PATC Module 2 – Infringement/Validity Obviousness

Obviousness What is Obviousness?

What is Obviousness? by a Court in patent litigation…” “One of the most difficult issues faced by a Court in patent litigation…” per Hughes J. in Novartis Pharmaceuticals Canada Inc. v Cobalt Pharmaceuticals Company, 2013 FC 985

Obviousness What is Obviousness?

Obviousness What is Invention?

Invention & Obviousness “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;

Invention & Obviousness Patent monopoly can only be given for an “invention” So “inventiveness” is implicit from definition of “invention” (third “requirement” for patentability)

Obviousness: Lack of Invention What is Obviousness? The absence of invention or “inventive ingenuity”

Inventiveness & Obviousness “To constitute invention it is not enough to disclose something that has been but dimly seen before. There must be ingenuity of invention” [Electrolytic Zinc Process Co. v. French's Complex Ore Reduction Co. of Canada Ltd., [1927] Ex. C.R. 94]

Inventiveness

Inventiveness Courts try to understand inventiveness “The Robot Curve” [84]           During the hearing of this matter, I drew Counsels’ attention to an article published in the October 2015, issue of Canadian Lawyer magazine.   The article, written by Kate Simpson entitled “Swimming Uphill on the Robot Curve: 5 lessons” at pages 28 and 29, reproduces a schematic prepared by Marty Neumeier, of Liquid Agency.  That schematic illustrates various stages of work descending from creative, to skilled, to rote, to robotic.” Amgen Canada Inc. v. Apotex Inc., 2015 FC 1261

Inventiveness

Inventiveness & Obviousness Inventiveness must be reflected by the patent claims (Each) claim must define subject matter that is inventive or “unobvious” in view of the prior art

Inventiveness Manifested Pioneer Patent Improvement Patents Combination (as opposed to mere aggregation) New Use for an old article or compound Selection Patents

Inventiveness Manifested Pioneer Patent Break new ground – “game changer” Telegraph (Marconi) Telephone (Bell) Insulin (Banting/Best) - (new chemical entities)

Inventiveness Manifested Improvement Patents An invention that changes or adds something to a known article so as to eliminate a disadvantage; or enables it to work better. An improvement patent is confined to the “improvement” and does not confer a new monopoly in the original article

Inventiveness Manifested Improvement Patents - Whirlpool One piece agitator machines (old) Dual action (two piece) agitator (CA 1045401)

Inventiveness Manifested Improvement Patents - Whirlpool Dual action (two piece) agitator Add drive means (CA 1049803)

Inventiveness Manifested Improvement Patents - Whirlpool Dual action agitator + drive means Replace rigid vanes with flex vanes (CA 1095734)

Combination vs Aggregation (Patentable) Combination Elements that combine to produce a new, unitary result (Unpatentable) Aggregation Mere juxtaposition of parts – One or more elements produces an independent result without combining to produce a common result

Combination vs Aggregation Patent for a pliable edge protector used to protect car door edges

Combination vs Aggregation Patent for a pliable edge protector used to protect car door edges A pliable edge protector comprising: an elongated extruded channelar member formed of pliable material, said extruded channelar member having a bight portion and a pair of spaced-apart flange portions projecting therefrom to form an interior throat therebetween; (b) a decorative elongated strip of thin material, said decorative elongated strip having two major surfaces and two minor edge surfaces extending along the length of the decorative strip, one of said major surfaces covering the exterior surface of said extruded channelar member and extending over the projecting ends of said flange portions to thereby dispose said minor edge surfaces within said interior throat; and (c) adhesive means disposed on the interior surface of said channelar member, said adhesive means being adapted to adhere to an edge inserted through the throat and into contact with said bight portion.

Combination vs Aggregation “In my opinion the elements I have above outlined perform essential independent functions. They do not collate to produce a new but common result. If any one of them were removed, the others, to my mind, would continue to perform their own individual function. There is here an aggregation, not a combination.” [Domtar Ltd. v. MacMillan Bloedel Packaging Ltd. et al (1977), 33 C.P.R. (2d) 182]. “… The U-shaped moulding continues to be a means of covering an edge. The more pliable it is the more easily it follows the contours of the edge. The decorative layer continues to decorate, and the 'wrap-around' feature of it continues to protect it. The adhesive inside continues to attach one object to another. While there was some suggestion in evidence and argument of the advantage of the closed throat in keeping glue from drying before installation, and of the combined effect of the shape of the moulding, the wrap-around feature and the glue in keeping out water after installation,these advantages are not claimed by the patent.” [Crila Plastic Industries Ltd. v. Ninety-Eight Plastic Trim Ltd., 18 C.P.R. (3d) 1]

Combination vs Aggregation

Combination vs Aggregation

Combination vs Aggregation “…it matters not, therefore,…the elements thereof are old and were already known in the art as separate entities. As was pointed out by this Court in Baldwin International Radio Co. of Canada Ltd. v. Western Electric Co. Inc. et al 32, "On this branch of the case, viz.: anticipation, the only point is whether the actual combination is new" … "It is idle to repeat that anticipation is not established by what may be qualified the 'imaginary assemblage' of separate elements gathered from glosses selected here and there in several and distinct anterior specifications."

Combination vs Aggregation “The invention lies in the particular combination, provided it is not a mere aggregation or a juxtaposition of known contrivances….”

Combination vs Aggregation “We have here a group of co-acting parts achieving a combined result or, as was said in British United Shoe Machinery Company Ltd. v. A. Fussell & Sons Ltd. 33, “ a collocation of intercommunicating parts so as to arrive at (what may be called) a simple and not a complex result." As was found in the Baldwin case supra, that satisfies the definition of a combination for the purposes of the patent law.” R. v. Uhlemann Optical Co., [1952] 1 S.C.R. 143

Inventiveness Manifested?

New Use for old article Example: Shell Oil Co. v. Commissioner of Patents, [1982] 2 S.C.R. 536: Invention: Known compounds (ethane-sulphinic acids) are useful as plant growth regulators Claim: Compounds diluted with an adjuvant

New Use for old article “…As Lord Cozens-Hardy put it:[ in Hickton’s Patent ] When once the idea of applying some well-known thing for a special and new purpose is stated, it may be very obvious how to give effect to that idea, and yet none the less is that a good subject-matter for a Patent. In my view, this is the thrust of the appellant’s appeal to this Court. It says: “I recognize that these compounds are old; I acknowledge that there is nothing inventive in mixing them with these adjuvants once their properties as plant growth regulators have been discovered; but I have discovered these properties in those old compounds and I want a patent on the practical embodiment of my invention”. I think he is entitled to receive it.”

Selection Patents SCC case (Apotex v Sanofi-Synthelabo) Selection patents are acceptable in principle, but are treated like any other patent – no unique grounds of invalidity Selection patent must be preceded by prior patent (genus or originating patent) from which selection is made [also see Lundbeck Canada Inc. v. Canada (Minister of Health), 2010 FCA 320]

Selection Patents Pfizer Canada Inc. v. Canada (Minister of Health), 2006 FCA 214 There are two general classes of chemical patents. The first is the “originating patent” where there is an originating invention involving the discovery of a new reaction or a new compound. The second is the “selection patent”, which is based on a selection from related compounds derived from the original compound and which have been described in general terms and claimed in the originating patent (see In re I.G. Farbenindustrie A.G.’s Patents (1930), 47 R.P.C. 283 (Ch. D.), at page 321, per Maugham J.).

Selection Patents: Genus

Selection

Selection Patents Pfizer Canada Inc. v. Canada (Minister of Health), 2006 FCA 214 at para. 5: “Selection patents exist to encourage researchers to further use their inventive skills so as to discover new advantages for compounds within the known class. A selection patent can be claimed for a selection from a class of thousands or for a selection of one out of two (see for example I.G. Farbenindustrie, at page 323 and E.I. Du Pont de Nemours & Co (Witsiepe’s) Application, [1982] F.S.R. 303 (H.L.), at page 310).”

Selection Patents To be valid, the selection must be based on a substantial advantage that is obtained by the use of selected members of the class. Advantage must be possessed by all members of the selected class Selection must pertain to a quality or special characteristic that is distinctive of the selected group [Pfizer Canada Inc v Minister of Health, 2006 FC 220].

Selection Patents Issue will be whether, on the facts, the selection has been anticipated If genus patent does not disclose the special advantages of the selection patent, the genus patent does not anticipate the selection patent Prior genus patent must provide enough information to allow a person skilled in the art to perform or make the claimed selection without “undue burden”. 

Selection Patents Selection patent must highlight special feature of selected group Unique advantage must be described

Selection Patents [75]           In Alcon Canada Inc v Apotex Inc, 2014 FC 699 (CanLII) at para 146, 459 FTR 255, the Court held that one of the hallmarks of a selection patent is a clear statement of the premise of the special advantages of the selected compounds over the genus. [76]           The central failing in respect of this part of the selection patent analysis is that there is no singling out of Cinacalcet as a selection invention. The 879 Patent does not describe any special advantages of Cinacalcet nor of any of the other compounds of the alleged selection patent. A single reference to Cinacalcet’s activity in a table that lists 61 other compounds is insufficient, absent something more, to meet this requirement of special advantage. Nothing stands out from this single reference. [Amgen Canada Inc. v. Mylan Pharmaceuticals ULC., 2015 FC 1244]

Invention vs. Discovery There is no inventiveness in: - discovering the properties of a naturally occurring property (e.g. just making a scientific observation) [see Hercules Inc. v Canada, 4 C.P.R. (3d) 289]

Invention vs. Discovery There is no inventiveness in: - discovering or verifying an inherent property of a known article, esp. through routine testing [e.g. Riello Canada Inc. v Lambert, 9 C.P.R. (3d) 324]

Invention vs. Discovery Some “discoveries” may be inventive, (i.e. new use for old compound) [Shell Oil Co. v Canada (Commissioner of Patents), 67 C.P.R. (2d) 1] But there must be inventiveness in reducing it to practice

Obviousness = No Inventiveness (Lack of Inventive Ingenuity) (Back to) Obviousness Obviousness = No Inventiveness (Lack of Inventive Ingenuity)

Obviousness is a question of mixed fact and law (Back to) Obviousness Obviousness is a question of mixed fact and law [i.e. Cobalt Pharmaceuticals Company v. Bayer Inc., 2015 FCA 116]

Obviousness: Basis under Old Act “judge-made” doctrine – derived from concept [& statutory definition] of “invention”

Doctrine developed from UK case law and adopted by Canadian courts Obviousness Doctrine developed from UK case law and adopted by Canadian courts [e.g. Crosley Radio Corp. v. Canadian General Electric Co., [1936] S.C.R. 551; R. v. Uhlemann Optical Co., [1952] 1 S.C.R. 143; Burns & Russell of Canada Ltd. v Day and Campbell Limited, [1966] Ex C.R. 673]

Obviousness (Old Act) Assessed as of “date of invention” Presumed to be priority date/first filing, unless patentee proves earlier date

Obviousness: New Act New Act: codifies the common law doctrine statutory basis for requirement of non- obviousness set out in s.28.3 Relevant date for determination of obviousness is the claim date [s.28.1]

New Act: s 28.3, Patent Act, R.S., c. P-4, c.1 28.3 The subject-matter defined by a claim in an application for a patent in Canada must be subject-matter that would not have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to: (a) information disclosed 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 information became available to the public in Canada or elsewhere; and (b) information disclosed before the claim date by a person not mentioned in paragraph (a) in such a manner that the information became available to the public in Canada or elsewhere.

Claim Date: Reference Date for obviousness 28.1 (1) The date of a claim in an application for a patent in Canada (the "pending application") is the filing date of the application, unless: (a) the pending application is filed by: (i) a person who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for Canada an application for a patent disclosing the subject-matter defined by the claim, or (ii) a person who is entitled to protection under the terms of any treaty or convention relating to patents to which Canada is a party and who has, or whose agent, legal representative or predecessor in title has, previously regularly filed in or for any other country that by treaty, convention or law affords similar protection to citizens of defined by the claim;

Claim Date: Reference Date for obviousness (b) the filing date of the pending application is within twelve months after the filing date of the previously regularly filed application; and (c) the applicant has made a request for priority on the basis of the previously regularly filed application. (2) In the circumstances described in paragraphs (1)(a) to (c), the claim date is the filing date of the previously regularly filed application. [Potentially different dates for different claims: multiple priority claims]

Obviousness: Skilled Person Obviousness is assessed from standpoint of “skilled person” AKA “Person of skill in the art”

Obviousness: Skilled Person Who is “skilled person”? Addressee of specification Fictional person- May be a composite of people, in terms of knowledge and skills, or a team of people

Obviousness: Skilled Person “Skilled person” will be assumed to be aware of common general knowledge in the art “The person to whom the invention is said to be obvious is the person skilled in the art, armed with the common general knowledge of such a person. That common general knowledge may include knowledge of particular patents which are sufficiently well known to have passed into general knowledge but does not include knowledge of all patents in the domain of the invention, even though these are considered to be public knowledge. General Tire & Rubber Company v. Firestone Tyre and Rubber Company Ltd (1972), 17 R.P.C. 457 (C.A.) at 482.” [Illinois Tool Works Inc. et al. v. ITW Canada Holdings Company, 2002 FCT 829:]

Obviousness: Skilled Person What field, skill set for the addressee? Will understand as a practical matter the problem to be overcome, how different remedial devices work, and the likely effect of using them No inventiveness, but deductive Understands the art in the field and will keep up

Obviousness: Skilled Person Inventor’s own skills, experience, inventiveness are not relevant [e.g. Certainfeed Corporation v. Commissioner of Patents, 2006 FC 436] But work done (or record of it) may be

Obviousness: Skilled Person Skilled person is knowledgeable, but lacking in ingenuity and creativity Limited capacity to test or experiment

Prior Art Available for Attack Worldwide art is eligible Patents Publications Prior public uses/sales Common general knowledge in the art (CGA) (Or some combination of the above)

Prior Art Available for Attack Individual references must be those that would have come to the attention of the skilled person at the relevant time Skilled person not presumed to know about everything in public domain – not expected to find obscure or unrelated subject matter references

Prior Art Available for Attack Tendency to view common general knowledge as pieces of prior art, but is really used as a skill set in understanding and extrapolating from specific prior patents, art, etc.

Mosaic of Prior Art Permissible Mosaicing References may be combined (“mosaiced”) (Differs from anticipation, where all elements must be found in one reference)

Mosaic of Prior Art Not enough for reference just to be published – s. 28.3 does not overrule old law [Novartis Pharmaceuticals Canada Inc. v Teva Canada Limited, 2015 FC 770 @paras 51-54]

Mosaic of Prior Art Combination must be plausible References that skilled person could find by means of a diligent search will be relevant [e.g. AB Hassle et al. v. Genpharm Inc. et al. 2003 FC 1443]

Mosaic of Prior Art Permissible Mosaicing Objective test used to decide whether skilled person “could be reasonably expected” to know about prior art reference [Cochlear Corp. v. Cosem Neurostim Ltee., 64 C.P.R. (3d) 10]

Prior Art Available for Attack Permissible Mosaicing Mosaic with the benefit of hindsight will be rejected

Obviousness: Classical Test Obviousness is an objective test Reference point is the fictional “skilled person”

Obviousness: Classical Test Inventiveness is presumed to be present, by reason of presumption of validity that attaches to a patent (s.43) [Apotex Inc. v. Syntex Pharmaceuticals International Ltd., (1999), 1 C.P.R. (4th) 22 (FC)]

Obviousness: Classical Test Low threshold for patentability – a“scintilla of invention” will suffice [Tye-Sil Corp. Ltd. v. Diversified Products Corp. (1991), 35 C.P.R. (3d) 350 (FCA)]

Obviousness: Classical Test Since only a “scintilla” of ingenuity is needed, expert evidence that the invention is obvious “given with the benefit of hindsight must be treated with extreme care” [e.g. Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2002), 22 C.P.R. (4th) 466; Beloit; Tye-Sil]

Obviousness: Classical Test Test is very stringent [skilled person]would arrive “directly and without difficulty to the solution taught by the patent” Precludes any need for experimentation No “worth a try” doctrine of obviousness

“Worth a try”/Cripps Question Derived from UK law Traditionally, has not applied in Canada because of deemed limitations in the skills and intuitive ability of the skilled person

Obviousness: Worth a Try (old approach) Pfizer Canada Inc. et al. v. Apotex Inc. et al. (2002), 22 C.P.R. (4th) 466 In Bayer, Mr. Justice Lederman wrote at pages 80 and 81: There appears, however, to be a significant difference in the abilities of the English hypothetical skilled technician and the Canadian one. Indeed, making inquiries or testing, seems to be something outside the ken of the notional Canadian skilled technician. In Cabot Corp. v. 318602 Ontario Ltd. (1988), 20 C.P.R. (3d) 132 at p. 146, 19 C.I.P.R. 204, 9 A.C.W.S. (3d) 317 (F.C.T.D.), Rouleau J. quoted H.G. Fox inCanadian Law and Practice Relating to Letters Patent for Inventions at pp. 70-1, as stating in part: "In order that a thing shall be 'obvious', it must be something that would directly occur to someone who was searching for something novel, a new manufacture, or whatever it might be, without the necessity of his having to do any experimenting or serious thought, or research, whether the research be in the laboratory or amongst literature." (My emphasis.)

Obviousness: Classical Test The modified “Cripps Test” was enunciated by the Federal Court of Appeal in Beecham Canada Ltd. v. Procter & Gamble Co. (1982), 61 C.P.R. (2d) 1 @ p. 27: “The question to be answered is whether at the date of the invention ... an unimaginative skilled technician, in light of his general knowledge and the literature and information on the subject available to him on that date, would have been led directly and without difficulty to the ... invention.”

Obviousness: Classical Test Beloit Test (most oft-cited statement of obviousness test): “The test of obviousness is not to ask what competent inventors did or would have done to solve the problem. Inventors are by definition inventive. The classical touchstone for obviousness is the technician skilled in the art but having no scintilla of inventiveness or imagination; a paragon of deduction and dexterity, wholly devoid of intuition; a triumph of the left hemisphere over the right. The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) 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. It is a very difficult test to satisfy.” Beloit Canada Ltd. et al.  v. Valmet OY (1986), 8 C.P.R. (3d) 289 (F.C.A.) at page 294

Obviousness Revisited: Sanofi case SCC has revisited test for obviousness (Apotex Inc. v. Sanofi‑Synthelabo Canada Inc., 2008 SCC 61) “Obviousness is largely concerned with how a skilled worker would have acted in the light of the prior art”.

Obviousness Revisited: Sanofi test New Approach (4 - step) (1)   (a)  Identify the notional “person skilled in the art”; (b)  Identify the relevant common general knowledge of that person;

Obviousness Revisited: Sanofi test New Approach (4 - step) (2)  Identify the inventive concept of the claim in question or if that cannot readily be done, construe it; -look to teaching of entire specification to discern “inventive concept” [Allergan Inc. v. Canada (Minister of Health), 2012 FCA 308]

Obviousness Revisited New Approach (4 step) (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;

Obviousness Revisited New Approach (4 step) (4)      Viewed without 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?

Obviousness Revisited In Sanofi, SCC has now said it “may be appropriate”(in some cases) to ask whether something was “obvious to try”?

Obvious to Try When Is the “Obvious To Try” Test Appropriate? - in areas where advances are often made by experimentation (e.g. pharma) -may not apply in mechanical cases [e.g. Uview Ultraviolet Systems Inc. v Brasscorp Ltd., 2009 FC 58]

Obvious To Try If “obvious to try” approach is appropriate, it is still only one factor in overall obviousness analysis Will come into play at step 4 of Sanofi analysis “Viewed without 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?”

Obvious To Try Relevant Factors (1)  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?  

Obvious to Try (2) 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 would not be considered routine?  

Obvious to Try (3) Is there a motive provided in the prior art to find the solution the patent addresses? (4) What is the course of conduct which was followed which culminated in the making of the invention?

Obvious to Try To show that something is “obvious to try” (and thus obvious), there must be evidence to convince a judge, on a balance of probabilities,that it was more or less self‑evident to try Mere possibility that something might turn up will not be enough

Obviousness Revisited History of Invention may also be relevant with new approach Although obviousness is an objective test, what inventors did may be relevant, esp. if their skill sets are similar to those of person

Obviousness Revisited If inventor reached the invention quickly, easily, directly and relatively inexpensively, in light of the prior art and common general knowledge, that may be evidence supporting a finding of obviousness, *unless*…

Obviousness Revisited ….the level at which they work and their knowledge base was above that of the notional “skilled person”. Suggests that a skilled person, using his/her common general knowledge and would have acted similarly and come up with the same result.

Obviousness Revisited If time, money and effort was expended unsuccessfully by inventor or others, this tends to suggest non-obviousness – skilled person would likely do no better

Obviousness Revisited From: Gilead Science Inc. v. Canada (Health), 2013 FC 1270: [35]          The strength of the ability to predict success is the lynchpin to an obvious to try analysis and not necessarily whether the means or methods employed to arrive at the result were well-known.  This point was recently emphasized by Pelletier J. A. in the following passage from Apotex Inc. v Sanofi-Aventis, 2013 FCA 186 (CanLII), [2013] FCJ No 856: 78  As a result, the Trial Judge found himself in exactly the same position as did the Supreme Court when it decided Plavix, cited above. The focus of the obviousness analysis in Plavix was not the difficulty in seperating [sic] the racemates covered by the '875 genus Patent - which included PCR 4099 - but the unknown properties of the resulting enantiomers. :  

Obviousness Revisited ..The method to obtain the invention of the '777 patent were common general knowledge. It can be assumed that there was a motive to find a non-toxic efficacious product to inhibit platelet aggregation in the blood. However, it was not self-evident from the '875 patent or common general knowledge what the properties would be and therefore that what was being tried ought to work.   Plavix, cited above, at paragraph 92

Obviousness Revisited 79        The reasons of the Trial Judge make it clear that, as was the case in Plavix, it was not possible to predict the properties of the separated enantiomers: Reasons, at paragraphs 673 and 676. The lack of knowledge as to these properties is precisely what led the Supreme Court in Plavix, cited above, to hold that it was not self-evident that what was being tried ought to work (Plavx [sic], at paragraph 92, quoted above). Simply put, the person skilled in the art would not think of separating PCR 4099 and testing its enantiomers in order to obtain the benefit of its properties when the existence and nature of those properties were unknown.  

Obviousness Revisited Also see: Novartis Pharmaceuticals Canada Inc. v Teva Canada Limited., 2013 FC 303; Novartis Pharmaceuticals Canada Inc. v Cobalt Pharmaceticals, 2013 FC 985 MedImmune Ltd. v Novartis Pharmaceuticals UK, [2012] EWCA Civ 1234  

Obviousness Revisited Obviousness analysis is contextual, flexible and pragmatic “[47] Sanofi-Synthelabo did not mandate the above test in every case, but held that it would be “useful in an obviousness inquiry”. Strict rules are inappropriate, since obviousness is a factual determination: Sanofi-Synthelabo at paragraphs 63 and 67.” Cobalt Pharmaceuticals Company v. Bayer Inc., 2015 FCA 116

Obviousness Revisited Sanofi questions should not be rigidly or mechanically applied – Beloit test is alive and well [also see e.g. Bridgeview Manufacturing Inc. v v. 931409 Alberta Ltd. et al, 2010 FCA 188; Corlac Inc et al v Weatherford Canada Ltd., 2011 FCA 228]

Obviousness Revisited Look for presence of a decision tree implicit in prior art - points along the path at which outcomes must be assessed or predicted

Obviousness Revisited

Obviousness Revisited uncertainty (???)/decision points along the way is inversely proportional to obviousness

Obviousness Revisited Strength of ability to predict success is key: “This might work”? “This should work” “This will work”.

Obviousness Revisited [12]           An obviousness challenge will not succeed if the prior art only establishes that something might work.  On the other hand it does not require that there be a guarantee of success.  The test is whether there would be a fair expectation of success:  [Janssen Inc. v. Teva Canada Limited, 2015 FC 184] Also see Apotex v Pfizer, 2009 FCA 8 ; MedImmune Ltd. v Novartis Pharmaceuticals UK, [2012] EWCA Civ 1234

Obviousness – back to Beloit The question to be asked is whether this mythical creature (the man in the Clapham omnibus of patent law) 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. It is a very difficult test to satisfy

Obviousness - back to Beloit

Obviousness – back to Beloit If this was such an easy path to take, why wasn’t it followed (done) already?

Obviousness – back to Beloit Need an answer – i.e. would have entailed an act of infringement – high risk course of action [Amgen Canada Inc. v. Mylan Pharmaceuticals ULC., 2015 FC 1244 @ para 96 ]

Combinations Where claimed invention resides in a combination, obviousness is not shown by deconstructing the combination and finding each component in the prior art [E.g. see Bridgeview Manufacturing Inc. v v. 931409 Alberta Ltd. et al, 2010 FCA 188; Corlac Inc et al v Weatherford Canada Ltd., 2011 FCA 228]

Secondary considerations (objective indicators of non-obviousness)? Commercial success [maybe, if due to merits of the invention] Long felt want or need Earlier failures by others Immediate or enthusiastic acceptance Industry praise [Almecon Industries Ltd. v. Nutron Manufacturing Ltd., 72 C.P.R. (3d) 397; Rothmans, Benson & Hedges Inc. v. Imperial Tobacco Ltd./Ltée, 47 C.P.R. (3d) 188; Bayer AG v. Apotex Inc., 2007 FCA 243]

Secondary considerations (objective indicators of non-obviousness)? Invention deviates from conventional wisdom Unexpected utility (Welcome Foundation Ltd. v. Apotex, 60 C.P.R. (3d) 135 (FCA): experience from testing and use of ciprofloxacin demonstrated that drug exceeded modest expectations of utility) [these support non-obviousness; absence not determinative of obviousness]

This is old/known:

Obvious?

Obvious?