Respect Please: Objective Indicia or Secondary Factors.

by Dennis Crouch

Amarin Pharma, Inc., v. Hikma Pharmaceuticals USA Inc. (Supreme Court 2021)

Obviousness is the key, the core, and the central doctrine of our US utility patent system.  The Supreme Court’s doctrine in Graham v. John Deere (1966) and KSR v. Teleflex (2007) serve as the pillars along with the statutory language from the 1952 Patent Act.

A patent for a claimed invention 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 before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

35 U.S.C. § 103.  Of course, in deciding Graham, the Supreme Court wrote that the new Section 103 ““was intended to codify judicial precedents” such as ” Hotchkiss v. Greenwood, 52 U.S. (11 How.) 248 (1851) and its progeny.

In a bench trial, the district court invalidated Amarin’s patent covering a drug treatment for hypertriglyceridemia — finding the claims obvious over a combination of prior art references that had been previously considered by the USPTO.  On appeal, the Federal Circuit affirmed without opinion (R.36).  Now, the patentee has filed a petition with the US Supreme Court asking for clarification of the Graham analysis.  In particular, what is the role of the objective indicia of non-obviousness.  We sometimes call these “secondary factors” — and that is the focus of the particular dispute. Does the Federal Circuit err when it (sometimes) relegates the objective indicia to a secondary status.

This Court has made clear that objective indicia must be considered along with the other factors before concluding that any invention is obvious, so that real world indicators—which are often the strongest evidence of nonobviousness—may guard against the risk that patents will incorrectly appear obvious in hindsight.

The Federal Circuit has improperly relegated objective indicia of nonobviousness to a secondary role. Under the Federal Circuit’s framework, a court first considers only the three technical Graham factors and reaches a conclusion of “prima facie” obviousness. Only then does the court consider objective indicia, merely as a basis for rebutting a conclusion already reached. The result is over-invalidation of patents through hindsight bias and the suppression of innovation.

The question presented is: Whether a court must consider objective indicia of nonobviousness together with the other factors bearing on an obviousness challenge before making any obviousness determination.

[Petition for Certiorari]

The key case in point is likely Goodyear Tire & Rubber Co. v. Ray-O-Vac Co., 321 U.S. 275 (1944).  In its decision, the Supreme Court explained that the patented “leakproof dry cell for a flash light battery” was within a crowded art which suggested that invention was obvious — especially when “viewed after the event.”   But, the court looked also to the long-felt unmet need before negating patentability:

During a period of half a century, in which the use of flash light batteries increased enormously, and the manufacturers of flash light cells were conscious of the defects in them, no one devised a method of curing such defects. Once the method was discovered it commended itself to the public as evidenced by marked commercial success. These factors were entitled to weight in determining whether the improvement amounted to invention and should, in a close case, tip the scales in favor of patentability. Accepting, as we do, the findings below, we hold the patent valid and infringed.

Id. Goodyear was a 5-4 decision written by Justice Owen Roberts. Justice Hugo Black dissented with a quote from a 19th Century Court decision: “a shadow of a shade of an idea.” A. Works v. Brady, 107 U.S. 192 (1883) (“It was never the object of [the patent] laws to grant a monopoly for every trifling device, every shadow of a shade of an idea, which would naturally and spontaneously occur to any skilled mechanic or operator in the ordinary progress of manufactures.”).  Black wrote:

If the patentee here has ‘discovered’ anything, it is that the creamy substance in a dry cell will not leak through a steel jacket which covers and is securely fastened to the ends of the cell. For that alleged discovery this patent is today upheld. I do not deny that someone, somewhere, sometime, made the discovery that liquids would not leak through leak-proof solids. My trouble is that, despite findings to the contrary, I cannot agree that this patentee is that discoverer. My disagreement is not based solely on the narrow ground that the record shows previous patents have been issued to others who put jackets of metal and other substances around dry cells. Antiquarians tell us that the use of solid containers to hold liquids predated the dawn of written history. That the problem of the quality and strength of the walls of such containers was one to which ancient people turned their attention appears from the widespread currency at an early age of the maxim that ‘new wine should not be put in old bottles.’ It is impossible for me to believe that Congress intended to grant monopoly privileges to persons who do no more than apply knowledge which has for centuries been the universal possession of all the earth’s people—even those of the most primitive civilizations.
Goodyear, dissent by Justice Black. Justice Robert Jackson also wrote a short dissent in Goodyear arguing that the patentee had not proven sufficient nexus between the invention’s merits and the product’s commercial success.  Rather, at the time there was a war going on that also drove business.

 

41 thoughts on “Respect Please: Objective Indicia or Secondary Factors.

  1. 7

    It seems that if SCOTUS was interested in these issues, they would’ve granted cert for Samsung in 2017. The CAFC’s en banc decision there leaned rather heavily (though supposedly not entirely) on secondary considerations such “mobile device with touch screen GUI” + “touch screen GUI with slide to unlock” was a non-obvious combination.

    1. 7.1

      It seems that if SCOTUS was interested in these issues, they would’ve granted [fill in the blank]”

      That ‘[fill in the blank]’ kind of exposes the fact that SCOTUS is NOT interested in actually promoting innovation (as much as they are for wanting the power to stick their finger into the Wax Nose of ‘law as they see fit to REwrite.’

      It is a massive mistake to think that the Supreme Court is not acting in accord with their own agenda.

  2. 6

    It seems to me that the trouble with the CAFC’s treatment of secondary indicia is that they are treated as less than secondary considerations. My impression is that time and time again, secondary indicia are presented, and the courts treatment of them seems to be to just dismiss them while paying lip service to the fact that they have been considered. The hurdles to climb to get the secondary considerations to count and to show that there was a “nexus,” just seem to increase, and then even when it seems like the hurtle has been successfully climbed, the CAFC just says, ya… but the evidence of obviousness is too overwhelming. There just does not seem to be a case where the current CAFC thinks that the secondary considerations make a difference. It seems to me that it is not enough just to establish rules for whether they should be considered with the rest of the evidence as a whole or an after thought, whichever way they are considered, if they essentially make no difference, they are less then secondary, and the rules for how to consider them is just mental gymnastics. If they were truly at least secondary considerations, they would make a difference a bit more often, no matter which way they were considered. However, that is just my impression, rather than a scholarly analysis of all the cases in which secondary considerations, which seemed reasonably solid, were presented and in the end did not make a difference.

    1. 6.1

      I’m going to be provocative here, OK.

      The judges can’t “handle” obviousness. All they have, to decide it, is there own prejudice, dressed up as “common sense”. But they are required to deliver a reasoned opinion. That’s quite often a task almost beyond them. That’s where the “secondary factors” come it.

      In a 50:50 situation, where the Justices haven’t the foggiest idea whether, not for them but for the PHOSITA, the claimed subject matter was or was not obvious, the trump card they cast around for, to get themselves out of the hole, their “Get Out of Jail Free” card, is the one labelled “objective indication”.

      It’s all very unsatisfactory, and renders 50:50 cases almost unlitigatable. But in a properly functioning patent system, the ONLY cases that should go to trial are those that are 50:50 on obviousness. Not just unsatisfactory then. More like absurd.

      That’s the Problem, but what’s the Solution? Bring back TSM. But do it strictly, predictably, rigorously. Don’t be bashful: copy how they do it at the EPO.

      I did say I was going to be provocative.

      1. 6.1.1

        You use the word “provocative.”

        I do not think that you understand what that word means.

        You being a shill for EPO-Uber-Alles for the umpteenth time does not qualify as provocative.

      2. 6.1.2

        “what’s the Solution? Bring back TSM. But do it strictly, predictably, rigorously. Don’t be bashful: copy how they do it at the EPO”

        So you suggest judges can’t be trusted with obviousness, but they should be trusted with selectively ignoring elements of the claim. That seems like getting out of the frying pan and into the fire.

        1. 6.1.2.1

          Ben, what EPO PSA does is to impose on the obviousness debate a strict structure. That structure exposes, even for a judge, what is obvious and what is not. Now that the EPO has made it compulsory to use video in all its trials, you can watch for yourself. I recommend it.

          1. 6.1.2.1.1

            MaxDrei,

            You should be familiar (by now) that our Royal Nine do not want any type of bright line “strict structure.”

            They “fear” the ‘scriviner’ who would take that strict structure and ‘manipulate‘ around it (because the scriviners on the side of those seeking innovation protection are immensely better than the scriviners in the black robes).

            1. 6.1.2.1.1.1

              Good point, anon. Judicial economy. In every sovereign jurisdiction.

              Keep strictures, constraints, prescriptive rules to a minimum. Maximise wiggle room. It’s the instinct of most every judge, high and low, but the higher they rise the more conscious of this point they become.

              That’s why they eschew defining such core terms as “invention”, “technology”, “useful arts” or for that matter “obvious”.

              1. 6.1.2.1.1.1.1

                Not sure that “judicial economy” is the correct word, as the desire to not be constrained appears to run to the opposite end of the spectrum, invoking uncertainty and practically a dependence for repeated trips to the chambers of the robed ones (to continue to feed that wax addiction).

                This “breaking the addiction” is a known feature of our Sovereign’s Act of 1952, which pulled the “Common Law treatment” of Gist of the Invention (and multitudes of similar words) from the judiciary, and in its place crafted our 35 USC 103. See the writings of the architect of that Legislative process: Giles Rich.

  3. 5

    In Truswal Systems Corp., the Fed. Cir. explained that “secondary considerations,” which usually arise subsequent to the invention, are “secondary” in time. But that does not mean they are secondary in importance. Quoting Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983) (“evidence of secondary considerations may often be the most probative and cogent evidence in the record”).

  4. 4

    The key fact being ignored here is that the term “secondary considerations” is from the Supreme Court itself! What kind of weight is going to be given to statements of some CAFC judges who have complained about that?* Graham v. John Deere Co.,(1966) expressly uses this term for a specific list of things which could serve as evidence of nonobviousness.
    *What kind of odds do attorneys quote clients for cert petitions like this? Do paying clients ask, or care?

    1. 4.1

      Deep in the cert petition is another important fact here: “The district court held a seven-day bench trial.” In other words, the patent owner failed to ask for a jury trial, where some of it’s drug success story evidence might have been more effective.
      [On the other hand, should that not have made a Fed. Cir. review consideration of the D.C. 103 invalidation decision more appropriate than their mere Rule 36 affirmance?]

    2. 4.2

      Paul,

      You seem to be putting an undue emphasis on the ‘key fact’ that the explicit words were written by the Supreme Court, as if it were that branch of the government designated by the Constitution to have authority to write patent law.

  5. 3

    From the petition it seems probable that folks can have differing views as to what the Federal Circuit actually does when applying secondary considerations, i.e., does it in practice 1) use them only as rebuttal evidence to a prima facie case of obviousness (as suggested by the question presented) or 2) apply them with equal weight to the other 3 Graham factors.

    I will not attempt to comment on the point of what happens in practice (or on the wisdom of any of the obviousness standards). But from a purely case law analysis as to what the court says about the issue, the Federal Circuit on numerous occasions has instructed that secondary considerations may NOT be merely used as a rebuttal to a prima facie case of obviousness. They must be considered in the totality of all four Graham factors BEFORE any conclusion on obviousness is reached.

    For example, in Lindeman Maschinenfabrick GMBH v. American Hoist and Derrick Co., 730 F.2d 1452 (Fed. Cir. 1984), the court reversed a finding that an invention was obvious because the district court erred in considering evidence of commercial success only from the perspective of whether that evidence overcame a showing of obviousness based on the prior art. The court explained:

    The district court correctly stated that commercial success cannot by ITSELF establish nonobviousness. However, having concluded that the claimed invention would have been obvious from the prior art, the court looked only to see whether the showing of commercial success was so overwhelming as to overcome that conclusion. That was error. All evidence must be considered BEFORE a conclusion on obviousness is reached.

    730 F.2d at 1461 (emphasis in original).

    Other cases to the same effect:

    Persion Pharm. LLC v. Alvogen Malta Operations Ltd., 945 F.3d 1184, 1194 (Fed. Cir. 2019) (rejecting the patentee’s argument that the district court improperly failed to consider the secondary considerations together with the other evidence on obviousness, the Federal Circuit noting that merely because the district court’s analyzed the secondary considerations, following its analysis of the prior art, that did not show that the district court had not considered the secondary considerations together with the other prior art evidence – “While the district court’s discussion of objective indicia follows its discussion of the asserted prior art, the substance of the court’s analysis makes clear that it properly considered the totality of the obviousness evidence in reaching its conclusion and did not treat the objective indicia as a mere ‘afterthought’ relegated to ‘rebut[ting]’ a prima facie case. Leo Pharm. Prods., Ltd. v. Rea, 726 F.3d 1346, 1357–58 (Fed. Cir. 2013); Cyclobenzaprine, 676 F.3d at 1075.”))

    Dako Denmark A/S v. Leica Biosystems Melbourne Party Ltd., 662 Fed.Appx. 990, __, 2016 WL 7030362, *4 (Fed. Cir. Dec. 2, 2016) (nonprecedential) (rejecting contention that the Board failed to consider all evidence of alleged secondary considerations before it made its conclusion that the claim was obvious – “… Reading the Board’s opinion in its entirety, it is clear that the Board properly considered all the evidence before coming to its ultimate legal conclusion. Indeed, in its opinion, the Board expressly evaluated Dako’s evidence of secondary considerations and appropriately considered it before ultimately determining that the claim was obvious. Therefore, we reject Dako’s arguments in this regard.”)

    Leo Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346, 1357-58 (Fed. Cir. 2013) (instructing the during inter partes reexamination the PTO must consider the secondary considerations together with all the evidence of obviousness and not just consider the secondary considerations as a rebuttal to a prima facie showing of obviousness – “Whether before the Board or a court, this court has emphasized that consideration of the objective indicia is part of the whole obviousness analysis, not just an afterthought. When an applicant appeals an examiner’s objection to the patentability of an application’s claims for obviousness, the PTO necessarily has the burden to establish a prima facie case of obviousness which the applicant then rebuts. However, during inter partes reexamination, the Board is reviewing evidence of obviousness—including objective indicia—submitted by two adversarial parties for the claims of an issued patent. Thus, the Board should give the objective indicia its proper weight and place in the obviousness analysis, and not treat objective indicia of nonobviousness as an afterthought.” – reversing obviousness rejection made during an inter partes reexamination)

    These cases appear to expressly refute the petitioner’s statement that “[o]nly then does the court consider objective indicia, merely as a basis for rebutting a conclusion already reached.”

    For those interested, there are more cases on this point collected in the Annotated Patent Digest at § 18:93 – Secondary Considerations are Part of the Obviousness Determination, They do Not Apply as Rebuttal Evidence.

    1. 3.3

      But see Ecolochem, Inc. v. Southern California Edison Co., 227 F. 3d 1361, 1375 (Fed. Cir. 2000) (“Ecolochem has, however, failed to rebut the conceded prima facie case of obviousness with regard to claim 20. We therefore affirm the district court’s conclusion that the invention of claim 20 would have been obvious.”).

      1. 3.3.1

        Would the fact that a party made an affirmative concession distinguish that case?

        1. 3.3.1.1

          I’m not sure – if the prima face/rebuttal concept didn’t apply in litigation, there would be nothing to concede. And you see this language in cases without such concessions. See, e.g., WMS Gaming, Inc. v. International Game Technology, 184 F. 3d 1339, 1359 (Fed. Cir. 1999) (“The objective evidence of non-obviousness may be used to rebut a prima facie case of obviousness based on prior art references.”) (citing PTO cases). It would be nice if the Federal Circuit said that the prima facie/rebuttal framework applies only to the PTO, but there are cases going both ways (it does and it doesn’t apply in litigation). Hence the cert petition.

          1. 3.3.1.1.1

            I think it to be reversed, as it is not a matter of ‘nothing TO concede” as it is a matter that a concession was made, and a party is held to their concessions.

            I tend to doubt that the case provides the rebuttal to the present thread that you think that it does.

            One party’s concession in one case does not — cannot — dictate an open ended binding rule on other parties in other cases (with those other parties NOT making any such concession).

            It’s like “admitted prior art” that turns out to NOT actually be prior art. Such non-prior art remains “prior art” to only the party making that admission. “Statements against interest” and all that…

            1. 3.3.1.1.1.1

              Did you take a look at the WMS case – the one that doesn’t involve any concession?

              1. 3.3.1.1.1.1.1

                Oops, no – thanks for emphasizing that.

                1. Yeah, the Federal Circuit has been pretty inconsistent in this area, which is why you see a lot of district court decisions applying the prima facie/rebuttal framework.

                2. So: Snowflake (aka Hall Monitor) says:

                  “I did tel Boundy — although not “made up stuff” — and in no uncertain terms. That’s one reason why he is so bu tt sore.”

                  So when you learn what “cite” means in the US legal system, although you will never get into a bona fide US law school, [a cite is not always to law but is often to the record for facts]. [what a maroon] … you can give us the cite. To the record. Not what we call decisional law, just to be clear. A cite to the written record.

                3. for this supposedly being a “rookie move,” YOU are making a similar mistake that Boundy made in thinking that blogs carry the same format and dialogue protocols that actions in the courts need to have.

                  It just isn’t so – and YOUR OWN lack of providing citations in your literally HUNDREDS of posts to and about me show my point to be true.

                  Your own game playing verifies my points.

                  Which is delicious, as you CONTINUE to seek to play games, and I profit off of your choices to do so.

                4. I LOVE your choice of posting with a false assertion of broken links.

                  It makes it so easy for posterity to judge your game-playing.

            2. 3.3.1.1.1.2

              “So when was the last time you yourself used a “cite” for a blog discussion?”

              Rookie move, Snowflake. You will never get into a US law school.

              But nobody says you cannot do the monkey dance.

              Monkey, Dance $$$$

                1. Why would you provide an unbroken link that proves my point?

                  But, whatever, Thanks ! $$$

                  Again $$$

                2. The whiff of your desperation is downright cloying.

                  There is NO ‘proving your point,’ as you only have false points.

                  That’s a direct byproduct of your choices and your gameplaying.

                  I am really not sure why you think that ANY of this from you reflects well on you, or somehow impugns me.

                  What was your job at the patent office before you retired? It seems to have really thrown your sense of reality to the winds.

                3. Your problem at its source: your thinking.

                  That should have been quite evident to you by now, Mr. W.E. Coyote.

                  (do you really think that your current set of games is going to end any differently than they have over the last two years?)

  6. 2

    I wonder. If you rely exclusively on a TSM approach to decide whether any given claimed subject matter was already obvious at the date of the claim, are you relying on “real world indicators”, are you also avoiding hindsight, and, if so, are you deciding obviousness objectively.

    1. 2.1

      Thank you MaxDrie. We know that your eyeglasses work for you.

  7. 1

    A key case… from 1944.

    Try again.

    (Also missing here is the distinct relation — and repudiation of the Supreme Court’s prior views on eligibility — Giles Rich is spinning)

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