Novartis: Inherency in Written Description

by Dennis Crouch

Novartis Pharms Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

Without any fanfare or dissent, the Federal Circuit has denied the Novartis en banc petition.  The court used a questionable procedure flip its own prior decision by replacing Judge O’Malley with a more defendant-friendly Judge Hughes for the rehearing.

The merits decision appears to further tighten-up on the written description requirement — especially with regard to ‘negative’ claim limitations.  The basic holding is that the written description must either expressly or inherently disclose the invention.  Novartis Pharm. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022) (rehearing majority decision).  Here, ‘inherently’ is a term of art in patent law and has much stricter definition than its cousin ‘impliedly.’  Inherency in patent law indicates unstated certainty.

The patent at issue in Novartis claims a drug treatment method.  Sometimes in drug treatment, you start a patient off with a high ‘loading dose’ to get the blood-levels up to an operational state.  The patent application does not discuss a loading dose one way or the other.  During prosecution, the patentee added a no-loading-dose negative limitation: “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.”

Someone skilled in the art might read the specification as implying that no loading dose was necessary. But, that same person would have to admit that the specification could be interpreted in alternative ways–and that the absence of a loading dose was not necessarily inherent in the disclosures.  Since the majority required inherency, the claim lacked written description support.

 

17 thoughts on “Novartis: Inherency in Written Description

  1. 4

    Good riddance. The first CAFC decision in this case was a travesty.

    Of course, these days your typical patent attorney from a “conservative” (lol!) state will just cite the earlier case anyway and pretend it was never reversed because, hey, zealous advocacy bro.

    1. 4.1

      was a travesty

      Lol – oh really?

      You have anything other than your feelings about that?

      How about the procedural tone here, with a dissent becoming a majority through very questionable means?

      Oh wait – this is just like how you viewed Supreme Court type “Ends justify the Means” (and later ATE that view when different Ends by the same mechanism occurred).

    2. 4.2

      “Of course, these days your typical patent attorney from a “conservative” (lol!) state will just cite the earlier case anyway and pretend it was never reversed because, hey, zealous advocacy bro.”

      Hey now, we don’t have the interbuts down hea now.

    3. 4.3

      MM bruh, I was online today and there is like 20 Venezuelan super hotties trying to get me to rescue them from the maduro goons per every day. Wat do bro? I’m pretty sure that they’re not even lesbians.

      In any event, does anyone know what I should do to get them over? Just fly them in and have them be on vaca visa/tourist visa, then claim asylum or what? Move to salt lake city and keep them all as sister wives?

  2. 3

    Interesting, the difference between “implied” under US jurisprudence and “implicit” as it is understood in Europe, where the “implicit disclosure” of any given document cannot be any more than that which is a “clear and unambiguous consequence of what is explicitly mentioned” . There isn’t much difference between “certain” (USA) and “unambiguous” (EPO) is there?

    What the USA calls “inherent” Europe calls “implicit”. What US jurisprudence calls “implied” is (I suppose) what Europe would call everything rendered obvious by the document. Is that it, in a nutshell?

    Dennis you aver that this represents a further “tightening up” of the WD standard. But is it really? Isn’t it no more than a confirmation of the existing standard?

    1. 3.1

      What the USA calls “inherent” Europe calls “implicit”. What US jurisprudence calls “implied” is (I suppose) what Europe would call everything rendered obvious by the document. Is that it, in a nutshell?

      I think that this is basically correct, except that many professionals tend not to be so precise or careful. The second panel decision was definitely careful to distinguish between the categories “inherent” and “implicit,” but I think that many other judges and many other attorneys would often use those two words synonymously. Now that we have a precedential opinion that makes the distinction, I expect that people will be more precise, but you will probably find people using those terms interchangeably for a while yet.

      1. 3.1.1

        Alternatively, Greg, perhaps the two terms will gradually come to be seen as synonymous?

        1. 3.1.1.1

          They could hardly “gradually come” to be seen as synonymous. They are already at present seen as synonymous. It would not be especially helpful for practitioners to persist in treating the terms synonymously—in view of they way that Novartis v. Accord turns on the distinction—but words mean what people take them to mean, and the perversity of humans is such that what you suggest might well happen, to the detriment of clients and the public alike.

    2. 3.2

      MaxDrie,

      You do realize that this is the same case many of us (including you) have already commented upon, and that the larger issue here is the procedural switcharoo, eh?

      1. 3.2.1

        Yes, anon. Nevertheless, I took the opportunity given here, to pick up on the statement from Dennis that this case signals a further ratchet up of the severity of the WD requirement in the USA. This (as you know) is a trend of particular interest for me, as a patent prosecutor, because I have long averred here that the shift to First Inventor to File makes that shift inevitable. The only uncertainty is how long the shift will take to complete.

        1. 3.2.1.1

          You are suffering from your “here, wear my prescription eyeglasses” syndrome again.

          You do realize here that “the change” has nothing to do with the change from First Inventor to First Inventor To File, right?

  3. 2

    I don’t see the decision on the CAFC’s opinions and orders page. Can you please link to the decision?

    1. 2.1

      It is not on the CAFC website. Law360 had a copy of the order in their write-up on this story this morning. The non-precedential order was issued per curiam, and says in its entirety that

      Novartis Pharmaceuticals Corporation filed a combined petition for panel rehearing and rehearing en banc.

      Law Professors and Civil Procedure Scholars David Hricik, Roger M. Baron, Lonny Hoffman, Jeffrey W. Stempel, Christa Laser, Emil J. Ali, and Dane Ciolino requested leave to file a brief as amici curiae which the court granted.

      Intellectual Property Law Professors Martin J. Adelman, Emily Michiko Morris, Adam Mossoff, Kristen Osenga, Mark F. Schultz, Ted Sichelman, and Joshua Kresh also requested leave to file a brief as amici curiae which the court granted.

      A response to the petition was invited by the court and filed by HEC Pharm Co., Ltd and HEC Pharm USA Inc. The petition was referred to the panel that heard the appeal, and thereafter the petition for rehearing en banc was referred to the circuit judges who are in regular active service.

      Upon consideration thereof, IT IS ORDERED THAT:
      The petition for panel rehearing is denied.
      The petition for rehearing en banc is denied.
      The mandate of the court will issue September 27, 2022.

      The order notes, in the footnotes, that Judge Linn participated only in consideration of panel re-hearing, and that Judge Stark did not participate at all.

      1. 2.1.1

        Hricik..?

        I have seen that name before.

        Also, looking forward to the Mossof take.

        1. 2.1.1.1

          This post has the amicus briefs.
          link to patentlyo.com

          There was one amicus brief by lawprofs on procedure, and a second amicus brief by different lawprofs on the merits. Mossoff signed the merits one, linked here:
          link to patentlyo.com

          1. 2.1.1.1.1

            Many thanks dcl.

  4. 1

    I am sympathetic to Novartis’ argument that this is just not how reconsideration is done in panel decisions, but fundamentally it does not appear that there is any actual law to which they can appeal on this point. I am not surprised that the CAFC decided to take a pass, and I expect the same outcome for a cert. petition.

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