Supreme Court asked to Review Federal Circuit’s Judicial Shell Game

by Dennis Crouch

Novartis Pharms v. HEC Pharm (Supreme Court 2023)

Some drug treatments perform better if the patient starts with a loading dosage before shifting to the regular daily amount. But, loading dosages can be risky because of the high dosage and because of the greater likelihood of mistakes.  Novartis was able to configure a multiple sclerosis treatment plan without the loading dosage.  Its claims require the administration of fingolimod “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” US Patent No. 9,187,405. The problem for Novartis is that its original priority application filings did not say anything positive or negative about a loading dosage, and the court eventually rejected the priority claims and thus invalidated the patent claims.

Novartis almost walked away a winner.  In the ANDA litigation, Judge Jordan (D.Del.) found the claims valid and infringed by HEC. On appeal Federal Circuit Judge O’Malley penned the majority opinion affirming the Novartis win. Judge Linn sided with O’Malley, with Chief Judge Moore in dissent.

But then an odd sequence of events occurred: (1) in February 2022, HEC filed a petition for panel rehearing; (2) but before the panel could rule on the motion, Judge O’Malley retired.  (3) At that point, Judge Hughes was added to the panel; and (4) Judge Hughes sided with Chief Judge Moore’s position.  The modified panel then issued a new opinion with Judge Moore’s prior dissent effectively becoming the majority, and Judge Linn now writing in dissent.  What made this more surprising was that the Federal Circuit had not provided any indication of Judge Hughes’ substitution.

Novartis petition for certiorari addresses both the procedural judicial shell game and the substantive written description question. Questions presented:

1. Whether 28 U.S.C. § 46 and principles of sound judicial administration preclude a court of appeals from adding a new judge to form a new panel and redecide a case after an original three-judge panel has already decided the case and entered its judgment.

2. Whether 35 U.S.C. § 112 should be interpreted consistent with its plain text as requiring that a patent specification contain a “written description of the invention” in a form that need only be understandable to “any person skilled in the art,” or whether the court of appeals properly read in a heightened requirement that allows it to deem the specification inadequate on de novo review and displaces the perspective of a person skilled in the art.

Novartis Petition for Cert 2023.   The Supreme Court will decide the Amgen enablement case later this term, but recently denied certiorari in the written description case of Juno v. Kite.

My thoughts: I think that Chief Judge Moore probably has the best argument on the merits of the written description question.  If you are going to claim some particular element of the invention (and use it to overcome the prior art), that element should be introduced at some level in the original specification.  But, written description is a question-of-fact, what that means is that the appellate court cannot simply substitute its decision in place of that of the district court. Rather, the district court’s finding of facts should be affirmed barring some clear error or abuse of discretion. The case is close enough here that I would not find a clear error by the district court judge.  The panel switch also smells very bad to me.

Pundits will tell you that the use  of top Supreme Court counsel helps get the court’s attention. That bonus is probably mostly because of their skill at framing the case, but their reputation within the Court probably also plays a role.  In this case though Novartis appears to go overboard and included a host of top Supreme Court counsel, including Deanne Maynard (MoFo), Willy Jay (Goodwin Procter), and Thomas Hungar (Gibsun Dunn), all of whom have successfully argued numerous cases before the Court.

17 thoughts on “Supreme Court asked to Review Federal Circuit’s Judicial Shell Game

  1. 6

    I realize the issue before the court is written description, but I am also of the opinion that the claims are obvious, and the written description issue is sort of moot, and need not be decided here. The prior art of MS drugs teaches that sometimes a loading dosage improves the therapeutic benefit and sometimes it in not needed. In the absence of the magic wand language “preceding loading dose” the claims are invalid over the art of record, the addition of such language should not be used to rebut the PF case.

    1. 6.1

      I tend to agree. Plenty of prior art that exists “without a loading dose.”

  2. 5

    I think that Chief Judge Moore probably has the best argument on the merits of the written description question... But,… [t]he panel switch also smells very bad to me.


    1. 5.1

      More broadly, it says ‘you don’t win/loose based on the strength of your case, but rather, on who is the judge.’ c.f., all of the handwringing about the Western District of Texas. Hopefully Roberts sees that this switch is making the judicial system look horrible

  3. 4

    >>Judge Hughes sided with Chief Judge Moore’s position.

    Did Moore pick the judicial activist anti-patent Judge Hughes to join the panel?

    1. 4.1

      The title of this particular blog entry indicates the point needing to be explored/resolved.

      A shell game was played in order to reverse and make the original dissent into the holding.

      Thus, one should take care to set aside any view of the Ends, and focus on the Means.

  4. 3

    “112” “and displaces the perspective of a person skilled in the art.”

    This is exactly what the CAFC has been up. The judicial activists with the backing of Lemley have been trying to limit the patent right by taking out what “a person skilled in the art” knows.

  5. 2

    Ends justify the Means.

    At multiple levels….

    1. 2.1

      Res Judica. I was never at any trial. So how do you figure it can’t be done again????? I have been denied Due Process. I havr never been allowed in a court room. If there was a Trial… who pretended to be me anon…? Is this why you only said Res…?

  6. 1

    I am surprised that a question as fundamental to patentability as Question 2 is still an open one. If the Federal Circuit finds itself unable, then the Supreme Court ought to address it, and settle it authoritatively, without any further delay.

    If you are on the Supreme Court to show the world that your legal mind is more incisive than anybody else’s, is not Question 2 an almost ideal vehicle for demonstrating that incisiveness?

    I have been suggesting in these threads for years that the switch to First to File heightens the WD requirement. I really really hope that the court accepts the invitation to answer Question 2.

    1. 1.1

      Max, Question 2 is not as quite what as clear or simple the petitioners make it seem. I would suggest that it doesn’t actually address the key issue. The specification of the patent is completely silent on the issue of a loading dose. The patent owners are trying to say that because the specification is silent on the issue, it means that it supports a method that does not require a loading dose. I would say a more accurate framing of the question/issue would be: Whether silence in the specification properly supports a negative claim limitation.

      1. 1.1.1

        Thanks for the comment, Dvan, but over here in First to File Europe, whenever there is competition between rival filers, manifested in inter Partes litigation between them, comparison of their respective WD’s is usually decisive to the outcome. And so there is rich case law on what description “counts”.

        For example, over here, “silence” as such has proven to be overly simple as a test. Relying on it can lead to injustice, and the wrong Party acquiring the status of “First to File”.

        Over here, the disclosure of a document includes everything that a skilled reader can “derive” from it, directly and unambiguously, taking into account everything that belongs to the common general knowledge of that skilled reader. Under such an enquiry into what a document discloses, much that is only implicit, no more, still counts as what the skilled person “derives” from the document. Here, was the absence of a loading dose “implicit”? I don’t know, because I’m not skilled in the art.

        If SCOTUS answers the “silence” question with a binary Y/N answer, as judicially economical as the question allows, I for one will be disappointed.


          You try too hard to see this through your EPO lenses as there is no “comparison of rival filers” in the present issue.


            OK, then let’s examine together what is “the present issue”. Might it be that one of the reasons for requiring a written description is to determine what was the invention that the applicant had in their possession already, as of the date which is decisive for the determination whether the claim is not invalid?

            If Applicant amends the claim during Patent Office prosecution, to direct it to an invention that was, as such, unannounced in the patent application on its filing date, what then? Is not Applicant illegitimately improving the position it had, relative to the public, on the filing date of the patent application? Does not such illegitimate improvement breach the quid pro quo (irrespective whether we are talking FtI or FItF)?


              Pardon potential (filter) repeat…

              Your questions “move the goalposts” from your post at 1.1.1.

              But let’s explore them anyway.

              Might it be that one of the reasons…

              Sure. I have never indicated otherwise. Possession at time of filing is not something that I have ever seen anyone assert otherwise. Have you?

              ..amends the claim… direct to… unannounced…, what then

              The great legal answer: it depends. From your past musings on this, I take your question to be the MORE “ipsis verbis” style of the EPO – which I have contrasted with the LESS such style of the US realm, and – as I have so often pointed out – the fact that most all US writers are well prepared to pivot with all (reasonable) amendments to reach whatever nook or crany may be in the application as filed. For us in the US, ALL of the application as filed may well serve “to announce.” This is not a new answer to your (old) question.

              Is not…. Illegitimately improving?

              See answer directly above. With my provisio, the sense of illegitimate is not reached. IF an amendment tries to reach for more (as we have ALREADY discussed), the US does also have a “no new matter rule,” and any such amendment would be rightfully rejected (and so, ‘illegitimate’ is not quite the right description, but rather, ‘p00r examination’ would be the right description.

              Does not such illegitimate…?

              Same as above.

              And I note, that YOUR inclusion of, “(irrespective whether we are talking FtI or FitF)?” only emphasizes my point that your post at 1.1.1 was trying too hard to see this through your EPO glasses. The possession and no new matter issues apply not just to FtI or FitF, but across all versions of filing. One simply does not GET to your EPO glasses with the issue.


                Be all that as it may, anon, a consequence of the switch from FtI to FItF is that text filed at the PTO is the only thing that counts, when it comes to establishing a date on which an inventor can rely. In a priority contest between two rival filers, their respective texts, as filed, will determine the matter. That was never possible, during the old days of FtI and interference practice. But now it is. And it will inevitably increase, incrementally, progressively, the intensity of scrutiny of the respective WD’s laid down by the rivals for the grant of exclusive rights.

                1. Again – not at issue here.

                  Those eyeglasses of yours are preventing you from seeing the issue at hand.

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