does not constitute the provision of legal or other professional advice. Intellectual property and regulatory laws are complex and evolving areas. Readers are encouraged to seek and obtain proper legal advice from a competent professional regarding their particular circumstances.

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See section on Contributing authors

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Patents

What is a patent and what does it do? A patent is an IP right granted by a country to a patent holder for a specific period of time. It gives the patent holder the exclusive right to prevent others from making, using, offering for sale, selling or importing articles covered by the patent without the patent holder’s permission. In exchange for this exclusive right granted by a country, the patent holder must disclose the invention to the public. A patent does not grant the right to make, use, offer for sale, sell or import the patented article. The patent holder must comply with laws that affect the manufacture, advertising, use and sale of the patented article. For example, the Food and Drugs Act 2 and its regulations may apply to a biotechnology invention (see section on the Food and Drugs Act ). A patent only offers protection in the country in which it is obtained. Therefore, prospective patentees should consider obtaining a patent in every country where a significant market exists for the patented invention and for articles developed from a patented process.

What criteria must my invention meet to be patentable? Invention Each country has its own laws governing what is patentable. In Canada, an invention is defined as “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.” In the United States, whoever “invents or discovers any new and useful process, machine, manufacture or composition of matter” 3 or any improvement thereof is entitled to a patent. In Europe, “any inventions which are susceptible of industrial application” 4 is patentable unless a specific exclusion is noted.

2 3 4

http://laws.justice.gc.ca/en/f-27/ 35 U.S.C. 101 of the Manual of Patent Examining Procedure (MPEP) Article 52 of the European Patent Convention

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Each country continues to clarify the limits of the law regarding what is and what is not patentable. For example, the Canadian courts and the Canadian Patent Act have established the following criteria: • • • •

the subject matter must relate to a useful art as distinct from a fine art; the prospective patentee must adequately describe the subject matter so that it is operable, controllable and reproducible; the subject matter must have practical application in industry, trade or commerce; and the subject matter must be 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, and are used as generally understood. Although this seems to include anything and everything, the Canadian courts and sections of the Patent Act exclude specific subject matter from being patentable. For example, a patent cannot be granted for software. However, according to a ruling of the Federal Court, business methods may be patentable. In the Amazon decision,5 the Court held that three important elements test whether subject matter falls within the definition of “art:” • it must have a practical application; • it must be a new and inventive method of applying skill or knowledge; and • it must have a commercially useful result. The law continues to evolve. In particular, prospective patentees should be cautious when attempting to patent diagnostic methods, methods of medical treatment, higher life forms, business methods, computer programs and any method or process in which “professional skill” must be exercised. The laws on these subjects vary from country to country, and the specific limitations can be subtle. Often, it is very helpful to consult a patent agent on these matters since they can design commercially valuable patent applications with appropriate wording. Higher Life Forms Canadian courts do not allow patents for non-human higher life forms, for example, plants and animals. The Supreme Court of Canada ruled accordingly in the Harvard Mouse decision6 relating to an oncogenic mouse. The Canadian Patent Office takes the position that fertilized eggs and totipotent stems cells are not patentable; however, pluripotent stem cells are so.

5 6

Amazon.com, Inc. v. The Attorney General of Canada and the Commissioner of Patents (2010), 2010 FC 1011 Harvard College v. Canada (Commissioner of Patents), [2002] 4 S.C.R. 45, 2002 SCC76

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In the subsequent Monsanto decision, the Supreme Court found that claims to a chimeric gene and a plant cell containing that gene were allowable and enforceable against an infringer possessing an entire plant.7 This decision gives inventors of higher life forms some protection. Methods of Medical Treatment Methods of medical treatment are generally not patentable in Canada. However, there are some exceptions, such as methods directed to diagnostic or non-invasive treatment of the body and methods for treating humans for natural conditions such as aging and pregnancy. Prospective patentees may secure some protection by converting non-patentable method claims into “use”-type claims, for example, “use of compound X for treating Y.” Europe does not allow methods of medical treatment to be patented, but it has an accepted “use” format similar to Canada’s. Methods of medical treatment are patentable in the United States. Novelty/Disclosure In many countries, an invention must not have been disclosed anywhere in the world before the initial patent application is filed, or the invention will not be patentable. Disclosure means any form of public disclosure including journal articles, published patent applications, abstracts, conference proceedings, trade pamphlets, magazine articles, theses, PowerPoint presentations, oral disclosures and trade-show viewings. In Canada, an exception to disclosure exists where the novelty of the invention will not be destroyed if the prospective patentee, or someone acquiring knowledge directly or indirectly from the prospective patentee, makes the information public within one year before the patent application is filed. Prospective patentees should pay particular attention to journals or conference materials that post material on the Internet before the print versions are published. The earliest public disclosure date will prevail. The United States, Mexico and Australia offer a similar grace period. Many countries do not allow grace periods. If the invention is disclosed anywhere in the world before the initial application is filed (even if it is filed in countries that do have a grace period), it will not qualify for protection in all the countries that do not have a grace period. For this reason, prospective patentees should not disclose their invention before filing appropriate patent applications. 7

Monsanto Canada Inc. v. Schmeiser (2004), 31 C.P.R. (4th) 161

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For Canadian patent applications, the grace period is one year back from the date of filing in Canada (irrespective of any claim to a priority date). A priority date is the date on which the first patent application is filed in any country. An application filed within 12 months of the first application may claim “priority” from this first application as long as the first application was filed in a World Trade Organization member country. Therefore, when a prospective patentee makes a public disclosure anywhere in the world, the prospective patentee must file a patent application with the Canadian Patent Office within one year of that disclosure so that the invention may still be considered novel in Canada. If the prospective patentee files the patent application after the grace period has expired, the disclosure counts as prior art (see section on Prior Art). If the prospective patentee must disclose all or some elements of the invention during business negotiations, the prospective patentee must protect the confidentiality of that information by having the recipient sign a confidentiality agreement (also called a non-disclosure agreement) beforehand. A confidential disclosure (preferably supported by a signed agreement) does not destroy the novelty of an invention. However, there is always a possibility that the recipient will disclose the confidential information, accidentally or otherwise. Since confidential disclosure also applies to clinical trials, the prospective patentee should make sure that a clinical trial agreement contains the appropriate confidentiality clauses if all patent applications relating to the product being used in the trial have not yet been filed. In Canada, selling a product that incorporates an invention does not constitute public disclosure if the product cannot be “reverse-engineered” to reveal the invention. If the sale of the product does not reveal or disclose the invention to the public, then a subsequent patent directed to that invention could still be granted to the prospective patentee.8 Inventive Ingenuity/Obviousness For subject matter to be inventive, it must not be obvious. Each country’s patent office makes its own determination of what is obvious. In most cases, it must be more than a mere workshop improvement. If someone with general knowledge in the subject matter could “discover” the invention, the invention is considered obvious and therefore non-patentable. In addition, a combination of known elements may make the subject matter obvious.9 Since everything appears obvious with hindsight, prospective patentees may find it helpful to consult a patent agent to determine whether the subject matter could be considered obvious.

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Baker Petrolite Corp. v. Canwell-Enviro Industries Limited (2001), 13 C.P.R. (4th) 193 (F.C.T.D.) KSR International v. Teleflex Inc. 550 U.S. (2007)

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As with novelty, many countries (notably, in Europe) do not allow a one-year grace period. In Canada, however, if the prospective patentee makes a public disclosure anywhere in the world, the disclosure will not apply against the Canadian patent application and make the invention obvious as long as the Canadian patent application is filed within one year of that disclosure. Again, as with novelty, the one-year grace period only applies if the prospective patentee, or someone acquiring knowledge directly or indirectly from the prospective patentee, discloses the information. A disclosure by any other person will count as prior art (see section on Prior Art). Utility To qualify as an invention, the subject matter must have utility. Utility is generally assessed on a claim-byclaim basis. In Canada, the patent application will be rejected if an invention does not do what the claim says it will do. The prospective patentee must carefully consider the claims stated in an application to avoid claiming any subject matter that does not work as described. In some cases, the subject matter does not have the sufficient or substantial utility required for patentability. For example, expressed sequence tags (ESTs) do not meet the utility requirement under many laws.10

Anything that won’t sell, I don’t want to invent. Its sale is proof of utility, and utility is success. Thomas Edison

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In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 12; Trilateral Project B3b “Comparative study on biotechnology patent practices Theme: Patentability of DNA fragments”

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Selections In the chemical arts, a prospective patentee may discover that one or more chemicals from a broader, existing class of compounds (a “genus”) possess special properties. Patents based on this type of discovery are called selection patents, and the Supreme Court11 has affirmed their validity. To be considered a patentable selection, • • •

the selected chemicals must provide a substantial advantage or avoid a substantial disadvantage compared to the chemicals of the larger genus of compounds; all the selected chemicals (subject to a few exceptions) possess the advantage or disadvantage in question; and the selection must represent a quality or a special character particular to the selected group.

The substantial advantage or disadvantage must have been known or predicted when the application for a patent based on a selection was filed, and it must be disclosed within the application. Antibodies Until early 2011, the disclosure requirements for “claiming” (see text box on terminology) antibodies— particularly monoclonal antibodies—were very high in Canada, and it was not unusual for the Canadian Patent Office (a branch of the Canadian Intellectual Property Office—CIPO) to require patent claims to be restricted to the specific antibodies exemplified and described in the application. In a 2011 decision,12 the Patent Appeal Board concluded that broad claims to monoclonal antibodies may be adequately supported and enabled based on a structural description13 of the antigen, specific immunoreactivity between the antibody and antigen, and predictable production methods that a skilled person would know. This decision suggests that the Canadian Patent Office may allow broader patent claims to monoclonal antibodies where the target is well defined. However, the Canadian Patent Office still typically objects to claims to specific sub-types of antibodies, such as humanized and chimeric antibodies, if the application does not disclose specific examples of these. As of March 2011, the Canadian Patent Office had not updated its Manual of Patent Office Practice (MOPOP)14 to reflect this change, or given the reasons behind it.

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Sanofi-Synthelabo v. Apotex (2008), 69 C.P.R. (4d) 251 (S.C.C.) Immunex Corporation Patent Application No. 583,988 In this context, the “structural description” requirement appears to be satisfied by providing a primary amino acid sequence Visit www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr00720.html for more information

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The filing date, the corresponding state of technology at that date and the experimental evidence presented in the patent specification continue to be important considerations for claiming antibodies. The Canadian Patent Office is likely to assess at least some of the following in determining whether a patent specification properly supports and enables a claim to a particular antibody that binds to particular antigen(s): • • • • • • •

whether the patent specification describes specific epitopes on the polypeptide; whether the patent specification describes a paratope of a monoclonal antibody; whether the prospective patentee was in possession of a monoclonal antibody; whether the prospective patentee could provide a biological deposit of a hybridoma producing a monoclonal antibody at the time of filing; the availability and/or ease of production of the polypeptide; whether the literature recommends more than routine experimentation or adaptation of known methods of preparing the antibodies; and whether the literature suggests that an actual or proposed method of preparing an antibody cannot be reproduced.15

Biological Polymers In Canada, claims to DNA, RNA and protein may be claimed by structure (sequence) or by distinguishing physical properties. Prospective patentees who claim by physical properties should make sure that the properties are sufficiently described to define what the biopolymer is, and not simply what it does. Depending on the facts provided, the Canadian Patent Office may accept claims to a sequence that has a certain degree of similarity to a reference sequence. Claims to genes are generally formulated to cover the gene in an “isolated” state. In the United States, there is some uncertainty as to whether isolated genes are patentable due to a 2010 decision16 of the New York District Court (Southern Division), which is under appeal. Prospective patentees considering the United States as a market should include a broad range of claims (such as methods, capture probes, amplimers, cDNAs, etc.) to adapt applications to the evolving legal situation. Prospective patentees thinking of patenting disease genes in Europe may find themselves limited to specific disclosed disease-associated mutations.

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Adapted from Re Central Sydney Area Health Service Patent Appn. No. 605,609, Patent Appeal Board and Commissioner of Patents (2008), C.D. 1283 Association for Molecular Pathology v. U.S. Patent and Trademark Office, No. 09-cv-4515, 94 USPQ2d 1683 (S.D.N.Y. March 29, 2010)

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What do I need to understand about patent laws? Each country has a set of laws relating to the protection of patents in that country. For example, patent law in the United States is set out in Title 35 of the United States Code. Canadian patent law is set out in the Patent Act.17 On October 1, 1989, amendments were made that changed the Canadian system from first-to-invent to a first-to-file. The Act was amended again, effective January 1, 1994, to comply with the North American Free Trade Agreement (NAFTA). As a result of these amendments and in response to the use of the first-to-file system, more amendments were made, effective October 1, 1996. Because of the changes over the years, it is important to refer to the relevant version of the Act and to the appropriate transitional rules. A patent application must be filed in each country for which patent protection is desired. Each country applies its own laws to determine whether the invention is patentable and will issue a patent, if appropriate. Filing in each country is costly so it is often desirable to delay these costs for as long as possible. The Patent Co-operation Treaty (“PCT�) is a multi-lateral treaty that provides an administrative procedure to allow a single international patent application to be filed for all countries that are a party to the treaty.18 Filing a PCT application allows the prospective patentee to express the intention to file national patent applications in the indicated countries, but permits the cost of translations and national filing fees to be deferred for at least 20 months from the first date on which an application was filed. Review of the merits of the application can often be delayed even further. Most jurisdictions permit national filing to be deferred for at least 30 months.19 First-to-invent In Canada, before October 1989, the rights to an invention were determined by the date of the invention. If two prospective patentees filed applications containing the same subject matter, a patent for the overlapping subject matter would be granted to the one who could prove the earlier date of invention. The United States is one of the few jurisdictions still operating under this first-to-invent system. Patents issued in Canada before October 1989 were granted a term of 17 years from their date of issue. Amendments that came into effect on July 12, 2001, extended this term to the longer of 17 years from the date of issue or 20 years from the date the application was filed. This extension applies only to patents that were filed before October 1, 1989, and in good standing as of July 12, 2001. A patent that expired before July 12, 2001, cannot be revived to benefit from the extension. In the United States, patents issued before June 8, 1995, were also granted a term of the longer of 17 years from issue or 20 years from filing. 17 18 19

R.S.C. 1985, c. P-4 as amended As of March 2011, 142 countries are members of the PCT Visit www.wipo.int/pct/en/texts/time_limits.html for further information on national and regional phase deadlines under the PCT

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Did you know... One hour before Alexander Graham Bell registered his patent for the telephone in 1876, Elisha Gray patented his own design. After years of litigation, the patent went to Bell.

Canadian invention... the telephone First-to-file Almost all countries operate on a first-to-file basis. This means that the exclusive rights granted in each country are given to the first person to file a patent application on the subject matter. Prospective patentees do not have to race to each patent office in the world to demonstrate first filing. Rather, in accordance with the Paris Convention,20 the filing of a “priority” patent application in any country that is a member of the Convention will be considered as the first filing date (or “priority date”) in each member country of the Convention if the application meets certain criteria. In particular, an application can “claim priority” to an earlier-filed application that described the same invention as long as the later application is filed no more than 12 months after the earlier-filed application and the subject matter in the earlier-filed application fully supports the claims in the later application. When properly filed and in a timely manner, the later application enjoys the benefit of a “priority date” or “claim date” that corresponds to the filing date of the earlier application. Where two or more prospective patentees claim the same subject matter in separate applications, the prospective patentee having the earliest claim date is entitled to a patent for the overlapping subject matter. For example, after October 1, 1989, when Canada converted to a first-to-file system, the filing date serves as the “claim date” to determine priority among competing claims to an invention.

20

As of March 2011, 173 countries are members of the Paris Convention

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As a member of the Paris Convention, NAFTA and World Trade Organization agreements, Canada will grant an earlier claim date if • • •

an application was filed in a country that is a member of one of these agreements;21 an application was filed in Canada within one year after the earliest-filed application; and the applicant claimed priority from the filing date of the earlier-filed application. Such an earlier filing date is referred to as the priority date or “claim date.”

It is important to note that each claim in a Canadian patent application has a claim date. Therefore, several priority applications may be relied on to support different claims in an application, provided that the Canadian application is filed within one year from the earliest application. A claim may derive its claim date from any of these priority applications, not necessarily the earliest one. Where several priority applications are relied on, claims in the Canadian application may have different claim dates from each other. This may be significant when determining the novelty and obviousness of the claimed subject matter—particularly when relevant prior art was published between the earliest filing of the priority application and the Canadian application. The United States and Europe are also members of Paris Convention, NAFTA and World Trade Organization agreements. Publication of Patent Applications Applications are published or “laid open” to the public 18 months after the earlier of the filing date or the priority date. There is a limited exception in the United States where an prospective patentee can request that the application not be published if the disclosed invention has not and will not be the subject of an application filed in any other country or under any multilateral agreement. Term of Patent Protection In most jurisdictions, the term for patents filed is 20 years from the date of filing. As of March 2011, no mechanism exists for extending the patent term in Canada. The United States has some provisions (for example, for pre-market regulatory review or for delays caused by the United States Patent and Trademark Office) for this.

21

At least one of the prospective patentees must be a resident or citizen of a country that is a signatory to these agreements

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How and where do I file patent applications? Canadian patent agents are fully trained to draw up the complex legal documents that make up a patent application in Canada. Prospective patentees should not to do it themselves. Patent agents are also better placed to handle the many deadlines and steps in the process from application to issuance. Many Canadian patent agents are qualified to file patent applications in Canada and in the United States. A Canadian patent agent may also file PCT patent applications and can assist in designing a strategy that helps preserve rights in each country where a prospective patentee wants to file for patent protection while minimizing costs.

How do I get the ball rolling for a Canadian patent application? Under the Canadian Patent Act, a prospective patentee has two options for filing a Canadian patent application: • •

filing an application directly in Canada, or filing a Canadian national phase patent application after filing a PCT application designating Canada as one of the countries in which patent protection is sought.

To file an application directly in Canada, the prospective patentee need only file the minimum required documents to obtain a filing date. For all applications filed after October 1, 1996, the minimum requirements are • • • • •

a written statement that a patent is being sought; a document in English or French that describes the invention; the name of the prospective patentee (which may be the inventor or the inventor’s university or research institution, depending on the arrangement between the inventor and the inventor’s institution); the address of the prospective patentee or their patent agent; and the application fee.

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The prospective patentee must file a Canadian national phase application of a PCT application in Canada within the later of (i) 30-months from the priority date or (ii) 42 months from the priority date with the payment of an additional late fee. To file a Canadian national phase application, the minimum requirements are to provide • a copy of the international application, if it has not been published; • a translation of the international application, if the published application is not in English or French; and • the basic national phase application fee. The filing date of the national phase application in Canada is deemed to be the same as the filing date of the PCT application. On receiving the application filed through either route, the Canadian Patent Office reviews the format of the application rather than its substance or merit. When only the minimum requirements are met, the application is considered incomplete. No new subject matter may be added to a Canadian incomplete application that is not already fully described or supported by the incomplete application after it is filed in Canada. The Canadian incomplete application is not a parallel process to that of the provisional patent application in the United States. The latter requires only a title, a written description of the invention, any drawings required to understand the invention, a filing fee and a cover sheet containing the names of the inventors and their details of residency. The application must be filed by an agent registered to practise before the United States Patent and Trademark Office. The provisional patent application in the United States is never examined and will automatically expire one year after its filing. Conversely, the 20-year patent term in Canada begins on the date the incomplete application is filed (or is deemed to be filed), not when it is completed.

Some useful terminology:

A “claim” is what the inventor says the invention will do. A “patent specification” is a detailed description of the invention, followed by a set of claims.

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How do I determine if I am an inventor? To be considered an inventor, a person must have contributed to the actual conception of an invention and to what is claimed in the patent application. For example, if a new class of compounds is identified from a routine experiment based on anomalies in a dataset, an inventor would be the person discovering the anomalies and identifying their importance. The person who simply conducted the experiments would not be considered an inventor. Likewise, a person who conceives a general idea or thesis is not necessarily an inventor. Inventorship is very different than authorship. It is very important to determine inventorship carefully and list only those inventors who contributed to the claims listed in the patent application. The contributions of personnel, such as students and laboratory technicians, must be properly assessed. Given that inventorship relates to the claims in an application, the list of inventors may change as claims are amended through prosecution. This is particularly true when a single application contains multiple inventions, and the claims are divided into one or more divisional applications (see section on Divisional Applications). Knowingly listing inventors incorrectly or omitting inventors may be considered fraud on the Canadian Patent Office and may cause the application to be rejected.

Do I have to test every possible embodiment of my invention? Depending on the nature and the technological field of the invention, prospective patentees may need to provide scientific examples to demonstrate the relevance of the invention to practice. Before filing an application, prospective patentees should consider using Postulation to extend the dataset out within the specification—provided that the postulation is a “sound prediction”22 and is speculation. There are three components in the test for sound prediction: • • •

22 23

there must be a factual basis for the prediction; at the date of filing the application, the prospective patentee must have an articulable and sound line of reasoning that can be inferred from facts; and the disclosure must be full and complete.23

Monsanto Co. v. Commissioner of Patents (1979), 42 C.P.R. (3d) 161 (S.C.C.) Apotex Inc. v. Wellcome Foundation Ltd., [2002] 4 S.C.R. 153

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There is no hard rule as to what degree or amount of data support “sound line of reasoning,” however, utility must be based on sound prediction. Should the Examiner discover a lack of utility in an area covered by sound prediction (meaning that an embodiment fails and lacks utility), then the claim or claims may be invalidated.

How many inventions may I claim in one patent? A patent is granted for one invention only, although a patent that includes more than one invention is not invalidated for that reason alone (see section on Divisional Applications). Under the Patent Rules, an application may include more than one invention if the subject matter forms a “single general inventive concept” by design or by operation. The Canadian Patent Office considers the following combinations to be acceptable in the same application: • • • • • •

a product and a process for making a product; a product and a use of the product; a product, a process for making the product and a use of the product; a process and an apparatus designed to carry out the process; a product, a process for making the product and an apparatus designed to carry out the process; and a product, a process for making the product, an apparatus designed to carry out the process and a use of the product.

An application may include claims to a final product and to an intermediate product used to directly manufacture the final product—but only if the two are similar enough that one product was clearly designed to prepare the other. The intermediate product may have the same use as the final product, but it must not have other uses. On the other hand, a single general inventive concept may not be present if an application includes (1) a claim to compound A, (2) a claim to compound B and (3) a claim to the combination of A and B. Claims (1) and (3) may be in the same application, or claims (2) and (3). However, claims (1) and (2) are directed to different substances and, therefore, lack unity. Such claims may be divided into one or more divisional applications (see section on Divisional Applications). Generally, unity of invention is said to exist when claims share a technical feature that distinguishes them over prior art.

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What if I have too many inventions in one patent? Divisional Applications In Canada, prospective patentees may file a divisional application based on a “parent” application at any time before the parent application issues to patent. Much like a family tree, if an application is divided more than once, the first divisional application may be a parent to a later one. Therefore, prospective patentees may still file divisional applications even though the original application has issued to patent, as long as at least one divisional application is pending that describes all the inventions. In Canada, the courts have affirmed that only one patent may issue per invention. Claims of co-pending application(s) must avoid overlapping subject matter and must also be “patentably distinct” (non-obvious) from one another to avoid vulnerability to attack on the grounds of “double patenting.”24 If the Canadian Patent Office insists that the application be divided (referred to as filing a divisional application “involuntarily”) on the basis of unity of invention attacks for double patenting will fail because the division was requested by the Patent Examiner. However, a divisional application filed “voluntarily” by the prospective patentee may be open to a double-patenting attack. Therefore, prospective patentees should avoid filing divisional applications voluntarily.

What else do I need to do to complete the application? The prospective patentee must file the following additional documents with the Canadian Patent Office within 15 months from the earlier of the earliest-claimed priority date and the Canadian filing date: • • • • • •

24

the petition; an abstract of the invention; claim(s) to the invention; any drawing mentioned in the description; a biological deposit number (for example, micro-organism), if applicable; and a sequence listing (for example, novel nucleotide or peptide sequence(s)), if applicable.

Consolboard Inc. v. MacMillan Bloedel (Saskatchewan) Ltd. (1981), 56 C.P.R. (2d) 145 (S.C.C.)

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The patent specification must describe the invention and its operation in such full and exact terms that anybody experienced in the subject matter (referred to as a “person skilled in the art�) can make, construct or use the invention. The entire patent specification must state the novel and inventive features of the invention, and it must end with a claim defining the subject matter. If the patent specification is not detailed enough, one or more claims may be found invalid. Before allowance (see When Will the Patent Office Examine My Application?), the prospective patentee must file a statement explaining how they are entitled to the invention. The prospective patentee cannot add new subject matter, such as new features, more data, recent developments or a more precise description, to the application once it has been filed. Biological Deposit Patent applications may refer to biological deposits as long as the deposit has been made with an International Depository Authority (IDA) on or before the date the application is filed. Where the application makes a priority claim to an earlier-filed application, the deposit is best made before the claimed priority. The prospective patentee must provide the accession number of the deposit and the name of the IDA with which it was made before the application is published. Canada has a fully accredited IDA in Winnipeg, Manitoba. Sequence Listing All patent applications filed after October 1, 1996, and containing a nucleotide sequence require a sequence listing submitted in electronic text format, except where a sequence has been identified as prior art.25 If an application requiring a sequence listing was originally filed without it, the prospective patentee must file a statement that the sequence listing filed subsequently does not go beyond the disclosure in the application. If the sequence listing is not filed within three months from filing a national phase application in Canada or 15 months from filing a Canadian application, the Canadian Patent Office will issue a requisition that the prospective patentee comply with the requirement and pay an additional completion fee.

25

Patent Rules, s.111(1), SQR/2007-90

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The accepted sequence format for a patent application differs significantly from the conventions accepted in other well-known databases, such as GenBank—particularly concerning how to present modified nucleic acid and amino acid residues. The standards for presenting such sequences are in Annex C 26 of the Administrative Instructions under the Patent Cooperation Treaty. A patent agent can help format the sequences correctly.

What does the Canadian Intellectual Property Office (CIPO) do? CIPO is responsible for administering and processing most IP in Canada. Its areas of activity include • • • • •

Patents — for new inventions (process, machine, manufacture, composition of matter) or any new and useful improvement of an existing invention; Trademarks — for words, symbols and/or designs used to distinguish goods or services; Copyright — for artistic, dramatic, musical or literary works (including computer programs), and for performances, sound recordings and communication signals; Industrial design — for the visual features of shape, configuration, pattern or ornament applied to a finished article of manufacture; and Integrated circuit topographies — for the three-dimensional configurations of electronic circuits in integrated circuit products or layout designs.

What is the Canadian Patent Office?

The Patent Branch within CIPO is commonly referred to as the Canadian Patent Office.

When should I file my patent application? Prospective patentees should file their patent application before any public disclosure to preserve the possibility of filing other applications anywhere in the world. On filing, the application must fully described the invention and its operation or use in full, clear and concise terms to enable a person skilled in the art to understand how make or use it. Before filing, prospective patentees should consider if the data generated at the time of filing are sufficient to support the teachings of the patent application such that they would be clearly understood by a person skilled in the art.

26

Visit www.wipo.int/pct/en/texts/ai/annex_c.html for more information

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When will the Patent Office examine my application? The Canadian Patent Office does not automatically examine applications. The prospective patentee has to file a request for examination and pay a fee within five years after the Canadian filing date. The deadline for this request and fee is the same for divisional applications as for the parent application. If that date has passed, the deadline is six months after the divisional application has been filed. Once a request for examination and the appropriate fee have been submitted, an Examiner will review the specification on its merits. If the Examiner finds that the application does not comply with the Patent Act or Patent Rules, the Examiner will issue an Examiner’s Report (also known as an Office Action) to the prospective patentee, requesting an argument and/or amendments to the application. However, if the Examiner finds no defects on the patent specification, the Examiner issues a Notice of Allowance, after which the application is “allowed,” and initiates the patent-granting process. Fast-tracking Applications Request to Advance Examination (Special Orders): A prospective patentee may ask the Canadian Patent Office to advance the examination of an application (Special Order) any time after the examination has been requested as long as the request is filed with payment of the related fee. This typically results in an Office Action being issued within about four months. Patent Prosecution Highway: The PPH prioritizes the examination of patent applications under certain conditions where patentable subject matter or novelty, inventive step and industrial applicability (in the international phase) have been indicated. To request entry into the PPH, the application must be published and the examination of the Canadian application must be requested but not yet have commenced. Where these and all other requirements are met, the prospective patentee asks CIPO or one of its PPH partner offices to accelerate the examination of a corresponding foreign application. As of March 2011, the Canadian Patent Office has PPH pilot programs in place with the United States, Denmark, Germany, Japan, Korea, Finland, Spain and PCT.27 Where at least one claim in a corresponding foreign application has been deemed allowable during examination, there is no cost to requesting expedited examination through the PPH. Entry into the PPH generally results in an Office Action being issued within about four months.

27

Visit www.cipo.ic.gc.ca/eic/site/cipointernet-internetopic.nsf/eng/h_wr02160.html for more information

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To request entry to the PCT-PPH, the prospective patentee must have filed a national phase entry application in Canada after January 31, 2011. As well, one of the international search authorities (ISA), the international preliminary examination authority (IPEA) or the international preliminary report on patentability (IPRP) must indicate that at least one claim is novel, inventive and industrially applicable. The claims filed in the national phase entry application must correspond to the one or more claims having novelty, inventive step and industrial applicability in the related PCT application.

What fees do I pay and when? A prospective patentee must pay the patent filing fee, the patent maintenance fees and, if the patent issues, the patent issuance fee to the Canadian Patent Office. The amount of these fees varies depending on the “small” or “large” entity status of the applicant. In Canada, this status is determined at the time of engaging the patent system.28 A small entity is defined as one that employs 50 or fewer employees or that is a university. It does not include an entity that • has transferred any right to the invention to an entity other than a university that employs more than 50 employees; or • has transferred any right to the invention to an entity that • employs 50 or fewer employees; or • is a university and knows of any subsequent transfer of any right to the invention to an entity, other than a university, that employs more than 50 employees. A large entity is one that is not a small entity, that employs more than 50 employees and that is not a university. Since the financial saving is relatively small (see sections on Filing Fees and Incorrect Fees), it may be prudent for prospective patentees to declare themselves as large entities at all times.

28

Patent Act, s. 27(2), Schedule II, item 1

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Filing Fees The amount of the filing fee depends on whether the prospective patentee is a small or large entity when the prospective patentee enters the patent system. The fee for a small entity is generally one half that of a large entity. Maintenance Fees For all applications filed after October 1, 1989, the prospective patentee must pay annual maintenance fees to maintain the application in good standing. The first maintenance fee is due on the second anniversary of the filing date and is payable every year until the patent expires. A prospective patentee may pay the maintenance fees up to one year after the due date—with an additional late payment fee. If the Canadian Patent Office does not receive such fees within the one-year grace period, the patent will lapse. A lapsed patent cannot be revived. Incorrect Fees Prospective patentees filing and paying fees on a small-entity basis may suffer serious consequences if they have declared this incorrectly. The Federal Court of Canada ruled that a Canadian patent may be invalidated if the prospective patentee has paid incorrect maintenance fees.29 To reinstate the application to good standing, the prospective patentee must pay the correct fees within one year of having paid the incorrect fees. It is up to the prospective patentee to verify the status of the entity and to pay the correct fees. Non-government Fees As well as government fees, there are traditionally additional costs related to preparing a patent application and responding to notices and Office Actions issued by the Canadian Patent Office.

29

Barton No-Till Disk Inc and Flexi-Coil Ltd. and the Commissioner of Patents v. Dutch Industries Ltd., 24 C.P.R. (4th) 157 (or “Dutch Industries”)

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What happens if I forget deadlines and payments? If the prospective patentee does not reply to requests from the Canadian Patent Office (for example, if the prospective patentee does not request examination of an application by the deadline), the application will be considered abandoned. If the prospective patentee has corrected all deficiencies and paid all outstanding amounts within one year after the date of abandonment, the application will be reinstated. If an application has been abandoned for more than one reason, dates of abandonment run from each failure, not simply from the earliest. This is why prospective patentee must pay multiple reinstatement fees to restore an application to good standing. For example, if an prospective patentee does not request examination within the time limit, the application becomes abandoned. If the prospective patentee does not pay the maintenance fee, the application is abandoned for that reason also. To fully reinstate the application, the prospective patentee must request examination, pay the examination fee, request reinstatement from failure to pay the examination fee, pay a first reinstatement fee, pay the outstanding maintenance fee, request reinstatement from the failure to pay the maintenance fee and pay a second reinstatement fee.

There’s a mistake in my application. Am I in trouble? If the prospective patentee has been diligent and not willfully misled the Canadian Patent Office, the patent will be assumed valid. However, this only applies to omissions or additions. The courts have been inconsistent in applying this provision, however. In one case,30 leaving out the names of some inventors was not enough to invalidate a patent because the failure was not false or misleading. In another case31 where none of the correct inventors was named, the patent was also not invalidated. Although the omission was false and misleading, it was not done willfully. On the other hand, a patent may be invalidated if the application contains untrue allegations, regardless of whether or not the allegation was made willfully.

30 31

Apotex Inc. v. Wellcome Foundation Ltd. (1998), 79 C.P.R. (3d) 193, at 264 (F.C.T.D.), aff’d. (2000), 10 C.P.R. (4th) 65 (F.C.A.) 671905 Alberta Inc. v. Q’Max Solutions Inc. (2003) 27 C.P.R. (4th) 385

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New data isn’t in the application. How do I deal with that? A prospective patentee may include new subject matter in a new Canadian application that may claim priority to an earlier Canadian application if it is filed within one year after the earlier application. The prospective patentee may file an incomplete application as early as possible after an invention has been made to obtain the earliest possible filing date for the disclosed subject matter. The prospective patentee may include improvements, alterations or additional data in a later application, which then has priority to the earlier one. This practice allows the prospective patentee 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 prospective patentee has the option of proceeding with both applications or only with the second one. Prospective patentees may make an unlimited number of priority claims. Claiming internal priority (that is, priority to a previously-filed Canadian application) is similar to making a priority claim on the basis of an application filed abroad. Once the one-year period after the earlier application has expired, internal priority may no longer be claimed. The patent term for the later application is calculated as 20 years from its filing date.

My invention relates to medicines. Are they treated differently? They are treated somewhat differently. Applications related to medicines must comply with the same rules as any other patent application. As well, once the patent issues, it becomes subject to two additional regimes: the Patented Medicines (Notice of Compliance) Regulations (NOC Regulations) and the Patented Medicines Prices Review Board (PMPRB). See sections on NOC Regulations and PMPRB.

Canadian invention... Insulin

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How do I ensure that my record-keeping will support my invention? Prospective patentees should take great care to document their invention by keeping proper laboratory notebooks. These notebooks should be dated, countersigned and contain a detailed account of research activities on each date. Prospective patentees should also take great care to avoid making particular statements in a notebook. For example, they should avoid stating that something is obviously going to work, because the statement could affect the inventiveness of the invention should it be challenged. In addition, prospective patentees should be careful about phrasing statements on testing that does not perform as expected. If testing was performed only to determine whether a compound meets a certain threshold to be considered for further development, this result should be explicitly stated. Testing documents should not imply that the compound did not work at all. If the application describes experiments as examples, it may be useful to create a list of those experiments or flag them in the laboratory notebook so that a patent agent can easily double-check that they were transcribed correctly. This list also supports the defence of a patent should it be subject to a validity challenge.

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What could somebody do to challenge my patent? Prior Art A third party may file prior art with the Canadian Patent Office that the third party believes may affect the patentability of any claim in an application. Prior art includes patents, published patent applications and printed publications such as journal or newspaper articles and advertisements that describe the subject matter of the claim in question. The publication (or publicly available) date of any of the publications should appear on the face of the documents. The third party must state the claim against which it believes the prior art is relevant and explain its relevance in writing. The third party does not have to pay a filing fee. The third party will receive an acknowledgement from the Patent Examiner that the prior art will become part of the Canadian Patent Office’s file, but will no receive further communication from the Canadian Patent Office. It is up to the third party to monitor the application to determine whether the Examiner has taken any steps. Once the prior art becomes part of the Canadian Patent Office’s file, the Examiner will review the prior art and decide if it is relevant to the claims in the application. If relevant, the Examiner will issue an Office Action to the applicant on that basis. If not relevant, the Examiner will take no further action. The third party is not limited to one filing of prior art. The third party may file further submissions against an application, including additional prior art in response to the Examiner’s decision that the previous prior art was not relevant. Throughout this process, the third party may remain anonymous.

Canadian invention... the goalie mask

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Should the third party decide to challenge the validity of a patent that issues from the application, the Federal Court may defer to the Examiner’s decision concerning the prior art. Because the Canadian Patent Office is a specialized tribunal that has already considered the prior art, the Federal Court may be reluctant to overturn the decision. Re-examination A third party may ask the Canadian Patent Office to re-examine any claim of a patent issued from applications filed after October 1, 1989. The third party may launch a re-examination by filing a Request for Re-examination along with prior art and the fee. The Request for Re-examination must state the relevance of the prior art and explain how it applies to the claim(s) being re-examined. When a third party requests a re-examination, the Canadian Patent Office will send a copy of the request to the patent holder. The Canadian Patent Office will set up a Re-examination Board made up of at least three people, at least two of whom must be employees of the Canadian Patent Office. The Board has three months to decide whether the Request for Re-examination raises any questions affecting patentability. The re-examination process takes place between the Board and the patent holder. If the Board decides that the Request for Re-examination raises a substantial new question affecting the patentability of a claim, it will notify the patent holder of this decision and the reasons behind it. The patent holder has three months to reply. Once the Board has received this reply (or after the time limit has expired), it will re-examine the claim at issue. The re-examination proceedings must be completed within 12 months of receiving the patent holder’s reply. When the re-examination is over, the Board will issue a certificate that is attached to the patent and becomes part of it. The certificate does one of the following: • cancels any claim of the patent determined to be unpatentable; • confirms that any claim of the patent is patentable; or • incorporates into the patent any proposed amendment or new claim determined to be patentable. The patent holder may appeal the Board’s decision to the Federal Court within three months from the date of the certificate’s issuance. The third party, however, has no right of appeal.

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What are the purchaser’s rights to a patented article? A person who buys a patented article also buys an implied licence to use the invention underlying it, to repair the article if it breaks and to modify the article as needed, unless the purchase also includes a specific notice of a more limited use. However, even if no notice of limitations is provided, these rights are limited to the specific units of the patented article purchased.

What about improvements to my patented invention? If the improvement is new and non-obvious, it may be considered an independent invention, and a prospective patentee may file a patent application directed to the improvement. However, the prospective patentee of the improvement does not gain any rights to the original invention if it was not the theirs to begin with. If a prospective patentee wants to make, use, or sell an improvement that somehow contains the original invention, the prospective patentee who filed the application directed to the improvement will need a licence from the patent holder of the original invention. Similarly, anyone licensing rights to the improvement will also need a licence from the patent holder of the original invention. The patent holder of the original invention does not gain any rights to the improvement made by the inventor of the improvement. Improvement patents often form the basis for cross-licensing arrangements, where the patent holder of the original invention and the patent holder of the improvement both have the right to exploit the original and the improved invention.

Does my invention have to show a patent mark? Preferably, yes. Markings on articles, such as “patented” (sometimes accompanied by a patent number) or “patent pending,” indicate the status of a patent. Markings should only appear when the statement is true. Making false claims is against the law in most countries. Articles patented in Canada no longer have to be marked as such. That said, marking may be important if articles are exported to jurisdictions with laws that require patent marking if the patent is infringed. Patent marking may also be beneficial in determining remedies where a patent is infringed. In any event, marking is a good practice and may help deter infringement.

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My patent has been infringed! What can I do? The patent holder may apply to the court for an injunction requiring the infringer to cease the infringing activities. If the infringement is proven, the patent holder may be entitled to an injunction against the infringer as well as monetary damages or a percentage of the profits attributable to sales of the infringed article. In nearly all cases, the infringer will defend by attacking the validity of the patent.

“

To turn really interesting ideas and fledgling technologies into a company that can continue to innovate for years, it requires a lot of disciplines. Steve Jobs

�

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Did you know... Dr. W.R. Franks and his colleagues (University of Toronto) invented the anti-gravity flying suit in 1939. It allowed jet pilots to withstand higher centrifugal forces without passing out, and is a forerunner of the space suits worn by astronauts today.

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Commercialization What is it all about?

The process of commercialization—moving a technology or discovery from the lab into the market—has many social and economic benefits, such as the social good that comes of making a technology accessible to the public or the creation of spin-off companies that provide jobs and wealth. Companies that recognize the value of their IP, build upon it and extract the value from it are in a much better position to compete nationally and internationally than those that do not. The real value in any IP lies in recognizing • • • •

its uniqueness and structuring an agreement that appropriately recognizes it; its competitive strength in national and international markets; its importance in the strategic plan of the current and potential owners; and the ability of the current and potential owners to develop it, commercialize it (including navigating the regulatory hurdles), recover their costs and make a profit from it.

Licences What is a licence agreement?

Licensing is the practice of a patent holder giving someone else permission (a licence) to use the patent holder’s invention, usually for commercial exploitation, subject to any restrictions that the patent holder may impose. Without that permission, the patent holder’s legal rights will be infringed. Is a licence the same thing as a contract?

Yes. As in other contracts, each party to the contract gives something of value to the other party. In the case of a licence, the patent holder (“licensor”) gives the other party (“licensee”) the right to use the patent holder’s property (for example, a patented invention) in return for a one-time payment, milestone payments (an amount due when certain events happen) and/or royalties (a percentage of the proceeds from the sale of products or services that use the licensed property) or anything else of value, such as shares in the licensee’s company.

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Did you know... Microsoft Corporation paid 12 million dollars for the right to use the Rolling Stones song “Start Me Up” to promote Windows 95.

As the licensor, does the invention still belong to me?

Yes. The licensor grants the licensee the right to use—but not to own—the invention and related IP rights. The licensor retains ownership and control (in the form of a contract) over the licensed invention. A licence is, therefore, not a transfer, sale or assignment of ownership in the invention. Are there different types of licences?

Yes. A licensor may grant licences to some or all of the licensor’s exclusive rights. • • •

An exclusive licence allows only one licensee to use the invention and related IP rights. The licensor may not use the property and related IP rights while the exclusive licence is in effect. A sole licence allows both the licensor and one licensee to use the invention and related IP rights. A non-exclusive licence allows an unlimited number of licensees, together with the licensor, to use the invention and related IP rights.

Can I restrict a licence?

Yes. A licence may be restricted or limited in a number of ways; for example, in • • • • • • •

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the number of users;32 time (one year, ten years, etc.); geography (for example, limiting the territory of the licence to one country); use (manufacturing, research and development, testing, marketing, distribution or sale, or all of them); therapeutic area, indication, disease or condition (such as bovine spongiform encephalopathy, chronic wasting disease, Creutzfeldt-Jakob disease); route of administration (injection, topical, oral, etc.); or subpopulation (age, ethnicity, genetic predispositions, etc.).

See above section

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My licence has been breached! What can I do?

If the licensee does not meet one or more of the main conditions of the licence, the licensor usually has the right to terminate the licence and regain full rights to the invention. Breaching a licence is the same as breaching any other contract. A licensor may require the licensee to fulfill the contracted obligations, pay monetary damages, stop a particular activity (where the licensee has used the property beyond the scope of the licence) and/or turn over any profits earned as a result of the breach.

Can I simply sell my IP? What is an assignment (or purchase and sale) agreement?

If the patent holder no longer wishes to own, control or maintain the IP rights, the patent holder may try to sell them. An assignment is a purchase and sale transaction; a one-off, one-time event. The purchaser usually has no ongoing obligations to the seller (unless the purchaser wishes to pay the purchase price or other consideration over time, or perhaps to adjust the purchase price depending on whether certain projected events happen, such as patent registration, governmental approvals and realization of revenue projections). The seller’s ongoing obligations to the purchaser may include guaranteeing the performance of the invention for a fixed period of time and protecting the purchaser from third party lawsuits concerning the invention. What should I watch out for?

Assignments do not usually give the seller and purchaser an opportunity to undo or amend the transaction unless the terms of the assignment explicitly allow for it and describe the circumstances under which it may occur. Therefore, it is important for the seller and purchaser to know as much as possible about the value of the invention so that the seller does not undervalue it and the purchaser does not pay too much for it or assume too many risks associated with it. Some factors to consider include the scope, patent term, territorial protection and competitive strength of the invention; the amount of time, effort, resources and infrastructure required to bring the invention to market (including acquisition of third-party technologies, if necessary); and each party’s ability to carry out the commercialization.

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What if I can’t pinpoint the value of my invention?

Where the value of the invention is difficult to determine, it may still be possible for the seller and the purchaser to structure the assignment so that both parties can share in the risks and rewards. For example, they may structure the compensation so that the purchaser pays the seller a fixed sum when the assignment is signed and additional sum(s) in later years (fixed or indefinite) based on how the invention actually performs in the market. Both parties establish objective criteria against which the invention’s performance can be measured so that the amount of the additional sum(s) can be determined accordingly.

I’m not ready to sell or license my IP. What else can I do? What is a research and development agreement?

If the owner of the invention is not ready to license or sell it, particularly if its value can be better determined or enhanced through further research and development, the owner may wish to enter into research and development agreements. Research and development are common activities in life sciences, whether to explore a new indication, dosage range, formulation or manufacturing process, or to improve existing technology. What should I include in my research and development agreement?

Where researchers from multiple parties (for example, the owner, universities, teaching hospitals and other research institutions) are going to carry out the research and development activity, the terms of the agreement should, at a minimum, address • • • •

what has to be done, by whom and when; what background information or knowledge each will contribute (to separate what each one already knows from what will be learned from conducting the research and development activity); who will own the data, results and any IP arising from the research and development activity; and who can use the data, results and any IP generated.

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What is an option agreement?

When the owner and the potential licensee or purchaser of the invention are not ready to enter into a licence or an assignment agreement but the owner is nevertheless willing to give the potential licensee or purchaser an opportunity (usually an exclusive opportunity) to obtain a licence or assignment at a later date if certain requirements have been met (preconditions), the parties may enter into an option agreement to temporarily reserve the rights to the invention for the potential licensee or purchaser (known as the “option holder”). The time period during which the rights to the invention are reserved is known as the “option period.” In exchange for temporarily reserving the rights to the invention for the option holder, the owner usually requires the option holder to pay a fee (known as the “option fee”). What kind of preconditions could there be?

Examples of preconditions include • • •

the owner receiving the patent or other governmental approval for the invention (to justify the licence fee or the purchase price); the option holder having the requisite funds, scientific, clinical or management personnel and/or facilities to carry out commercialization activities effectively; and/or the option holder being satisfied with results of tests that confirm the value of the invention or its market demand.

The owner and the option holder must also negotiate when the option commences, how long the option period lasts, how much the option fee is and what preconditions the option holder must meet before the owner enters into a licence or assignment agreement to give the option holder more long-term or permanent rights to the invention.

Did you know... In 1834, Charles Babbage designed the analytical engine, the precursor of the computer. The government thought it would be worthless and refused to fund its develoment. 34


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Are there other commercialization issues that I should know about? What are Patented Medicines (Notice of Compliance) Regulations?

The Notice of Compliance (NOC) Regulations were developed to facilitate rapid market entry of generic products once the 20-year term of patent protection for an innovator product expired. The Patent Act contains an exception that allows a company to submit its regulatory approval submission for the generic product to Health Canada without being penalized for infringing an existing patent.33 The NOC Regulations work in parallel with the Patent Act and allow preliminary patent-related issues to be handled while Health Canada assesses the safety and efficacy of the generic product.34 The NOC Regulations create a link between the regulatory approval of generic medicines pursuant to the Food and Drug Regulations and a preliminary determination of patent infringement and validity under the Patent Act. What happens if my patent relates to a medicine?

When a patent contains a claim to a medicine, a formulation, a use or a dosage form and it relates to the drug to be marketed in Canada (see section on What Types of Patents Are Most Likely to Be Listed on the Patent Register?), it can be listed on the Patent Register if appropriate forms are filed with Health Canada at the time a New Drug Submission is filed. Once a patent is listed on the Patent Register, any company wishing to copy the drug must either wait until the patent expires or send to the manufacturer35 of the brand named drug a detailed statement indicating why the patent will not be infringed or why it is invalid. The company marketing the drug may then, within 45 days, start a court proceeding to have a judge consider these issues in a preliminary way to determine whether the company copying the drug’s allegations are justified. This proceeding takes less than two years to complete. However, the company wanting to copy the drug cannot bring its copycat product to market during this proceeding. If the manufacturer of the brand named drug is successful, the company wishing to copy the drug will be prohibited from bringing it to market until the patent expires. If the manufacturer of the brand named drug is not successful, the company wishing to copy the drug can bring the copycat product to market as soon as it receives regulatory approval from Health Canada. 33 34 35

Patent Act, R.S.C. 1985, c. P-4, as amended, s. 55.2 Regulatory Impact Analysis Statement (RIAS), SOR/98-166 at 1055-1056 A contact person is listed on the Form 4 patent list; visit www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/form/priv_briv-eng.php

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To take advantage of the NOC Regulations, the drug manufacturer must also meet very strict timing requirements. It must file a patent list that records all existing patents that relate to the drug at the same time as it files the New Drug Submission. Any patent that issues after the patent list has been filed and that relates to the drug must be filed within 30 days of the date of patent issuance. The drug manufacturer must also file a patent list with every supplementary New Drug Submission or other submission for a drug. These deadlines cannot be extended under any circumstance. What other protection does my new drug have?

If the new drug contains a medicinal ingredient that Health Canada has not already approved and the ingredient is not a variation of an approved medicinal ingredient (such as a salt, ester, enantiomer, solvate or polymorph), it could be considered an innovative drug. This means that no company seeking to copy that drug may file a New Drug Submission or an abbreviated New Drug Submission based on a direct or indirect comparison to the new drug for six years after the first NOC has been received. Furthermore, a company wishing to copy the drug will only receive its own NOC eight years after the first NOC has been received. This latter period can be extended by six months if clinical trials relating to the use of the innovative drug in relevant pediatric populations have been performed.36 What types of patents are most likely to be listed on the Patent Register?

To be eligible for listing on the Patent Register, a patent must contain a claim to a • • • •

medicinal ingredient; formulation that contains the medicinal ingredient; dosage form; or use of the medicinal ingredient.

The patent must also relate to the drug that is on the market. A number of court decisions have held that the patent claim must have a great deal of specificity with the product on the market. For formulation, use and dosage form claims, the medicinal ingredient in the product should be listed in the patent claim. Simply mentioning the medicinal ingredient in the description of the patent is not generally considered sufficient. For combination products, medicinal ingredients for each product in the combination should be listed in the patent claim. In addition, any other parameters in the patent claim must also match the product on the market. For example, if excipients are listed in a formulation claim, excipients listed in the patent claim must also be in the product monograph. Likewise, if pharmacokinetic parameters are listed in the patent claim, they must match the pharmacokinetic parameters of the product as found in the New Drug Submission. 36

Section C.08.004.1(4), Food and Drug Regulations

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Therefore, it is extremely important for the company’s regulatory department to communicate fully with its patent department when making drug submissions and patents are issuing. It is also important for departments to communicate in an ongoing manner during patent prosecution to ensure the application(s) include enough support for the drug that precise claims may be inserted at some point before patent issuance. What is the Patented Medicine Price Review Board’s (PMPRB) role?

The PMPRB regulates the prices of all patented medicines in Canada. The PMPRB defines its jurisdiction very broadly. All patents that relate to a medicine—even by the slenderest thread—must be reported to the PMPRB, which retains jurisdiction over the price of the related drug until all patents relating to that drug expire. The PMPRB’s jurisdiction applies to the formulation, use, dosage form, process and polymorph patents, etc., regardless of whether they are used to manufacture the drug, and whether or not the patent is eligible for listing on the Patent Register. A company must report the first patent related to a marketed drug to the PMPRB within seven days of issuance, and it must report all other patents to the PMPRB within 30 days of issuance. Reporting requirements apply regardless of whether the patent is owned or licensed by the company. What does Canada’s Food and Drugs Act 37 do?

The federal Food and Drugs Act and its regulations govern the advertising and sale of all food, drugs, cosmetics and medical devices in Canada—even though they may be manufactured abroad. Its regulatory regime is complex and changes frequently. Any new drug that is manufactured, advertised or sold to diagnose, treat, mitigate or prevent a disease, disorder or abnormal physical state or its symptoms, or to restore, correct or modify organic functions in humans or animals must comply with the Food and Drugs Act.

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Visit http://laws.justice.gc.ca/en/f-27/ for more information

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How do I know if my invention fits the “New Drug” category?

A “new” drug is one that contains or consists of a substance that has not been sold in Canada for enough time and in enough volume to check the safety and effectiveness of that substance as a drug. A new drug can also be a combination of two or more drugs that have not been sold in that combination or in the proportion in which those drugs are combined for enough time and in enough volume to check the safety and effectiveness of that combination and proportion. As well, a new drug can be a new use (including dosage, route of administration or duration of action) of a drug that has not been sold for that use in Canada for enough time and in enough volume to check the safety and effectiveness of that use. Do I need a product licence and/or a facility licence for a new drug?

In general, yes. No person may advertise, import or sell a drug unless Health Canada has issued a product licence. As well, no person may manufacture, package, label or import a new drug without having first obtained a facility licence (see section on Facility Licences for New Drugs) from Health Canada. Product licences for new drugs To apply for a product licence for a new drug, the manufacturer must provide Health Canada with information that will allow Health Canada to assess the new drug’s safety and effectiveness. Information required includes the type and amount of medicinal and non-medical ingredients; animal and clinical tests conducted to establish safety; tests applied to control potency, purity and stability; the premises and equipment used in the manufacture, preparation and packaging; the quality control measures used in the manufacturing, preparation and packaging; and substantial evidence of clinical effectiveness determined from clinical trials performed in Canada and abroad.

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Facility licences for new drugs To apply for a facility licence, the manufacturer, importer, distributor and wholesaler must provide Health Canada with information on their respective activities that will allow Health Canada to assess whether proper quality control and assurance procedures (good manufacturing practices) are being applied—even if the new drug is manufactured abroad. Information to be provided includes • • • • • • •

the premises where the new drug is fabricated, packaged or labelled (to see if they were designed, constructed and maintained to allow performance of operations under clean, sanitary and orderly conditions and to prevent contamination and the introduction of extraneous materials); equipment (to see if it is designed, constructed and maintained to prevent contamination of one drug by another drug and by extraneous materials, such as rust); personnel (to see if they have the technical, academic and other training necessary to perform the duties and responsibilities allocated to them, and if they have undergone the necessary health examinations); sanitation program (to verify the adequacy and regularity of cleaning procedures for the premises and equipment); raw material testing (to see if the testing of each lot or batch is adequate to confirm the identity of the raw materials and to assure that the quality of the drug will not be altered by defects in the raw materials and that the raw materials will give the desired quantity or yield during the manufacturing process); manufacturing control (to verify that the process is properly documented and that any deviation from the documented procedures is described, investigated, followed-up and documented); and recall and record-retention procedures.

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How does the Act handle the new medical device I invented?

Any article, instrument or apparatus/device that has been manufactured, sold or represented to • diagnose, treat, mitigate or prevent a disease, disorder or abnormal physical state or its symptoms in humans or animals; or • restore, correct or modify a body function or the body structure of humans or animals must comply with the Food and Drugs Act. All devices fall under one of four categories (Class I, II, III or IV) based on their level of health risk to the patient and to the healthcare professional administering the device. Class I devices present the lowest risk. Do I need a product licence or a facility licence for a new medical device?

In general, no person may advertise, import or sell a Class II, III or IV device unless Health Canada has issued a product licence. Class I devices do not need a product licence. No person may manufacture, package, label or import a device (including a Class I device) without having first obtained a facility licence from Health Canada.

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Product licences for new medical devices To apply for a product licence for a new Class II, III or IV medical device, the manufacturer must provide Health Canada with information that will allow Health Canada to assess the device’s safety and effectiveness. The manufacturer must provide more information for Class III or IV devices than for Class II devices. Information to be provided includes • • • • • • • • • • • •

the name and class (Class II, III or IV) of the device and whether the device is part of a system, test kit or a larger device grouping; the place of manufacture; a list of any national or international quality system standards (for example, ISO standards) applied by the manufacturer to the manufacture and testing of the device; features of the device that allow the device to be used for the medical conditions, purposes and uses stated; materials used in the manufacture and packaging; the sterilization method used for devices sold in sterile condition; the manufacturing process; an analysis and evaluation of the risks; risk reduction measures; bibliography of all published reports on the use, safety and effectiveness of the device; results of clinical studies; and countries outside of Canada where the device has been sold (including the number of devices sold and a summary of any reported problems and recalls).

Facility licences for new medical devices To apply for a facility licence, the importer and distributor of the new device must provide Health Canada with information on their respective activities that allow Health Canada to assess whether they are applying proper quality control and assurance procedures—even if the device is manufactured abroad. Manufacturers of Class I devices must also provide this information if the device is to be sold directly to a retailer or healthcare facility instead of through a licensed importer or distributor. Information to be provided includes the premises where the importation or distribution activity is performed, the manufacturer’s medical specialties and classes of the devices it manufactures, documented procedures for distribution-record retention, complaint-handling, recalls, storage, delivery, installation, corrective action and servicing. 41


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What are my responsibilities to the consumer?

No drug or device may be labelled, packaged or sold in a way that is false, misleading or deceptive or could create an untrue impression regarding its intended use, character, value, quantity, composition, merit or safety.

Can I commercialize my invention through a spin-off company? Yes, however, creating a company is a life-changing commitment. Inventors must weigh the risks and benefits associated with being a founder or co-founder of a spin-off company. What is a spin-off company?

A spin-off company is a separate, commercial legal entity that • • •

licenses an invention developed at a university; provides funding to the university to develop an invention that the company will later license from the university; or provides a service through university-derived expertise.

How do I know if the time is right to launch a spin-off company?

The decision to launch a spin-off company may happen shortly or many years after the invention has been developed. Typically, companies created around software or information technology are launched sooner because there are fewer business and regulatory hurdles to jump. Life sciences companies, on the other hand, usually require greater infrastructure and resources to develop their technologies and overcome regulatory hurdles and so take longer to get off the ground. Timing is influenced by a number of factors, including the • • • • • • • •

scientific and commercial value and the innovativeness of the invention; nature and scope of the IP protection; need for complementary and/or enabling technologies; existence of competing technologies; time and money needed to protect and commercialize the invention; commitment of the inventors and other founders to the commercialization process; availability of potential strategic partners to advance development and commercialization; and existence of potential investors for the company. 42


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Am I better off launching a spin-off company or licensing my invention to an existing company?

Inventors need to consider many factors, some of which may be unique to their universities and their own circumstances, before making that decision. Some of the factors that are critical to forming spin-off companies include whether • • • • • • • •

the invention fulfills an unmet need; a global market exists for the invention; a champion (entrepreneur or self-starter who has succeeded in similar enterprises) is present; a strong management team is available to lead the company; a credible business plan is in place; adequate funding is available for the early stages and future funding is likely to be forthcoming; infrastructure and other resources are readily accessible; and the university strongly supports the invention.

Where can I find money to support my spin-off company?

Various sources of funding exist for setting up a company. In the early phases, funding is often obtained from credit lines, friends and family. Angel investors may also play a role. Angel investors are individuals who provide financial backing to very early-stage businesses or business concepts or prototype development. Often, these individuals look for a higher rate of return than would be required by more traditional lenders and investors, such as banks. Angel investors also look to play an active role in managing the company. As a spin-off company ramps up, it will require more funds to finance technology development and to hire an experienced management team. Typically, this is where venture capital plays a role. Venture capital generally comes from a group of wealthy investors, investment banks and other financial institutions that pool their investments to fund new businesses. Some venture capital companies fund businesses in the early stages, but most do not. Those that do tend to invest only in companies that have an experienced management team and that can prove the claims they make about their technology and the market potential. If venture capital companies do provide funds, they usually require a say in company decisions as well as equity (for example, shares) in the company.

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Conclusion This handbook has been written for those who are relatively new to intellectual property and commercialization. Whichever avenue you decide to follow, we suggest that you work with the technology transfer office of your university or research organization and/or seek competent legal advice to guide you on this rewarding adventure. Good research and good luck!

“

Before everything else, getting ready is the secret of success. Alexander Graham Bell

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Resources Canadian Intellectual Property Office (CIPO) The Canadian Intellectual Property Office, associated with Industry Canada, is responsible for administering and processing most IP in Canada. http://strategis.ic.gc.ca/sc_mrksv/cipo Canada Business Canada Business is a government information service for businesses and start-up entrepreneurs in Canada. http://www.canadabusiness.ca Industry Canada The government of Canada’s business information site. http://www.ic.gc.ca National Research Council—Industrial Research Assistance Program (NRC-IRAP) NRC-IRAP provides a range of both technical and business oriented advisory services along with potential financial support to growth-oriented Canadian small and medium-sized enterprises. http://irap-pari.nrc-cnrc.gc.ca Federal Partners in Technology Transfer FPTT is a network established by the government of Canada committed to working together to enhance their professional capacity and to ensure the expeditious transfer of the value created in federal laboratories. http://www.fptt-pftt.gc.ca Canadian Innovation Centre Canada’s leading organization dedicated to assisting inventors, entrepreneurs and innovative companies. http://www.innovationcentre.ca Justice Canada • Food and Drugs Act http://laws.justice.gc.ca/en/showtdm/cs/F-27 • Patent Act http://laws.justice.gc.ca/en/showtdm/cs/P-4 45


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Contributing authors

Borden Ladner Gervais LLP Christine J. Collard (613) 787-3552 ccollard@blg.com

Kathleen E. Marsman, PhD (613) 787-3572 kmarsman@blg.com

David Conn, PhD (613) 787-3541 dconn@blg.com

Gordon J. Zimmerman (416) 367-6282 gzimmerman@blg.com

Andrew Loh (604) 640-4069 aloh@blg.com

J. Erin Pisko (604) 632-3541 episko@blg.com

Beverly Moore (613) 369-4784 bmoore@blg.com

Graeme R.B. Boocock, PhD (613) 369-4775 gboocock@blg.com

Editor Sylviane Duval (613) 537-2728 alpha@sylvianeduval.ca

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