Federal Circuit has No Opinion; Senju Asks the Supreme Court for Its

by Dennis Crouch

Back in 2017, I published an article condemning Federal Circuit’s ramped-up practice of issuing R. 36 judgments in cases on appeal from the USPTO.  Rather than simply arguing about policy, I looked at the statute and concluded that Section 144 of the Patent Act requires the Federal Circuit to issue its opinion, not just judgmentsDennis Crouch, Wrongly Affirmed Without Opinion, 52 Wake Forest L. Rev. 561 (2017). Over the past two years many petitioners have raised this argument to both the Federal Circuit and the U.S. Supreme Court.  However, neither court has responded (denying those petitions without opinion).

Now comes Senju Pharmaceutical Co., Ltd., et al. v. Akorn, Inc., No. 18-1418 (Supreme Court 2019) with the following two questions:

  1. Whether 35 U.S.C. § 144’s directive that the Federal Circuit “shall issue … its mandate and opinion” in all appeals from the Patent and Trademark Office precludes the Federal Circuit from resolving such appeals through a Rule 36 judgment of affirmance without opinion.
  2. Whether, under this Court’s decisions in Graham v. John Deere Co., 383 U.S. 1 (1966), and KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Patent Trial and Appeal Board must consider all relevant evidence, including any objective indicia of non-obviousness, when assessing whether a patent is invalid under 35 U.S.C. § 103.

[Read the Petition].

= = = = =

Senju’s U.S. Patent 6,114,319 claims an emulsified difluprednate (DUREZOL) used in a eye dropper to treat inflammatory eye disorders.  The claimed composition includes castor oil, and polyoxyethylene (20) sorbitan monooleat.

DUREZOL (difluprednate ophthalmic emulsion) Structural Formula Illustration

At the time of the invention (2000), difluprednate was known for the treatment of eye ailments; and the prior art also taught how to formulate steroids in emulsions in ways recited by the patent document.  However, Senju argued against any motivation to combine the prior art by migrating known steroidal suspensions into an emulsion. In addition, Senju presented objective evidence of non-obviousness: including unexpected results and industry praise.  Senju also asked the court to draw an inference from the fact that no other steroid emulsion has been approved by the FDA:

If [Akorn’s] argument that the teachings of Ding made emulsions an obvious choice were correct (which it is not), then one would expect to see several other FDA-approved emulsions after Ding was published—but we do not. . . .

[I]f a steroid eye drop emulsion were obvious in light of the prior art, then some industry player—including the assignees of the scientists whose inventions supposedly rendered petitioners’ invention obvious—would have chosen that formulation. The fact that none did is strong objective evidence of non-obviousness.

These secondary consideration arguments were ignored by the PTAB (although others were considered).  On appeal, the Federal Circuit affirmed without opinion and denied Senju’s petition for rehearing en banc.

= = = = =

 

45 thoughts on “Federal Circuit has No Opinion; Senju Asks the Supreme Court for Its

  1. 9

    This feels like a pretty easy certiorari denial.

    For the first ground, it’s not clear how the petitioner has standing to appeal the Section 144 “opinion” issue. The petitioner did not suffer any injury-in-fact from the fact that the court did not provide an explanation or reasoning for its decision. The petitioner cannot show that the outcome of its appeal would have been any different had the court been forced to provide an explanation for its reasoning. In other words, it doesn’t matter if the court issued a Rule 36 affirmance, or affirmed with a written opinion, as the petitioner would be in the same place under either scenario.

    This is probably why there’s a second throwaway argument about secondary considerations, to create some live controversy. The second issue is not interesting in any way, they’re just appealing the fact-specific application of the Graham/103 factors in their specific case, although they try mightily to dress that up as a legal issue.

    1. 9.1

      Not sure I agree with the first point, given that actually spelling things out may provide the grist for a next higher up action. It aimed down to the fact that Congress acted for a reason in making the item NOT optional (and your point resolves to the item being de facto optional).

      Further, the lack of what is required by law (whether or not you or anyone deems it “interesting”) does become a substantive matter given the lack of grist.

      1. 9.1.1

        anon is right. And the case or controversy is that they weren’t given the explanation required by statute. Plus if they can’t appeal, then no one could.

        First point –no.

    2. 9.2

      Interesting point LR. How is there any requisite “case or controversy” standing to be decided by the Sup. Ct. [even if 35 U.S.C. § 144 was violated by a Rule 36 affirmance without opinion] if there cannot be any effective argument that the decision would have been different if there was an opinion, in view of all the judge’s votes to affirm? Appeals are against decisions, not opinions.

      1. 9.2.1

        Paul,

        Read my reply.

      2. 9.2.2

        Appeals are against decisions, not opinions.

        Only as true as far as the immediate words go — which is to say that this misses the point BECAUSE it is the “opinion” OF the decision that may provide the (Congress-required) grist as to WHY the decision may be wrong and BE ready for appeal.

        I don’t believe that I have to point this type of thing out.

    3. 9.3

      >> if the court issued a Rule 36 affirmance, or affirmed with a written opinion, as the petitioner would be in the same place under either scenario.

      I suppose what the holding of the case is whatever the lower court said it was and the CAFC has merely affirmed the lower court holding. So a cert should be based on the lower court’s holding and the CAFC becomes irrelevant as they merely affirmed with no reasons.

      1. 9.3.1

        The reason for their review is to give reasons.

        That is why Congress made this aspect mandatory. There are some times for which a court has latitude.

        This is not one of those times.

        1. 9.3.1.1

          anon >>>The reason for their review is to give reasons.

          Why do you write things like this? You seem to miss the point. The point of my post was not what should be or is supposed to be, but to think about what a cert petition would look like based on the merits of the case. Just imagining if I had to write a cert petition. What would the holding be is the question I was answering.

          1. 9.3.1.1.1

            You provided a “supposition” that is pure conjecture and simply not in accord with the required text of the law.

            My reply provides the heart of your “cert petition.”

            Not sure why you would take this as saying anything against your post….

      2. 9.3.2

        With respect, none of these responses identify any constitutionally sufficient injury. They simply argue that the Supreme Court should be able to review the issue, because they think it’s important, but none of the comments explains how the appealing party is injured for purposes of Article III standing.

        I mean, geez, recent CAFC decisions have made clear that even a person who loses an IPR, and is subject to statutory estoppel under 35 USC 315, has no standing to appeal that decision unless it basically admits it’s infringing or going to infringe the patent. The injury-in-fact requirement is real, and it requires concrete injury from the complained-of conduct.

        In this case, unless you can show the CAFC would have ruled differently had they been forced to write an opinion (which you could never show), it’s really hard to articulate any concrete injury. The fact that having a written opinion might make you feel better about the court’s decision, or may give you some intangible benefits, is too speculative to show standing to appeal.

        So to anon, Night Writer, Paul, etc, please answer this simple question: how is a person who receives a Rule 36 affirmance without opinion tangibly and concretely injured differently than if that person received an affirmance with a short written opinion?

        1. 9.3.2.1

          You are mixing apples and oranges with the attempted bootstrap IPR to Article III standing item.

          Further, you seem oblivious to the “grist” element and a record clear enough upon which TO appeal (and why that is important – which should go without saying).

          You ask – and I have already answered.

        2. 9.3.2.2

          Not, per 9.2 [agreeing with you].

  2. 8

    Nice to see a law professor advocating for the good of the legal system. What they are doing is something other than justice.

  3. 7

    This cert petition will not be successful (which is very unfortunate) is not persuasive because it never mentions (or discusses) the independent judgement rule. There are a significant amount of USSC cases outlining the content requirement of a Art. III court’s opinion in an intra Art. III procedural scenario. And then there is a distinct and separate line of USSC cases dealing with a different content requirement of a first Art. III opinion when reviewing a prior federal agency adjudication (Art. II).

    1. 7.1

      There are numerous Constitutional doctrines not yet argued in cert. petitions or published in law review articles which clearly prohibit the Rule 36 practice by the Fed. Cir., especially in the procedural context of a later Art. III opinion and a prior Art. II agency adjudication, if one looks at the Constitutional standard associated with discovery, inventions and non obviousness going back to the Riding Circuit opinions and the New Deal constitutional case law.

      1. 7.1.1

        Summary affirmance, Jonathan, presents no substantial constitutional issues, and that’s why they’re not being argued here.

        There is no constitutional right to an explanation for a particular decision of a court. I fully appreciate and understand why litigants want written explanations for why a court went the way it did, as it increases the respect of the court by allowing people to understand the basis for the decision. Decisions without explanations raise a specter of results-oriented decision-making that ultimately undermines the public’s confidence in the court. But the desire for written explanations doesn’t translate into a constitutional mandate.

        Written opinions were largely unheard of in early English common law courts, they would just announce the decision or judgment (often orally), and even today, decisions and judgments are commonly rendered in courts without accompanying explanation (even in capital cases). The Supreme Court has upheld the practice of summary affirmance. And perhaps most ironically, the Supreme Court has refused to hear the challenge to CAFC summary affirmances at least five times in the last two terms, saying only, “the petition for writ of certiorari is denied,” without providing any reasons.

        Constitutional issues aside, the statutory question is more interesting. Section 144 states that “[u]pon its determination the [CAFC] shall issue to the Director its mandate and opinion, which shall be entered of record in the Patent and Trademark Office and shall govern the further proceedings in the case.” Dennis and the bandwagon riders have argued that the statute thus requires not just a mandate, but an opinion, which Rule 36 (“no opinion”) judgments don’t have. Others have argued that this language does not really require that the CAFC issue any opinion; it instead mandates that if an opinion is rendered, it must be entered in the record of the PTO. I think Dennis has the better of the argument (“shall issue… its mandate and opinion” seems to mandate an opinion).

        But given the longstanding tradition of allowing courts to control the manner in which they handle cases and dispositions, I can understand the reluctance to read too much into that language. But it’s all kind of a waste of time in my book. Even if the statute were read to require a separate “opinion,” the CAFC could issue a boilerplate one-liner saying, “upon consideration of the arguments submitted, it is the opinion of the court that appellant’s arguments are unpersuasive and the judgment below should be affirmed.” Nothing in the statute would require anything more.

  4. 6

    Wow – I love how off topic the comments get on everything here now…anyway. This means Dennis you agree with Gene Quinn on something as he has been talking about how terrible this is for a long time…

    I think this may be the first time that has happened…?

    1. 6.1

      DC,

      Malcolm’s blight has now surpassed its 14 year anniversary.

      Sadly, when no one notes the blight, there is an unfortunate group of people that somehow believe that since they read the item on Patently-O, that there must be some truth to the item and we see a proliferation of wrongheadedness that then turns and infects (or tries to infect) other patent law topics.

      It would be nice id such diversions were automatically shunted to a more appropriate forum (and I have made a number of such “let’s have a nice ecosystem” suggestions over the years), but there is no apparent will** to carry such out.

      ** Notwithstanding the additional fact that Malcolm has had more posts expunged for being inappropriate than anyone else — more posts expunged for being inappropriate than EVERYONE else combined.

  5. 5

    The Restaurant Revisited
    Two women having an argument in front of a waiter who has been listening

    A: … That, in conclusion, is why you are incorrect.

    B: Let’s ask the waiter… But first, let me APPEAL to his common sense and sensibility, by making the following FURTHER ARGUMENTS illustrating why your conclusion is wrong… *addressing the waiter* A is wrong because, her premises r, t, y, are misguided and in some cases incorrect, points X, Y, and Z are bald assertions with no basis, and what she concludes from these dubious premises and bald assertions also arise from faulty reasoning methods and logical fallacies l, p, and o. A’s supposed basis for why I am incorrect are thus fully rebutted. I submit, contrary to A’s position, that K is correct, for the following reasons I, ii, iii, …. I rest my case.

    C: *interrupts the conversation – disagrees with B – argues with B at some length about what A originally said and about B’s refutation of A’s conclusion*

    B: *after C trails off… B looks at the waiter* So, what’s your opinion?

    A: *scoffs*

    W: Hmmm, I agree with A. *looks at A*

    A: *smiles*

    B: But I just… that whole … are you saying…? *sigh* OK… So, what’s your opinion in view of what I JUST SAID?

    C: *interrupts almost slurring* and what I said…

    W: I agree with A. *looks dubiously at C*

    C: *grunts and wanders off*

    B: But… *clears throat* you can’t agree with A in view of what I JUST SAID… all she did is scoff, she never said anything about what I JUST SAID, so how can you agree with her about what I JUST SAID? I mean you could say you agree with C… but frankly he made no sense…

    A: *rolls eyes*

    W: *shrugs* I agree with what she said BEFORE…

    A: *grins*

    B: … but I just showed you… what she said before?… but that was said BEFORE I… OK, What’s your opinion about the matter, including, specifically the FURTHER ARGUMENTS I provided, all those reasons I presented which shows WHY A’s original conclusion (which did not see into the future and directly address my refutation of them… and do not address them in any case) was wrong? And that other stuff C said, or tried to say… for that matter.

    W: *shrugs* I like the stuff she said.

    B: *eyes wide for a moment of disbelief* OK. I’ll grant… your likes… are your likes… But… er… You can only actually agree with her if my APPEAL to your common sense and sensibility providing FURTHER reasons WHY she was wrong… are themselves in fact flawed, erroneous, or incorrect in some way. And look, I asked for your opinion in view of what I SAID showing WHY she is wrong… this literally asks in part your OPINION of what I JUST SAID, it is not a request for you to tell me IF you WOULD HAVE agreed with what she said before I said anything! All of what I have raised literally is unanswered… because I’m not only asking IF you agree with her… I’m asking WHY you agree with her in view of what I said.

    W: *tilts head quizzically*

    A: *winks at W*

    W: *raising an eyebrow, clearly not so interested in reasoned analysis* … Look, who says I HAVE to both state IF I agree AND state WHY I agree? … Originally you just wanted to know my “opinion”. Suppose I actually DO agree with her and suppose I know WHY I agree with her even after listening to everything, does it matter whether I state WHY I agree with her?

    B: *scowls* Well this argument isn’t actually resolved until you have told us the reasons addressing all we’ve stated… and in particular my new arguments showing WHY she is wrong. I mean, the issue is unresolved until it has been… well RESOLVED… for us, for everyone… out here. In your head…maybe the argument is resolved or maybe it is not resolved at all…. In the absence of stating WHY you agree with her, you could be totally ignoring what I said, you could be in a rush or lazy … too busy or tired to think about what I said…. or what C tried to say, *squinting a little at W* … Too preoccupied *looking at A* to bother to state the WHYs…which you may or may not in fact have thought about sufficiently…

    *B looking back at W intently* Stating you “agree with A” without giving any reasons is the same as stating that you HAVE an opinion, whereas, the REASONS WHY you agree with A, IS what your opinion would consist in, and a statement of then would constitute your providing that opinion.

    A: *smiling at W*

    B: *continuing* … stating you’ve thought about it is not providing your thoughts about it… and well, maybe you have not thought about it…

    W: *smiling at A*

    B: *looking back from A to W* in fact… maybe you just like her… *lowering to a mumble bringing her glass to her lips* I mean what’s to stop you from just saying you “like what she said” for any irrelevant reason or for no reason whatever… or

    *B sighs* just because… she’s cute? *takes a drink*

    A: *playfully pokes B, beams, and raises a glass* Now, there is a “reason” if I ever heard one!… shall we take that as another win for me? Cheers!!

    B: *rolls eyes then shrugs*

    W: *winks at A*

    *Clink!!*

    Everyone Laughs.

    1. 5.1

      Ah,

      If only the Rule of Law was meant to approximate what a restaurant waiter may do….

      Maybe it’s a good thing that the Jusicial Power comes with more strings than that.

  6. 4

    You are doing great work Dennis. Thanks.

    1. 4.1

      In my opinion, one of the reasons that Rule 36 is used so frequently is because of the vast splits in panels of the CAFC regarding many issues. The anti-patent judicial activists (Taranto, Hughes, etc.) vs. the old liners (Newman). There are many splits in law in the CAFC now that cannot be resolved.

      Rule 36 is like a pass that they don’t have to write an opinion that is going to grate against other members of the CAFC.

      We should abolish the CAFC. Obama has stacked the CAFC with very low quality people be it the totally ignorant of science and patent law judges (e.g., Reyna) to the infinitely clever and h#ter of patents (e.g., Taranto) to a judge with serious personality problems (Stoll.) There is one low quality judge that refuses to even follow the law.

      Let’s face it. Obama was in the pocket of SV. They were in the WH everyday. They gave huge sums of money to the Ds. Obama did his best with the AIA and stacking the CAFC to burn down the patent system. Task accomplished.

      Obama destroyed the patent system. The only possible way back is to undo what he did. Overturn the AIA and dissolve and reform the CAFC.

  7. 3

    Unless the statue is amended to require specific elements that must be present in the opinion, winning on this issue would be a hollow victory. There is nothing in the statute of how detailed the opinion must be. Instead of a Rule 36 affirmance, the court could issue a one sentence opinion, such as “Having reviewed the record, it is our opinion that no errors were committed, and therefore we affirm.”

    1. 3.1

      Sure, it won’t matter at all. But what an incredible relief it will be to know that we are truly a Nation of Laws* once again!

      *applies only to laws which advantage wealthy white men who enjoy fondling bibles and guns

      ROTFLMAO

      1. 3.1.1

        W
        T
        F

        Get a grip and find an appropriate forum for your non-patent rants.

        1. 3.1.1.1

          “Get a grip and find an appropriate forum”

          Translation: “I’m a wingnert snowflake and I’d rather that my daughter be forced to carry a r@ pist’s baby than have to endure comments that I think are off-topic! Help me, d@ddy!”

          1. 3.1.1.1.1

            Bad translation.

            How about you recognize and respect that this is a patent law forum?

            Too difficult for you to control your feelings to that level?

            (yes, we know the answer – hence, you being the Trump of this blog)

    2. 3.2

      Agreed, Greenacre.

      Perhaps the “required level” would be such that enough clarity as to each possible issue be spelled out such that a record clear enough for a reviewing court would be able to opine.

      Sort of in the vein that Office needs to at least present enough facts (and reasoning) for review at the appellate level.

  8. 2

    For the Einstein sanity quote perspective – why would this attempt result in anything different?

    1. 2.1

      why would this attempt result in anything different?

      Ask the state of Alabama. They’re very serious people! At least when it comes to f cking over women because (as everyone knows) that’s what Invisible Sky Daddy wants most of all. Kiss your healthcare goodbye, ladies! And thank the Rep uk k k e party for that, and all the @ h0les who vote R ep u k k ke or who sit around with their hands in their pockets shrugging away because “both sides.”

      1. 2.1.1

        Your rant is entirely off-topic.

        Please get back on the rails.

        1. 2.1.1.1

          entirely off-topic.

          Nope. Legal precedent, what it means, what is the impact of it, and how much of it is necessary. That’s the topic.

          Granted, whether some patentee gets one paragraph or two from the CAFC is a tiny peanut of a problem compared to the problem of turning vast numbers of people into murderers or accomplices thereto because some religious nertcases and mig 0gynists like it that way. But you get the idea.

          1. 2.1.1.1.1

            The only idea to be “gotten” is that you feel that YOUR feelings are so important that they need not be restrained to the actual purpose of THIS blog.

            How very Trump of you.

            1. 2.1.1.1.1.1

              YOUR feelings

              LOL

              Last time I checked I’m not the one trying to criminalize someone else’s private actions with respect to their own reproductive organs. Those would be your friends, Bildo.

              1. 2.1.1.1.1.1.1

                Again, you ill-aimed and mindless ad hominem misses the mark.

                Stop one-bucketing.

                Start trying to respect what this forum is for.

      2. 2.1.2

        “Kiss your healthcare goodbye, ladies!”

        “healthcare”lol

        MM abortin’ on babies is not healthcare. But did you also hear that abortion is #cancelled?

  9. 1

    Person 1: “I’ll have the hamburger. It sounds delicious.”
    Dennis the Waiter: “Thank you for choosing the burger. It’s excellent. And you, sir?”
    Person 2: “What she said.”
    Dennis the Waiter: “Excuse me?”
    Person 2: “I’ll have the same thing, for the same reasons.”
    Dennis the Waiter: “I’m sorry, I need you to express your opinion so I can tell the chef what to make for you.”
    Person 2: “I did that already.”
    Dennis the Waiter: “No. You just adopted someone else’s opinion.”
    Person 2: “Right.”
    Dennis the Waiter: “That’s not an opinion.”
    Person 2: “Sure it is.”
    Dennis the Waiter: “Nope. I’ll come back later.”
    Person 2: “Suit yourself. I’m going to tell you the same thing.”
    Dennis the Waiter: “You didn’t tell me anything.”
    Person 2: “I sure did. I said I’d have the same thing she’s having, for the same reason.”
    Dennis the Waiter: “That’s her order, not yours. I need your order. Those are the rules.”
    Person 2: “What about the rule that the customer is always right?”
    Dennis the Waiter: “Don’t get philosophical on me.”

    I’m obviously having a little fun here but this topic continues to strike me as a very silly one.

    1. 1.1

      Except for the little bothersome fact that Person 2 CANNOT order what Person 1 orders (the facts of the cases are simply not the same).

      (Not so) minor issue with your playful attempt.

      1. 1.1.1

        Special orders don’t upset us.

        1. 1.1.1.1

          Great – just remember that facts to a case (like the particular patent) are rather important as to what is “being ordered.”

          (another instance in which “one bucketing” is just not appropriate)

          1. 1.1.1.1.1

            Have it your way.

            1. 1.1.1.1.1.1

              It is NOT as if “my way” is at issue here.

              It is not “my way” for you to respect what this forum is for and for you to control your feelings in order to find an appropriate forum for those feelings.

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