Patents Summary Mgbeoji W2003, Osgoode General Patentability Criteria: a) Patentable Subject Matter (note that this depends on the country) b) Novel c) Inventive (i.e. unobvious) – this requirement is inferred from the s.2 definition of “invention” d) Useful (utility) a) Statutory Subject Matter (what is an invention?) 1 The main issue is the juridical definition of “invention” since it is broadly defined in the Patent Act and more importantly, which inventions are patentable Under statutory subject matter an invention must be both an invention and patentable The guidelines for determining whether an invention is patentable is found in the s.2 definition of “invention” and the s.27(8) limitation on patentable inventions S.2 – an “invention means any: o new and useful art, process, machine, manufacturer or composition of matter, or o any new and useful improvement in any art, process, machine, manufacture or composition of matter” s.27(8) – “patents are not available for mere scientific principles or abstract theorem” o this provision is hard to apply b/c it is difficult to delineate theorems from the products that exploit them but courts have rewarded applied science (a product, process) rather than theoretical ideas o furthermore, discoveries of the “laws of nature” are not patentable although both the US and Canada have similar definitions for patentable inventions they interpret the definition differently the US provision includes anyone who “discovers” and therefore more patents are given in the US than in Canada there is also a global standard for inventions and patentability that is stated in article 27 of the TRIPs agreement: o article 27: “patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step, and are capable of industrial application” “industrial application” is synonymous with the reproducibility of the process (therefore the invention must not be a fluke) o also in article 27 are exceptions to patentability: plants, animals, inventions that would endanger public order or morality diagnostic, therapeutic and surgical methods for the treatment of humans/animals inventions that are prejudicial to the environment, plant life or health, or human and animal life Thus from a combined reading of s.2, s.27(8) and article 27 there are two types of inventions, those that are patentable under s.2 and those that are not (s.27(8) and TRIPs article 27) Non-patentable inventions: o Discoveries of the “laws of nature” These claims are struck down on the argument that the discoverers of the laws of nature are not the inventors of the laws Patents Summary Mgbeoji 2 W2003, Osgoode EST and cDNA are from nature but are patentable under physical matter since they are composed of pure chemicals (Rothstein in Harvard Mouse) One anomaly is that Tungsten does not naturally occur in nature and yet the court refused to grant a patent for the product while granting a patent for the process to purify it (the court refused to grant a monopoly for policy reasons) Patents are granted for applied science, but not for science per se. E.g. Drug to treat diabetes – Can patent the actual drug w/o knowing how it works exactly. Then, find out how it works – That is just a discovery, not patentable. Can only file a new patent if drug has a separate use (i.e. based on applicability). o professional skills – Lawson v. Commissioner of Patents (subdivision of land into champagne glass shaped lots) Cattanach – professional skills are not patentable since they are not a manual art or skill and instead belong to the professional field. The subdivision of the land through an ingenious method is not a manufacture since it does not change the character of the land. Therefore in this case professional skills where not an art or manufacture that would be the subject matter of a patent. If this ratio is applied to other skills, methods of doing something that does not result in a vendible product, i.e. a scheme or plan, result by means of person’s interpretive or judgmental reasoning, i.e. own skill (Surgical methods – Different in the US) would be unpatentable o aggregations and combinations combinations (have a synergistic effect) may be patentable aggregations (maintain their separate effects) are unpatentable the distinction between aggregations and combinations is the important issue A combination (patentable) must compose of elements cooperating and interacting to give a novel, unified (Domtar), and non-obvious result (was it obvious to a person skilled in the art). o Domtar: The combination of integers or common and known elements must function cooperatively to achieve a new unitary result The unified result must be greater than the sum of the parts or the elements put together Lord Tomlin in British Celanese: o The mere placing of old integers so that each performs its own function independently of any others is not patentable (eg. Williams v. Nye - Sausage machine where two machines were just placed in tandem) o Where the old integers when placed together have some working interrelation producing a new or improved result (must be unobvious to someone skilled in the art), this combination is patentable subject mater o computer-related subject matter generally computer programs involving calculations are unpatentable Schlumberger Patents Summary Mgbeoji W2003, Osgoode o 3 The court equated the computer program to newly discovered mathematical formulae which cannot be patented b/c if done by humans they would purely mental and not the proper subject matter of a patent. (but there is a loop-hole - if the calculations could not be done by humans, would the program be patentable?) b/c of this restrictive approach and the loop-hole the Patent board has issued guidelines on computer-related subject matter: unapplied mathematical formulae are equivalent to mere scientific principles or abstract theorems and are unpatentable due to s.27(8) the use of a computer or computer program does not effect the patentability of the claim new and useful processes incorporating a computer program or an apparatus incorporating a computer program is only patentable if the computer-related subject matter falls within an area which is traditionally patentable medical procedures or methods of medical treatment (controversial) the problem is determining the boundary between medical products (patentable) and medical methods (unpatentable) Tennessee Eastman, Application for Patent of Wayne State University Tennessee Eastman (1970) Exchequer Ct of Can o Methods of medical treatment are not manual or productive arts nor, when applied to the human body, does it produce a result in relation to trade, commerce or industry or a result that is essentially economic (no economic utility). In this case the method (new use for surgical purposes of a known substance) lied in the professional field of surgery and medical treatment of the human body even though the method may be applied at times by persons not in that field. Tennessee Eastman (1974) SCC o Claim in Q was a surgical method using a particular (old) compound for bonding tissue. No limitation in method claim on the process by which compound was made. o Professional skill does not come under the PA o The court stated under s.41 that “the therapeutic use cannot be claimed by a process claim apart from the substance itself (if it was intended for food or medicine). S.41 is no longer part of the PA. As well, both methods of medical treatment and surgical treatment are not patentable “processes” and “inventions” under the Patent Act. Re Application for Patent of Wayne State University (1988) Patent Appeal Board and Commissioner of Patents o Here the court reversed the decision in Tennessee and said that the new use of a known medical compound may be entitled to patent protection and are separate from method of medical treatment claims which require professional skill and judgement and are thus unpatentable. The court further stated that the patent deals with an economic area related to trade (the sale of drugs) and thus has utility, which can be Patents Summary Mgbeoji 4 W2003, Osgoode distinguished from surgery which is non-economic and nontrade related. In the US patents are denied for the performance of a medical or surgical procedure on the body (s.287 and Pallin v. Singer) Diagnostic kits have been patentable (Re Goldenberg) Method of administering a vaccine was unpatentable (Re Ackerman) In Australia the courts have validated patents on medical procedures and said that processes for the cosmetic appearance of the body are patentable while processes for the treatment of disease are unpatentable (Joos v. Commissioner of Patents). The problem then becomes determining cosmetic appearance from disease (Bristol-Myers Squibb [2000] AIPC 91. In determining if a medical method is patentable: Think of the Claims o A method of treating diabetes comprising of administering and effective amount of insulin to a patient in need thereof. (NOT PATENTABLE). o A use of insulin in the treatment of diabetes. (PATENTABLE) Think of the Jurisdiction In the US, not caught up in semantics. Methods of medical treatment are patentable in the U.S. However, during Clinton era, the US has passed a law that inhibits the enforcement of method of medical treatment claims against physicians per se (obvious public concerns) Are Life Forms patentable? Until 1980 transgenic life forms were not juridical inventions Diamond v. Chakrabarty (US ) First product patent for a life form as all patents prior were given to processes utilizing life forms The man made life forms consisted of genetically modified bacteria (a new life form that was not naturally occuring) that could degrade oil The court stated that “manufacture” and “composition of matter” should be given a broad scope and the application for a non-naturally occurring manufacture of composition of matter that was a product of human ingenuity having a distinctive name, character and use Congress must determine the limits of patentability and not the courts Re Application of Abitibi Co. (1982) Can. – Chakrabarty comes to Canada The application in this case was for a product patent for a mixture of previously known strains of yeast that were acclimatized to digest sulfite from pulp plants The court stated that higher life forms such as yeasts will be patentable and other life forms that are produced en masse as chemical compounds in large quantities and that possess uniform properties and characteristics will be patentable The organisms created must not occur naturally and it must be sufficiently different from known species and thus possess inventive ingenuity, as well, it must also be useful In order to fulfil the “disclosure” requirement in the specification (s.36 now s.27) for life forms they must be deposited in a registry Patents Summary Mgbeoji 5 W2003, Osgoode S.36 (now s.27) requires that someone skilled in the art but be able to reproduce it Pioneer Hi-Bred v. Commissioner of Patents (1987) FCA The applicant created a new variety of soybean derived from artificial cross-breeding but cultivated naturally. The court stated that new plant varieties do not come within the meaning of s.2 under “manufacture” and “composition of matter” and cannot comply with s.27(3) regarding disclosure b/c too much luck was involved in it’s creation The court stated that the legislature left out plants from the Patent Act b/c they didn’t intend the PA to cover plant strains, varieties or hybrids Pioneer Hi-Bred v. Commissioner of Patents (1989) SCC The court distinguished hybridization in this case from transgenic intervention but rejected patentability on the failure of adequate disclosure under s.27(3) The cross-breeding was the only inventive work and since this procedure was not disclosed adequately (due to the element of luck involved in successful cross-breeding) the application is rejected The court cannot “stretch the scope of patent protection beyond the limits of existing legislation” on disclosures Harvard College v. Commissioner of Patents (2000) FCA Rothstein, Linden said that an oncomouse is unobvious, a new and useful composition of matter and thus an invention and the they did not go into the analysis of whether the oncomouse was a manufacture Ikechi says that Rothstein was wrong to equate the ingenuity of a product to its ingenious process of manufacture The commissioner rejected the patent by saying there where different criteria to apply to claims of higher life forms compared to lower life forms The commissioner said that in making the mouse there is no human interaction in it’s development and that “composition” and “manufacture” means that the mode is under the control of the inventor and is consistently reproducible The court said that transgenic unicellular material such as a fertilized mouse egg injected with an oncogene is a composition of matter since both the DNA and the fertilized egg are forms of matter The use of the laws of nature (breeding mice) do not invalidate a patent when it includes both the laws of nature and human ingenuity The fact that the mouse could occur naturally in nature does not negate the patentability of the oncomouse Usefullness includes control and reproducibility of the art/process (Organon) and the product (Oncomouse Fed). Usefulness requires control over the final product regarding the useful trait Commissioner of Patents v. Harvard College (2002) SCC Majority: The Patent Commissioner cannot refuse patents based on policy reasons (s.40) Patents Summary Mgbeoji 6 W2003, Osgoode The majority said that higher life forms are not a manufacture or composition of matter Lower life forms are compositions of matter and a manufacture b/c they can be produced in large numbers with uniform properties and characteristics The Patent Act does not include without limit “anything new and useful that is made by man” The definition of “invention” under s.2 of the Patent Act is exhaustive and is commonly understood to denote a nonliving mechanistic product or process Both cross-breeding and genetic manipulation result Patenting life forms would involve a radical departure from the traditional patent regime and clearer legislation is required on the matter The enactment of the Plant Breeder’s Right Act implies that a similar scheme should be in place for higher life forms to be patentable The court should not delineate the line of patentability between higher and lower life forms The fact that the Patent Act in its current state is ill-equipped to deal appropriately with higher life forms as patentable subject matter is an indication that Parliament never intended the definition of invention to extend to this type of subject matter CBAC – Canadian Biotech Advisory Committee Parliament and not the courts should determine whether and to what degree patent rights ought to extend to plants and animals This could lead to the commodification of human being which could not prevented by s.7 of the Charter since foetuses are not legal person Minority: The oncomouse should be patentable since the egg is patentable (the final product of the egg should be patentable) Human modification of the genetic material of the mouse is an inventive composition of matter under s.2 The Patent Commissioner cannot deny a patent b/c of public interest and s.40 of the Patent Act prevents these activities Canada should harmonize its IP laws with other countries which have granted patent to the oncomouse Patents should not be denied due to public policy b/c parliament did not include a clause in the Act stating that patents could be denied due to public policy The Patent Act is intended to promote R&D such as the oncomouse Patents help drive inventions in the Biotech sector The oncomouse creators did not merely “uncover” a naturally occurring oncomouse and the complexity of the genetic splicing did not “follow” the laws of nature Connaught – cell lines are patentable Patents Summary Mgbeoji W2003, Osgoode Burger from Chakrabartty: The proper distinction is not between the living and inanimate but between the discovery of a product of nature and human-made invention Both higher and lower life forms are compositions of matter (genetic material is chemical matter and mouse eggs are biological matter) If the mouse is not matter than what is it made of? How do you define higher life form? Animal rights can be protected by other acts Laws of nature of are a part of most inventions and shouldn’t deny patentability (eg. Drugs use natural processes yet are patentable) There should be a TRIPs balancing act (the benefit of mankind should outweigh the harm to animals and the uncontrolled dissemination of unwanted genes) Summary of the patentability of life forms in Canada Unicellular transgenic organisms are patentable Multi-cellular animal organisms are not Cell lines, and other genetic materials are patentable Transgenic algae and fungi are patentable From s.2 – inventiveness is determined by two concepts, novelty and inventive ingenuity b) Novelty 7 “Absolute novelty” in most countries – i.e. not publicly disclosed (e.g. a casual conversation), not already in the public domain, thus novelty requires that the subject of a patent application to be new in relation to similar products (this can be on a global, or national scale, in Canada the claimed invention must be novel on a global scale, in the US it must be novel in the US and not described in any written form outside the US) Test for absolute novelty s.28.2(1): No prior application pending describing the same invention No prior application of the same invention due to a convention filing date A 3rd party does not disclose to the public The applicant has up to one year after disclosure to the public (available to the public) to file the patent Available to the public The disclosure of the invention to one person nonconfidentially puts the invention in the public domain and unpatentable (Gibson) Anticipation becomes an issue when the invention is available to the public The principle of anticipation is related to novelty and will deny patentability of an invention on the basis that info/knowledge is part of the “prior art” or is available to the public Anticipation test (defence to infringement of the patent by claiming the patent is invalid due to anticipation or that the infringing patent is in the prior art and does not infringe – both arguments are the Gilette defence): Invalidating of patents through anticipation is done under s.34.1(1) after publication of the pending application “Prior art” consists of the body of knowledge in the specific field in issue ordinarily known and available to the average person working in Patents Summary Mgbeoji 8 W2003, Osgoode that relevant and specific field of knowledge and is thus narrower than the “public domain” An invention is anticipated if prior to the filing of the application, another patent, document and/or reliable information had previously described, embodied or put in public use that alleged invention Thus the idea expressed in the invention was already disclosed to persons skilled in that art (Beloit) and it is immaterial that the inventor is unaware of the prior description The claimed invention is an ingenious combination and not a mere aggregation of previously known components (Electro Sante) Does this include oral disclosure of the invention? The law is unsettled in this matter Tenneco Chemicals – oral disclosure will invalidate a patent on the grounds of anticipation Electro Sante – oral disclosure might not invalidate a patent on the grounds of anticipation Limits on anticipation: Mosaicism: Mosaicism, or the gathering of various references in order to compose a composite case of anticipation is not permitted to prove anticipation although it may be permitted in proving obviousness There must be a single document or invention that anticipates the invention Overall anticipation test from Baker Petrolite: The prior art or info disclosed to the public must: Give an exact description Give directions which will inevitably result in something within the claims Give clear and unmistakable directions Be contained in a single doc Give info equivalent to the subject patent Gives the reader of the doc what they wish Product containing invention is sold to any member of the public who is free to use it as they please An exact copy does not have to be disclosed to the public but the disclosed item must fall within the claim of the patent The Anticipation requirement to invalidate a patent is hard to fulfill Invalidating a patent under novelty due to “prior use” Prior use by public experimentation does not invalidate a patent (Gibney Motor) Mere sale or public use of black-box inventions will invalidate the patent (Risi Stone) The prior sale must also be an “enabling disclosure” for example, the purchaser must be able to discover the invention through analysis of the product although actual evidence of this is not necessary (Canwell v. Baker Electrolite) Patents Summary Mgbeoji W2003, Osgoode But - one-year grace period in the Canada and US for disclosures by the inventor (w.r. to filing) “On sale” bar in the US – more complicated than case in Canada. Simply offering to sell the invention (but not discussing it) can start the clock ticking. BL: Beware of timing. Most countries are on a “first-to-file” system – Canada is, but US is not. Baker Petrolite v. Canwell Enviro-Industries Ltd. (2002) FCA c) Inventive ingenuity (Inventiveness, test for unobviousness) The invention cannot be “obvious” – would a “person of ordinary skill in the art” be able to come up with the invention without “undue experimentation”? (also called wertuitel in Germany) – if yes – then there is no inventive ingenuity. Thus a patent must be both novel and unobvious Inventiveness is based on the obviousness test The obviousness test is in s.28.3 of Patent Act (added in 1993) 9 This test is very subjective and judge-based S.28.3 o The subject matter defined by a claim in an application must not have been obvious on the claim date to person skilled in the art or science to which it pertains, having regard to: Info disclosed >1 yr before the filing date or by a person who obtained knowledge, directly/indirectly, from the applicant in such a manner so that it is available to the public in Canada or elsewhere and Info disclosed before the claim date by a person not mentioned above so that the info is available to the public in Canada or elsewhere Public in the above means, “a specialized group of persons skilled in the relevant art or science and not the ordinary public” Factors the court consider in determining non-obviousness: o Is the alleged invention novel and superior to what was available until then o Has it been widely used in preference to alternate devices o Have competitors or experts in the field ever thought of anything like it o Did amazement follow its public disclosure o Was it a commercial success Irrelevant factors in determining non-obviousness: o The amount of effort the invention took o The invention was due to luck Overall test for obviousness (Beloit): o Whether a skilled but unimaginative technician would have come directly and w/o difficulty to the solution taught by the patent The difficulty is determining “mere improvements” on one end of the scale over “inventive spark or genius” After a patent is granted the onus is the person invalidating the patent to prove that the patent is obvious or lacks inventiveness The prior art is reviewed and its cumulative effect weighed Obviousness is not anticipation!!! Pioneering inventions are of the “inventive spark” kind and are easy to distinguish The judge must compare the patent application with the current state of the art and thus must make a judgment on the quantum of the inventiveness Patents Summary Mgbeoji W2003, Osgoode There can be inventive ingenuity in the discovery of a new use for an old compound Note the patent system must be liberal to encourage improvement e) Utility Test for utility (this test must be passed during the application process): The invention, at the date of the application, must perform or produce whatever is claimed as described in its specification. Furthermore, an invention has utility if someone skilled in the art could take the specification and construct the apparatus that would answer some beneficial purpose (X v. Commissioner of Patents). Limitations on operability must be disclosed in the claims (Monsanto) The applicant must disclose all info that will enable the invention to be put into effect. If this is in doubt the examiner can request that a model be submitted. The invention must solve the problem as stated in the specification. Inutility for the purpose of the patent will invalidate the patent. Utility means industrial value, “the invention gives either a new article, a or a better article, or a cheaper article, or affords the public a useful choice” (Consolboard). The patent cannot be for worthless art. The invention must be reducible to a workable artifice, or product, process or composition of matter (X v. Commissioner of Patents). The specification must enable a person skilled in the art to “make, construct, compound, or use the invention (X. v. Commissioner of Patents). In determining utility the entire specification must be read and construed with a view to determining what the whole of the patent would have meant to a skilled workperson as of the date the claims were filed (Hughes & Woodley). Commercial success will not automatically validate the utility of an invention. Conversely, future required modifications of the invention to ensure operability will not invalidate a patent if the invention worked on the claim date. Manufacturer preference as the sole reason for the patent will not satisfy the utility requirement (Mailman v. Gillette). Potential harmful devices will not necessarily be lacking in utility. A backward step in development may also pass the utility test. Specifications 10 Section 27(3) Patent Act contains two parts the, description and the claims S.27(3) the description/disclosure (enables construction and use of the patented device after the patent expires): 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; Patents Summary Mgbeoji W2003, Osgoode 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 s.27(4) the claims (the legal boundary of the monopoly): the specification must end with a claim or claims defining distinctly and in explicit terms the subject-matter of the invention from other inventions Although the patentee must disclose a description of the invention they don’t have to disclose the inventive genius (Consolboard) The origin of the specification can be traced back to Lord Mansfield comments in Liardet v. Johnson (1778) where he said that the, “specifications must be detailed, specific and technical in such a manner as would enable a person skilled in the art to replicate, make or create the invention” The description (general comments): Must describe the invention and its operation or use as contemplated by the inventor Must be clear and accurate, and should be as simple, direct, and free from obscurity and ambiguity as possible Is addressed to persons skilled in the art or science to which the invention pertains, and must be so written that those persons would be able to put the invention to the same successful use as had the inventor (i.e. must be complete enough) – Does not mean that invention has to be used b/f you file for a patent The court’s construction of the Description/disclosure The court views the disclosures from the intellectual perspective of the person skilled in the relevant art (Electro Sante) Outside or extrinsic evidence is not consulted during the process although technical vocabulary and expert evidence may be used to explain the terms of the disclosure Disclosures that inadequately describe the invention by requiring the person skilled in the art to unduly experiment with the invention to achieve the described result will invalidate a patent due to Insufficiency An honest put potentially misleading statement may not invalidate a patent if it would not have misled a person skilled in the art The court must be fair to both the inventor and the public (Consolboard v. Macmillan) Disclosure and biotechnology (s.38(1)) “when the invention is a composition of matter, the applicant, if required by the Commissioner, shal furnish specimens of the ingredients, and of the composition, sufficient in quantity for the purpose of experiment “Best Mode” disclosure: “best mode” is referenced to the claims and the state of the art at the claimed date The “Bargain” justification for disclosure through the specification – Disclosure of invention to public for monopoly type right to the inventor Often referred to as the quid pro quo of patents In exchange for the inventor’s full disclosure of the invention, the inventor is given an exclusive right to prevent others from making, selling, or using the invention for a fixed term (i.e. a monopoly) Lamer J., Pioneer Hi-Bred (1989), SCC 11 Patents Summary Mgbeoji W2003, Osgoode “The inventor must, in return for the grant of a patent, give to the public an adequate description of the invention with 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 the period of the monopoly has expired.” Infringement of Patents After a patent is issued there is a presumption that the patent is valid (s.43(2)) A patent is infringed when anyone, w/o the permission of the patentee, “makes”, or “constructs” or “uses” or “sells” the patented invention (s.42) Patent infringement suits can be brought in the jurisdiction in which the infringement is said to have occurred (s.54) The patent infringer is liable to the patentee for “all damages sustained by the patentee, by reason of the infringement” (s.55) There is a 6 yr limitation, from the time of the infringing act, to bring an action of infringement (s.55.01) The court can issue equitable injunctions restraining the infringer from further use, manufacture or sale s.57(1) Infringement does not require intention Other remedies include “inspection” and “accounting” of the proceeds of infringement The Claims are the basis of determining infringement Since the claims define the legal monopoly they are usually drafted in broad terms to catch all potential infringers (eg. In Harvard mouse the claim covers all non-human animals but the actual product is a mouse) Claim construction (question of law) and whether the infringer’s actions (question of fact) fall under the scope of the claims are the major factors in determining patent infringement US approach to claim construction and infringement: o The claim construction method is called the “doctrine of equivalents” and infringement involves “taking the pith and marrow” and leaving aside “useless embodiments” of the invention o This method hinges on determining the essential elements of the invention and whether the potential infringer has appropriated these elements regardless of the description and claims of the infringing invention (thus the substance of the claim is infringed where the offending article is the equivalent of the original) o Equivalence is determined at the time of infringment o This method has been adopted previously in Canada in McPhar: Here the defendant achieved the same result in the infringing invention by changing a non-essential element of the original invention and thus took the “substance” of the invention The infringing patentee can only rely on the doctrine of equivalence defence if the equivalent elements are non-essential to their invention Canadian purposive approach 12 The Canadian purposive approach to claim construction and infringement (the same test is used in validity – Whirlpool) Patents Summary o o o o o o o o o Mgbeoji W2003, Osgoode In Canada, the claims define the legal boundary of the state-conferred monopoly rather than the substance The starting point of this approach is to determine the words/phrases in the claim that describe what the inventor considers to be essential elements of the invention (Whirlpool v. Canco) These words/phrases are then construed to determine their intended meanings by the inventor which can lead to either a pro-patentee or pro-infringer construction (Whirlpool) This can also lead to either an expansion or constriction of the literal text in the claim (Whirlpool) Unlike the US however outside or extrinsic evidence is not allowed in determining the meaning of the claims or the intent of the patentee This leads to a determination of the essential and non-essential elements of the claim which the court then uses to determine infringement (Free World) The essentiality (substitutability) of elements can also be determined by reference to a person skilled in the art after reading the application (Free World) Non-essential elements are substitutable leading to possible infringement by the defendant patentee while substitution of an essential element will the take the offending patent outside of the scope of the patent and thus there is no infringement The purposive approach to claim construction however, is also tempered by the predictability requirement which ties the patentee to their claims and, by fairness, by interpreting the claims in an informed and purposive way (Free World) Innocent infringement and intent of the infringer Genetic patents challenge the traditional notion of infringement since infringement can be due to the forces of nature Monsanto v. Schmeiser (2001) FCC o A person may be liable for patent infringement even where genetic pollution or promiscuity lead to the infringement and was beyond the control of the alleged infringer Inducing infringement This occurs when a person does something that leads another person to directly infringe a patent. In Windsurfing the court stated that a party (non-patent holder) is guilty of procurement to infringe when they sell a patented invention that can be assembled by the purchaser to create the patented invention.—see also Beloit Defences to Infringement 13 Bona fide experimental use (see Gibney above) S.56 defense o An invention acquired prior to the Canadian or other previously filed application for the same invention does not infringe o Merck v. Apotex (1995) FCA The court in this case looked at the definition of “specific article” in s.56 Patents Summary Mgbeoji W2003, Osgoode “Specific article: has broad meaning and the court must look to the purpose and utility of the patent in granting immunity. A patent in a different form but with the same original purpose will still be granted immunity under s.56 if acquired prior to the application date. A change in the form of the patented product after granting its immunity under s.56 will not invalidate immunity if the purpose of the product is not changed. The original patent is invalid due to: o Known in the prior art by being anticipated or obvious o Non-patentable subject matter (see above) o Non-utility (see above) o Novelty (see above) Remedies for Infringement Accounting for Profit Beloit v. Valmet court always has jurisdiction to award the equitable remedy of accounting of profits. Section 57.1 B of the Patent Act and the Federal Court Act explicitly grant this authority. The accounting of profits is a discretionary remedy--delay, misconduct, etc. may prevent accounting from being awarded. In this case, patent validity was litigated, patent held invalid at trial, defendant entered into profitable contracts after trial, plaintiff appealed successfully--defendant must compensate plaintiff for infringement, but accounting for profits not granted. Accounting Discretionary, but Only Witheld for Good Reason Merck v. Apotex granting of remedy of accounting of profits is not automatic, but there's no reason to deny the request of successful plaintiff ( where the plaintiff has elected for profits rather than damages-- a bifurcation order) While accounting of profits is discretionary, if it is sought as is a remedy for patent infringement is ordinarily awarded unless there be circumstances that would warrant withholding it from a successful plaintiff. Note defendants argued that profits from their efficiency not infringement--This was held irrelevant. Also long length of prosecution of the patent-- 11 years--was not sufficient to warrant refusing election for profits rather than damages Interlocutory Injunctions for Patent Infringement Proctor and Gamble v. Nabisco -interlocutory injunction available when damages at the common law would not be an adequate remedy--for example, irreparable harm to the plaintiff, defendant would be unable to pay damages after trial 14 -historically, interlocutory injunction to restrain infringement would not be granted if the defendant also was attacking the validity of the patent. --But now, the granting of a patent provides good reason for supposing the patent to be valid, rendering obsolete the former Patents Summary Mgbeoji W2003, Osgoode regarding interlocutory injunctions in actions for infringements--no special rules anymore for injunctions regarding patent infringement, now it’s the same as other interlocutory injunctions 15