Written Description: Four Points Are Not A Range

This is an important written description case involving ranges, and highlights a tension within the court over when special disclosure is required within the specification.

Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2021)

IPR challenges are limited only to obviousness and anticipation arguments, and so a patent cannot be directly challenged via IPR for lack of enablement or written description. However, Section 112(a) issues do arise in situations where the challenged patent purports to claim priority back to a prior filing.  The priority claim fails if the earlier filing fails to support the challenged claims, and this permits  assertion of intervening prior art.

Dr. Reddy challenged Invidior’s U.S. Patent 9,687,454 via IPR. The patent claims priority to a chain of prior applications:

  • The ‘454 patent is a continuation of application No. 14/715,462, filed on
    May 18, 2015, now abandoned;
  • The ‘462 Application is a continuation of application No. 14/478,786, filed on
    Sep. 5, 2014, now abandoned;
  • The ‘786 Application is a continuation of application No. 13/964,975, filed on Aug. 12, 2013, now abandoned;
  • The ‘975 Application is a continuation of application No. 13/923,749, filed on Jun. 21, 2013, now abandoned;
  • The ‘749 Application is a continuation of application No. 12/537,571, filed on Aug. 7, 2009, now Pat. No. 8,475,832.

The challenged patent covers a sublingual film containing some drug treatment.   The claims include several different limitations regarding the amount of polymeric matrix used for the film.

  • Claim 1: “about 40 wt % to about 60 wt % of a watersoluble polymeric matrix”;
  • Claims 7 & 12: “about 48.2 wt % to about 58.6 wt %”; and
  • Claim 8: “about 48.2 wt %”;

The problem though is that the original specification does not recite any of these amounts or ranges directly. The specification does include two tables that collectively include four examples that, when calculated-out, all fall within the range of 48.2-58.6%.  However, that calculation process is not express in the specification and the specification does not note particular reason why the particular endpoints form a “range.”  On appeal, the court agreed with the PTAB that “written  description support of a claimed range” requires “more clarity.”

Here, one must select several components, add up the individual values, determine the aggregate percentages, and then couple those aggregate percentages with other examples in the ’571 application to create an otherwise unstated range. That is not a written description of the claimed range.

Slip Op. The court also notes that the specification provided no additional support for particular ranges and instead indicated that “[t]he film may contain any desired level of . . .polymer” and that in one embodiment it is “at least 25%.”

[The patentee] failed to provide persuasive evidence demonstrating that a person of ordinary skill would have understood from reading the ’571 application that it disclosed an invention with a range of 48.2 wt % to 58.6 wt %. A written description sufficient to satisfy the requirement of the law requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention. “[A] patent is not a hunting license. It is
not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).

Slip Op. Although the ranges were not supported, the court did find sufficient evidence to affirm the PTAB’s determination that the individual point of “about 48.2 wt %” was supported by the original specification: “given that claim 8 does not recite a range, but only a specific amount, which can be derived by selection and addition of the amounts of selected, but identified, components, we accept that there is substantial evidence to support the Board’s decision concerning claim 8.”  Without that priority, the claims were clearly invalidated by prior art published between 2009 and 2015.

The majority opinion was filed by Judge Lourie and joined by Judge Dyk.

Judge Linn wrote in dissent, arguing that the majority’s approach creates “an overly demanding standard for written description of ranges” and is contrary to cases such as In re Wertheim, 541 F.2d 257 (C.C.P.A. 1976) and Nalpropion Pharms., Inc. v. Actavis Labs. FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019).  The majority had recognized the value of those precedents, but argued that written description is an intensely fact intensive question.

 

36 thoughts on “Written Description: Four Points Are Not A Range

  1. 9

    “..an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention” reminds me of former SAPJ McKelvey’s statement that “a brief is not an invitation for a truffle hunt by the judges.”

  2. 8

    That’s why it’s good to put a continuous graph function in the Figures.

    1. 8.1

      Should a continuous graph in an unpredictable art be considered as prophetic examples?

      1. 8.1.1

        Certainly, pitfalls in the presentation of data are often under appreciated (as exemplified by comments on the graph choices of Prof. Crouch).

  3. 7

    Greg et al.: InFlAtIoN doesn’t matter!

    Regular dood small fry youtuber w near viral vid: Workers getting priced out of society! I’m paying close attention to those prices nowadays!

    link to youtube.com

    1. 7.1

      Duly noted.

  4. 6

    Excellent, well-reasoned case. Keep on keepin’ the grown-up arts legit.

    1. 6.1

      Any time Malcolm mentions “grown-up,” the irony meter goes through the roof.

      1. 6.1.1

        Cleta Mitchell called. She’d like you to wipe her.

        1. 6.1.1.1

          I hope she reads your message and sues you for defamation. She certainly has grounds to do so. Your comment is disgusting on all sorts of levels.

          1. 6.1.1.1.1

            Big +1 Lurker.

            Dennis — please join Gene in banning Malcolm.

            PatentlyO is better than this.

          2. 6.1.1.1.2

            READ my new post. I discuss the reasons why Nancy Jones left. Another absolute proven trespass. I’m going to get my DUE PROCESS. The SAG and then the US ATTYS. OFFICE who are well aware of who contacted Nancy about what was going to happen, and did.

            1. 6.1.1.1.2.1

              Did you know VICK had so much control that he was able to protect individuals by hiring a relative during the time a statute would have applied! Problem for him is that won’t matter because his power and power behind him blocked my DUE PROCESS. And that does not add up to timing a statute.

        2. 6.1.1.2

          Meh, no idea who Clea is, or why Malcolm would be 0bsessing so, but frankly, Malcolm being Malcolm is just not enough to make anyone he names all that upset (he just is not that important enough nor have any real impact with his silly whines).

          1. 6.1.1.2.1

            I disagree, he should be banned, and if Dennis does not do so, he is equally culpable. Cleta Mitchell is a well known elections lawyer, and did several TV interviews on all the major networks during the Gore-Bush case, if my memory serves me well.

            On another topic, I decided to do a google search to see who this Malcolm Mooney really is, and nothing comes up when you search that name together with patent (or IP) attorney. Is he using a nom de plume? Or are my online search methods just that poor?

            1. 6.1.1.2.1.1

              That certainly is not his real name.

              And — Malcolm being Malcolm — in the archives one may find Malcolm whining incessantly that “s0ck pupp etry” was the worst thing ever even as I busted him for that very behavior over at PatentDocs.

              Heck, I have already noted that his re-entry after just over a year absence was sniffed out practically immediately even as he was using different monikers before settling on “The Prophet.”

              And by the way, just prior to his ‘sabbatical,’ he had reached a 15 consecutive year run of his “style” of posting on this blog (courtesy of comments from Night Writer and a crawl through the archives).

      2. 6.1.2

        anon,
        Identity theft and in the crime may effect the sovereign. And as for my copyrights they belong to me. I’m sure they don’t fall under that sovereign and why Juicy Brucey was removed, anf why Pallantee was too.

  5. 5

    So glad that Judge Linn is involved with CAFC cases every now and then, since like Judge Newman, he is the patentee’s best friend. Having been fortunate to have worked under him during his short time at Foley & Lardner, I can say with utter confidence that he is a super-intelligent person, and, sorry to say, it is too bad that his take on the Alice line of cases was not what the Supreme Beings adopted. Life would have been so much different than it is today (like the “Dark” shows, which are so interesting).

    1. 5.1

      Jon,
      You get what you pay for. So, not getting paid you get what you asked for.

    2. 5.2

      Gotta give some props to Foley for quickly expunging sick stain on humanity Cleta Mitchell from their ranks. On the other hand, how does a person with those kind of low integrity and intelligence issues get hired in the first place?

  6. 4

    I’m not going to invest the time in going through the family of filewrappers but if someone wanted to waste away the hours doing so, it would be interesting to know how many different prosecutors worked on this family of applications. Different prosecutors, different claim drafting styles, etc. Sometimes, it comes down to the prosecutor trying to find a creative way to extract additional claims from a specification that has been picked clean.

  7. 3

    Anyone: why so many abandonments?

    Inquiring minds want to know.

    Happy Thanksgiving everyone.

    1. 3.1

      Why, I do not know. I can tell you, however, that I have had dealings with Invidior before, and they do this in all their patents—file CON1, then CON2, then let CON1 go while they continue with CON2.

      1. 3.1.1

        Does the patent family contain a clue. UK Applicant, EP grant opposed by German competitor, Lohmann. Greg, are the two of them fierce competitors with each other, routinely playing cat and mouse at the USPTO, watching the other, waiting for the other to make a move? Might that explain Invidior’s fondness for strings of continuations?

        If so, why don’t lots of other foreign Applicants with non-US competitors also find it useful to string out prosecution at the USPTO more or less indefinitely?

        Incidentally, given the technical field worked by Invidior, opioids, I should have expected domestic firms to dominate the US market. Do they, I wonder?

    2. 3.2

      There are several reasons for so many abandonments. If you use serial continuations, and do not abandon their parents, grandparents and great-grandparents, you risk obviousness-type double-patenting problems. So what are the good reasons for serial continuations [and/or divisionals]? First, it keeps you “in the catbird seat” as one case put it. That is, years of being able to watch competitors products launch and still being in a position to change your claims to try to cover them [even though you give up that part of your patent term]. Also, you can cite and ex parte distinguish prior art that comes up later in litigation assertions of prior related patents. Also, with enough continuations you may get a different examiner, one more willing to allow claims you want. And/or, as here, apparently not having time [or management priority] to check to see if every added claim element in the final continuation has had 112 written description [or enablement] support in the great-grandparent application as filed.
      Serial continuations thus probably would be used a more if it did not fit corporate-bean-counters modern model of efficient patent prosecution, or pharma obsession with maximizing patent term length?

      1. 3.2.1

        Well, Paul, every Applicant would like, ideally, to “keep something pending” at the PTO right through to the end of the patent term, wouldn’t they? If they could afford it. For example, at the EPO you can file as many generations of divisional as you like, all through the 20 year term. It is just that all those accumulated EPO annuity fees get very burdensome, the later on in the 20 year term you file your divisional. Thus, only the high value cases feature divs still pending at the end of the patent term.

        Of course, the savagery of the EPC, when it comes to adding subject matter after the PCT base date, also renders increasingly futile the filing of ever-later generations of divisionals. Bit like the WD squeeze, eh?

        1. 3.2.1.1

          Max, I suggest that it is not really that the EPO is legally stricter against adding “new matter” into divisionals than the PTO, rather. it’s that EPO examiners get, via higher fees, more time to look for it and enforce it. In contrast to too many U.S. examiners not checking the new or amended claims in divisionals or continuations to see if something is being newly claimed that had no supporting description as being part of the claimed invention under 112, or no enablement under 112.
          So, in the U.S. more typically one does not get “caught at it” until the patent is asserted and challenged in a D.C. [as here] or license negotiation. Or, only incidentally challenged in an IPR if it makes a priority date difference that makes a prior art availability difference.

          1. 3.2.1.1.1

            Paul, what you write may be so but perhaps the greater factor is the so-called “inescapable trap” set by the interaction of Art 123(2) EPC and its Art 123(3). It works like this: if it turns out, after grant, that you added matter during prosecution, you need to amend to cure the invalidity. But, you see, you can’t amend, if the effect is to widen the scope of protection. Art 123(3) forbids it.

            The trap works alarmingly often, whenever you amend the independent claim during prosecution. Which one does. Often.

            And who does the patent owner blame, if the expensively acquired European patent turns out to be incurably invalid, purely and simply because of an injudicious prosecution amendment? Why the patent attorney. Of course. Who else?

            What is so elegant about this horrific CATCH 22 is that it is self-policing. Attorneys police themselves (or else get sued for malpractice). There is no need for any EPO Examiner’s slumbers to be interrupted at all. It is the very first thing that prospective opponents look into, for if there is such a validity attack available it is the express route to wipe out the patent at a stroke.

            Disproportionate, you might cry in disgust, but nobody will pay any attention.

            Being a man of experience, you already knew all this, didn’t you? Interesting however is to wonder what percentage of US patent attorneys (or readers here) know it.

            1. 3.2.1.1.1.1

              Max, you changed the subject to post-grant changes, but in any case the interesting part about EPO 123 to me is this emphasized language difference:
              “(2) The European patent Application OR European Patent may not be amended in such a way that it contains subject-matter which extends beyond the content of the application as filed.
              (3) The European Patent may not be amended in such a way as to extend the protection it confers.”
              That is, (3) only applies to patents, while (2) also applies to applications, and (3) is to “extent of protection” [claim broadening] instead of “beyond content of application” for (2) [We are of course stuck with whatever the latter is held to mean by the EPO, but this text should logically not prevent amendments of pending claims that do not require new matter support?]
              In the U.S. you can file a claim-broadening reissue application for two years after grant, to remove non essential claim limitations or provide more generic claims, or you can file claim-narrowing reissues or reexamination for the enforceable life of the patent. [Albeit reissues are rarely used, far less often than they should be.]

              1. 3.2.1.1.1.1.1

                Yep, Paul. Indeed. You can regard the difference between 123(2) and 123(3) as a reflection of different public policy objectives. In any First to File system, you cannot allow those prosecuting pending applications to amend to claim subject matter (say an inventive selection from a wider range) that was beyond their conception at the time they filed their patent application. That’s 123(2).

                But neither should those who have carefully perfomed an FTO analysis be surprised by, and expected to live with, post-isssue scope-widening amendments. That’s Art 123(3) EPC. You still need Art 123(2) though, throughout the life of the patent, for those occasions when the patent owner amends the issued patent to remove a ground of invalidity of the patent as issued (which they can do throughout the life of the European patent).

                Why is there a 2 year cap on widening reissues, I wonder. Why 2 years and not 1 year or five years?

                1. Re: Max: “Why is there a 2 year cap on widening reissues, I wonder. Why 2 years and not 1 year or five years?”
                  I knew it was historical parallelism, but I had to check for the dates: reissues have been available in U.S. law since 1832, while statutory bars were only changed from 2 years to 1 year in 1940.

  8. 2

    Sounds a bit like the other bugaboo in those art fields: an effective amount…

    (B-b-but we cannot look too closely at possession AT TIME OF FILING because waiting until actually passing FDA trials [for that same “effective” claim element] would be too long)

    1. 2.1

      But for the required listing of the clinical trial primary and secondary endpoints on CT.gov, I am sure pharma practitioners would gladly wait for the clinical trial results prior to filing. However, the requirement to publish prior to getting results forces the crystal ball hypotheticals we see in these types of cases.

  9. 1

    These are the sort of claims that a good prosecutor will almost always be able to get to grant from the USPTO, but which even the best litigator will be unable to hold up when asserting. One sees this phenomenon all the time. I guess that it was something to list on the Orange book (better to have something listed than nothing listed), but not otherwise worth much.

    1. 1.1

      Greg I’m interested in the category of cases which i) get past the PTO but then ii) fail to be enforceable against an infringer. The degree of annoyance suffered by the party who has financed the entire operation will (I suppose) vary with the reason for the claim’s ineffectiveness.

      I guess that lack of patent eligibility must be the most frustrating for the investor, no? Failure because of prior art already considered by the PTO must be close behind but that hardly ever happens, right?

      Least upsetting must be when the infringer puts up knock-out prior art which the PTO was not able to take into account.

      Issues of WD and lack of enablement must be, I suppose, somewhere in the middle, in that the patent owner is itself responsible for the unenforceability. Or not?

    2. 1.2

      >These are the sort of claims that a good prosecutor will almost always be able to get to grant from the USPTO, but which even the best litigator will be unable to hold up when asserting.

      +1 Patents are a strange area of law where neither Chevron deference nor an express statutory presumption of validity seem to mean much.

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