Check your Patent Term Adjustment for Applicant Delays due to Late IDS Filings

by Dennis Crouch

Supernus is an important case that may substantially extend the patent term adjustment (PTA) for your client.  You’ll need to review the case files of recently issued cases to determine whether PTA was reduced by some supplemental filing (such as a late IDS). You may get the time back with a showing that the delay was reasonable. Deadlines in this area are tight. – DC

Supernus Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2019)

This case involves calculation of patent term adjustment (PTA) that extends the 20-year patent term due any delays in obtaining the patent.  The statute attributes most delays to the USPTO (extending PTA), but some are attributed to the patent applicant (reducing PTA). With regard to PTA reduction, the statute particularly calls-out late office action responses as “failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.”  35 U.S.C. 154(b)(2)(C). In addition, the statute particularly gives the PTO Director authority to “prescribe regulations” that spell-out the times where PTA should be reduced due to an applicant’s failure to engage in such reasonable efforts.

This case involves supplemental filings by a patent applicant that potentially delay prosecution.  The dates here are important:

  • February 2011, Supernus (the patentee here) filed a request for continued examination (RCE) in the case;
  • August 2012, Sandoz filed an opposition in the the parallel European case that cited 10 new documents.
  • September 2012, Supernus received notice of the opposition from its European counsel.
  • November 2012, Supernus filed an information disclosure statement providing the cited documents.

When the patent issued, the USPTO caculated the patent-term-adjustment as 1,260 days.  Although that adds years to the patent term, the patentee wanted more. In particular, the PTO had reduced the term by 646-days — the entire time from the filing of the RCE until the filing of the IDS.  The PTO stood-by its calculation and cited its regulation that PTA is reduced by any “submission” by the applicant “after a reply has been filed” by the applicant.   37 C.F.R. 1.704(c)(8).   Under the regulation, the PTA reduction is calculated as the number of days between the original “reply” filing (here, the RCE) and the later “submission” (here, the IDS).

Supernus has a legitimate complaint. The statute says that PTA should be reduced when the applicant has failed to engage in reasonable efforts.  Here, Supernus apparently had no knowledge of the new documents for at least 18-months (Feb 2011 – Aug 2012). In fact, one of the documents (the opposition itself) had not even been created yet.  The point here is that even a highly reasonable actor could not have submitted the documents during that 18-month period.

A difficulty for Supernus is that the Federal Circuit previously upheld this particular regulation ( 37 C.F.R. 1.704(c)(8)) — finding it “reasonable.” Gilead Scis., Inc. v. Lee, 778 F.3d 1341 (Fed. Cir. 2015).

On appeal here, the Federal Circuit has distinguished Gilead and sided with the patentee.  In Gilead, the information found in a late-filed IDS was already known to the patentee — thus it was proper to attribute the entire delay to the applicant. The basic holding in Gilead was that the PTO does not have to prove that applicant delay actually caused a delay in issuance.

Here, the court focused on whether the PTA reduction can exceed “time during which the applicant failed to engage in reasonable efforts to conclude prosecution.”  After considering the language of the statute, the court concluded that the USPTO is only permitted to reduce PTA for periods where the applicant acted in an unreasonable manner.  This conclusion follows easily from the statute:

The period of adjustment of the term of a patent under paragraph (1) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the application.

35 U.S.C. § 154(b)(2)(C)(i) (emphasis added by the court).

Although the PTO has authority to regulate this area, it does not have authority to contravene the statute — as such the office acted inappropriately here. “We find the USPTO’s PTA reduction to be inconsistent with the PTA statute and, as a result, we accord no deference to the USPTO’s application of the regulations at issue in these circumstances.”

The PTO will now need to think-up some new regulations.  Two potential solutions.

=  = = = =

The patent at issue – U.S. Patent No. 8,747,897 – is somewhat interesting in the way that it claims the use of polyvinyl pyrrolidone (PVP) as a “complexing agent” in its pills.

30 thoughts on “Check your Patent Term Adjustment for Applicant Delays due to Late IDS Filings

  1. 5

    Dennis – I think you meant the title to read “Check Your ….”

        1. 5.1.1.1

          LOL.

          Looks like Billy “PC is the worst thing evah!” McHypocrite is having another one of his snowflake moments. Poor widdo baby. *sniffle*

          1. 5.1.1.1.1

            Malcolm talking about someone (anyone) else being a hypocrite…

            Stultifying.

            You acting like Trump (again), rather dull.

      1. 5.1.2

        Silence as to that type of improvement…?

        Not shocking Prof.

        Sad, sure. shocking? No. Even as you have expunged more of Malcolm’s posts than any other poster EVER (more than ALL other posters combined EVER), Malcolm’s blight STILL runs rampant.

        Approaching the end of 14 solid years…

  2. 4

    I wonder if there is a general impression among the peanut gallery about whether EP Office Action documents or papers filed in an opposition need to be submitted to US Examiners in order to comply with the duty of disclosure?

    Note that I’m not talking about submitting material, non-cumulative prior art references that haven’t been submitted before. I’m talking about submitting an EP Office Action or an Opposition Brief filed in the EP that cites, e.g., previously cited art with some arguments about the impact of that art on the claims under European patent law. Are such opinions going to be “relied on” by a USPTO Examiner, so that fairly to disclose is inequitable conduct? Is the same true of Canadian, Australian, Indian, or Chinese Office Actions? I’m not aware of any case law finding a patent unenforceable for failure to disclose such a document. I am aware of case law holding that the failure to disclose a US Office Action in a subject-matter related US case can definitely be a problem.

    1. 4.1

      about whether EP Office Action documents or papers filed in an opposition need to be submitted to US Examiners in order to comply with the duty of disclosure

      Even though the EP has their own Sovereign rules, the rule of thumb here has always been: when in doubt submit.

      All firms – and all practitioners that I know – submits ALL foreign related material to the USPTO. And yes, this material is all material and not limited to references.

      1. 4.1.1

        All firms – and all practitioners that I know – submits ALL foreign related material to the USPTO.

        So … I pull my US case from issuance to file an Office Action from India that cites a reference that I’ve already cited and overcome (by argument providing unexpected results) in the US case? What’s the argument for inequitable conduct if I don’t do that?

        And recognize that if I’d got say, four or five cases related by subject matter that are each filed in 6 or 7 foreign jurisdictions, the chances of receiving some item of “foreign related material” during the period between a Notice of Allowance and a grant are close to 100%.

        I’m also curious as to how many law firms you’ve actually canvassed in support of this statement. I think you’re a long way off from reality.

        1. 4.1.1.1

          Your hypo is odd (and quite the strawman).

          My answer is that I don’t need to pull anything from issue, as I have timely filed all foreign items.

          My Indian actions typically come well before the US app reaches that point.

          No. I have to disagree with your “100%” part of your hypo.

          Maybe you are doing something wrong.

          Further, I “canvassed” no Law Firm’s and my answer did not state (nor imply) that I “canvassed” any law firms.

          My answer was strictly on what I know from the host of my compatriots in other law firms.

          Have you canvassed any law firms?

          1. 4.1.1.1.1

            Your hypo is odd (and quite the strawman).

            It’s actually commonplace, which you’d know if you actually did any foreign prosecution. It’s also not a “strawman” because it’s a commonplace example of the issue I’m discussing (which is related to the situation presented the patentees in the instant case). You really do s ck at this stuff, Billy, in a profoundly depressing away.

            I “canvassed” no Law Firm’s

            Thanks for the admission, Billy. You’re a very serious person! And I have zero reason to believe you’ve ever filed a PCT application, much less gone into multiple jurisdictions afterward.

            I have timely filed all foreign items.

            Assuming this is true for the sake of argument, you do this presumably because you believe that foreign patent law is relevant to US Examiners. That’s another interesting admission. I’m sure MaxDrei will get at least as many chuckles out of this as I already have.

            1. 4.1.1.1.1.1

              You funny.

              Not in the way that you think, but hey, the way that you think is most odd anyway.

              Aside from your own microcosm and views (which apparently are the only things “real” in your mind), you having “zero reason” — taken in context of this being you — is really no surprise. You often display that you have zero reason.

              And no, what may be commonplace to you is NOT commonplace for MANY people.

              As I indicated, perhaps this is a YOU issue.

              And whether or not the foreign patent law is relevant to US examiners is simply not a call being made (after all, it is up to the examiner to make that call) – ALL I need do is imagine that it might be relevant, and — as I stated — the best course is to simply err on the side of caution.

              Is that really such a strange concept for you? Or is this merely you attempting a Tr011ing?

              1. 4.1.1.1.1.1.1

                Shorter “anon”: “Derp derp deederp.”

                what may be commonplace to you is NOT commonplace for MANY people

                No doubt, Billy. But a lot of us grown-ups do routinely file subject-matter related applications around the world, even if you don’t. That doesn’t make my hypothetical a “strawman.” It just makes you kind of an outlying pipsqueak plugging away in the dank trenches of Nobodycaresland. But we knew that already.

                1. There is nothing that you should take away form the comment of you being odd that what you do is normal for “grown-ups” or that I am only concerned with “Nobodycaresland” — whatever it is that you think that THAT is.

                  That you “file around the world” is a rather “Whoop-de-do Basil” kind of thing.

                  I would easily gather that most people (grown-ups or “otherwise”) won’t have the issues that you seem to have (at anywhere close to 2%, let alone 100%.

                  You are not doing something right.

                2. There is nothing that you should

                  *click*

                  Or you could just admit that you don’t understand the concept of a hypothetical, and you don’t know what a “strawman” is. And you could apologize for being such a t 0 0l.

                  [shrugs]

                3. chances of receiving some item of “foreign related material” during the period between a Notice of Allowance and a grant are close to 100%.

                  But you Accuse me of being the one not understanding…

                  Quite naturally, you top your skill set off with your number one meme of Accuse Others Of That Which Malcolm Does/Is.

                  How very Trump of you.

                4. you Accuse me of being the one not understanding…

                  I do.

                  By the way, cutting and pasting an accurate statement and then continuing on with your derp derp derping isn’t a very effective argument, Billy. Only proves what we’ve all long suspected about your prosecutorial experience (LOL). Or maybe you’re just tired from writing “on a processor” next to ineligible junk all day, hoping to secure a “big win” for your b0ttom feeder clients before Fraud Iancu’s guidelines get trashed by every court in the country.

                5. You have no basis to talk about what is or what is not an “effective argument” Malcolm.

                  None.

                  As to repetition, THAT only exemplifies your own beyond stale Accuse Others meme – how soon you forget your choice to opt for the highest “security” setting in the DISQUS days only when it was pointed out that the average setting allowed anyone to see all of the posts of a particular poster gathered together.

                  You are the epitome of the word hypocrite.

                  As to the Iancu new protocol, maybe you should try actually reading what I have posted on those. This should not be that difficult for you, as you had previously boasted of being able to read every single one of my posts (ever) in a four hour window.

                  Well, reading and comprehending ARE two different things, and I would want you to do more than merely “read” since for you, “reading” apparently does not mean treating what you read with any sense of inte11ectual honesty.

        2. 4.1.1.2

          Re canvassing law firms: That is a good point. It is very difficult to determine if there is a general consensus on the best practice on this and many other finer points. I also think it is very likely to get an OUS office action between the notice of allowance and issuance.

          1. 4.1.1.2.1

            I also think it is very likely to get an OUS office action between the notice of allowance and issuance.

            Of course it is very likely and every adult in the room who has worked in a decent-size firm for a serious client knows this.

    2. 4.2

      It is quite clear that the CFR’s do not require third-party opinions about your claims. The PTO encourages submission of “prior art cited in search reports of a foreign patent office….” but does not encourage submission of the search reports themselves. If the PTO wanted negative EP office actions, they have had decades to ask for them. Still, you might not want to be the guy who has to clarify the rule with a trip to the Federal Circuit.

      1. 4.2.1

        as noted, “ the rule of thumb here has always been: when in doubt submit.

        For some odd reason, Malcolm wanted to turn this into an “odd” or “bad” thing.

        Most likely, he simply wanted to Tr011, but the rest of his posts show an alarming propensity to NOT be getting (yet another) area of patent law, and his “doing this wrong” in yet another area (while somehow at the same time, STILL thinking of himself as a Legend in his own mind).

        1. 4.2.1.1

          For some odd reason, Malcolm wanted to turn this into an “odd” or “bad” thing.

          No, I didn’t.

          I asked a serious question and I got a flippant j@ ck @ ss answer from the blog’s resident j@ ck @ ass who hasn’t filed a PCT application in his life.

          1. 4.2.1.1.1

            translation: anon is correct (again) and Malcolm does not know how to handle that (again).

  3. 3

    Seems like a lot of trouble to go through just because you did not know about 37 CFR 1.704(d)(1). Timely submission of the IDS would have avoided the need for appeal to the Federal Circuit.

    1. 3.1

      Sure. No doubt. I like this result, but there is no doubt that the better policy would have just been to submit the art within the 30-day grace period.

  4. 2

    Sara Nelson: There is a humanitarian crisis unfolding right now for our 800,000 federal sector sisters and brothers who are either locked out of work or forced to come to work without pay due to the government shutdown.

    These are real people who are facing real consequences of being dragged into the longest shutdown in history. No money to pay for rent, for childcare, or a tank of gas to get to work. …

    We can do this. Together. Si se puede. Every gender, race, culture, and creed. The American Labor Movement. We have the power.

    Love it. She’s calling for a general strike of airline workers until Perznit R @ c i st Derpderp and his r @ c i st enablers throw in the towel.

    I wonder how Fr@ud Iancu’s employees will behave when their checks dry up?

  5. 1

    The patent at issue – U.S. Patent No. 8,747,897 – is somewhat interesting in the way that it claims the use of polyvinyl pyrrolidone (PVP) as a “complexing agent” in its pills.

    Why is that “somewhat interesting”, Dennis? I assume this isn’t just a lame attempt at bothsiderism here.

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