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Pages 323 to 358 (Chapter 3, part 1 - 3(a)) INTRODUCTION What is a patent? A patent is a statutory monopoly o No inherent right to a patent, must qualify for it in the statutory reqt o Given by govt for your invention o Patent is entirely governed by statutes, not common law. Bargain theory lies at the heart of patent protection o In giving society your invention, the Crown grants a monopoly for a particular period (i.e. 20 years) o Consideration for the grant: 1) There must be a new and useful invention 2) Inventor must give full and complete disclosure of all the information necessary to practice the invention Policy rationale coax disclosure so that useful knowledge is made available to the public A patent grants the owner of a patent the right to exclude the world from practicing the invention as defined in his patent for a limited term. Its a negative right. In exchange for this right, the patentee discloses his invention to the world and teaches them how to practice it. Our Court has often spoken of the balance struck under the Patent Act in which the public gives an inventor the right to prevent anybody else from using his or her invention for a period of 20 years in exchange for disclosure of what has been invented. As a general rule, if the patent holder obtains a monopoly for something which does not fulfil the statutory requirements of novelty, ingenuity and utility, then the public is short-changed. See Whirlpool Corp. v. Camco Inc., [2000] 2 S.C.R. 1067, 2000 SCC 67, and Free World Trust v. lectro Sant Inc., [2000] 2 S.C.R. 1024, 2000 SCC 66. If its later found out that the public is short changed, then your patent will be held as invalid. Patents are granted by the Patent Office under the Patent Act. Patents are intended to stimulate the creation and development of a new technology. Once a patent has been granted, an annual maintenance fee must be paid to maintain the patent. Companies might not want to patent certain things like Cokes recipe (trade secret) as it would become publicly available in 20 years.

Page |2 Government wants to encourage putting things in public domain e.g. pharmaceutical companies invest a lot of $ in making drugs and they have to create a patent in order to recuperate the cost of making the drug and the research going in that product as well as others. This is why drugs cost so much to buy but cost little to make.

Term of Patent Old Act Patent (pre-October 1989): 17 years from date of issuance (section 46) New Act Patent (post-October 1989): 20 years from date of filing (section 44) Patent is filed when invention is first created, then go into clinic trials which takes like 10 yrs. So by the time youre done, you only have 10 years of patent protection. This is another reason why drugs are so expensive.

What is an invention? Patents are granted for inventions. To get patent protection in Canada, the invention must be patentable subject matter in accordance with the statutory requirement of s.2 of Patent Act. An invention is defined as Invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter. In patent law, an invention is something new, useful and unobvious that has not been previously disclosed to the world. A simple derivate of a previously known thing or a simple aggregation of previously things will not be sufficient If the invention doesnt fall into one of above categories, the inquiry ends and invention is not patentable. In recent years, higher life forms and computer programs are areas w/ lots of interest. No patent if invention does not fall in one of these categories (i.e. transgenic mouse doesnt meet the s.2 defn; one click business method does meet s.2)

Grant of a patent The grant of a patent gives the patent owner the exclusive right of making, constructing and using the invention The effect is the right to exclude the world from practising the invention during the term of the patent o negative right rather than conferring rights

Page |3 Application process A patent application must be submitted thru a patent agent. Patent rights will be assigned in accordance w/ the claim date, usually the filing date. Unlike the US, the Canadian system is a first to file system not first to invent This means that the patent is granted to the inventor who first submits his application regardless of invention date. The claim date may be the earlier of 1) the filing date of an application in a foreign country made under the Patent Co-operation Treaty (PCT) (also called the priority date) or 2) the filing date of the Canadian application. However, the foreign date must not be more than 12 months prior to the Canadian filing date.

CONSTRUCTION OF A PATENT A Canadian patent consists of several parts: 1) Title page 2) Abstract 3) Specification meat and bones of the patent a. Disclosure b. Drawings c. The claims To understand patent / claim construction, we must appreciate the significance of each of these sections of a patent. Disclosure section states out what is claimed and explains what is invented. Also describes what is in the prior art (what has been invented). Can be from a couple of pages to hundreds. Whatever is claimed is whatever that is protected. The meaning of the claims often is used by judges to decide who wins or loses the case. When you are attacking a patent, you are saying that the invention claim is not new etc. You do not have to claim everything that you invent if it doesnt meet novelty reqt

Specification Patent Act s.27 27.(3) An applicant shall in the specification of his invention (a) correctly and fully describe the invention and its operation or use as contemplated by the inventor; (b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it appertains, or with which it is most closely connected, to make, construct, compound or use it;

Page |4 (c) in the case of a machine, explain the principle thereof and the best mode in which he has contemplated the application of that principle; and (d) in the case of a process, explain the necessary sequence, if any, of the various steps, so as to distinguish the invention from other inventions. (4) Claims to be stated distinctly - The specification referred to in subsection (1) shall end with a claim or claims stating distinctly and in explicit terms the things or combinations that the applicant regards as new and in which he claims an exclusive property or privilege. In determining whether the disclosure of a patent is sufficient, the Federal Court of Appeal has recently reiterated the following test:

For a patent to be valid, an invention must be sufficiently disclosed. The specification represents the bargain between the Crown on behalf of the public and the inventor (Consolboard, supra). Accordingly, the patent must contain enough information to allow a person skilled in the art to make the invention. The claims must be precisely laid out, without being overbroad. If the disclosure requirements are not met, the patent will be invalid even if it is new, useful and not obvious. Pfizer Canada Inc. v. Novopharm Ltd. (2010), 88 C.P.R. (4th) 405 at para. 76 (F.C.A.) The Claims The claims define the scope of the monopoly Fences within which the inventor can claim protection Disclosure outlines the nature of the invention for which the monopoly is claimed the claims must not be broader than what is disclosed the disclosure cannot be used to broaden the claims fences can be placed around different aspects of invention

Types of claims Composition Use Method Process Markush Product by process

e.g. Claim 1 of patent is always going to be ti go listen he broadest claim (reflected in the disclosure). Subsequent claims are more and more narrow. Genus (related family of molecules) substitutions of the molecules (taking molecules out and putting another one in) make up the genus. This is called the composition claim: claim 2 is a component of claim 1 etc..

Page |5 Claim 1 will be the whole genus. The broader the claim, the more likely its in the public domain and be subject to a validity attack. Claim 2 narrower, and claiming a subset of the genus. Claim 3 5 might be the exact compound that works the best. There can also be use claims e.g. antibiotics. o Claim 1 5 to treat upper respiratory tract infections o Claim 2 5 for sinus infections o Claim 5 for a specific infection Its good to have narrow claims, but wont provide as good a protection. Need the claims to be broad to capture infringers but might be subject to validity claims. A single process can cover all: composition, use, method and process. Dont have to file multiple patents.

CLAIMS CONSTRUCTION Claim construction is key to understanding what exactly is claimed. - The question is whether the claim is valid not the patent itself. - Necessary to understand the scope of the monopoly and defines the monopoly distinctly and in explicit terms - Must be done before considering issues of infringement and validity. - Claim construction must be done through the eyes of a person skilled in the art o Person skilled in the Art Person to whom the patent is addressed. Who that person is, is a question of law, usually determined by expert evidence. Important bc different terms will have different meanings. o E.g. bench means differently to judge, scientist, weightlifter. o Determining which person is the skill of the art is often the question of litigation. 2 parts in a patent: disclosure and the claims; together known as specification. The disclosure explains the invention The claims are construed in order to build the fences around the patent, an understanding of how the claims are construed is integral to understanding the limits of the monopoly defined by the patent. The SCC has explained that claims construction is to be done purposively and are to be construed before addressing either infringement or validity. Claim construction = what the claims mean, not what it says. Claim construction is a question of law to be decided by the judge Judge can be assisted by the evidence of experts to assist in understanding the meaning of terms in a patent Judge is not bound by expert evidence Claims are to be construed as of the date of their publication. Patent becomes public and published about 18 months after filing

Page |6 Whirlpool Corp v. Camco Claims construction. F: Two patents for dual action agitators for automatic washing machines. o W had patent on flexible vanes. o Camco claims that Ws patent claim of vanes include both flexible and rigid. Thus, if there was prior art of flexible vanes, the claim is invalid. o W says that vanes mean rigid. Camco admitted it infringed Whirlpools 803 patent which claimed outwardly extending substantially vertically oriented vanes Whirpool had a previous patent covering flexible vanes Camco contended that the word vanes in the claims of the 803 Patent included both flexible and rigid vanes and was therefore invalid (as being not new there was prior art). I: Claim construction issue determinative: is the word vanes in the 803 patent limited to rigid vanes or does it include flexible vanes? R: The content of a patent specification is regulated by s.34 of Patent Act. The first part is disclosure where patentee must describe the invention w/ sufficiently complete and accurate details as will enable a workman, skilled in the art to which the invention relates, to construct or use that invention when monopoly expires. The disclosure is in exchange for the 20 yr monopoly on the exploitation of the invention; which is enforced by statutory and equitable remedies. The public notice function is performed by the claims that conclude the specification and must state distinctly and in explicit terms the things or combinations that the applicant regards as new and in which he claims an exclusive property or privilege. (34(2). An inventor is not obliged to claim a monopoly on everything new, ingenious and useful disclosed in the specification. What is not claimed is considered disclaimed.

Held: The claim language: An agitator for a washing machine having a driven oscillating shaft, said agitator comprising: a first agitator portion capable of being mounted on said shaft by means of a locked, non-rotating connection and have an upper part, and a lower part provided with outwardly extending substantially vertically oriented vanes; a second agitator portion in the form of a sleeve having at least one outwardly extending, inclined vane, said sleeve being rotatably mounted on the upper part of the first agitator portion; and a one-way clutch located between the first and second agitator portions, the first agitator portion being adapted to drive said clutch and the second agitator portion being adapted to by driven by said clutch so that rotation of the first agitator portion gives a position rotation to the second agitator portion in only one direction of rotation of the first agitator portion, said inclined vane being inclined upwardly with respect to the direction of positive rotation of the second agitator portion, and at least the lower parts of said

Page |7 vertically oriented vanes extending radially outwardly by a greater amount than said at least one inclined vane. Now the leading case in Canada on principles of claim construction Considered whether claims should be construed literally or purposively Infringer argued for literal interpretation (vane means any vane flexible and/or rigid. If they wanted to cover rigid, should have specified) Patentee argued for purposive construction (read in context, vane means rigid vane) o E.g. in bench example, literal interpretation means any types of benches. Purposive interpretation would look at context. Since it talks about weight lifting, should mean weight lifting bench not judges. SCC adopts U.K. approach as set out in, inter alia, Catnic Components Ltd. v. Hill & Smith Ltd., [1982] R.P.C. 183 o A patent specification should be given a purposive construction rather than a purely literal one derived from applying to it the kind of meticulous verbal analysis in which lawyers are too often tempted by their training to indulge. o determine the pith and marrow of the invention claimed Key paragraph 49: The key is that claims are to be construed purposively o The claims must be construed with reference to the entire specification, and the latter may be considered in order to assist in apprehending and construing a claim, but the patentee may not be allowed to expand his monopoly specifically expressed in the claims by borrowing this or that gloss from other parts of the specification. 803 specification is silent on type of vane to be used (rigid or flexible) drawing appears to show rigid vanes Judge accepted the expert for Maytag who testified that a skilled person reading the patent would understand vane as used in the claim to mean rigid only

Principles of patent claims construction First Step in Analysis: - When construing claims should receive one and the same interpretation for all purposes. - The first step in patent suit is to construe the claims, and then comes the consideration of validity and infringement. - Not to be construed with an eye on infringing device or prior art Purposive Construction: - Claims set out distinctly and in explicit terms. - Claim construction should use purposive construction (not read literally). Claim is read within the entire context, from beginning to end.

Page |8 Need to determine what are the essential elements or the pith and marrow features, of the claim determined by a person skilled in the art and expert evidence - identifying particular words in the claim as to what inventor thinks the essential elements are Patent read as a whole against context of what was generally known to those skilled in the art. Disclosure should give skilled readers enough information to practise the invention with little difficulty when the patent period ends, and meanwhile to experiment with/try to improve it. Interpretation has to be fair and reasonable to the public and the patentee

Use of the Specification: - Purposive construction can and should use the specification, in the context of the specification as a whole, but must remain within the four corners of the specification - Dictionary approach is inappropriate - Purposive construction can cut either way expand or restrict claims Construction Date: - Date of construction should be the date of publication Free World Trust v. Electro Sante F: Patents in issue relate to an apparatus that bombards specified parts of body with low frequency electro-magnetic waves. Case heard and decided with Whirlpool v Camco. Main issue concerned construction of the term control circuits App uses control circuits to regulate the magnetic field of waves or pulses whose frequency, orientation and amplitude are critical to therapy. Resp uses a microcontroller which regulates the magnetic field in a diff way. App contends that the end result is the same and its monopoly was infringed. Resp argues that 1) App didnt make a new discovery of anything. Apps patents teaches nothing that was not already known. Thus its patents are invalid. 2) Even if patents are valid, App overreaches its bargain w/ the public by now asserting a monopoly over devices that are in no way disclosed, taught or claimed in its patents. App is trying to get sth for nothing. App has given no consideration of the patent protection it seeks.

I: the extent to which a patent monopoly protects the substance or the spirit of an invention, as distinguished from what is literally described in the written claims. Whether the claims patented by appellant. are sufficiently elastic to catch the electro-magnetotherapy machines of the respondent. Held: for respondent. Too much elasticity in the scope of interpretation creates uncertainty and stifles competition. Too little protection robs inventors of the benefit they were promised in exchange for making a full and complete disclosure of the fruits of their ingenuity. Patent claims are frequently analogized to fences and boundaries giving the fields of the monopoly a comfortable pretence of bring line demarcation.

Page |9 Fences must be clearly placed w/ no ambiguity, obscurity, not flexible, clear and precise so that the public will be able to know.

R: Essential vs non-essential elements - Patent claims are like fences which demarcate the boundaries of the monopoly - The precise elements of the fence may be crucial or essential to the working of the invention as claimed - other elements may be easily substituted without making any material difference to the working of the invention - The task of the court in construing the claims of a patent is to determine and distinguish the essential from the inessential elements Note: If alleged infringing device simply adds a bell or whistle still infringes If alleged infringing device substitutes an essential element no infringement E.g. invented lens and claimed glasses w/ lens. Someone put those lenses in ski goggles. You would argue that the glasses element is non-essential that a person in the state of the art would understand to be so, the lens is essential and substituting something that is nonessential is just adding bell or whistle. Thus, theres infringement. E.g. substituting sucrose w/ dextrose is non-essential. But making the absorbing property a certain way so the stomach can absorb is the essential component.

Principles of claim construction (1) Interpretation (construction) must precede any review of infringement or validity, it must not be "results oriented". (2) One and the same interpretation is to apply to both infringement and validity.

(3) The approach must be as a "mind willing to understand" so as to pay close attention to the purpose and intent of the inventor. (4) Extrinsic evidence such as file wrappers (entire history of the prosecution of the patent) cannot be resorted to; the Court must restrict itself to the specification. Usually cant use dictionary to interpret something. However, a person of skill of the art can use common knowledge to interpret something e.g. if theyre a doctor, they are allowed in interpreting a patent, use the knowledge they accumulated as a doctor.

(5) The whole of the specification and the claims must be looked at to determine what, on a reasonable view, the inventor in good faith invented. (6) Purposive construction may result in a restriction as well as an expansion of the claims.

P a g e | 10 (7) The Court should look to the context of claims in the specification and avoid resort to dictionaries or grammatical or etymological approaches that are inconsistent with the specification. should go w/ defn in disclosure if theres inconsistencies. (8) Expert evidence is admissible to assist the Court in construing the patent, not to interpret the patent, but to enable the trial judge to do so in a knowledgeable way. The Court is entitled to the assistance of experts in understanding the terms used in the patent as well as the underlying science, but that is where it ends. The Court must construe the patent; the expert cannot substitute his or her opinion as to the proper construction for that of the Court. (9) A Court should not be quick to find ambiguity that will invalidate a patent, and should refuse to do so where a claim can, with some effort, be construed in a meaningful way. VALIDITY Patent Act s.43(2) - Every patent that is granted bears a statutory presumption of validity unless there is any evidence adduced to the contrary. This is a very weak presumption. There are many grounds to attack its validity. A patent will only remain valid if only a portion of the claims are struck out as invalid. A valid patent must encompass patentable subject matter, thus every patent is open to attack on the grounds that it does not meet the statutory reqt set out in s.2. Moreover, a patent must be new, useful and non-obvious. Every case will dispute the validity the patent by the alleged infringer.

Subject matter The validity of a patent is determined according to s.2 of the Patent Act Invention means any new and useful art, process, machine, manufacture or composition of matter, or any new and useful improvement in any art, process, machine, manufacture or composition of matter. o Invention is something that is non-obvious. o New = novel. Anticipation is the opposite of novelty, so not new. o Usefulness = utility. The act does explicitly exclude certain subject matters in s.27(8) no patent shall be granted for any mere scientific principle or abstract theorem. Mere discovery (like melting point), an idea or concepts are not patentable as it doesnt fall under s.2. If they had a business method or if the idea was put it in a concrete form, then maybe patentable. Transgenic mouse didnt have to look at the new, useful or non-obvious qualities bc its not a protectable subject matter i.e. not art, process, machine, manufacture or composition of matter or improvement.

P a g e | 11 Shell Oil v. Commissioner of Patents F: Discovery of compounds having specific chemical structure w/ useful properties as plant growth regulators. Altho these compounds were already known, their usefulness for this particular purpose was not known. In order to use them for this purpose, it has mixed them w/ adjuvants creating a new compound. Theres nothing inventive in mixing the compound w/ adjuvant. Seeking the patent on compositions formed by mixing w/ adjuvant, not seeking patent on invention. I: is the new use for an old compound patentable under the Act, if Y, how is it patented? Held: patent granted Under s.2 the invention is the application of this new knowledge (applying old compounds w/ the new) to effect a desired result which has a commercial value. This falls under any new and useful art. o Art means learning or knowledge. The discovery here has added to the wisdom on the subject by recognizing unrecognized properties. The compositions are practical embodiment of the new knowledge. o The inventive ingenuity is in the discovery of the new use and no further inventive step is required in the application of the compounds to that use, i.e. in the preparation of the appropriate compositions. o An idea new, original and very meritorious, is patentable even if there is no invention required to put the idea into practice Thus in this case, even if there compounds are old, there is nothing inventive in mixing them w/ adjuvants, there is an invention from the discovery of these properties in those old compounds. If falls under s.2, nothing precludes apps claim. compound was old, nothing inventive in mixing compound with adjuvant inventive ingenuity lay in discovering new use New use on old compound is patentable. The appellants discovery in this case has added to the cumulative wisdom on the subject of these compounds by a recognition of their hitherto unrecognized properties and it has established the method whereby these properties may be realized through practical application. In my view, this constitutes a new and useful art

Harvard College v. Canada F: issue to patentability of higher life forms: a mouse that has been genetically altered to increase its susceptibility to cancer, making it useful for CA research. The patent claims also extend to all non-human mammals similarly altered. Seeks to protect process which the oncomice are produced and the end product of the process. I: whether manufacture and composition of matter are broad enuf to include higher life forms as subject matter?

P a g e | 12 Held: Rejected patent of higher life form. Mason thinks that today, it would be patentable. Whether higher life forms ought to be patentable is a matter for Parliament to determine as there are many practical, ethical and environmental concerns not contemplated by Act. By reading the Act in the entire context, harmoniously with the scheme of the Act, object and intention ct held that Parliament didnt intend to include higher life forms within the defn of invention in Patent Act. Higher life form i.e. oncomouse isnt easily understood as manufacture or composition of matter.

s.2 Parliament chose to adopt an exhaustive defn, thus there was clear intent to include certain subject matter as patentable and to exclude others. Manufacture is defined as something made by the hands of man, do not imply a conscious, sentient living creature. Composition of matter doesnt include higher life form either. o The process by which a fertilized egg becomes mouse is a complex process, elements of which require no human intervention. The body of a mouse is composed of various components but none of which is mixed together by a person. Thus, composition of matter doesnt include higher life form whose genetic code has been altered. Parliament could not have anticipated genetic alteration, and would not have foreseen that higher life forms could be created in a manner reasonably understood as an invention. They are better regarded as discoveries.

Schlumberger Canada F: the purpose of the invention is to ease the exploration for oil and gas by using measurements obtained from boreholes are recorded on magnetic tapes and transmitted to a computer program according to the math formula. This produces useful information in charts and graphs. Commissioner rejected patent on the grounds that it claimed a computer program App claims the invention is not a mere computer program, its a process whereby calculations are performed to extract useful information from measurements. The invention is not the computer program, it is the complex process effected by computer of transforming measurement s into useful information. R: No protection for a method of operating a computer in a selected manner to accomplish math calculations, the end results being merely numbers useful in making certain decisions by skilled geologists. Held: The discovery of the various calculations to be made of the math formula used to make those calculation are not patentable.

P a g e | 13 If those calculations are not done by computer but by men, the subject matter would clearly be math formula and a series of purely mental operations; which are not patentable. Mere scientific principle or abstract theorem under 28(3) are not patentable. The same operation done mechanically is not patentable (done by computers instead of by humans), as this would turn sth that was not patentable into one that is. S. 28(3) explicitly precludes mere scientific principles or abstract theorem from patentable subject matter. Mental operations and processes are not covered by section 2 The fact that the calculations here are performed by computers, not people, does not transform otherwise unpatentable subject matter into patentable subject matter. A computer used to implement a discovery does not change the nature of that discovery (which in this case is merely the discovery that by making certain calculations according to certain formulae, useful information can be extracted.

Motorola Patent F: application relates to a method and a device for efficient evaluation of exponential function. R: Not possible to obtain a patent containing claims to an algorithm per se A method which does nothing more than set out the step needed to solve the algorithm is also not patentable. An apparatus claim which consists only of a series of means-plus-functions statements is usually considered to be nothing more than a disguised method claim and if the method itself is not patentable, this type of apparatus claim is also not patentable.

Held: board determined that applicant has discovered an algorithm for use in evaluating exponential functions, has converted this algorithm into a series of method steps and developed a device to carry out this series of steps. The devise disclosed and claimed is more than a means-plus-functions statements. It includes a read-only memory coupled to modification means this piece of hardware is specific and thus this claim is limited to specific configuration of at least one physical element as well as some elements which are ordinary components of a well-known digital computer which are programmed to carry out desired functions. The device is specifically adapted to carry out the method of solving the algorithm which the applicant developed. o The device contain many means-plus-functions statements also includes at least one specific piece of computer hardware which is a real physical element. o Thus, the claim goes beyond being directed to a mere scientific principle or abstract theorem.

P a g e | 14 o Thus, a device which is adapted to carry out a method of solving an algorithm is not directed to mere scientific principle or abstract theorem itself but is seeking to exclude others from using the device OK.

Ct is looking for something that is concrete and tangible not something abstract or an idea. What if u discover an invention that has been patented? Like Viagras erectile dysfunction has been patented. But if you discover another use like hypertension, you can patent it for use purpose. However, you cant distribute it without licensing from company, or wait until patent is over and licence to company for its use as hypertension. Oftentimes, its likely the company thru clinical trials, already know of this side effect. If man distributes the drug for the purpose of hypertension which he has patent, but the doctors are prescribing it for ED, then company has no claim on man. Doctor would be inducing infringement, but no company will sue the doctors. Business method patents are big in the US, but doesnt rise as big in Canada. Companies like RIM and banks file these. Issue: Does Amazons one-click patent qualify as patentable subject matter under section 2? Commissioner of Patents said no Decision based in part on policy considerations as to why business method patents arent patentable.

Federal Court said yes Court focused on whether the claims amounted to patentable art under section 2 Relied on Shell Oil decision, dont bring in policy consideration. Mason thinks this is what the mouse case shouldve done, look at defn less policy.

Applies Shell Oil decision -- the subject matter of the claim must not be a disembodied idea but have a method of practical application (in the case of business methods, mere business scheme will not be patentable; requires some sort of manifestation or effect or change of character); must be a new and inventive method of applying skill and knowledge; and must have a commercially useful result A practical business model that is tangible (instruction) w/ direct application might be patentable. Right now, business model patent are patentable. Next yr, might change in appellate ct.

P a g e | 15 Page 358 415 Hockey stick patent Canadian Intellectual property office = only office that can issue patents 806 patent Date of filing = date on which the validity of patent is accessed. Date of publication (2005/04/20) = construing the claim is on date of publication. Priority date = date on which the US patent was filed. Inventions are the property of the company. Abstract is not part of specification, not used in claim construction. Page 1 onward of disclosure portion of the specification = making of stick and problems associated w/ its manufacturing. Claims 1 13 = method claims. The claim gets narrower, claim 1 being the broadest. The protectable invention would be the narrowest claim (Claim 14 21) Note tho that claim 14 is still a broad claim and 15 21 are narrower claims of 14. E.g. composition claim Genus claim: the broadest claim of a compound can include substitute group (which could be any molecules). If one of those compounds is in the prior art, that could invalidate your claim, so you create a narrower claim to down to 250K. If only 20 were claimed, that would be the next narrow claim The narrowest claim is your most promising invention. (bullet compound)

UTILITY Patent Act s.2 = in order to be valid, an invention must be new, useful and non-obvious useful = utility the inventor must establish utility as of the date the patent is applied for this is a low threshold and commercial utility is not required, the invention must actually perform what it sets out to do. Actual utility is a patent itself e.g. testing compound and it had a reading of -8 on plate, described the process how u got it on petri dish w/ that specific reading. If inventor cant establish actual utility, patent may nonetheless be saved if inventor had a sound basis to predict utility sound prediction. Your claim was ethanol + water. As example, you state 50-50: 1) claim construction: all combination of ethanol + water. If the combination doesnt work, then the claim lacks utility. Try to argue that there is another way of interpreting the claim in a way that makes sense: that person of ordinary skill of art would know that a certain amount of ethanol is needed, thus, ethanol + water actually means a combination of both with a certain ethanol to make it work. Ct didnt buy this, as that specific combination didnt state that. If claim is too broad, then that claim will be invalid, but other claims could still be ok.

P a g e | 16 Consolboard v. MacMillan R: Although s.36(1) requires the inventor to indicate and claim the part, improvement or combination which he claims as his invention and to be patentable an invention must be something new and useful s.2, and not known or used by any other person before the applicant invented it s.28(1)(a) the words of s.36(1) doesnt oblige the inventor in his disclosure or claims to describe in what respect the invention is new or in what way it is useful. He must say what it is he claims to have invented. He is not obliged to extol the effect or advantage of his discovery, if he describes his invention so as to produce it. Inutility means the intention will not work, whether in the sense that it will not operate at all or, more broadly that it will not do what the specification promises that it will do. practical usefulness of the invention does not matter commercial utility does not matter unless the specification promises commercial utility nor does it matter whether the invention is of any real benefit to the public, or particularly suitable for the purposes suggested. If you do what the specification tells you to do, can you make or do the thing which the specification says that you can do or make

SOUND PREDICTION If the inventor is unable to establish the actual utility of his invention as of the filing date of the patent, the invention may still be valid if the inventor had a sound basis to predict the utility of the invention based on the information and expertise then available. o eg. common for chemical patents to disclose in vitro testing only yet claim use of compound to treat disease patents utility must be actually shown via evidence. If its later shown that the prediction was unsound, the patent is invalid based on lack of sound prediction. If the prediction was sound but later shown to be incorrect, patent will be held invalid on the basis that it lacks utility.

Apotex v. Wellcome F: W holds patent on the use of AZT for HIV/AIDS treatment. A argues that the identification of AZT as a prophylactic and treatment benefits were a shot in the dark, a speculation based on inadequate information and testing, but turned into a lucky guess. AZTs success was unknown and unknowable by W. Note that Ws only contribution was a new use of AZT, the compound itself isnt novel. AZT patent AZT invented by DICR in 1964 as a possible cancer drug (not by Glaxo) Glaxo began looking at AZT in 1984 as a possible treatment for AIDS

P a g e | 17 tested on mice T-cells looked promising - questionable whether predictable for humans To patent or not to patent ethical issue re: cannot withhold treatment from AIDS patients while waiting to establish human efficacy. Company were essentially forced to disclose information, so they filed patent based on mice data alone. Glaxo not equipped to do human testing By mid-Feb 1985, AZT found to work in vitro against HIV Priority patent application filed in March 1985 Apotex argues no sound prediction for efficacy in humans because it was not yet known whether AZT would work as a treatment in humans Glaxo argued in vitro data sufficient basis to predict utility in humans

I: whether there was an invention within s.2. if the utility of AZT for treatment of HIV was unpredictable at the time of patent application, then the inventors had not made an invention and had offered nothing to the public in exchange for a monopoly except wishful thinking. R: patent upheld as sound prediction. Patent: The public should not be expected to pay an elevated price in exchange for speculation, or for the statement of any mere scientific principle or abstract theorem or for the discovery of things that already exist, or are obvious. A patent is not intended as an accolade or civic award for ingenuity o Inventor gets a monopoly in exchange for disclosure of the invention o Monopolies are associated with higher prices o Public should not be expected to pay an elevated price in exchange for speculation the patent monopoly should be purchased with the hard coinage of new, ingenious, useful and unobvious disclosures Was the patent a shot in the dark/lottery ticket/lucky guess? o Cannot predict w/ certainty that although it works in mice, it will work in human.

Utility S.2 of the Patent Act defines an invention as new and useful The utility must be demonstrated or be a sound prediction based on the information and expertise available. Thus, predictability is a question of fact, based on evidence. If a patent sought to be supported on the basis of sound prediction is subsequently challenged, the challenge will succeed if the prediction at the date of the application was not sound or, irrespective of the soundness of the prediction, there is evidence of lack of utility in respect of some of the area covered.

P a g e | 18 Sound prediction 3 components : 1) There must be a factual finding for the prediction; its supplied by the test data, other factual underpinnings, nature of the invention. 2) inventor must have at the date of the patent application an articulable and sound line of reasoning from which the desired result can be inferred from the factual basis 3) proper disclosure. Full, clear and exact description of the nature of the invention and the manner which it can be practiced is suffice do not have to explain why it works The inventors could make a sound prediction that the compound offers an unexpected utility but then, only when the invention is disclosed, will there be real consideration for the monopoly benefits sought.

Held: Ws key results of the in vitro test of AZT against HIV in human cell together w/ Ws own data on AZT, including mouse tests, provided a factual foundation. Ws knowledge of mechanism by which the virus reproduces and the chain terminator effect of AZT, as disclosed by the patent, was found to provide the sound line of reasoning by which utility could be established as of the date of the patent application. The factual basis of prediction must be in patent itself, but not necessary the line of reasoning, if its something that a skilled person would know. (Eli Lilly Canada v. Apotex). Note: human clinical trials are not necessarily required to uphold your patent claim especially since theres the policy argument of disclosing any new methods of treating against disease and patent should be granted early (its encouraged) especially since clinical trials can be so long.

ANTICIPATION (NOVELTY) Anticipation is a subcategory of validity. S.2 Invention must be novel (new) to be patentable. Novelty defined in s.28.2(1) of the Act. Test for anticipation s.28.2(1)(b)

28.2 (1) The subject-matter defined by a claim in an application for a patent in Canada (the pending application) must not have been disclosed (a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject-matter became available to the public in Canada or elsewhere; (b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject-matter became available to the public in Canada or elsewhere; Disclosure could be in journal, posting on the net, prior use (use is more tricky = inherent anticipation as prior use e.g. Brazilian have been taking plants to clear sinuses. If you synthesize that compound, that compound is transformed as metabolite in your body that metabolite is a prior use.)

P a g e | 19 Prior disclosure = anything publicly available, doesnt matter that no one has read it. E.g. patent claiming compound X, which is made by compound Y + heat = X. Y is known in public to treat infections, X is also used for same thing but better. When Y was tested, the melting pt was found to be 120 and X was found to have been made during the procedure. o That is a prior disclosure of X as it existed although fleetingly and melted. o Very harsh test. This is very harsh, if your invention is disclosed at all one yr before your patent application, then youre screwed. Unless you (the inventor) is the one who is disclosing the invention, then you have a yr. An invention that is anticipated is not novel. An invention is anticipated if it can be derived from a single prior sources (aka prior art). Test for anticipation is Sanofi. 2 step-approach 1) is there a prior disclosure and 2) is the disclosure enabling. Prior to Sanofi, the relevant test in Beloit only asked if a person skilled in the art was given such a clear direction that, by reading and following the patent, he would in every case and without possibility of error come to the invention.

Beloit v. Valmet Anticipation or lack of novelty asserts that the invention has been made known to the public prior to the relevant time. Anticipation must be found in specific patent or other published document, its not enough to pick bits and pieces from a variety of prior publication and meld them together to come up with the claimed invention. One must be able to look at a prior, single publication and find in it all the information is needed to produce the claimed invention w/o the exercise of any inventive skill. The prior publication must contain so clear a direction that a skilled person reading and following it would in every case and w/o possibility of error be led to the claimed invention. Where the invention consists of a combination of several known elements, any publication which doesnt teach the combination of all elements cant be anticipatory.

Apotex v. Sanofi-Synthelabo F: A challenges validity of selection patent (a patent whose subject matter is a fraction of a larger known class of compounds which was the subject matter of a prior patent) on the grounds of anticipation, obviousness, and double patenting. 875 Patent = Genus patent = prior art that covers 250,000 compounds useful for inhibiting platelet aggregation activity in the blood amongst the 250,000 compounds is clopidogrel bisultfate 777 patent claims clopidogrel bisultfate

P a g e | 20 clopidogrel bisultfate not specifically identified and was never made or tested (although the racemate was, and racemate went into clinical trials) Anticipated by 875 patent? CB was included in 875s claim 1 as the giant broadest claim w/ 250K compounds.

R: 2 reqt for anticipation, high threshold / hard to prove anticipation 1) Prior disclosure The prior patent must disclose subject matter which, if performed, would necessarily result in infringement of that patent. E.g. everytime u take melting point of Y, X is created necessarily There is no room here for trial and error or experimentation by the skilled person. Hes simply reading the prior patent for the purposes of understanding it. If no such disclosure is apparent from reading the document, there is no anticipation. If prior disclosure is found, the second requirement to prove anticipation is enablement Subject-matter of subsequent patent is a particularly useful compound for treating hypertension these special advantages are present only in 777 not in 875 The prior patent didnt disclose the special advantages of clopidogril Racemate was disclosed in 875 and there were 5 methods known in art to separate the compounds. 2) Enablement. If disclosure reqt is satisfied, the 2nd reqt is the person skilled in the art would have been able to perform the invention of the new/selection patent as disclosed in the prior/genus patent in light of common general knowledge without undue burden. Trial and error is allowed here, the person skilled in the art may engage in some routine trial and error experiments in order to get the invention to work, but inventive steps or any prolonged and arduous trial and error experiments are not permitted. The purposes of enablement is no longer what the skilled person would think the disclosure of the prior patent meant, but whether he would be able to work the invention. extensive investigation required to separate racemate into isomers

Held: 777 not anticipated. 1) No prior disclosure. There was no evidence that the person skilled in the art would know from reading 875 patent that the more active isomer would be less toxic than the racemate or other isomer. 875 didnt disclose advantages of the isomer either, thus no disclosure and no anticipation. 2) Not necessary to do 2) but ct held that the invention required extensive investigation and months of work.

**An element not in nature and that youve discovered is patentable. An element in nature thats not isolated may be patentable if you described a usefulness for it, then it is. If youve just

P a g e | 21 discovered it w/o a use, then not patentable. E.g. insulin has existed forever but is patentable when its discovered and its beneficial use to treat diabetes was found. A mere claim of insulin w/o utility is not valid thats just discovery, not an invention. Claim of insulin, claim for use. But someone else can have a different claim for use of it, even though you have a claim on the actual compound (so they have to get a licence from you).

OBVIOUSNESS Most common validity attack, can make a claim using prior acts from multiple sources a skilled person would be able to do this. Obviousness = not inventive Inventive step = (going from what is known to what you have claimed) If theres an inventive that is necessary, then you get an invention. A scintilla of inventive step is required, not a new invention entirely. Consider from perspective of person of ordinary skill in the art not inventor or expert. Longstanding test from Beloit now supplanted by Apotex v. Sanofi An obvious patent is invalid. Obviousness analysis is broader in scope than the anticipation analysis. For anticipation, the prior enabling disclosure must be found in a single prior art document For obviousness, it can be from many, can look at more than one prior source mosaic With anticipation, the thing may be inventive but not new. With obviousness, the thing may be new but not inventive

Beloit v. Valmet Obviousness is an attack on a patent based on its lack of inventiveness. Anticipation or lack of novelty is an attack that there has been an invention but it has been disclosed to the public prior to the patent application Obviousness should be dealt first as a patent that lacks inventiveness cant be novel, while one that lacks novelty can be inventive. The question to be asked is whether the man would in the light of the state of the art and of common general knowledge as at the claimed date of invention, have come directly and without difficulty to the solution taught by the patent

Apotex v. Sanofi R: The obvious to try test is one of the factor to assist in an obviousness inquiry. For a finding that an invention as obvious to try there must be evidence to convince a judge on a balance of probabilities that it was more or less self-evident to try to obtain the invention. Mere possibility that something might turn up is not enough. The 4 step approach is:

P a g e | 22 1) identify the notional person skilled in the art and identify the relevant common general knowledge of that person. 2) identify the inventive concept of the claim in question or if that cannot readily be done, construe it what is the invention 3) identify what, if any, differences exist between the matter cited as forming part of the state of the art and the inventive concept of the claim or the claim as construed. state of the art = sum of all literature 4) Viewed w/o any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention? is it obvious for person to look at the state of the art w/o accounting for your invention Obvious to try test is appropriate in areas of experimentation e.g. inventions in pharmaceutical industry might warrant obvious to try test since there may be many chemically similar compounds that can elicit diff responses and offer benefits - If the obvious to try test is warranted, then these non exhaustive list factors should be considered as the 4th step of the obviousness inquiry. - Obvious to try doesnt mean worth the try, obvious to try means more or less self evident! I. Is it more or less self-evident that what is being tried ought to work? Are there a finite number of identified predictable solutions known to persons skilled in the art? II. What is the extent, nature and amount of effort required to achieve the invention? Are routine trials carried out or is the experimentation prolonged and arduous, such that the trials wouldnt be considered routine? III. Is there a motive provided in the prior art to find the solution the patent addresses? IV. Not an actual factor: Another factor is considering the course of conduct culminating in the making of invention. o E.g. if inventor quickly, easily and cheaply reached the invention in light of the prior art and common general knowledge, that may indicate obviousness unless the level at which they worked and their knowledge base was above what should be attributed to the skilled person. o If used money, time, effort but turned up fruitless, that may indicate non-obviousness as it would suggest that the skilled person, using common general knowledge and prior art would have done no better. Held: Using 4 factors 1) Notional person skilled in the art is the trained pharmachemist. 2) Relevant common general knowledge of that person: 5 well known methods to separate racemate into isomers 3) The inventive concept: inventive concept is not readily discernable from the claims themselves. A bare chemical formula in a patent claim may not be sufficient to determine its inventiveness. Thus, the ct read the specification of the patent to determine the

P a g e | 23 inventive concept of the claims e.g. a compound useful in inhibiting platelet aggregation which has greater therapeutic effect and less toxicity. 4) Differences btw the 875 and 777 claim: 875 didnt disclose certain specific benefits and didnt discern btw the properties. 777 claim did. 5) Viewed w/o knowledge of 777, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require a degree of inventiveness: ct held its here where obvious to try test should determined if it should be used. It should bc the test would recognize the beneficial properties of the isomer and its salt and the methods for finding them. Factors Not self evidence that what was tried should have worked bc a skilled person would not know, before separating this racemate into isomers and then testing those isomers that their properties would be different from properties of the racemate and another isomer. o Just bc there are known methods to do doesnt mean that a person skilled in the art would apply them. o A possibility of finding the invention isnt enough. The invention must be self-evident from the prior art and common general knowledge. Effort required: there were 5 well known ways to separate racemate into isomers but no evidence that at the relevant time, a person skilled in the art would know which one would work with the specific racemate nor know before separating, what their properties would be. o Not routine, took long time to do procedure and used 5 methods. Process was long and arduous. Motive: nothing in the 875 patent provided a specific motivation for the skilled person to pursue the 777 invention. Company decided to develop the isomer and abandon work on racemate. Whether the invention of 777 patent was obvious to try? o Whether the patent was obvious? No bc they went down a completely different road before they steered to right direction. o Methods to obtain the invention of 777 patent were common general knowledge. o There was a motive to find a non toxic product to inhibit platelet aggregation. o However, not self evident from 875 patent or common general knowledge what the properties of the isomer would be o Course of conduct and time spent on advantages of the isomer wasnt quickly nor easily predictable. If it was, company would have opted for it before unnecessary time and investment were spent on the racemate. o Thus obviousness not justified.




Insert slides Rare that the 3 below attacks would be successful. All 3 must be accessed at standpoint of a person w/ a willing mind to understand in a nonambiguous way. No rigid standard of insufficiency

P a g e | 24 Ambiguity of disclosure is same as sufficiency Ambiguity of claims Validity can only be challenged when the patent has already been issued.

INSUFFICIENCY One of 3 technical attack on patent based on question of fact due to failure to meet reqt of s27(3). Disclosure doesnt properly explain to a person of skill in the art how to practice the invention. Application must give a full and correct description of the invention and its operation or use Patent will be insufficient when its disclosure doesnt properly explain to a person skilled in the art how to practice the invention s.27(3) states: (3) The specification of an invention must (a) correctly and fully describe the invention and its operation or use as contemplated by the inventor; (b) set out clearly the various steps in a process, or the method of constructing, making, compounding or using a machine, manufacture or composition of matter, in such full, clear, concise and exact terms as to enable any person skilled in the art or science to which it pertains, or with which it is most closely connected, to make, construct, compound or use it; (c) in the case of a machine, explain the principle of the machine and the best mode in which the inventor has contemplated the application of that principle; and (d) in the case of a process, explain the necessary sequence, if any, of the various steps, so as to distinguish the invention from other inventions. (4) The specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention for which an exclusive privilege or property is claimed. When analyzing the sufficiency of a patent, the specification must be read by a mind willing to understand, not by a mind desirous of misunderstanding, and should not be defeated on a mere technicality. Sufficiency must be assessed based on the content of the patent and not on date other than the patent. Consolboard v. MacMillan R: Ct held that the concluding words of [s.34(1)] does not oblige the inventor in his disclosure or claims to describe in what respect the invention is new or in what way it is useful. He must

P a g e | 25 say what it is he claims to have invented. He is not obliged to extol the effect or advantage of his discovery, if he describes his invention so as to produce it. The test is whether the specification adequately describes the invention for person skilled in the art, in the case of patents, a highly technical and scientific person.

Held: sufficient. AMBIGUITY Another technical attack Issue is whether the scope of the monopoly can be understood. A patent fails here when it doesnt properly describe the invention. Similar to sufficiency disclosure, the specification must be read by a mind willing to understand, not by one desirous of misunderstand, and should not be defeated on a mere technicality.

Letourneau v. Clearbrook Iron Works F: C claims patent is invalid bc the disclosure is ambiguous for failing to full and correctly describe the invention: lacking size of offset and lateral offset term is ambiguous w/ no certainty. L claims that the failure to refer to or define a term in the disclosure isnt sufficient reason to invalidate patent for ambiguity. Also, its expert didnt have trouble understanding the meaning of the claim or determining the offset. R: L wins. describes 2 kinds of ambiguity: ambiguity of disclosure (same test as sufficiency) describe invention define the way it is produced or built or how to ambiguity of claims Court can imply meaning and may rely on experts ambiguity of claims

put it into operation or use

By his claims, the inventor puts fences around the fields of his monopoly and warns the public against trespassing on his property The terms of a claim must be clear and precise and free of ambiguity so that the public will be able to know not only where it must not trespass, but also where it may safely go A claim is not invalid if not a model of concision Court must give a purposive construction without being too astute or technical If more than one possible construction favour the one that upholds the patent

P a g e | 26 The test: Application must disclose everything essential for the invention to function properly There are 2 conditions: 1) describe the invention and define the way its produced or built. 2) define the nature of the invention and describe how its put into operation. Failing 1) would invalidate the application bc of ambiguity. Failing 2) would invalidate for insufficiency. The description must enable a person skilled in the art or field of invention to produce it using the instructions contained in the disclosure. The specification must be read by a mind willing to understand, not by one desirous of misunderstand, and should not be defeated on a mere technicality. A claim is still valid even though its not a model of concision and lucidity. Few patents are. Claims are drafted to be understood by ppl w/ practical knowledge and experience in the specific filed in the invention. The ct must give a purposive construction to a claim w/o being too technical.

Held: evidence is shown that a person of ordinary skill in the art of construction safety and fall protection would understand the invention defined and is able to make and use the invention.

OVER BREADTH harder to fail than ambiguity and sufficiency (both always fail) 3rd technical attack Patent is overbroad when an invention claim is broader than the disclosure can support, i.e. it extends beyond the subject matter of the invention. The consideration which the patentee gives to the public disclosing his inventive idea entitles him in return to protection for an article which embodies his inventive idea but not for an article which, while capable of being used to carry his inventive idea into effect, is described in terms which cover things quite unrelated to his inventive idea, and which do not embody it at all. Inventor is not entitled to monopolize anything more than what he or she invented Claim cannot claim more protection than the discovery entitles Court cannot rewrite an overly broad claim due to broad drafting, Amfac Foods v. Irving Pulp & Paper F: A had a bath of water holding potatoes that are pumped up and fired thru a nozzle against a grid. The claim was not limited to the slabbing blade.

P a g e | 27 I: was the slabbing blade an essential feature of the invention? App tried to argue that the variance clause at the end of the disclosure permits variations form the invention described w/o affecting validity. R: where a claim is fatally defective, bc it fails to include an essential element disclosed in the specification, the defect cant be cured by characterizing it as a minor variance Held: the cutting and separation of the outside slabs are essential to the invention the claim goes beyond the invention disclosed. The importance of slabbing and separate removal of the undesirable outside cuts to get the long, uniform center cuts of potatos for fries is evident throughout the disclosure. The inventions major advantages are the slabbing blades and separation means which were not mentioned in the claim, thus the claim is broader than the invention disclosed and invalid. Infringement No definition of infringement in Patent Act Infringement is a question of mixed fact and law First, determine scope of claims (claim construction a question of law) Then, determine if the allegedly infringing device falls inside claim(s) a question of fact. 1 Construe the claim first w/o regard to validity or looking at the accused article. Claim construction remember: o Claim language has primacy: language of claim and read them in light to patent as a whole. Shall not look at abstract or title to construe a Cad patent. o Disclosure second: look for nuggets here, if meaning of the word isnt apparent in claim try disclosure. o **Claims, disclosures and drawing second read by a person skilled in the art. Can look at accused article to inform the court and yourself what the issue is, but state youre only looking at claim.

Patent Infringement Patent owner has exclusive rights make use or sell section 42 (making, using, constructing and using the invention and selling it to others). Monsanto

F: Canola resistant to pesticide, Monsanto has patent for the gene. PS found selling canola seed which possessed the gene. I: Did Percy Schmeiser use invention (gene)? H: Make: PS didnt make the gene although he was a plant cultivator. Ct didnt delve in that Use: Focus here.

P a g e | 28 Sell: Yes he did. Ct didnt deal with that either, even though he did. R: Analyzed what use means. SCC is willing to take an expansive view on patent protection. Purposive construction on the claim based on statute which is to protect commercial activity. So anything that deprives a defendant of its invention, the SCC will hold that its a use. Note: Patent act is about commercial activity fixated on biz and commercial value of things. Patent protection extends to situations where the patented invention is contained within something else used by the def. Note: pg 424: 7 propositions of use (use if use or possession is at issue) #2: broad proposition which wasnt stated in Patent Act. Although he didnt use the patent, he possessed it, so was deemed to have a use on it. This is a broad protection covering anything with commercial activity a patent that covers zipper making machines zippers will infringe even if zipper is not. Zipper monopoly expired, machine to make zipper has patent. Patent for machine, which commercial benefit includes selling zippers, thus monopoly is extended. o expansive doctrine

Defendant infringes a patent when the defendant makes or uses a patent part that is contained within something that is not patent, provided patented part is significant or important. E.g. Monsanto: selling a whole (oil from seeds or plants) which is not patentable but incorporated a patent technology thus patent infringement. o Hard to draw the line esp in below examples: lego blocks patented, building is not battleship built with infringing hammer infringe process patent for making saccharin sale of saccharin infringes defendants intention is irrelevant

Saccharin doctrine: patent on compound had expired but there was one on the process for making it. Def used the process and imported to UK. UK ct held that Saccharin is in public domain, using the process which is an infringement in a country that was an infringement is an infringement in UK. S.55(1) of PA: if theres a process claim, u dont have a monopoly on thing. If its a new item, the person is deemed to have used the process. Onus on def to prove they didnt use the patented process (reverse onus). machine contains a patented part but is never used and never intended to be use no infringement

P a g e | 29 Free World Trust UK: Catnik: def copies lentil but changes slightly, the claim requires it to be vertical. Ct looked at pith & substance of the invention, look at claim to find substantive infringement. US: is there literal infringement (No), if not is there substantive infringement (Y: does same thing with same result)? SCC rejected UK, and US approaches. Cad approach: Purposive construction: look at specification, drawings. paramountcy of claims: in attempting to strike a balance btw inventors contribution w/ public knowledge of the invention to make use of it and avoid infringement ct should still stick with the claim language. If you stick with claim, you will find that def that makes a minor change will avoid infringement since claims are paramount. To avoid this unfairness, ct held: Must construe the claims and decide which elements in claim are essential and which are not. What do all the words mean? Then make a list on which are essential. If you conclude that a claim is essential then there can be no variation, no substitution. If not essential, and def has substituted, there can still be infringement by a variant so long as the ct concludes that this variant does the same thing w/ the same result and not essential (e)(iii) Substitute w/ Essential no infringement Non essential but does not do same thing no infringement. Non essential but does same thing w/ same result infringement. Note: can look at the article but only to determine the infringing claim It would be unfair to allow a patent monopoly to be breached with impunity by a copycat device that simply switched bells and whistles to escape the literal claims of a patent determine essential and non-essential elements look at variant and ask questions at (iii) para 55 of FWT MOST IMPORTANT IS P426 PARA 31. Dont write anything about spirit of invention! if a variant of an aspect of a claim has no material effect on the way the invention works, there is a presumption that the patent is infringed and that the patentee intended that that variant falls within the scope of the claim

** Majority of infringement claims turn to claim construction. Remedies - Section 55 (1) and (2). - 2 stream of monetary: damages and accounting of profits - Patentee and anyone claiming under the patent can sue (licensees (implied), distributors of product, anyone related to the patentee). - Successful party may elect (based on equitable rights) between damages and an accounting of profits. Delay (e.g. in instituting case) may lead to denial of election very arbitrary though.

P a g e | 30 If election is refused, stuck with damages. Liability phase is separate from damage phase, theyre separate trials.

Damages compensate plaintiff for losses suffered by the plaintiff as a result of the infringement. Amount of profits earned by infringer is irrelevant. - Damages = lost profits or reasonable royalty (not both) - Plaintiff entitled to profits on the sales it would have made but for infringement. If cant prove sales, plaintiff entitled to reasonable royalty (accessed by ct as what the royalty would have been paid if parties were willing licensor and licensee.) 55(2); patentee can claim for compensation up to date patent was published (where world was on notice). Btw Publication and issuance, def pays royalties. When patent is issued def liable to pay profits. Accounting of profits aims to disgorge any profits improperly received by the defendant as a result of its wrongful use of the plaintiffs property (such profits having been earned through the use of plaintiffs property) Irrelevant that defendant could have taken steps to avoid the claims of the patent or obtained a license Apportionment generally not available to limit damages. Dont apportion in damages case, but on accounting side, you can apportion but is limited. Def argues that Pls loss would still have occurred due to non infringing alternative this has been rejected and also is no alternative. Accounting of profits: ct looks at benefits def got. Remember accounting is based on equity, so apportion is allowed. Accounting is more flexible than damages (where CL will apply).

Sale of a good made by an infringing machine goes to plaintiff Damage period starts from publication of patent (reasonable royalty) 3 approaches: differential profit, differential cost and full cost approach. Other remedies Injunction (temporary and permanent). Interlocutory injunctions are NEVER available for patents since patents are always compensable. 3 parts for interlocutory injunction (RJR): serious issues (patent usually meets this), irreparable harm (patent never meets this), balance of convenience. Perm inj are usual remedies at the end of trial. Court looks at equitable factors , there must be a good reason to refuse perm inj. Anton Pillar Order: civil search order, go to judge ex parte, must show all factors like serious issue and that def will likely destroy evidence if they know of your motion. Search order is broad, the person served has to comply with you, peace officers are called. This type of order is tightened, now require a lawyer to explain w/ def whats up.

P a g e | 31

Superior ct has inherent jurisdiction. Fed ct jury trial, deals w/ declared invalidity, to get injunction for province. Majority of cases occur here. If patent is declared invalid, that invalidity applies to the whole world. Findings of invalidity only applies btw parties.

PATENTED MEDICINES (NOTICE OF COMPLIANCE) REGULATIONS NOC address the issue of if cant get interlocutory injunction in pharmaceutical, a patent is pretty much worthless. Generic man required to get licence for any patents, royalty was 4% = no patent protection for pharm products. This led to most expensive generic drugs and the biggest generic rip offs in the world. In 1993 under intl pressure TRIPs provided relieve. To get health and safety approval, must get NOC. NOC takes many yrs to get. For generic drug wanted to launch in Cad, also need NOC, they have to prove that the active level of their drug is the same as a brand of another in Cad. These are much faster, hit the market in 3 mths A brand w/ NOC can take a patent and place it on linkage regulation. If NOC takes a patent and puts on min of health minister patent register, cant issue generic launch unless patent expires or generic challenges parent as invalid or their generic dont infringe. Brand has 45 days to start proceeding and prove unjustified claims. Brand gets a stay for 2 yrs where minister cant issue to generic a NOC. If you lose tho, brand is liable to pay for loss of profits of generic. Brand cant appeal. NOC cases are decided quickly, so read the cases w/ caution. Tend to side w/ generics.

Generic drugs and socialized medicines Compulsory licensing Offside TRIPs protect patents NAFTA agree to respect patents per TRIPs Patent gives 20 year monopoly Generic has to await expiry before using invention to make generic copy Takes 2 years to get generic approval Gives 22 year monopoly How do we ensure that generic gets on market at patent expiry?

P a g e | 32 PM(NOC) Regulations PM(NOC) Regulations == balance patent rights with timely entry Interplay with Patent Act and Federal Courts Act and Regulations 55.2 early working exception can infringe patent for purposes of regulatory workup BUT, can go on market with patent 55.2 early working exception but subject to PM(NOC) PMNOC Regs patent list submits relevant patents if generic applies for NOC, has two options 1. await expiry 2. serve NOA Practice Problems: 1. Read entire specification (disclosure and claims) 2. Construe claims o through eyes of skilled person as of filing date o purposive construction (Whirlpool; Free World Trust) 1. Patentable subject matter? 2. Consider various potential validity challenges 3. Determine whether patent infringes