The inventive step and non-obviousness reflect a general patentability requirement present in most , 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 Prior art".Barton, John H. (2003)
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.
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".Merges and Duffy, , p. 622 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." Ch.III Merges and DuffyMerges and Duffy, p.671 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?"
1) "The nonobviousness standard has the ironic effect of turning progress in the pharmaceutical sciences against itself because the standard withholds patent protection from drugs based on the scientific advances that allowed researchers to identify them as ones that are likely to be effective." Pharmaceutical companies "frequently abandon promising drug candidates on account of perceived weaknesses in their patent protection." "The problem of obvious—and thus unpatentable—drugs promises to grow worse over time because the nonobviousness requirement, almost by definition, turns progress in the pharmaceutical sciences against itself; that is, it denies patent protection to new drugs based on the very advances in science that led to their discovery." "The real problem is the nature of the nonobviousness requirement itself, which withholds patent protection from the drugs that appear most promising in early research and penalizes progress in the pharmaceutical sciences. Given these strange tendencies within the doctrine, it is not surprising that drug researchers frequently encounter the nonobviousness requirement as a barrier to patenting their discoveries."http://heinonline.org/HOL/LandingPage?handle=hein.journals/tlr87&div=19&id=&page= "The social costs of losing such drugs likely far outweigh any benefits to the public from faster access to inexpensive generics of the unpatentable drugs that actually reach the market." "Whenever the patent rules prevent the introduction of a new drug or therapy, or even just delay it, as may be happening with finasteride (for preventing prostate cancer), the injury to the public can be severe." "Current patent policy, which withholds patent protection from drugs because they lack novelty or are obvious, therefore poses a substantial threat to the public's well-being." "the patent standards suppress pharmaceutical innovation by limiting patents to innovative new ideas for drugs such that the system offers no incentive for the development of socially valuable drugs that were disclosed or made to look promising in earlier publications." /ref>
Also, it has been suggested that "since the FDA's clinical-trial requirements are the reason why firms rarely develop drugs without protection from generic competitors", the FDA should be able to administer the reward of exclusivity with the need for that protection, offering a convenient fix for the patent system's inadequacies in promoting drug development."Roin BN (2008). Tex L Rev 87:503.
2) The fact that an inventor's own disclosures can be used as a prior art—not only for novelty but also for non-obviousness analysis—forces both for-profit and not-for-profit (since the Bayh-Dole Act in the USA) business to delay (or to completely stop) dissemination of their research findings, complicates collaborations between different institutions, and gets in the way of the patents' constitutional purpose" to promote Progress of Science".
3) Very often the original patent on the invention, that has a very strong inventive step representing a major breakthrough invention, is filed more than 20 years before the commercialization of its technology commences, and the original inventors do not reap the fruits of their invention. Instead, people who came up later (closer to the start of the commercialization) with incremental improvements to the original technology, with such improvements have much weaker inventive step(s), get a better chance to monetize their invention(s). A famous example of such situation is Vanadium Redox-Flow Battery technology, invented and patented originally by Pelligri and Spaziante in 1978 (UK Patent 2030349, Oronzio de Nori Impianti Elettrochimici S.p.A., 1978) but not widely commercialized until ca 2017.Journal of Power Sources 431(2019)239-249 DOI: 10.1016/j.jpowsour.2019.05.035
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.E.W. Kitch. The Nature and Functioning of the Patent System. 20 J.L.& Econ.265, 284 (1977) Also, many countries have, in addition to patents, , 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).
/ref>). Also, unique to the USA 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 Kodak, 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."Innovation, Science and Economic Development Canada, A Study on the Patent Law Standard of Non-obviousness: Chapter 3 . The US Supreme Court, however, has criticised the patent agency for failing to follow the same standards as the courts:
It 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." Graham v. John Deere Co., 383 U.S. 1, 18 (1966).
The Supreme Court of Canada affirmed the test for non-obviousness laid out in Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd. Windsurfing International Inc. v. Tabur Marine (Great Britain) Ltd., 1985 RPC 59 (CA). 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 http://www.lambertlaw.ca/patent_process.html:
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 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 right date valid for the claim under examination.
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): 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.
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.
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. /ref> 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. /ref> 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." 340 U.S. at 152-53; Duffy p. 671. 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".In re Antonie - Federal Circuit, 1977.
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: "Only 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 thoughthttp://heinonline.org/HOL/LandingPage?handle=hein.journals/cathu43&div=23&id=&page= 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.
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.
In Graham v. John Deere Co.,383 U.S. 1 (1966). 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."In Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530 (Fed. Cir. 1983)
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."see Dann v. Johnston
During this period, other courts have considered additional secondary considerations as well (in the order on importance according to Judge Learned Hand:Patent Law and Policy: Cases and Materials*** 4th Edition, by Robert Patrick Merges and John Fitzgerald Duffy. (2007 LexisNexis)
1) long felt need for a solution to a real problem which has been recognized in the prior art or in the industry.Railroad Dynamics, Inc. v. A. Stucki Co., in Edoco (1970)
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.In Panduit (Fed. Circ. 1985), Hardinge Bros. v Marr Oil Head Mach. Corp. (7th Circ. 1928), Bethlehem Steel (CCDNJ 1909), Eli Lilly &Co. v Generix Drug Sales (5th Circuit, 1972), United States v Ciba-Geigy Corp. (DNJ 1981)
4) skepticism or disbelief before the invention as an indicator of non-obviousness.In Environmental Designs, Ltd. v. Union Oil Co. of Cal., 713 F.2d 693, 697-98, 218 USPQ 865, 869 (Fed. Cir. 1983)
5) copying, praise, unexpected results, and industry acceptance as indicators of non obviousness.In Allen Archery, Inc. v. Browning Mfg. Co., 819 F.2d 1087, 1092, 2 USPQ2d 1490, 1493 (Fed. Cir. 1987)
6) copying as an indicator of non-obviousnessIn Diversitech Corp. v. Century Steps, Inc., 850 F.2d 675, 679, 7 USPQ2d 1315, 1319 (Fed. Cir. 1988) and Panduit Corp. v. Dennison Manufacturing Co. (1985) (However, merely copying, without a connection to the copier's views of the claimed invention, or the claimed features of the invention is not indicative of non-obviousness)
7) commercial success.In Edoco (1970)
8) unexpected advantages.In Hybritech, Inc. v Monoclonal Antibodies, Inc. (FC 1986)
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.
Further, the combination of previously known elements can be considered obvious. As the Federal Circuit asserted in Winner Int'l Royalty Corp. v. Wang,202 F.3d. 1340, 1348 (Fed. Cir. 2000). 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.See In re Kahn, (Fed. Cir. 2006). 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 (2006).
|change in the “principle of the machine” (Evans, 1822)|
|unusual or surprising consequences (Great Atlantic, 1950)|
|Only when the whole in some way exceeds the sum of its parts is the accumulation of old devices patentable." (Great Atlantic, 1950)|
|Non-predictable results from a substitution/combination (reversed Adams)|
|Synergism from a combination (reversed Adams).|
|skepticism or disbelief before the invention (Environmental Designs, 1983). Failure of others (Graham)|
|copying, praise, unexpected results, and industry acceptance. Allen Archery, 1987. Commercial success (Graham).|
|Non-predictable result(s) even if the combination involves known elements and methods, and better yet if an element or a method is new.|
|Non-predictable result(s) of a substitution.|
|Use of a technique to improve dissimilar devices (methods, products) even if the technique is known in another field|
|If the solution is unpredictable and found experimentally, and better yet, if the very existence of a solution (suitable range) is unpredictable.|
|Use of a technique, even if known in another field, to improve dissimilar devices (methods, products) if "the actual application is beyond his or her skill" (KSR) =i.e. variations are unpredictable.|
|Long felt but unsolved needs (Graham) unless these needs are solved by a newly publicly disclosed method (with a predictable claim range)|
|unless the actual application is beyond PHOSITA's skill...(Sakraida)|
|commercial success (Graham)|
|commercial success (Graham)|
|the elapsed time between prior art and the patent's filing date (Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1350 (Fed. Cir. 2013))|
|Prior art teaches away from the claimed solution.|
|commercial success (Graham, 1966)|
|long felt need for a solution to a real problem which has been recognized in the prior art or in the industry.(Graham)|
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".Christopher A. Cotropia, Predictability and Nonobviousness in Patent Law After KSR, 20 MICH. TELECOMM. & TECH. L. REV. 391 (2014).
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: