Bits and Bytes from the PPAC Meeting

Notes from PPAC:

  • Eligibility: Gene Quinn discusses the patent eligibility debate and Robert Bahr’s update at IPWatchDog.
  • China: 2015 the Chinese Patent Office (SIPO) received 2.8 million patent applications.  The country is looking to move from a “big” IP country to a “strong” IP country. [Link]
  • Designs: Design patent applications expected to reach 40,000 for FY2016 – up from under 30,000 in FY2010. The PTO is working to improve design patent prosecution speed – current wait of more than a year for a first office action. [Link]
  • Regional Patent Offices: Around 500 examiners are working in the regional patent offices. [Link]
  • PTAB: David Ruschke is now fully in charge as PTAB Chief. Scott Boalick continues as deputy. Ruschke was Chief Patent Counsel of Medtronic for many years. [Link]
  • PGR Filings: Although there are now tens of thousands of issued AIA patents, very few PGR petitions have been filed.
  • Ex Parte Appeals: The number of pending Ex Parte appeals continue to drop. Great work PTO.


Finally, off topic – read Prof Holbrook’s essay on The Real Reason the EpiPen and other off-patents are so expensive at the conversation.

26 thoughts on “Bits and Bytes from the PPAC Meeting

  1. 4

    I’m waiting for the shocking statistic that design patent assertions are up a few hundred % over the past few years. Used to be rare, now there are some in every daily litigation report.

    Check this beauty: US D626,356 S It’s in litigation. Behold the novelty. Behold the ornamentation, which so far as I can see, is zero, while the utility of the object is 100%.

    What a system.

    1. 4.1

      There are (or were) at least two utility continuation apps pending which claim priority to that design patent. See, e.g., link to

      Allegedly this rack is easier to “fold, or assemble and disassemble” compared to the prior art storage racks. Something about the rear support members being “pivotably connected.”

      1. 4.1.1


        Hahaha; glad I’m not the only one that happens to. It’s a pain that every time I’m in Geneva, Google insists on switching me over to (and keeps pushing it back to “.ch” from “.com” no matter how many times I redirect).

  2. 3

    As to “The number of pending Ex Parte appeals continue to drop. Great work PTO.“…

    How are the other decks coming along? I am thinking specifically of the deck where the chairs are being moved to (from the appeals deck): the “re-instituted “in process” deck and the “well, we will just put these on the far back-burner RCE” deck.

    Without counting RCE’s as “new,” what do the TOTAL queue time statistics look like (and how much of any “improvement” is coming by way of the “Gist/Abstract” new 101 mechanism)…?

  3. 2

    GQ discusses the patent eligibility debate and Robert Bahr’s update at IPWatchDog.

    Short Robert Bahr: Because we massively overpaid crybaby patent attorneys are so incredibly clueless, it’s essential that the PTO tells us exactly how to leverage every “pro-patent” CAFC decision into a zillion different patents. It’s doubly important when the case is a really junky 101 decision like Bascom because it gives us even less time than usual to fabricate a bunch of nonsense about how important it is.

    Shorter GQ: I have no idea what Mayo was about because I don’t want to know. But it must be overturned! Also something about that case always makes me really hungry.

    1. 2.2

      Short MM: I enjoy summarizing content without reading it.

      (Bahr is a deputy commissioner at the PTO.)

  4. 1

    Replying to the off topic, it is not fair to say that Epipen is off-patent. Four patents expiring in 2025 are listed in the Orange Book for Epipen directed to the autoinjector component of the product.

      1. 1.1.1

        so have versions without that feature.

        How many do you have for sale and what’s your asking price?

        Meanwhile, the point remains: the epipen isn’t “off-patent.”

        The more important point, of course, is that’s neither junky patents nor the “slow” FDA that is the major source of the problem here. It’s a disgustingly greedy corporation that goes out of its way to gouge sick people because “legal.”

        Almost makes Prometheus, Myriad and Sequenom look good by comparison. Just kidding. It’s too early to say that. Maybe we should take a good look at Mylan’s awesome patent claims, though, just to be sure. I’m sure the improvements that Mylan made to the earlier epipen designs are, like, totally non-obvious. Because how else would they have gotten those patents granted?


          link to

          Mylan CEO Heather Bresch: No one’s more frustrated than me… My frustration is, the list price is $608.

          Oh my! How frustrating that must be!

          At 47, Bresch has spent most of her life at Mylan, working her way up from a secretarial desk in the basement of what was then a small West Virginia firm. In the ensuing years, Bresch has overcome an academic scandal, hostile takeover attempts, and questions about her true control over Mylan. She has also become one of the drug industry’s highest-paid CEOs, pocketing more than $18 million in cash and stock last year

          Super dooper frustrating to be her! She’s lucky she isn’t the privileged daughter of a US Senator or anything like that. Can you imagine how irritating that would be?


            One interesting bit in the CNBC article that your first quote came from is that $334 of that $608 is apparently from down-stream price increases (with $274 being Mylan’s net sales price).


          Wasn’t it something similar to albuterol inhalers? Perfectly good inhalers/injectors got outlawed bc of bs reasons and it just so happened that the bs reasons were peddled by the companies that held patents to not medically better alternatives?


          How many do you have for sale and what’s your asking price?

          You really have to try really really hard to miss the point, do you not?

          The off-patent portion (minus the upgrade) IS off-patent.

          See – connect the dots like that with an easy and direct sentence.

          Any time you want to try speaking inte11igently instead of being an arse, please feel free to do so.


            Actually, it is that difficult to get versions without that feature (i.e. pre-filled epi syringes).

            There’s a shortage of pre-filled epi syringes (non-autoinjector-based), and the only big company that mfg’d them stopped in 2015. Two other mfgs haven’t gotten FDA approval.

            A different auto-injector company (AUVI-Q) also issued a voluntary (not FDA-urged) recall based on unconfirmed malfunction reports in 2015.

            Honestly, the whole turn of evens seems very fishy the more you read into it.


              Actually, it is that difficult to get versions without that feature (i.e. pre-filled epi syringes).

              Great – but that too misses the point.

              Last I checked, in this country one cannot force someone into a business (something about slavery and all). But the choice of companies to not BE in a business should NOT be conflated with whether that avenue is open to be taken (especially when it is further conflated with the “blame patents” meme).


              “There’s a shortage of pre-filled epi syringes (non-autoinjector-based), and the only big company that mfg’d them stopped in 2015. ”

              Why did they stop?

      2. 1.1.2

        A generic must have the “same label” as a branded product. FD&C Act Section 505(j)(2)(A)(i). If I was the patent attorney for the Epipen, I would make sure that the patented features were essential for safe operation of the device. The prior device, now superseded, is not in a separate NDA, so cannot be separately referenced. As long as you make a different device operate differently with respect to the instructed use of the drug, there is no way around the patent short of doing a study of some kind and filing a paper NDA under FD&C Act Section 505(b)(2).


          You (badly) assume that the prior device – on the antler with the blessing of the FDA – is somehow (magically) now “unsafe” given the new version (with different patent features).

          Nowhere is this assumption supported.

          Additional facts currently not present may support such a proposition, but such just are not a part of the current discussion.


            That’s what I was thinking in all this. Maybe you could make a mint by bringing back the old, non-“auto” injector injectors and selling them at $50 a pop. What was on the market in the late `70s et seq was safe and effective.

            You (as a patient, or someone administering the adrenaline to the patient) just had to be brave enough to push the plunger yourself down to that first stop. (And if you needed a second dose, rotate 90 degrees and push to the second stop).

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