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12 September 2023FeaturesBig PharmaJeffrey Lewis and Stuart Knight

Is there a step between ‘inventive’ and ‘nonobviousness’?

US law requires a patented invention be nonobvious, ie, a patent may not be obtained “if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious … to a person having ordinary skill in the art to which the claimed invention pertains.” 35 U.S.C. 103.

The European Patent Office (EPO), on the other hand, requires that patents be “granted for any invention … provided they … involve an inventive step”; inventive step—like nonobviousness—is defined as “having regard to the state of the art, [the invention] is not obvious to a person skilled in the art.” European Patent Convention (EPC), Articles 52, 56.

The UK adopts similar language. Patents Act 1997, §§1(1)(b), 3; see also TRIPS, Article 27.1 and Note 5.

Despite their common language, there are meaningful differences between the nonobviousness and inventive step requirements. Practitioners should be aware of the differences that have emerged from the case law and published guidelines.

Nonobviousness and inventive step frameworks

Courts and patent offices in these jurisdictions have developed different frameworks for making nonobviousness and inventive step determinations. The seminal US 1966 case of Graham v John Deere applies a four-step approach to determine nonobviousness: (1) a court determines the scope and content of the prior art; (2) it then ascertains the differences between the prior art and claims at issue; (3) while considering the level of ordinary skill for the pertinent art; and (4) against this background, analyses whether the subject matter as claimed is obviousness. 383 U.S. 1, 17 (1966).

The UK’s Windsurfing/Pozzoli framework adopts a different approach, although there is overlap: a court (1) identifies the notional person skilled in the art and the relevant common general knowledge of that person; (2) identifies the inventive concept of the claim in question or, if it cannot, construes the claim; (3) identifies what, if any, differences exist between matter cited as forming part of the “state of the art” and the inventive concept of the claim or claim as construed; and (4) views without any knowledge of the alleged invention as claimed, whether those differences constitute steps which would have been obvious to person skilled in the art. Pozzoli SPA v BDMO SA [2007] EWCA Civ 588.

At heart, both the US and UK frameworks require that a court consider the differences between the prior art and the claimed invention before making an obviousness determination—but there are many differences.

For example, UK law focuses on the “inventive concept” while in the US courts focus on the “claims at issue”. The “inventive concept” may, arguably, permit a court or party to rely on the specification to a greater extent than occurs when the US looks at the “claims at issue” during obviousness determinations. By way of further example, the UK imports “common general knowledge” into the mind of the notional person skilled in the art, a concept that is less familiar in the US.

That is not an insignificant difference: “[o]ne cannot overstate the importance of the notion of common general knowledge. It is central to everything that is required of the hypothetical skilled person.” UK Manual of Patent Practice, §3.29.

As the UK manual notes, this can include information found by ordinary research techniques and internet searches (§3.30.0) even if they are so complex that no skilled worker could possibly be expected to know even a fraction of the available information (§3.30.1) so long as it is common general knowledge in the UK (§3.30.3).

There are more significant differences with the EPO’s problem-solution approach. The EPO requires starting with the closest prior art and objective technical problem to be solved before determining whether the claimed invention would be obvious to a skilled person. Guidelines for Examination in the EPO, Part G, VII at 5. US practitioners may analogise this to the “lead compound” approach set out in Otsuka Pharm Co v Sandoz (678 F.3d 1280 Fed Cir (2012)), which sets forth a two prong inquiry for determining whether a new chemical compound would have been obvious by first selecting one or more lead compounds for further development, and then asking whether the prior art supplied sufficient motivation to modify the lead compound to arrive at the claimed compound with a reasonable expectation of success.

Notably, the EPO’s problem/solution approach may result in a different outcome compared to the US and UK frameworks where, for example, the problem itself is nonobvious—so if identifying the problem is the invention (eg, once the problem is identified then the solution is obvious) it could mean that the EPO would uphold a patent whereas the US and UK would continue the inquiry into whether the problem itself was an apparent issue to those skilled in the art at the time of invention. The EPO, like the UK, also permits using common general knowledge.

The body of prior art

Moreover, what constitutes “prior art” varies across the US, EPO, and UK. In the US, prior art must be analogous to the art of the claimed invention. This requires that the prior art be either from the same field of endeavour (regardless of whether it addresses the same problem) or be reasonably pertinent to the particular problem which the inventor was trying to solve. In re Bigio, 381 F.3d 1320 (Fed Cir 2004).

Practically speaking, however, this shapes the nonobviousness analysis only in limited circumstances, particularly in light of the Supreme Court’s continued emphasis of “flexible” patent law tests. See, eg, KSR Int’l v Teleflex, 550 US 398 (2007).

The UK and the EPO are seemingly less restrictive, requiring that prior art constitute all matter available to the public. Patents Act 1997, §2(2); EPC, Article 54(2). As Judge Laddie explained, under UK law “[a] real worker in the field may never look at a piece of prior art[,] for example he may never look at the contents of a particular public library or he may be put off because it is in a language he does not know,” “[b]ut the notional addressee is taken to have done so.” Pfizer Patent [2001] FSR 16.

The EPO adds a further limitation: the prior art must concern “such kind of information as is relevant to some field of technology.” Guidelines for Examination in the EPO, Part G, VII at 2.

Combination of references

Once the body of material that constitutes prior art has been determined, each law treats the circumstances under which references may be combined to show obviousness or lack of inventive step differently.

In the US, it is common for parties to combine references to create a claimed invention, thereby rendering it obvious. To do so, the person of ordinary skill in the art must have been motivated to combine references with a reasonable expectation of success.

The US adopts a flexible approach when considering whether there was a motivation to combine; an explicit teaching, suggestion, or motivation in the references themselves is not necessary. KSR Int’l.

Similarly, while the problem/solution approach starts with a single prior art reference, the EPO permits the combination of that reference with additional prior art where obvious to do so; the EPO normally considers it obvious to combine a reference with a well-known or standard textbooks in the relevant field (ie, common general knowledge) or where there is a clear and unmistakable reference to the other. Guidelines for Examination in the EPO, Part G, VII at 6. Contrary to the US, the EPO considers that where references would not be combined “in practice,” such combinations are not normally regarded as obvious. In fact, the EPO may consider the need to combine more than one piece of prior art to arrive at a combination of features as an indication that the invention has an inventive step.

As with the EPO, the threshold to combine prior references in the UK seemingly is higher than in the US, with (as is phrased in the UK) “mosaicking” permitted only where the pulling together of information would itself have been an obvious consequence of the prior art’s disclosure, such as either by an express cross reference or the prior art directing the skilled person to use a disclosure for a particular purpose and it would be obvious where and how to find other details in order to do so. UK Manual of Patent Practice, §3.4.

The use of common general knowledge in the EPO and UK may explain, at least in part, the higher threshold to combine prior art compared to the US.

Objective indicia

Objective indicia of nonobviousness, including secondary considerations, may also play a role in nonobvious/inventive step determinations before the US, EPO, and UK, although to varying degrees. In the US, objective indicia may include, but is not limited to, evidence of unexpected results, teaching away, and secondary considerations, such as commercial success, long felt but unsolved needs, and failure of others.

Secondary considerations are thought to give light to circumstances surrounding the origin of the patented subject matter, being secondary only in time and not in importance. Howard T Markey, Special Problems in Patent Cases, 57 J. Pat. Off. Soc’y 675, 684 (1975) (Reprint of speech before a Judges’ Seminar on October 16, 1974).

Indeed, these “objective guideposts” are considered in the US to be a means to protect against hindsight and must be considered when offered. WBIP v Kohler, 829 F.3d 1317, 1328 (Fed Cir 2016).

Before the EPO, secondary indicia may likewise be considered, such as technical known prejudice, long felt need, commercial success, market competitor’s efforts, and surprising effect, but are only considered important “in cases of doubt.” Case Law of the Boards of Appeal, §I.D.10.

As such, they remain mere auxiliary considerations; the EPO considers a mere investigation for indications of the presence of inventive step is no substitute for a technically skilled assessment of the claimed invention. The UK likewise considers objective indicia, such as long felt want and commercial success, but typically with less fanfare than the US.

Obvious-to-try

Finally, “obvious-to-try” tests are present in all three jurisdictions, with significant overlap. In the US, the fact that a combination was obvious to try might show that it was obvious. A party advancing an obvious-to-try theory must establish a design or market need to solve a particular problem, and show that there are a finite number of identified, predictable solutions that would lead to an expectation of success. Grunenthal v Alkem Labs, 919 F.3d 1333, 1345 (Fed Cir 2019).

Similarly, in the EPO a course of action can be found obvious if the skilled person would have carried it out expecting some improvement or advantage having a reasonable expectation of success. Case Law of the Boards of Appeal, §I.D.7.1.

Likewise, the UK considers whether it would have been obvious to undertake a specific piece of research which had a reasonable or fair prospect of success. The UK Supreme Court recently articulated a list of relevant considerations when determining whether there would have been a reasonable or fair prospect of success, including the routine nature of research, the burden and cost of research, the existence of alternative or multiple paths of research, and the motives of the skilled person. Actavis Group PTC EHF & Ors v ICOS & Anr [2019] UKSC 15 (March 27, 2019).

Conclusion

So is there a step between inventive and nonobviousness? Despite the common language across the pertinent statutory provisions, real differences have emerged as these provisions have been developed by the courts and published guidelines. Those differences call for careful consideration when patents are involved in multi-jurisdictional prosecution and litigation.

Jeffrey Lewis is a partner at Foley Hoag. He can be contacted at:  jidlewis@foleyhoag.com

Stuart Knight is a senior associate at Foley Hoag. He can be contacted at:  sknight@foleyhoag.com

The views expressed are solely those of the author and should not be attributed to their firm or any clients of the firm.

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Big Pharma
17 January 2023   The pharma company’s arguments focusing on ‘inventive step’ failed to convince a London court that the Israeli generic drug maker had infringed, explains Azadeh Vahdat of EIP.
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9 November 2020   Plausibility in the context of the inventive step and sufficiency requirements can be a contentious issue before the European Patent Office. Markus Grammel of Grünecker reports.

More on this story

Big Pharma
17 January 2023   The pharma company’s arguments focusing on ‘inventive step’ failed to convince a London court that the Israeli generic drug maker had infringed, explains Azadeh Vahdat of EIP.
Europe
9 November 2020   Plausibility in the context of the inventive step and sufficiency requirements can be a contentious issue before the European Patent Office. Markus Grammel of Grünecker reports.

More on this story

Big Pharma
17 January 2023   The pharma company’s arguments focusing on ‘inventive step’ failed to convince a London court that the Israeli generic drug maker had infringed, explains Azadeh Vahdat of EIP.
Europe
9 November 2020   Plausibility in the context of the inventive step and sufficiency requirements can be a contentious issue before the European Patent Office. Markus Grammel of Grünecker reports.