Inventive step and non-obviousness

The inventive step and non-obviousness reflect a general patentability requirement present in most patent laws, according to which an invention should be sufficiently inventive—i.e., non-obvious—in order to be patented. In other words, "[the] nonobviousness principle asks whether the invention is an adequate distance beyond or above the state of the art".
The expression "inventive step" is predominantly used in Europe, while the expression "non-obviousness" is predominantly used in United States patent law. The expression "inventiveness" is sometimes used as well. Although the basic principle is roughly the same, the assessment of the inventive step and non-obviousness varies from one country to another. For instance, the practice of the European Patent Office (EPO) differs from the practice in the United Kingdom.
Rationale.
The purpose of the inventive step, or non-obviousness, requirement is to avoid granting patents for inventions which only follow from "normal product design and development", to achieve a proper balance between the incentive provided by the patent system, namely encouraging innovation, and its social cost, namely conferring temporary monopolies. The non-obviousness bar is thus a measure of what society accepts as a valuable discovery. Additional reasons for the non-obviousness requirement are providing incentives for fundamental research rather than for "incremental improvements", and minimizing the "proliferation of economically insignificant patents that are expensive to search and to license".
According to the inducement theory, "if an idea is so obvious that people in the field would develop it without much effort, then the incentives provided by the patent system may be unnecessary to generate the idea". Thus, there is a need "to develop some means of weeding out those inventions which would not be disclosed or devised but for the inducement of a patent." Merges and Duffy regret that "the inducement standard was not influential in the legal doctrine, and its absence from subsequent case law raises one of the great unanswered questions of patent law: How can courts continue to ignore a seemingly reasonable and theoretically solid approach to determining patentability?"
Controversies and alternatives.
While trying to weed out the "easy" inventions, the non-obviousness requirement brings in several downsides to the overall patent system, particularly in the pharmaceutical field, which depends on patent protection most heavily. For example,
Although all countries with actively functional patent systems currently have a requirement for inventive step, the need for such a doctrine has been questioned. For example, "substantial novelty" has been proposed as an alternative approach. Also, many countries have, in addition to patents, utility models, which have a lower (or none) requirement for non-obviousness in return for a shorter monopoly term duration. The availability of utility model protection minimizes for inventors, developers and manufacturers the risk associated with the uncertainty of non-obviousness analysis (litigation) outcome (see below).
In the US, there is no gradation stronger inventive step - longer patent duration, and all-or-nothing approach is used. Under such a system, drawing the line between inventive(all) and obvious (nothing) is ambiguous, as numerous lawsuits with changing outcomes on appeal illustrate (e.g. "Sanofi-Aventis GmbH v. Glenmark Pharmaceuticals", 748 F. 3d 1354 (Fed. Circuit 2014)). Also, unique to the is the possibility to introduce as the evidence of non/obviousness facts, discovered after filing the patent application in question. (e.g. "Knoll Pharm. Co. v Teva Pharm. USA, Inc." 367 F.3d 1381, 1385(Fed. Circ.2004) and "Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc." 655 F.3d 1291, 1307 (Fed.Circ.2011), In re Khelgatian 53 CCPA 1441, 364 F.2d 870, 876 (1966)).
Although the need for low bar of inventiveness has been well acknowledged, the proposed means of actually measuring such a bar have all been rather unsuccessful despite 200 years of case law history. "A standard that is clear and easy to apply consistently will mark where the non-obviousness bar exactly rests, providing society as a whole, and lawmakers in particular, with a benchmark to gauge the patent system's efficacy. Moreover, such a standard will allow the lower courts to determine non-obviousness correctly and consistently, at least hypothetically reducing uncertainty, inducing uniformity, and lowering reversal odds." Mr. Cecil D. Quillen Jr., Senior Advisor to Putnam, Hayes and Bartlett, Inc., and former General Counsel to the Eastman-Kodak Company, concurs: "The PTO should apply the same standard followed in the courts so that patentees receive a patent that is worthy of respect rather than merely an invitation to the roulette wheel of litigation." The US Supreme Court, however, has criticised the patent agency for failing to follow the same standards as the courts:
[I]t must be remembered that the primary responsibility for sifting out unpatentable material lies in the Patent Office. To await litigation is, for all practical purposes, to debilitate the patent system. We have observed a notorious difference between the standards applied by the Patent Office and by the courts. While many reasons can be adduced to explain the discrepancy, one may well be the free rein often exercised by Examiners in their use of the concept of "invention".
Jurisdictions.
Canada.
The requirement for non-obviousness is codified under section 28.3 of the Patent Act (R.S.C., 1985, c. P-4).
The Supreme Court of Canada affirmed the test for non-obviousness laid out in "Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd." in "Apotex Inc. v. Sanofi‑Synthelabo Canada Inc.":
Canadian courts also recognize the equivalents of the US objective indicia, i.e. Factors That Support Patentability of an Invention :
European Patent Convention (EPC).
Pursuant to Article 52(1) in conjunction with Article 56, first sentence, EPC, European patents shall be granted for inventions which, among other things, involve an inventive step, that is, the invention, having regard to the state of the art, must not be obvious to a person skilled in the art.
The Examining Divisions, the Opposition Divisions, and the Boards of Appeal of the EPO almost always apply the "problem-solution approach" in order to assess and decide whether an invention involves an inventive step. The approach consists in:
This last step is conducted according to the "could-would approach". Pursuant to this approach, the question to address in order to assess whether the invention involves an inventive step is the following (the question is the climax of the problem-solution approach):
If the skilled person would have been prompted to modify the closest prior art in such a way as to arrive at something falling within the terms of the claims, then the invention does not involve an inventive step.
The point is not whether the skilled person could have arrived at the invention by adapting or modifying the closest prior art, but whether he would have done so because the prior art would have incited him to do so in the hope of solving the objective technical problem or in expectation of some improvement or advantage. This must have been the case for the skilled person before the filing or priority date valid for the claim under examination.
United Kingdom.
The fundamental test for assessing whether there is an inventive step remains the statutory test: "Actavis v Novartis" [2010] EWCA Civ 82 at [17]. That test is as follows: an invention shall be taken to involve an inventive step if it is 'not obvious' to 'a person skilled in the art', having regard to any matter which forms part of the 'state of the art' by virtue of section 2(2): s 3 "Patents Act 1977".
Courts of the United Kingdom have adopted a general framework to assist in approaching (not answering) the fundamental statutory test. It is known as the "Windsurfing" or "Pozzoli" test.
In "Windsurfing International Inc. v Tabur Marine (GB) Ltd." [1985] RPC 59 the Court of Appeal suggested the following framework:
This test has been slightly reworked in the more recent Court of Appeal case "Pozzoli Spa v BDMO SA & Anor" [2007] EWCA Civ 588 (22 June 2007):
In "Schlumberger Holdings Ltd versus Electromagnetic Geoservices AS" [2010] EWCA Civ 819 (28 July 2010), the Court of Appeal clarified that the fictional skilled addressee (which may be a skilled team) used for determining inventive step can vary from the one used for determining claim construction or sufficiency.
United States.
"Non-obviousness" is the term used in US patent law to describe one of the requirements that an invention must meet to qualify for patentability, codified in 35 U.S.C. §103. One of the main requirements of patentability in the U.S. is that the invention being patented is not obvious, meaning that a "person having ordinary skill in the art" (PHOSITA) would not know how to solve the problem at which the invention is directed by using exactly the same mechanism. Since the PHOSITA standard turned to be too ambiguous in practice, the U.S. Supreme Court provided later two more useful approaches which currently control the practical analysis of non-obviousness by patent examiners and courts: "Graham et al. v. John Deere Co. of Kansas City et al.", 383 U.S. 1 (1966) gives guidelines of what is "non-obvious", and "KSR v. Teleflex" (2006) gives guidelines of what is "obvious".
Historical development.
Constitutionally, the non-obviousness requirement is established by Article 1, Section 8, Clause 8: "The Congress shall have the power … to promote the Progress of Science .., by securing for limited Times to … Inventors the exclusive Right to their … Discoveries". The phrase "to promote the Progress of Science" defines the purpose of the patent system, which is to encourage private investments into fundamental science research rather than to grant monopoly on something that is taken from a public domain (or on something that limits the opportunities for doing research, e.g. research tools are not patentable). The "Progress of Science" requirement constitutionally validates the pragmatic approach to non-obviousness described below. The word "Discoveries" establishes the level to which the contribution to the "Progress of Science" must rise to deserve the temporary monopoly.
1790-1850: the early days.
The first patent statute enacted by the Congress in 1790 required patentable inventions or discoveries to be "sufficiently useful and important". One can interpret "important" as important for the "Progress of Science" since the importance for economy is stated by "useful". The next Patent Act of 1793 did not have the "important" language, but stated that "simply changing the form or the proportions of any machine, or compositions of matter, in any degree, shall not be deemed a discovery." (This statement was actually adopted from the French Patent Law of 1791). This was echoed in Thomas Jefferson's 1814 letter explaining that changing material, for example, from cast iron to wrought iron was insufficient for patentability.
The difficulty of formulating conditions for patentability was heightened by the generality of the constitutional grant and the statutes implementing it, together with the underlying policy of the patent system that "the things which are worth to the public the embarrassment of an exclusive patent", as Jefferson put it, must outweigh the restrictive effect of the limited patent monopoly. The 1836 Patent Act did not have the "simply changing" language but stated instead that the Commissioner of Patents was authorized to issue a patent for any "sufficiently used and important" invention or discovery.
The U.S. Supreme Court considered the issue of inventiveness/non-obviousness/discovery for the first time in 1822 in "Evans v. Eaton" (20 US 356,431) when it approved the interpretation of a lower court that a patentable improvement must involve a "change in the "principle of the machine"" not "a mere change in the form or proportions". Currently, such variations are usually interpreted as a lack of novelty not of an inventive step.
1851–1951: struggles to find practical criteria.
The issue of non-obviousness reached the U.S. Supreme Court again in 1851 in "Hotchkiss v. Greenwood". The question was whether a substitution of known door knob materials such as metal or wood for a new material—porcelain—deserved a patent. The court concluded that "the improvement is the work of a skillful mechanic, not that of the inventor" and invalidated the patent. Such approach foresees the line of thought which was later formulated as the PHOSITA (person having ordinary skill in the art) approach to the analysis of inventiveness. Despite beginning to develop the PHOSITA approach, the Court did not give practical means to determine what how much inventiveness deserves a patent. It is worth noting here that Eaton and Hotchkiss, respectively, illustrate the heretofore existing trend to state the appropriate inventiveness by defining both what is obvious (lacks an inventive step / discovery) and what is non-obvious (has an inventive step / discovery).
During the period from 1851 to 1951, several new cases related to the non-obviousness of claimed subject matter in patents reached the Supreme Court. One noteworthy case is "Rubber-Tip Pencil Co. v. Howard" 87 U.S. (20 Wall.) 498 (1874), in which the Supreme Court invalidated a patent on a pencil with a rubber eraser cap, on the theory that everyone knows rubber will stick to wood inserted into a hole in the rubber. In another noteworthy case, "Sinclair & Carrol Co. v. Interchemical Corp." (1945), the U.S. Supreme Court found that a patent was "not the product of long and difficult experimentation", and that "reading a list and selecting a known compound to meet known requirements is not more ingenious than selecting the last piece to put into the last opening in a jig-saw puzzle".
However, during that time the Courts struggled to find both the required levels of inventiveness and obviousness and practically useful criteria to measure these levels. One notable example of this struggle is the 1941 US Supreme Court case of "Cuno Engineering v. Automatic Devices Corp.", which was said to establish the flash of genius doctrine as a test of patentability of an invention: "the new device must reveal the flash of creative genius, not merely the skill of the calling".
The Flash of Genius approach was thought to have shifted the analysis of inventiveness from importance and from PHOSITA to the state of mind of the inventor; it caused uproar in the patent law community as courts struggled to find alternative approaches. One notable example of this struggle is the positions of Justice Douglas in "Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp." in 1950, where he opined that to deserve a patent, an invention "had to serve the end of science—to push back the frontiers of chemistry, physics, and the like"; while two years prior in "Funk Bros. Seed Co. v. Kalo Inoculant Co." he stated that the discovery of a new natural principle—is not patentable of itself, "however ingenious the discovery of this natural principle may have been".
Similar problem arose again in "Mayo Collaborative Servs. v. Prometheus Labs., Inc." (2012), where the U.S. Supreme Court majority stated: "The conclusion is that (1) a newly discovered law of nature is itself unpatentable and (2) the application of that newly discovered law is also normally unpatentable if the application merely relies upon elements already known in the art." It is worth noting, however, that this opinion remains highly controversial; as Justice Stephen Breyer stated, it risked rendering "all inventions unpatentable because all inventions can be reduced to underlying principles of nature which, once known, make their implementation obvious." Mayo, 132 S. Ct. at 1303–04
This position raised issues as to a need to establish the boundary of the patentable domain, not only with routine improvements but also with major advancements in science, i.e. creating too much monopoly which may impede rather that promote the Progress of Science. Currently, the latter boundary is established via the requirement for patent-eligible subject matter (research tools, scientific theories and laws are not patent eligible) while the issue of how much inventiveness is required to deserve a patent is supposed to be defined via the non-obviousness requirement.
The trend that started to develop around 1950 (and dominates today) was to require disclosure of an element of discovery, while granting patent monopoly on only one or a few "particular applications of [natural] laws" that the discoverer came up with before the very first disclosure becomes published. The duality between the non-obviousness requirement and an overbroad scope of claims is expected to receive further development by the U.S. Supreme Court in due course.
The U.S. Supreme Court's decision in "Great Atlantic & Pacific Tea Co. v. Supermarket Equipment Corp." in 1950 is often considered the high-water mark of the pragmatic approach, as the Court reversed (after affirmations in two lower courts) the patent grant of a commercially successful but very simple mechanical device as merely a "gadget". Based on its decision that a combination "which only unites old elements with no change in their respective functions" is unpatentable because such a patent would "obviously withdraw what already in known into the field of its monopoly and diminish . . . the resources available to skillful men." Another example of insufficient inventiveness of that time can be found in In re Aller (CCPA, 1955) "It is not inventive to discover the optimum or workable ranges by routine experimentation." This restriction was, however, lifted later in cases where "a parameter must be recognized as a result-effective variable before a determination of routine experimentation".
As a practical test for the pragmatic approach for lower courts to use, the Supreme Court proposed "unusual or surprising consequences" from the combination of old elements: "[O]nly when the whole in some way exceeds the sum of its parts is the accumulation of old devices patentable." Although the time validated the pragmatic approach (does the patent promote the progress of science or does it take away from the public domain), the for- criterion of "unusual or surprising consequences" turned out to be too ambiguous and too high in practice. On the other hand, the against-criterion for a combination that "only unites old elements with no change in their respective functions" has been useful in practice ever since.
Another relevant case from this period is "Graver Tank & Manufacturing Co. v. Linde Air Products Co."
It established the line of thought that what was not claimed by the inventor in an issued patent but is an obvious variation of what was claimed should be considered as covered by the claims via the Doctrine of equivalents.
However, neither the pragmatic approach nor the "unusual or surprising consequence" criterion received further development at that time, because the Congress took in 1952 a different approach to determining non-obviousness going back to a subjective factor similar to the inventor's (called PHOSITA, i.e. Person Having Ordinary Skills In The Art) state-of-mind.
1952–1964: PHOSITA.
In order to reduce the impact of non-obviousness on patentability, to eliminate the flash of genius test, and to provide a more fair and practical way to determine whether the invention disclosure deserves a patent monopoly, the Congress took the matter in its own hands and enacted the Patent Act of 1952 35 U.S.C. Section § 103 reads:
The last sentence about the manner was added in order to overrule the flash of genius test.
The Patent Act of 1952 added 35 U.S.C. § 103, which effectively codified non-obviousness as a requirement to show that an idea is suitable for patent protection. The section essentially requires a comparison of the subject matter sought to be patented and the prior art, to determine whether or not the subject matter of the patent as a whole would have been obvious, at the time of the invention, to a Person having ordinary skill in the art a.k.a. PHOSITA. (Similar criteria were enacted and are currently used in many other countries.) Clark held that the Congress, in passing the Act, intended to codify and clarify the common law surrounding the Patent Act by making explicit the requirement of non-obviousness. However, this test turned out be ambiguous and of little help in practice since PHOSITA does not exist.
1964–1984: The "Adams" trilogy & "Graham" factors.
The Supreme Court soon gave more practical interpretation of the Patent Act of 1952. It followed the approach it started in "Great Atlantic" with the rejection rule for a combination that "only unites old elements with no change in their respective functions" and soon added acceptation rules. It was done it was is now referred to as the "Adams trilogy": "Calmar v. Cook Chemical" (1964),[9] "Graham v. John Deere Co." (1966), and "United States v. Adams" (1966).
In "Graham v. John Deere Co.", the Court held that § 103 required a determination of the following questions of fact to resolve the issue of obviousness:
In addition, the Court mentioned "secondary considerations" which could, when appropriate, serve as evidence of non-obviousness. They (along with of Great A.&P. Tea's rejection rule for a combination that "only unites old elements with no change in their respective functions") constitute what is a practically useful approach to the determination of what claimed invention is non-obvious, and they are commonly referred to as the "Graham factors". The latter, after several revisions by lower courts, look in the modern form as follows:
Subsequent case law developments emphasized that Graham factors and other secondary consideration cannot overcome a strong "prima facie" case of obviousness.
In practice, these (and other later added) secondary considerations became the most useful criteria for non-obviousness: 
"Indeed, evidence of secondary considerations may often be the most probative and cogent evidence in the record. It may often
establish that an invention appearing to have been obvious in light of the prior art was not."
"United States v. Adams" (1966) is a particularly noteworthy case where a single inventor working in his garage on a primary Mg/CuCl/Cu battery won a patent infringement case against the US government in the Supreme Court, based primarily on the "Graham" factors (e.g. repeated failures of others). In the "non-obviousness trilogy", the Supreme Court further developed positive secondary of non/obviousness in addition to the Graham factors as negative secondary considerations, but noted that the secondary factors could not overcome a strong "prima facie" case of obviousness. 
In contrast to "United States v. Adams" , where the Court recognized that 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, In "Anderson's-Black Rock, Inc. v. Pavement Salvage Co." (1969), the two pre-existing elements in combination did no more than they would have accomplished in separate, sequential operation. Similarly, in "Sakraida v. Ag Pro Inc." (1976), a unanimous US Supreme Court found a claimed invention (a water flush system to remove cow manure from the floor of a dairy barn) obvious because it "simply arranges old elements without "producing a new or different function", although "doubtless a matter of great convenience, producing a desired result in a cheaper and faster way, and enjoying commercial success." This is an important precedent because it reversed the 1st Graham's factor (commercial success). Also, in "Dann v. Johnston"(1976) the Supreme Court cautioned that "the mere existence of differences between the prior art and an invention does not establish the invention's nonobviousness. The gap between the prior art and respondent's system is simply not so great as to render the system nonobvious to one reasonably skilled in the art."
During this period, other courts have considered additional secondary considerations as well (in the order on importance according to Judge Learned Hand:
1) long felt need for a solution to a real problem which has been recognized in the prior art or in the industry.
2) failures of others to solve the same problem (while equipped with the same knowledge)
3) significant efforts and high cost of developing the invention.
4) skepticism or disbelief before the invention as an indicator of non-obviousness.
5) copying, praise, unexpected results, and industry acceptance as indicators of non obviousness.
6) copying as an indicator of non-obviousness
7) commercial success.
8) unexpected advantages.
The presence of several favorable considerations make the case for non-obviousness stronger.
Another important result of Graham was the decision that the non-obviousness of a patent claim is a question of law rather than a question of fact, i.e. it must be decided by a judge rather than by a jury. Nevertheless, the Court commented that
"the section 103 condition (obviousness) "lends itself to several basic factual inquiries." This was a dramatic reversal of 150 years of precedent history that treated the questions of patent validity as questions of fact. 
Nevertheless Graham's language left ambiguity "whether the Court meant to indicate that obviousness is a factual conclusion drawn
from evidentiary findings or a legal conclusion based on factual inquiries." Subsequently, lower courts clarified this issue:
although the determinations relating to the scope and content of the prior art, the differences between prior art and the patented object, and the level of skill in the relevant art are factual in nature (and left to a jury), the ultimate conclusion of obviousness is one of law (decided by a judge)... A finding of obviousness under section 103 therefore constitutes a finding that a group of individuals were capable of making the same improvement in the prior art as was made by the patentee.
1984–2006: Teaching-suggestion-motivation test.
At the same time the newly established United States Court of Appeals for the Federal Circuit, which was supposed to establish a uniform case law for patent validity appeals, started to reject the "unusual and surprising approach" altogether and introduced the "teaching, suggestion and motivation" (TSM) test in "ACS Hosp. Sys. (1984)". The test allowed the rejection of a patent for obviousness only when factual teaching, suggestion or motivation from the prior art show the propriety of the patented combination. 
Further, the combination of previously known elements can be considered obvious. As the Federal Circuit asserted in "Winner Int'l Royalty Corp. v. Wang", there must be a suggestion or teaching in the prior art to combine elements shown in the prior art in order to find a patent obvious. Thus, in general the critical inquiry, the Federal Circuit maintained, is whether there is something in the prior art to suggest the desirability, and thus the obvious nature, of the combination of previously known elements.
This requirement is generally referred to as the "teaching-suggestion-motivation" (TSM) test and is said to serve to prevent against hindsight bias. As almost all inventions are some combination of known elements, the TSM test requires a patent examiner (or accused infringer) to show that some suggestion or motivation exists to combine known elements to form a claimed invention. Some critics of the TSM test have claimed that the test requires evidence of an explicit teaching or suggestion to make a particular modification to the prior art, but the Federal circuit has made clear that the motivation may be implicit, and may be provided for example by an advantage resulting from the modification. In other words, an explicit prior art teaching or suggestion to make a particular modification is sufficient, but not required for a finding of obviousness.
The TSM test is actually more similar to the requirement for novelty than for non-obviousness. Despite an immediate and overwhelming uproar in the technical and legal communities criticizing TSM as being too low, the Congress did not act to overturn the TSM standard. However, its application was refined by the US Supreme Court in "KSR v. Teleflex" (2007).
2006 to the present: the post-KSR period.
As of 2016, the guidelines for establishing a "prima facie" case obviousness adopted by the USPTO based on the KSR v Teleflex decision are as follows:
The KSR decision has been criticized because it apparently replaced the requirement of non-obviousness with the requirement of non-predictability, thus making it more difficult to get patents in the predictable arts, and creating a contradiction with some Graham's factors such as "failures of others".
The Graham and KSR guidelines were not affected by the America Invents Act, despite the change in general rule 35 U.S.C. §103 which defines the non-obviousness requirement effective on March 16, 2013:
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