1. Obviousness April 17, 2014 Don Cameron Donald M. Cameron

2. 2 What’s a patentable invention need to be? New Useful Inventive – Judge made An 1890 judge-made addition to patentability 1936: SCC required “a degree of ingenuity” to be present – Now in the Patent Act – “plain as day”, “crystal clear”

3. 3 Hard to express a test for obviousness/inventiveness What it is – “proper subject matter” – an “invention”, inventive – Obvious, very plain, plain as day, crystal clear The Quantum – an inventive step – a “scintilla” of invention The Path to get it/there – Directly and without difficulty (but lack of difficulty doesn’t mean it’s obvious) – Out of track with what was known at the time The mind it comes from, or doesn’t – Inventive: the product of an inventive mind – Obvious: the product of a non-inventive mind

4. 4 Hugesson J.A. in Beloit – Would any idiot have come up with it, directly and without difficulty? "The test for 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.”

5. 5 Beware of formulae: obvious just means obvious House of Lords in General Tire: “ We agree, however, with what was said by Diplock, L.J. (as he then was) and Willmer, L.J. in the Johns- Manville case [1967] R.P.C. 478 at 493 and 496 deprecating “coining” phrases which may later be suggested to be of general application. “Obvious” is, after all, a much- used word and it does not seem to us that there is any need to go beyond the primary dictionary meaning of “very plain”.”

6. The “Immediately Possible” What’s immediately possible? What an obvious improvement over what’s known? 6 what’s known

7. The sunspot analogy, cont’d Key: – Black “umbra”: what’s old – Dark aura “penumbra”: what’s obvious – Yellow: what’s inventive – Outside the picture: what’s not “adjacently possible” (what’s impossible: can’t be done, yet) 7

8. 8 The “Inventive Step”

9. 9 New Inventive It’s been done/taught before, in one place Hasn’t been done before but anyone could have done it Can mosiac Explaining the difference – How many coins?

10. 10 The Scientific Method & Experiments

11. THE RIGHT APPROACH (ACCORDING TO SANOFI) Windsurfing/Pozzoli

12. Windsurfing case, as updated in Pozzoli (1) (a) Identify the notional “person skilled in the art”; (b) 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; (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; (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? 12

13. Obviousness 13

14. WHEN EXPERIMENTS DRIVE INNOVATION

15. Plodders get patents too “Very few inventions are unexpected discoveries. Practically all research work is done by looking in directions where the “state of the art” points. On that basis and with hindsight, it could be said in most cases that there was no inventive ingenuity in the new development because everyone would then see how the previous accomplishments pointed the way. The discovery of penicillin was, of course, a major development, a great invention. After that, a number of workers went looking for other antibiotics methodically testing whole families of various microorganisms other than penicillum noatum. This research work was rewarded by the discoveries a number of antibiotics such as chloromycetin obtained from streptomyces venezuelae as mentioned in Laboratoire Pentagone v. Parke, Davis & Co. [1968] R.C.S. 307, tetracycline as mentioned in American Cyanamid Co. v. Berk Pharmaceuticals Ltd. [1976] R.P.C. 231 where Whitford J. said (at p. 257): “A patient searcher is as much entitled to the benefits of a monopoly as someone who hits upon an invention by some lucky chance or inspiration.” Farbwerke Hoechst v. Halocarbon (Ontario) Limited et al (1979), 42 C.P.R. (2d) 145 (S.C.C. per Pigeon J.), at paras. 33-35. 15

16. Iterative drug design If this works, tweak it a little and try that and so on 16

17. So when do experiments result in obvious results? On the one hand: “It is enough that the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial”. Johns-Manville Corporation’s Patent [1967] RPC 479 (per Lord Diplock) at 495 – the UK “worth a try” test On the other hand: “Practically all research work is done by looking in directions where the “state of the art” points.” Farbwerke Hoechst 17

18. 18 Experiments Two kinds of experiments: – Ones where you already know the answer – Ones where you don’t know the answer

19. 19 Experiments where you already know the answer It’s been done before – You’ve done it before good experiments are repeatable – You’ve learned from others good experiments are repeatable AND It’s highly likely to happen again – The sun will rise tomorrow – Apples fall from trees

20. 20 Experiments where you already know the answer = confirmatory experiments Should not be entitled to a patent. You haven’t really contributed anything new The solution is obvious.

21. 21 Experiments where you don’t know the answer If you don’t know, you do research to find out the answer. Trial and error – If you have errors, you went the wrong way – Therefore the right way wasn’t obvious or you would have done that first – Long recognized to be a legitimate route to a patentable invention Hoescht: once penicillin discovered, try other microorganisms. That begat chloromycetin and tetracyclin – patentable American Cyanamid: “a patient searcher is as much entitled to the benefits of a monopoly as someone who hits upon an invention by some lucky chance or inspriation”

22. 22 Experiments where you don’t know the answer How well can you predict the outcome? – They’ll tend to polarize to either end of the spectrum Guessing…………………….Likely…………….Highly Certain Coin Toss…………Pen at Reception Desk…Sunrise tomorrow

23. 23 Obvious to Try or Worth a Try Obvious to try – The microorganisms after penicillin discovered – Not determinative: May be obvious, but may not. Worth a try … but if uncertain of result, it can’t be obvious

24. 24 Experiments when you know an answer’s there Question: Where are my glasses? Usual Answer: Look in the obvious places – Where did you last see them? – Where were you last?

25. 25 An expected result Which is the sharpest knife in the drawer? – One is. – Measure by routine testing – Should the identification of the sharpest knife be patentable? Probably not – you’re confirming what’s is a given What if it’s really sharp? Surprisingly sharper than the rest?

26. 26 An expected result What is it’s melting point? – Merely measuring a physical characteristic – You’re just observing – that’s science Find me an application and that might be patentable.

27. A BUMP IN THE ROAD

28. 28 Would require “undue experimentation” IKEA furniture – It can be done, but it’s not always easy To implement an invention after reading a patent, you may have to play around with it a bit Patent is supposed to be “enabling’ – disclose what you need to know to make it work If it took “undue experimentation” to implement, the disclosure is lacking Converse adopted: if there wasn’t undue experimentation to make it, it’s obvious.

29. THE EASY ONES

30. 30 An unexpected result “Surprise, surprise”

31. 31 Going the wrong way Doing things backwards resulted in a patented process.

32. 32 Led Directly and Without Difficulty Reality check: How hard was it for the inventor? – If circuitous, it wasn’t obvious to the inventor – If easy, may or may not be inventive

33. 33 “a mere application of mechanical skill does not make you an inventor” Corn flakes case: – Q.: Is the first person to do it an inventor? – A.: Not if he was just the technician working the machine. Over-transmogrified into: If its merely an exercise of mechanical skills, there’s no invention.

34. 34 Other indicia of inventiveness If it’s “wow” – it’s probably an invention If creative people say, “I was there and I never thought of it” – it’s probably inventive

35. 35 Summary If you can put 2 and 2 together and come up with 4, it’s obvious If you don’t know the answer/solution and have to do research (even if by pedestrian means), it’s not obvious

36. NEWS FROM THE SOUTH: KSR

37. 37 KSR – US Supreme Court Adjustable car pedal for drivers of different heights Sensor that controlled throttle, etc. Sensor attached to a fixed pivot point Prior art: – A+B – A+C – B+C Invention A+B+C

38. 38 KSR TSM: – Teaching – Suggestion – Motivation “a patent claim is only proved obvious if ‘some motivation or suggestion to combine the prior art teachings’ can be found in the prior art, the nature of the problem, or the knowledge of a person having ordinary skill in the art.”

39. 39 KSR TSM is not a rigid rule – your don’t have to have it in every case in order to find obviousness Instead, you start with where things were and ask if it was obvious to go to the invention: – “The Court of Appeals considered the issue too narrowly by, in effect, asking whether a pedal designer writing on a blank slate would have chosen …” – “The consequent legal question, then, is whether a pedal designer of ordinary skill starting with Asano would have found it obvious to put the sensor on a fixed pivot point.”

40. 40 KSR – “Predictable results” “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” “… when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” “If a person of ordinary skill can implement a predictable variation, § 103 likely bars its patentability.”

41. 41 KSR – “Predictable solutions” “… a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.” “Where there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”

42. 42 KSR – some weird stuff “A person of ordinary skill is also a person of ordinary creativity.” “And as progress beginning from higher levels of achievement is expected in the normal course, the result of ordinary innovation are not the subject of exclusive rights under the patent law.” What the heck is “ordinary creativity” or “ordinary innovation”? – OK if: Creating something new but non-inventive?

43. 43 KSR – weird stuff “The proper question to have asked was whether a pedal designer of ordinary skill, facing the wide range of needs created by developments in the field of endeavor, would have seen a benefit to upgrading Asano with a sensor.” What triggers the vision? Surely doesn’t mean you ask the notional person, “Would you see a benefit doing this upgrade? That’s a leading question inventors are never asked. OK if: Where were we? Where was obvious to go from there?

44. 44 KSR – weird stuff Synergy: the whole is greater than the sum of its parts. THERE’S NO SUCH THING!!!!! a “patent for a combination which only unites old elements with no change in their respective functions … obviously withdraws what is already known into the fiield of its monopoly and dimishes the resources available to skillful men” Stuff just does what it does … but you can have a new result – example – the sailboard

45. ST. GOBAIN (2005) Predictability from UK 45

46. “Worth a try” test gets buried “Mere possible inclusion of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions that were patentable. The only research which would be worthwhile (because of the prospect of protection) would be into areas totally devoid of prospect. The “obvious to try” test really only works where it is more or less self-evident that what is being tested ought to work.” Saint-Gobain PAM SA v. Fusion Provida Ltd., [2005] EWCA Civ 177 at para. 35 (per Lord Jacob). 46

47. SANOFI

48. 48 If something is worth trying, is it obvious? UK Johns-Manville 1967 Diplock L.J.: – It’s obvious if it is: “obvious to try” and “It is enough that the person versed in the art would assess the likelihood of success as sufficient to warrant actual trial...” 1972 Technograph case Sach L.J.: – “He would be expected to try out all obvious modifications or combinations of these methods which seemed to him worth trying."

49. 49 1974 Hoechst F.C.T.D. – obvious if you could predict success Collier J.: – "Mr. Sim sparred at some length with Dr. Schmutzler, pressing and exploring the hypothesis that the liquid phase process was, to a skilled person, "worth a try". Using the magnifying spectacles of hind-sight (a half borrowed phrase), it is easy to say that any experiment, if time and expense are unlimited … is or was worth a try." – “Using a paraphrase of the “Cripps question”: Was it for all practical purposes obvious to any skilled chemist in the state of chemical knowledge existing at the date of the invention, which consists of the chemical literature available and his general knowledge, particularly in the filed of fluorine chemistry, that he would successfully produce isohalothane (assuming the monomer used here and the hydrogen bromide) in the liquid phase? …

50. 50 Hoescht FCA: success doesn’t have to be predicted Federal Court of Appeal, Jackett C.J.: – “The learned trial judge appears to have proceeded upon the assumption that the requirement of “inventive ingenuity”, is satisfied unless the “state of the art” at the time of the alleged invention was such that it would have been obvious to any skilled chemist “that he would successfully produce isohalothane (assuming the monomer used here and hydrogen bromide) in the ‘liquid phase’.” (The italics are mine.) I do not think that the learned trial judge’s assumption is correct as a universal rule. I would not hazard a definition of what is involved in the requirement of “inventive ingenuity: but, as it seems to me, the requirement of “inventive ingenuity”, is not met in a the circumstances of the claim in question where the “state of the art” points to a process and all the alleged inventor has done is ascertain whether or not the process will work successfully.”

51. 51 1979 Hoechst SCC In my view this statement of the requirement of inventive ingenuity puts it much too high. Very few inventions are unexpected discoveries. Practically all research work is done by looking in directions where the “state of the art” points. On that basis and with hindsight, it could be said in most cases that there was no inventive ingenuity in the new development because everyone would then see how the previous accomplishments pointed the way. The discovery of penicillin was, of course, a major development, a great invention. After that, a number of workers went looking for other antibiotics methodically testing whole families of various microorganisms other than penicillum noatum. This research work was rewarded by the discoveries a number of antibiotics such as chloromycetin obtained from streptomyces venezuelae as mentioned in Laboratoire Pentagone v. Parke, Davis & Co. [1968] R.C.S. 307, tetracycline as mentioned in American Cyanamid Co. v. Berk Pharmaceuticals Ltd. [1976] R.P.C. 231 where Whitford J. said (at p. 257): “A patient searcher is as much entitled to the benefits of a monopoly as someone who hits upon an invention by some lucky chance or inspiration.”

52. 52 Predictability of success 0%100% “obvious to try” obvious if worth trying “reasonable expectation of success” 1977: UK Johns- Manville 1979 Hoechst USA obvious if can predict success

53. 53 Canadian case law develops If any research (learning something new) is needed, the invention is not obvious “Undue experimentation” – renders a discovery non-obvious – less than undue experimentation makes it obvious If the result of the experimental is highly predictable or the result expected (the experiment is confirmatory rather than exploratory), then the result is obvious.

54. 54 2005 UK “obvious to try” test moves Saint-Gobain PAM SA v. Fusion Provida Ltd. per Jacob: – “Mere possible inclusion of something within a research programme on the basis you will find out more and something might turn up is not enough. If it were otherwise there would be few inventions that were patentable. The only research which would be worthwhile (because of the prospect of protection) would be into areas totally devoid of prospect. The “obvious to try” test really only works where it is more or less self-evident that what is being tested ought to work.”

55. 55 Predictability of success 0%100% “obvious to try” = enough to try a trial “reasonable expectation of success” 1977: UK Johns- Manville 1979 Hoechst USA success 2005: Saint- Gobain “ought to work”

56. 56 2007 USA KSR decision Rejected CAFC’s restrictive TSM test – Teaching – Suggestion – Motivation “Consider everything” approach, including “obvious to try”: “The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was “obvious to try”.... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103.”

57. 57 Rothstein in Sanofi “It is now clear that both jurisdictions accept that an “obvious to try” test can be relevant in an obviousness inquiry. The United States Supreme Court has now stated so explicitly in KSR. The convergence of the United Kingdom and the United States law on this issue suggests that the restrictiveness with which the Beloit test has been interpreted in Canada should be re-examined.”

58. 58 Obviousness – the Sanofi test (Windsurfing redux) (1)(a)Identify the notional “person skilled in the art”; (b)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; (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; (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?

59. 59 “Obvious to try” test – for cases involving experimentation “Obvious to try” test – Could be part of step #4 in cases “where advances are won by experimentation” Rothstein’s Questions: – (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? – (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? The path followed by the inventor(s) is worth examining. – (3)Is there a motive provided in the prior art to find the solution the patent addresses?

60. 60 Obviousness Rothstein’s Questions (redux): – (3) What was the motive? To try? To combine those references? – (2) How easy was it for the inventor(s)? Prolonged and arduous (inventive) vs. “routine” (obvious) – (1) Was it predictably successful? Was it“ more or less self-evident” that it “ought to work”? Were there a finite number of identified predictable solutions?

61. 61 (3) What was the motive? Marketplace was searching for an effective, non-toxic product – [How does that make it obvious? – [More likely to make it non-obvious if everyone was looking and nobody found it] The genus patent did not provide a specific motivation to pursue the right handed enantiomer.

62. 62 (2) How easy was it for the inventor(s)? What was known: – Separation methods – Methods of testing properties – Finite number of salts But the inventor took 5 months – That’s prolonged and arduous (inventive) vs. “routine” (obvious)? – [That’s a new definition for “routine”.]

63. 63 (1) Was it predictably successful? Was it “more or less self-evident” that it “ought to work”? (Were there a finite number of identified predictable solutions) Skilled person would not have known: – before separating the racemate into the two isomers and testing them, that the properties of the right-handed isomer would be different than the properties of the racemate or the left-handed isomer; – the relative advantage of the right-handed isomer; – what to select or omit from the genus patent was not self-evident; – before trying the salts in combination with the right-handed isomer, what the bisulfate salt’s beneficial properties would be; – the right-handed isomer ought to work. Therefore, the right-handed enantiomer salt was not obvious.

64. OBVIOUSNESS SINCE SANOFI

65. Don’t trip on the “inventive step” UK “Windsurfing/Pozzoli” approach was based on UK statute Our “New Act” has specific language: “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 in such a manner that the i) information disclosed before the claim date by a person not mentioned in paragraph (a) became available to the public in Canada or elsewhere.” 65

66. Windsurfing approach redux for New Act 2.Identify the invention of the claim in question or, if that cannot readily be done, construe it; 3.Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the invention of the claim as construed; 4.Viewed without any knowledge of the alleged invention as claimed, would the invention as claimed have been obvious on the claim date to a person skilled in the art or science to which it pertains, having regard to the information referred to in s. 28.3(a) and (b)? 66

67. First application to New Act patent Apotex v. Pfizer (PMNOC for VIAGRA’s sildenafil citrate) “Although there was a significant amount of evidence indicating that cGMP PDE inhibitors should be further explored with regards to the treatment of ED in the months leading up to the Pfizer discovery, the evidence does not in my view establish that the solution taught by the patent was obvious at the time. At best there was speculation, which in hindsight proved to be correct, that PDE5 inhibitors might treat impotence. Experiments with zaprinast, a cGMP PDE inhibitor, had been performed but in an effort to understand how the erectile process works, not how to treat ED.” 67

68. What’s the invention/inventive concept? Servier (FCA) – Approved what Snider did: look to the claims – Adopted Angiotech v. Conor: “… the invention is the product specified in a claim and the patentee is entitled to have the question of obviousness determined by reference to his claim and not to some vague paraphrase based upon the extent of his disclosure in the description.” 68

69. What’s the invention/inventive concept? Corlac v. Weatherford (FCA) – For a combination, look to the whole of the claim: – “Although they maintain that the judge did not specifically identify the inventive concept of the patent (as contemplated at Pozzoli step two), they acknowledge that he did refer to the patent’s three “key concepts” in his reasons. In any event, the second step indicates that it will be sufficient to construe the patent if the inventive concept is not readily discernible from its claims. As indicated earlier in these reasons, the judge properly construed the patent’s claims. Moreover, the '937 Patent is a combination patent. Therefore, its essence lies in the unique combination claimed even though individual elements of the invention, considered in isolation, may not have been inventive. As recently explained by this Court, “[i]t is not fair to a person claiming to have invented a combination invention to break the combination down into its parts and find that, because each part is well known, the combination is necessarily obvious”: Bridgeview Manufacturing Inc. v. 931409 Alberta Ltd., 2010 FCA 188, 87 C.P.R. (4th) 195, para. 51 (Bridgeview), leave to appeal dismissed, [2010] S.C.C.A. No. 346.” 69

70. APPLYING “OBVIOUS TO TRY”

71. “Obvious to try” open to mis- application? Abbott Laboratories v. Canada, 2009 per Hughes J. Held, the patent at issue was anticipated. Obiter re obviousness: – it would have been self-evident to a person skilled in the art to try the solubility of the crystalline form to see if it would work. – testing for solubility was routine. – it was self-evident that a person skilled in the art would test the solubility of any newly identified crystal to determine if it was soluble at a rate sufficient to give therapeutic utility and concluded that the invention was obvious. He did not ask, however, whether it was more or less self-evident that what was being tested ought to work 71

72. “Obvious to try” – when applicable Sanofi, at para 68: – “In areas of endeavour where advances are often won by experimentation, an “obvious to try” test might be appropriate. In such areas, there may be numerous interrelated variables with which to experiment. For example, some inventions in the pharmaceutical industry might warrant an “obvious to try” test since there may be many chemically similar structures that can elicit different biological responses and offer the potential for significant therapeutic advances.” 72

73. “Obvious to try” – when not applicable Mechanical devices: not really that kind of case UView Ultraviolet Systems Inc. v. Brasscorp Ltd. – charging a closed, pressurized air conditioning system. Bridgeview Manufacturing Inc. et al v. 931409 Alberta Ltd. – A hay bale buster 73

74. Not self-evident Abbott Laboratories v. Canada (Health) and Sandoz – clarithromycin extended-release 500 mg tablets Heneghan J. did it all right: – dealt sequentially with each of the differences between the prior art and the alleged invention – factors why the chosen polymer would not have been a likely choice – nothing in the prior art that would suggest that this formulation would be suitable – other prior art that taught away from the invention – failure of other prior users to make the invention 74

75. Just finding a salt: obvious Ratiopharm Inc. v. Pfizer Limited (amlodipine maleate) Start with amlodipine maleate Find a suitable salt 75

76. Nature & Amount of effort required: routine trials the prior art provided: – means of creating acid addition salts; and – predicted the results, which Pfizer merely had to verify through routine testing; and The type of experiments used by Pfizer’s scientists to verify the physicochemical characteristics of each salt were held not to be equivalent to the trial and error procedures often employed to discover a new compound where the prior art gave no motivation or suggestion to make the new compound nor a reasonable expectation of success. 76

77. Old considerations still apply Sharlow J.A. in levofloxacin infringement case: 1.The invention 2.The hypothetical skilled person referred to in the Beloit quotation 3.The body of knowledge of the person of ordinary skill in the art 4.The climate in the relevant field at the time the alleged invention was made 5.The motivation in existence at the time the alleged invention to solve a recognized problem 6.The time and effort involved in the invention: Secondary factors: 1.Commercial success 2.Meritorious awards 77

78. Corlac v. Weatherford (FCA) Sanofi said that an “expansive and flexible approach that would include ‘any secondary considerations that [will] prove instructive’ will be useful”. 78

79. Conclusions An obvious truth: – a predictable solution may be obvious; but – an unpredictable outcome cannot be an obvious solution. 79

80. Thank You Don Cameron DCameron@bereskinparr.com Bereskin & Parr LLP