Anticipation and Obviousness in Canada since Sanofi
February 15, 2012
Donald M. Cameron What’s a patentable invention need to be?
• New • Useful
• Inventive • An invention of the court: • 1890: it’s an “invention”, so it must be “inventive” • 1936: SCC required “a degree of ingenuity” to be present • Now in the New Patent Act, s. 28.3
2 New – Novelty/Anticipation Current Patent Act
• 28.2 (1) The subject matter defined by a claim in an application for a patent in Canada (the "pending application") must not have been disclosed • (a) more than one year before the filing date by the applicant, or by a person who obtained knowledge, directly or indirectly, from the applicant, in such a manner that the subject matter became available to the public in Canada or elsewhere ; • (b) before the claim date by a person not mentioned in paragraph (a) in such a manner that the subject matter became available to the public in Canada or elsewhere;
4 What Sanofi said
• Enabling disclosure
5 What Sanofi said
6 What Sanofi said
7 Enablement: The “IKEA” threshold
8 Cases since Sanofi
Merck v. Apotex (2010) • Prior art: fermentation disclose enable process with yeast – did it produce lovostatin? • No disclosure: • Not inevitable that claimed product would be produced • No evidence process was actually used before key date
9 Cases since Sanofi
Sloan Kettering (P.A.B.) • Claim was for an antibody disclose enable • No disclosure: • BTW: No enablement: • starting material: you couldn’t buy it, you’d have to make it • To make it would take: • “hopeful yet prolonged and arduous experimentation”
10 Cases since Sanofi
AstraZeneca v. Apotex • esomeprazole, a disclose enable stereoisomer of enalapril • Prior art said it separated optically pure compounds • Apotex: slight change in process produced esmeprazole • AstraZeneca: no it didn’t • Court: result not consistent
11 Cases since Sanofi
Easton v. Bauer • Hockey skate boot: a one disclose enable piece rear quarter • Used in test league, but in public rink • Disclosed but not enabled • You’d have to dismantle the skate to reproduce it
12 Conclusions since Sanofi
Mechanical: • “The Caramilk bar test” disclose enable • If you can see it, you can figure it out • Observing isn’t “experimenting”
13 Conclusions since Sanofi
Chem/Pharma: • “The Coca-cola test” disclose enable • Can’t figure out how they made it.
14 Inventive Obviousness Hard to express a test for obviousness/inventiveness
• What it is • Obvious, very plain, plain as day, crystal clear • Quantum: need an inventive step, a scintilla of invention
• How to get to it • 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, if the product of an inventive mind • Obvious, if the product of a non inventive mind
16 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 .”
17 Obvious – New Act
• “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 .”
18 What Sanofi said Obviousness – the Sanofi approach (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 ?
20 “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?
21 “Obvious to try” – an unfortunate misnomer
• Did he really mean it? “For a finding that an invention was “obvious to try”, there must be evidence to convince a judge on a balance of probabilities that it was more or less self evident to try to obtain the invention .” [emphasis added] • and then, in addressing the evidence: “I conclude that the prior art and common general knowledge of persons skilled in the art at the relevant time were not sufficient for it to be more or less self evident to try to find the dextro rotatory isomer .”
22 Then clarified I think
“The invention must be self evident from the prior art and common general knowledge in order to satisfy the “obvious to try” test.”
23 Lessons since Sanofi
24 Applying the Windsurfing approach 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.”
26 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) ?
27 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.”
28 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.”
29 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.”
30 Applying “Obvious to try” “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
32 “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.”
33 “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
34 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
35 Just finding a salt: obvious
• Ratiopharm Inc. v. Pfizer Limited (amlodipine maleate) • Start with amlodipine maleate • Find a suitable salt
36 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.
37 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
38 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”.
39 Conclusions
• An obvious truth: • a predictable solution may be obvious; but • an unpredictable outcome cannot be an obvious solution.
40 Anticipation and Obviousness in Canada since Sanofi
February 15, 2012
Donald M. Cameron