The Sound of Silence and the Inherency Doctrine for Written Description

by Dennis Crouch

The basic issue in Novartis v. Accord is quite familiar. A new limitation was added to the claims during prosecution that is not found expressly in the specification, but would be expected by someone of skill in the art.  Does the claim violate the written description requirement of 35 U.S.C. 112? In its most recent statement, the Federal Circuit finds failure of written description unless the invention is either expressly or inherently disclosed in the original specification. Novartis Pharm. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022) (rehearing decision). One quirk here is that the court identifies the particular limitation as a “negative claim limitation” and there are wide ranging policy views on how those limitations should be treated. However, the Novartis court explained that its express-or-inherent holding here applies regardless of whether claim limitations are expressed in positive or negative form.  Novartis has no petitioned for en banc rehearing.

The appellate procedure in this case is strange and important to its current status: The district court sided with Novartis (infringed + not-invalid) and the Federal Circuit affirmed on appeal in a January 2022 decision.  That original CAFed decision was penned by Judge O’Malley and joined by Judge Linn.  Chief Judge Moore wrote in dissent — arguing that the majority had been way too lenient.

By January 2022, Judge O’Malley had already announced her plans to retire from the judiciary in early March 2022. The appellant’s rehearing petition would have ordinarily been due on Groundhog Day, February 2, but HEC requested and was granted a 21-day delay and that meant that Novartis’s response would not be due until after Judge O’Malley’s retirement.  Rather than waiting for the deadline, Novartis  filed its responsive brief with a four-day turn around.  But to no avail; Judge O’Malley retired before acting on the rehearing petition.

After Judge O’Malley’s retirement, the court added Judge Hughes to the panel to decide the rehearing.  Of any judge that might have been added, Judge Hughes was one very likely to find against the patentee in this situation.  My understanding is that the court did not announce Judge Hughes addition to the panel until it issued a revised panel opinion on June 21, 2022.  Presumably in this case, there was some randomness in Judge Hughes’ selection, but the rules don’t expressly require that.

The panel re-composition flipped the outcome.  Chief Judge Moore had previously written in dissent, but now Judge Hughes joined her opinion–putting her in the majority. With the loss of Judge O’Malley, Judge Linn’s position flipped to the dissent.  Thus, the new opinion sided with the accused infringer–concluding that the district court “clearly erred” in finding the claims not invalid.   The decision here is apparently the first time that a Federal Circuit panel has flipped the outcome following a change in panel composition.

Now, Novartis has filed its petition for rehearing.  The petition raises two issues: one on the merits of the written description issue; and a second focusing on the unusual appellate procedure.

  1. Patent Law Merits: Whether 35 U.S.C. §112 and this Court’s precedent require that, to have adequate written description, a claim limitation must be either expressly disclosed in the specification or necessarily present in some express disclosure, even if a skilled artisan would otherwise read the specification to disclose possession of the limitation.
  2. Appellate Procedure: Did the court procedurally err by issuing the new decision on rehearing.

Lets start with procedure and panel dependence. The other circuits have an internal rule or practice that a panel rehearing will not be ordered unless at least one judge in the majority votes for the rehearing.  The idea behind a panel rehearing to raise issues that the majority can recognize that it “overlooked or misapprehended.” FRAP 40(a)(2). But, no one in the majority changed their outlook. Rather, the addition of Judge Hughes provided an end-run around the majority by adding a new panel member.

The Federal Circuit has previously written about this issue – but not in a self-reflective way. Rather the court was in its then supervisory role of the US Claims Court. Universal Restoration, Inc. v. U.S., 798 F.2d 1400 (Fed. Cir. 1986).  In Universal, one panel member of the Claims Court had been replaced following its original determination.  That recomposition resulted in a flipped the outcome on rehearing.   On appeal, the Federal Circuit reversed on the merits, but in a footnote explained that the recomposition was improper:

Where the original panel reconsiders and changes a decision, a member of the original majority must vote for the change. In the Supreme Court where less than a majority may order rehearing, a member of the original majority must vote for the rehearing. These procedures are readily acceptable as “fair.” Sup.Ct.R. 51.1 (1980); Ambler v. Whipple, 90 U.S. (23 Wall.) 278, 281–82 (1874). . . . What appears to be the case here is that there was in fact no reconsideration. A different panel simply disagreed with the first decision.

Id.  The Federal Circuit does have a rule regarding replacement of a missing panel member. Federal Circuit Rule 47.11. That rule calls for the Chief Judge to secure an additional judge in situations where “a judge of a panel that has heard oral argument or taken under submission any appeal, petition, or motion is unable to continue with consideration of the matter.”  If the remaining two judges are unable to resolve the matter,  then the chief judge should appoint another judge.  Id.  In its petition, the Novartis argues that this rule is inapplicable based upon the aforementioned general tradition and because panel rehearing petitions are not “argued” or “taken under submission.”

On the merits: The petition argues that the new majority opinion improperly creates an “express-or-inherent rule:” That the invention as claimed must be either expressly or inherently disclosed within the specification.  Chief Judge Moore explained:

[I]t is possible that the written description requirement may be satisfied when a skilled artisan
would understand the specification as inherently disclosing the negative limitation. . . [However], testimony from a skilled artisan as to possibilities or probabilities that the recited element would be excluded would not suffice, lest such testimony could effectively eliminate the written description requirement. If silence were generally sufficient, all negative limitations would be supported by a silent specification. If, however, a patent owner could establish that a particular limitation would always be understood by skilled artisans as being necessarily excluded from a particular claimed method or apparatus if that limitation is not mentioned, the written description requirement would be satisfied despite the specification’s silence.

Id.   The petition argues that Judge Moore has improperly created a bright-line rule in an area where “there are no bright-line rules.”

The new majority’s inflexible heightened standard conflicts with a substantial body of precedent. It makes written description turn not on what the specification “reasonably conveys to those skilled in the art,” but on what the specification expressly or necessarily discloses. And because the new majority expressly declined to limit its holding to negative claim limitations, that holding could be applied to reverse any written-description finding.

Novartis En banc Petition.

What is the invention: Fingolimod was a known immune suppressant.  In its patent, Novartis claims a method of treating multiple sclerosis (RRMS) by administering fingolimod at a particular daily dosage of 0.5 mg.

Many drug regimens begin with a loading-dose to quickly raise the blood-level. The dosage is then reduced to a lower maintenance dosage. During prosecution some prior art was uncovered that started with a loading dose and then reduced dosage down to a level close to that claimed by Novartis. But the Novartis invention did not require a loading dose.  Prosecutors amended the claims to make that clear: “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.”

The Sound of Silence: The problem identified by Chief Judge Moore is that the Novartis patent application documents never mention loading doses or the absence of loading doses. They don’t say anything one-way-or-the-other.  Novartis provided evidence that loading doses in this area were common and that PHOSITA would have understood that silence regarding loading doses was actually a disclosure that no-such loading doses were required.  Judge Moore rejected this argument; holding instead that “Silence is not disclosure.”  Further, Judge Moore adopted the inherency doctrine as a limiting rule. That doctrine is quite tight and only finds  disclosures inherent if they necessarily flow from express teachings.

74 thoughts on “The Sound of Silence and the Inherency Doctrine for Written Description

    1. 13.1

      Back to riding that particular trick pony….?

  1. 12

    “… to have adequate written description, a claim limitation must be either expressly disclosed in the specification or necessarily present in some express disclosure, even if a skilled artisan would otherwise read the specification to disclose possession of the limitation”

    Its new matter to the spec;

    It seems also that adding the new matter limitation, should not be necessary if it is true a POS in the art somehow already inherently understands its presence, in such instance adding the language adds nothing.

    Its new matter if it wasn’t in the spec. and if the POS inherently understands it, there is no need to add it.

  2. 11

    The use of “reasonably conveys” in this petition is very masterful, because the full term is reasonably conveys that the inventor possesses the invention. By using “reasonably conveys” without reference to what the applicant possesses it makes it sound like its a PHOSITA obviousness standard rather than an inventor possesses anticipation standard.

    It’s pretty clear the standard has to be anticipation and not obviousness or the claim scope would expand beyond what the inventor invented and instead become a scrivener at time of examination would recognize could have been understood by a PHOSITA.

    1. 11.1

      Off – as usual – on all accounts.

      Leave law to the lawyers, you just are not good at this.

    2. 11.2

      “It’s pretty clear the standard has to be anticipation and not obviousness or the claim scope would expand beyond what the inventor invented and instead become a scrivener at time of examination would recognize could have been understood by a PHOSITA.”

      I think there are some syntax issues in this quote but this is correct. Claims are incredibly important. Write them well and write them early. Know the prior art and also think ahead.

      Above all, never assume you are going to be allowed to amend the claims to describe something you didn’t expressly call out in the specification. That’s worse than blithely assuming you are going to be able to rely on the doctrine of equivalents.

  3. 10

    OT, but re the impracticality of the losing Arthrex-suit argument that only the Director or Assistant Director can perform [personally – no delegations] any of the various statute or rule “Director” actions. Especially since those positions must be newly appointed every 4 years with a presidential party change. Illustrated by only just now finally getting an Assistant Director appointed nearly half-way through the whole term, and only after only recently finally getting a new Director.

    1. 10.1

      I think that there are two moving pieces in Arthrex, one of which has more punch than the other. First is the argument that review of IPRs is a non-delegable power of the Director. There is a category of non-delegable powers recognized in our law, but review of IPRs has little to cause a court to slot it into this category. This appears a weak argument.

      Second, however, is the argument that—while this power may be delegated—Hirshfeld was not the legally proper delegee. This is not a crazy argument. As you note, the deputy director job has sat empty for years now. Under the FVRA of 1998, the deputy director—not the commissioner of patents—is the one who should have received the delegated power. Because the deputy job was vacant, the president could have named Hirshfeld to assume this power, but neither Pres. Trump nor Pres. Biden ever did. Hirshfeld just stepped into the role because no one else was there.

      The CAFC got around this by saying that FVRA does not apply. This is possibly correct, but not entirely clear either way. If the CAFC en banc or the SCOTUS decides that FVRA does apply, then Hirshfeld’s exercise of the review power was ultra vires, and a proper reconsideration by Vidal is still due.

      1. 10.1.1

        “Hirshfeld just stepped into the role because no one else was there.”

        Worse. The Biden administration told Hirshfeld to do so, so that they could avoid the headaches associated with “acting” officers.
        It was bad when Trump did it, and it’s still bad when Biden is doing it.

        1. 10.1.1.1

          Thanks for the clarification. Has this been reported somewhere that I missed? Or is it just PTO scuttlebutt?

          [A]void[ing] the headaches associated with “acting” officers… was bad when Trump did it, and it’s still bad when Biden is doing it.

          I agree that end runs around constitutional chains of command are not good. The experience with Hirshfeld demonstrates, however, that Title 35 ought to be amended to delegate that authority explicitly to the commissioner for patents. Hirshfeld did not do a bad job of it. If the director’s and deputy director’s offices are both vacant, the commissioner for patents is the obvious person to review IPRs and PGRs. Meanwhile, the commissioner for patents is an officer in the 35 U.S.C. §3 chain, so there should not be Arthrex problems with the commissioner overseeing this work (if anyone disagrees on that last point, I would be obliged for the explanation of why this would make for an Arthrex problem).

          1. 10.1.1.1.1

            Dave Boundy has provided an explicit accounting of why what Hirschfeld and the Patent Office did violates the controlling law.

            Your, “however, that Title 35 ought to” is very much merely an opinion of what the law COULD BE. It is simply immaterial as to what type of job Hirshfeld DID do.

            And yes – there very much IS a problem with the Constitutional chain of authority in the games that the Office decided to play by NOT using “Acting” and instead merely using “Performing the Duties of.”

            This – of course – is one of those Means and Ends things.

            As EVERY attorney should know, law is just not the area that you want to engage in, let alone encourage. an Ends justify the Means approach.

            1. 10.1.1.1.1.1

              Re: “Dave Boundy has provided an explicit accounting of why what Hirschfeld and the Patent Office did violates the controlling law.”
              How is that legally relevant after the recent Fed. Cir. Arthrex decision has rejected it?

              1. 10.1.1.1.1.1.1

                Arthrex has petitioned for review en banc. Until that petition is denied, the CAFC cannot be said completely to have rejected the contentions.

              2. 10.1.1.1.1.1.2

                Perhaps you are confused there Paul – the argument at current cert is NOT what the Fed Cir rejected.

                1. …the cert provided a MORE particularized argument — one which BOTH Davey (in his forum of choice) and myself (in this forum) have already spelled out in detail.

          2. 10.1.1.1.2

            WHO ARE YOU KIDDING GREG?
            If Trump was in the loop. this would have been very useful to his treasonous behavior.

    2. 10.2

      Paul F Morgan with his strawman parade…

      (slow day at the cheerleader farm)

  4. 9

    One more time for the world:

    When a limitation is added to avoid the prior art, it is extremely reasonable to require that the limitation be expressly or inherently closed.

    The argument that “reasonably convey” somehow excludes any rule that would require an express or inherent disclosure in any context is very silly.

    Kudos to the CAFC for getting it right and cleaning up their mess.

    1. 9.1

      “… expressly or inherently DISclosed …”

    2. 9.2

      5560312 fine and dandy, then stolen. Patent 5832857, written with intent after finding he was exposed. Deal made if he gives up my Patent application by those that already stole 5,560,312 with all 20 claims ( 20 claims make it easy to steal.) TO me until the nylon was understood when I made my model with vinyl. Only changing it because I didn’t have a welding machine handy for vinyl. So buddy you lose. You stole my first Patent on July 18, 1995. So the more you try to make the second one that wasn’t necessary, only filed to make sure you had Loffler by the throat, and me through your obvious malpractice, espionage, and intent. DO YOU REALLY THINK THE FAX NOTATION ON THE CLAIMS THE POSTMASTER SENT IS GOING TO GO AWAY.. GOOD LUCK.
      Then you hire the Cherrys’ to kill me. What about my address changes? HOW about Burroughs telling me I couldn’t have a mail box, David is it?

  5. 8

    What about: The Specification should be sufficient to allow a POSITA to build the claimed invention without undue experimentation.

    Is it now: The Specification should be sufficient to allow a POSITA to build the claimed invention without any experimentation.

    What about: The Specification may not be used to interpret the claims unless the claims are Means claims?

    Did CAFC just overturn umpteen years of patent law and invalidate umpteen numbers of patents?

    1. 8.1

      “ What about: The Specification should be sufficient ”

      No.

    2. 8.2

      Hey, cool a time traveler.

      Exactly which pre-2010 year are you speaking to us from?

      1. 8.2.1

        I am not a time traveler.

        Don’t be silly.

        I went offworld in 2010 and just recently returned.

        Has anything noteworthy happened while I was gone?

        1. 8.2.1.1

          You don’t want to know. Probably you will be happier if you just stay off-world. Can I tag along with you?

        2. 8.2.1.2

          Noteworthy ? Most notably perhaps, “global senior management” has come out of the background, and openly announced its intents.

          This makes investing, interalia, easier.

          1. 8.2.1.2.1

            This makes investing, interalia, easier.

            ONLY if you want to but into that RESET.

            (I posted the Dr. James Lindsay podcast castigating such thinking previously).

            1. 8.2.1.2.1.1

              (lol – autocorrect nabbed “buy,” but an extra “t” may have been appropriate as well)

            2. 8.2.1.2.1.2

              I’d imagine there’s a lot of perceptions on that. anciently in the 90’s I’d found Tragedy and Hope by Professor C. Quigley, a good. Grand Chessboard by Z. Brz. had a lot of factualoids. Most ppl don’t know I bet, that the first US flag adopted by G. Washington was a carbon copy of that of the British East India Co. , flown on the first official US ship, the Alfred. Heald Square features Wash, Morris, and Saloman, symbolic of Ecclesiastes 1:9 or so where it talks about “nothing new under the sun” Military-politoco, Mercantilism, and Finance. They’re like 3 branches.

              Can’t wait to see who will be the first to make a fully 100% 3-D printed automobile……. oh Elon, help us.. !

              1. 8.2.1.2.1.2.1

                Not sure what all of the add-on comments have to do with, but the notion of “global senior management” and the Great Reset quite stand on their own — and stand for some VERY BAD ideas.

  6. 7

    I thought that the test for the presence of a WD was akin to a question of novelty (rather than obviousness). But now I read that the WD of a document includes everything that the document “reasonably conveys” to its skilled reader.

    What a document “conveys” to me though is not confined to what it discloses, express or implied. It also “conveys” to me what it indisputably obvious to me.

    I sympathise with 6 who writes (at #6) that the present WD test is “rough”. Who here says he’s wrong?

    1. 7.1

      Who here says he’s wrong?

      Not to put words into Greg’s mouth, but to take the words that he has already provided:

      Incidentally, this tough standard is good public policy.

      Of course, he is fundamentally wrong in his view of the Quid Pro Quo (it is just NOT good public policy to put the thumb on the scale between “the public” and inventors.

      His view is nothing more than blind short term thinking, and “the public” actually benefits when the inventor is Fully rewarded.

    2. 7.2

      [N]ow I read that the WD of a document includes everything that the document “reasonably conveys” to its skilled reader.

      It is black letter law in the United States that “[a] description which renders obvious the invention for which an earlier filing date is sought is not sufficient.” Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997). “Reasonably conveys” is the standard for assessing obviousness (when one is discussing the prior art), but not written description.

      1. 7.2.1

        “Reasonably conveys” is the standard for assessing obviousness (when one is discussing the prior art), but not written description.

        Or, perhaps more precisely, when you read “reasonably conveys” in a WD case, do not imagine that the phrase means the same thing as when you read those same words in an obviousness case. As noted, the U.S. case law makes clear that “makes obvious” is not good enough for WD purposes, so if all you mean by “reasonably conveys” is “makes obvious,” then that is not adequate WD support.

  7. 6

    I think that express or inherent is a bit rough, implied should also be included. There are many things that are implied in a disclosure and should be fair game for claiming imo.

    1. 6.1

      I should add that in the chemical/pharma context the rule in this particular case is likely the correct one to use.

    2. 6.2

      Why?

      1. 6.2.1

        More precisely, why is “express or inherent… a bit rough”? “Rough” how?

        1. 6.2.1.1

          There are a lot of things implied, which some people consider to not be a part of “inherency” (tho others will think that things which are “implied” are “inherent”). And there are some occasions were there is technically a genus set forth but tis a small genus (e.g. 2-4 species included and appreciated by one of skill in the art) where the species may be fairly said to be set forth by the disclosure. etc. etc.

          But in the complicated pharma context, idk man, tough one but I think it’s probably correct to use the standard more or less as it was done here. Why? Because you’ve really got to be specific about that sht in pharma and they know that.

    3. 6.3

      What is the distinction (as you understand the terms) between the categories of “implied” by the disclosure and “obvious” from the disclosure?

      1. 6.3.1

        That’s a good question, Greg, if only because the difference is very clear for those who practise before the EPO. Here a Link to the relevant page of the EPO’s MPEP. That which is “implicit” in a documentary disclosure is necessarily implied by the explicit wording of the document, a clear and unambiguous consequence of what is disclosed explicitly.

        What the disclosure of the document renders “obvious” to the mind of its appropriately skilled reader is a very different enquiry.

        link to epo.org

        1. 6.3.1.1

          That which is “implicit” in a documentary disclosure is necessarily implied by the explicit wording of the document, a clear and unambiguous consequence of what is disclosed explicitly.

          That sounds like the EPO category “implicit” is co-extensive with the U.S. category “inherent.” I gather, however, that 6 must have a different idea in mind when he speaks of “implied,” because he considers that “express or inherent is a bit rough” (emphasis added).

          1. 6.3.1.1.1

            Not being a US attorney, Dozens, I cannot say exactly what “inherent” means, in the context of patent law. But my eye is caught by the recurrence of the word “necessarily” both when talking about “implicit” and “inherent”. Of course, I’m in favour of the clarity which the all-embracing definition of “disclosure” which after 40 years of rehearsal the now-established case law of the EPO brings to bear in answering all questions of i) novelty ii) WD and iii) whether a claim is entitled to Paris Convention priority. That definition? Disclosed is that which is “directly and unambiguously derivable” by the skilled reader of the document in view, that person being deemed to be in possession and to be relying upon the common general knowledge of the skilled person within the field.

            Nothing less than that. But nothing more than that either.

            Perhaps 6, if he were working with that definition, would find it forensically powerful and also not quite so “rough”.

            Alternatively, is that EPO definition practicable only in a civil law jurisdiction? Who can say?

          2. 6.3.1.1.2

            “I gather, however, that 6 must have a different idea in mind when he speaks of “implied,” because he considers that “express or inherent is a bit rough” (emphasis added).”

            We generally set our bar a little lower max. If tis fairly implied the PTO will give WD to the applicant in my art.

            1. 6.3.1.1.2.1

              My oh my, how that’s a matter of perspective:

              We generally set our bar a little lower max.

              Double check your matching orders there 6 (Your requirements in the MPEP for the higher bar of establishing a prima facie case of a rejection under 35 USC 112).

        2. 6.3.1.2

          MD. “ That which is “implicit” in a documentary disclosure is necessarily implied by the explicit wording of the document, a clear and unambiguous consequence of what is disclosed explicitly.”

          This is inherency.

          1. 6.3.1.2.1

            So, Prophet, Implicit = inherent. Just one concept. Excellent. But as we see in this thread, people have difficulty recognising it when they encounter it. So how can we help those (such as PTO Examiner 6, and all the patents judges) to recognise it when they encounter it in their everyday work? Needed is a pragmatic working litmus test.

            At least in Europe, the age-old (the “General Tire” case back in 1972) English definition of whether document D1 destroys the novelty of a claim often helps. Does the document i) contain “clear instructions” to do something within the ambit of the claim, or is something within the ambit of the claim an “inevitable result” of following D1’s teaching? If either is so, D1 anticipates, otherwise not.

            Is there in the USA today any echo of the General Tire questions? Perhaps they (like so much other legal thinking) even originated in US jurisprudence. I wonder.

      2. 6.3.2

        “What is the distinction (as you understand the terms) between the categories of “implied” by the disclosure and “obvious” from the disclosure?”

        Implied ones that are not inherent are rather rare, admittedly, and I don’t have one on deck for discussion at the moment. But they do pop up in my job maybe one every couple years in claiming or proposed claiming. Obvious ones are things that are obvious, either legally, or just to the everyman. The difference is one is merely implied by the disclosure, the other is something that it is legally considered some obvious modification, say to a person of ordinary skill in the art, or would be an obvious modification to the everyman. There can be some overlap in those categories for sure, but the venn diagrams do not fully overlap so to speak.

    4. 6.4

      Had the claims been written differently, e.g., by reciting that the daily dose is o.5 mg, beginning with dose 1, the claim would have been supported. When one tries to recite a negative limitation, more precision is required.

      I agree that the change in panel should not have yielded a change in result.

  8. 5

    Doesn’t look like there’s support to me, but the reversal of fortune seems pretty unfair.

    1. 5.1

      +1

    2. 5.2

      Boo flipping hoo.

      1. 5.2.1

        Yes, Malcolm; we are all well aware of your “Ends justify the Means” (especially if a patent holder is stiffed)/

        But as you are (or should be) well aware, that abdication of Rule of Law has the tendency to select Ends that you may not like.

        US Supreme Court as a case in point.

        1. 5.2.1.1

          Patent stiffer? You must mean also stiffed by a former US copyright agent. Was Maria Pallante locked out the copyright office because she helped DADT, who wasn’t given the promise. Or was it because the case I was also left out of?

  9. 4

    Bottom-line: Even negative limitations need to be expressly or inherently disclosed.

    1. 4.1

      Would a line in the spec that “Everything that is not disclosed herein is herein incorporated by reference” suffice? Or should pharma cases have boiler plate pages of:
      no loading dose necessary;
      no need to ingest with liquids;
      no need for the formulation to have X,Y, Z excipients;
      no need to take with X,Y,X drugs
      ad infinitum

      1. 4.1.1

        If you are going to rely on a particular limitation to distinguish your claims from the prior art, it is really not asking to much that you should put that limitation—explicitly or inherently—into the application text.

        1. 4.1.1.1

          When the prior art requires a loading dose and your invention does not, would an option be to change the preamble to “consisting of”? Would that accomplish the same thing? On the other hand, wouldn’t changing the language to “consisting of” be argued that this is also a negative limitation because, in essence, one is excluding that which is not recited?

          1. 4.1.1.1.1

            I agree that no one is going to give you grief about switching “consisting of” for “comprising,” while they likely will push back against adding “without a loading dose” when there is no mention of “without a loading dose” language in the spec. This seems fair, however. “Consisting of” confines your claim to a discrete set of steps that you really did disclose. By contrast, adding “without a loading dose” leaves open a million other possibilities that you never disclosed, while trying to close off just one, for which there is no evidence in the application that you contemplated closing. These are not the same thing, in other words.

            As a practical matter, I expect that the patentee could have saved themselves a lot of bother if they had run with “consisting of.” As long as it tracks exactly the language in the drug label, this will still serve to stop FDA approval of a generic. The fact that a potential infringer could get around the claim by adding irrelevant steps will not help, because the FDA will not permit them to add irrelevant steps to the label. Too bad that they did not try this.

            1. 4.1.1.1.1.1

              Claim: 1. A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, comprising orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.

              2. The method according to claim 1 wherein 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol hydrochloride is administered.

              Gileyna label:

              2.3 In adults and pediatric patients 10 years of age and older weighing more than 40 kg, the recommended dosage of GILENYA is 0.5 mg orally once-daily. In pediatric patients 10 years of age and older weighing less than or equal to 40 kg, the recommended dosage of GILENYA is 0.25 mg orally once daily.

              11. Administered as fingolimod hydrochoride.

              Would adding “consisting of” messed up the “or in a pharmaceutically acceptable salt form” of claim 1? Generics do not have to be the same salt form. So I would have had two independent claims:

              A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, [comprising] ‘consisting of’ orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol ‘hydrochoride’ [, in free form or in a pharmaceutically acceptable salt form,] at a daily dosage of 0.5 mg [, absent an immediately preceding loading dose regimen].

              AND

              A method for reducing or preventing or alleviating relapses in Relapsing-Remitting multiple sclerosis in a subject in need thereof, [comprising] ‘consisting of’ orally administering to said subject 2-amino-2-[2-(4-octylphenyl)ethyl]propane-1,3-diol, in free form or in a pharmaceutically acceptable salt form, at a daily dosage of 0.5 mg, ‘wherein the salt is selected form the group consisting of hydrobromide, sulfate, acetate, fumarate, maleate, benzoate, citrate, malate, methanesulfonate, sodium, potassium, calcium, aluminium, triethylamine, and lysine.’ [absent an immediately preceding loading dose regimen]

              Salt list taken from spec.

              1. 4.1.1.1.1.1.1

                I think the problem with adding “consisting of” here is not the salt issue, but the fact that there will always be other steps in treatment beyond just taking medicine. As an example, periodic lab work, doctor’s appointments, probably other medicine, etc. are very likely in a patient with MS. And so you add “consisting of”, and literally any step in treatment other than just giving the medicine arguably takes you out of infringement. You go to the doctor once a year as part of treatment? No longer (literally) infringing the claim. You can see where this goes.

                I also wonder though, its so easy to add a “loading dose” to get around infringement here, that it seems like the value of the claims with the negative limitation would be pretty low…

                1. No one is ever going to sue the individual patients or physicians under §271(a). You will want, instead, to sue the generic manufacturer for inducing infringement based on the method steps that they list on the product label. The FDA will not permit the generic manufacturer to add extra method steps to the label, so the idea of adding steps is not actually a viable non-infringement work-around.

  10. 3

    When a limitation is added to avoid the prior art, it is extremely reasonable to require that the limitation be expressly or inherently closed.

    The argument that “reasonably convey” somehow excludes any rule that would require an express or inherent disclosure in any context is very silly.

  11. 2

    The petition argues that Judge Moore has improperly created a bright-line rule in an area where “there are no bright-line rules.”

    This is not a helpful way of framing the question at issue. It sheds more heat than light.

    Judge Moore is correct that “express or inherent” is the standard, and always has been the standard. The new opinion cites Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997) for the proposition that “[a] description which renders obvious the invention for which an earlier filing date is sought is not sufficient,” but this approach to written description law goes back much further, and antedates the CAFC.

    In In re Ruschig, 379 F.2d 990, 995 (C.C.P.A. 1967), Judge Rich explained that “It is an old custom in the woods to mark trails by making blaze marks on the trees. It is no help in finding a trail or in finding one’s way through the woods where the trails have disappeared—or have not yet been made, which is more like the case here—to be confronted simply by a large number of unmarked trees.” The appellant there argued that “the activity table ‘stresses’ compounds in which R2 is a primary alkyl radical… The stress resides in the fact that eight of the ten are such compounds. And one of them, N-(4-chlorobenzenesulphonyl)-N’n-butyl urea, is a homolog of the compound of claim 13.” Judge Rich responded that “[i]t must be admitted that this is getting close… Appellants submit to us… an imaginary specific example patterned on specific example 6 by which the above butyl compound is made so that we can see what a simple change would have resulted in a specific supporting disclosure being present in the specification. The trouble is that there is no such disclosure, easy though it is to imagine it” (emphasis added). This was not enough. The appellant lost in Ruschig.

    In other words, the fact that the written description of the invention makes it easy for the skilled reader to envision a particular claim element is not enough. It has to be there (either expressly or inherently), not just be easy to derive from that which is expressly or implicitly given. That has long been the standard in written description. If this is a “bright line,” so be it. That is just how the law is and has been for longer than any of us have been practicing.

    1. 2.1

      Incidentally, this tough standard is good public policy. You want to make it easier for beneficial ideas to fall into the public domain. If a patent disclosure fails to claim all that it has enabled, that is just more good stuff for the public to enjoy. If the reason that it fails to claim the enabled subject matter is because it failed to describe the subject matter, then that failure is the patentee’s own fault. There is no reason why the public should be denied the goodies just to salve wounds that resulted from the patentee’s own mistakes.

      1. 2.1.1

        Greg: “ If the reason that it fails to claim the enabled subject matter is because it failed to describe the subject matter, then that failure is the patentee’s own fault.”

        But describing stuff is hard! Especially with all the prior art out there. Next thing you know the PTO is going to require applicants to submit entire DNA and protein sequences! That could add hours to the application prep time. This is why innovation in the US is dead.

        1. 2.1.1.1

          Ha!

  12. 1

    The CAFC is — and long has been — rudderless.

    1. 1.1

      Oh, the CAFC has a rudder.

      One which — more often than not — directs their boat to the welcoming shores of the infringers.

Leave a Reply

Your email address will not be published. Required fields are marked *

You can click here to Subscribe without commenting

Add a picture