Secondary Factors vs Objective Indicia of Nonobviousness

by Dennis Crouch

I wrote earlier about the Supreme Court petition in Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc. (Supreme Court 2021) that focuses on secondary considerations of non-obviousness such as commercial success and long-felt un-met need.  There has been a small movement over the years to refer to these as “objective indicia of nonobviousness” as opposed to secondary considerations.  That movement did not arise with the Supreme Court.  Rather, the Supreme Court has repeatedly referred to these as “secondary factors” or “secondary considerations” of non-obviousness.  It did so in both Graham (1966) and again in KSR (2007).  In KSR, the court particularly suggested that they have a role in negating obviousness — effectively as rebuttal evidence. “Teleflex has shown no secondary factors to dislodge the determination that claim 4 is obvious.”  In Amarin, the patentee is arguing that commercial success and the other factors should not be relegated to rebuttal evidence but rather be used on-par with the other Graham factors.

I wanted to see what language courts have been using and so pulled up the 2,500+ Federal Court decisions since 1966 that talk about either objective indicia or secondary considerations (or both). [Search strings below].  The results.  Most cases — about 2/3 — follow Graham and speak of “secondary considerations.” Another 13% are what I call “overlapping” and use forms of characterizing the analysis.  Finally, 20% speak in terms of “objective indicia.”  The charts below shows these results along with the time series.

* To find the cases, I used Westlaw and limited the search to only patent-cases.  For “objective indicia” cases, I looked within the opinin (OP) for (“objective indicia” or “objective factors”) /s (obvious! or nonobvious!).  For “secondary considerations” cases, my search string was (“secondary factors” or “secondary conditions”) /s (obvious! or nonobvious!).  Note – there are some problems with attempting longitudinal studies with Westlaw for several reasons, including changes in how cases are recorded and coded within the service.

14 thoughts on “Secondary Factors vs Objective Indicia of Nonobviousness

  1. 5

    I wonder if the same data displayed by author of opinion would reveal anything interesting (like an author changing how they presented the issue, or conversely, if no author ever changed how they presented the issue).

  2. 4

    How can any construct of a human being- even a legal fiction like PHOSITA- be considered purely objective? It’s nonsensical. How can the word “success” be considered an objective concept? More nonsense.

    Much of the trouble is in the auspices; which art is the art for the purposes of the inquiry. That means a formal step to construct the invention, which now lacking, is done by a completely subjective Alice “analysis”.

    1. 4.1

      Is “success” any less subjective than “common sense”? Or less subjective than the “the inferences and creative steps that a person of ordinary skill in the art would employ”?

    2. 4.2

      Oh come on, Martin. Seriously? Consider the difference between the objective and subjective assessment of what was disclosed over the table, between buyer and seller. Subjective is what the seller understood. Objective is what the alert, intelligent and well-informed, disinterested by-standing “fly on the wall” understood was disclosed.

      The PHOSITA is that fly on the wall, no?

      1. 4.2.1

        MaxDrei,

        You should be (well) aware by now that Marty does not like to use words as understood by those ‘in the terrain’ of patent law.

        His views depend on misusing the words.

  3. 3

    OT but re the complaints here that that IPR decisions err to strongly on the side of petitioners [as should expected to some extent for those petitions that presented a strong enough argument have been granted an IPR trial]. But note that even for fully tried IPRs the Fed. Cir. has several time reversed favorable decisions for patent owners against petitioners. The latest is Canfield Scientific, Inc. v. Melanoscan, LLC, 19-1927 — in an opinion by Judge NEWMAN, no less. The Federal Circuit overturned an IPR decision that Melanoscan’s claims were patentable. Canfield had argued that the USPTO erred by refusing to consider its arguments and evidence concerning whether the device would have been obvious over a combination of references.

    1. 3.1

      Also the recent CAFC reversal of a PTAB IPR decision finding patentable claims directed to using photography to scan for skin conditions based on a test of motivation to combine inconsistent with KSR: Canfield Scientific, Inc. v. Melanoscan, LLC, Fed. Cir., No. 19-1927, 2/18/2021

  4. 2

    I believe that this is the type of data that should be normalized for the ordinate values. The focus of the presentation including time effects (without normalization) introduces a hidden complication that your annual pool is nowhere near constant. The “pretty picture” can be — and should be — made more accurate.

  5. 1

    Dennis, your post reminds me of logic and the hoary old example: All dogs have a tail. That animal has a tail. Therefore that animal is a dog.

    All secondary considerations are objective indicia. A TSM is an objective indicium of obviousness. Therefore, when enquiring into whether any given claim coves matter that is obvious, a TSM is to be seen as no more than a “secondary” consideration.

    If the courts and the litigators cannot free themselves from the mindset that objective = secondary, it’s no wonder that, in the USA, everybody mistakenly supposes that the primary enquiry into obviousness is irredeemably subjective. It isn’t.

    1. 1.1

      Do we “mistakenly suppose” that the Supreme Court in KSR established “that the primary inquiry into obviousness is irredeemably subjective”?

      1. 1.1.1

        Indeed, TSM was poorly argued and understood. IMHO, TSM was just a framework to say – objective evidence – objective evidence in creating a trial record that is subject to review on appeal. Inasmuch as Doubert applies to any expert testimony, it must have a some basis in evidence, in order too, at least one some level, objectively challenge said expert opinion. Meh, Breyer probably understood that much when he said TSM was ok, but then tossed it out with the “common sense” to combine. Which is not objective – it is subjective. And subjective evidence is not so much evidence as just rank naked opinion. To make KSR worse, the court could apply common sense to combine, as Breyer did in the case. I hope my post concerning Marconi gets thru the screen blocker.

        1. 1.1.1.1

          Indeed!

          That legal fiction, the skilled person, is deemed to have compendious knowledge of the content of a prior art universe. No one real human engineer or scientist has the same knowledge base as the imaginary PHOSITA.

          How flimsy is it then dear Justices, for you to rely for your decision on what you invoke as the “common sense” possessed by the PHOSITA? It strikes me that such reliance is nothing more than a “smoke and mirrors” trick to camouflage your purely subjective judgement. Shame on you, I say.

          1. 1.1.1.1.1

            The Shame goes deeper — and as has been discussed for several years now, the Supreme Court did not like that they were punched in the nose (with their fingers therein) when Congress rebuked them with the Act of 1952 and removed their “Gist of the invention” (and multitude of similar sounding phrases) and replaced their Common Law writing ‘finger in the Wax Nose of eligibility’ with 35 USC 103.**

            The shame is NOT just inserting subjectivity, it is inserting THEIR subjectivity.

            ** the rebuke also involved Flash of Genius, expanding “process” to include not only the legal notion of process as “art,” but to open process up to be methods, and the permissive ability to use terms sounding in function.

    2. 1.2

      Word.

      And then see all the decisions where the “judges” “find” that “secondary considerations” can’t overcome a “strong” prima facie case of obviousness.

      Ridiculous.

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