Federal Circuit Denies En Banc Request in BPCIA case

by Dennis Crouch

Following the Federal Circuit’s first interpretation of the Biologics Price Competition and Innovation Act (“BPCIA”), neither the patentee (Amgen) nor the biosimilar applicant (Sandoz) were satisfied. Each petitioned separately for en banc rehearing and both petitions have now been denied in a per curium opinion.  (Background from Andrew Williams at PatentDocs). Both parties will likely petition the Supreme Court for further interpretation of the “biologics patent dance

[AmgenSandozDenial]

15 thoughts on “Federal Circuit Denies En Banc Request in BPCIA case

    1. 1.1

      Can’t see how you wouldn’t think that was transformative.

      The Lord of the Rings is a fantasy series. It’s purpose is to tell a story and entertain.

      Being able to search to see how many times the phrase “One Ring” is in the series is not part of the purpose of the story. Nor is the name of the author (factual), how many words are in the book (factual), how many times the word ‘The’ is used (Factual), nor any other factual heuristic about the book, story, and author.

      Physics books have a purpose, to record and distribute information about chemistry. The [i]facts[/i] in the book cannot be copyrighted. Nor can you copyright [i]facts[/i] about the book itself (note that applies to Lord of the Rings as well, the facts about the book are not copyrightable, such as who authored it, how many times the word ‘The’ appears in the work, etc). Textbooks have always had very distinctive styles [i]because[/i] copyright is much harder on factual data, and always has been.

      Building a database that determines what phrases are in a physics book, and using that to search for Physics Textbooks that contain the word ‘Centrifugal Force’ so that I can check the reference in the book, and see if it endorses it. If it does, I don’t buy that text book, because there is no centrifugal force. This is not something the Copyright on the physics text book covers (which is only the layout and presentation, not facts about what it teaches).

      So yes, it is transformative (the database is not the same as the book, it has no pictures, the layout is lost, it’s no longer in a book or book file format), it provides information about the book, not the information *in* the book.

      Could it be used to infringe the copyright on the book? Absolutely, if it’s used wrong. Plenty of things can infringe if you infringe, but aren’t illegal (VCRs for example!). As the judge noted, if the thing is used to infringe, then the copyright owner can sue for the infringement, just as they always have been able to.

      It sometimes amazes me how some people decide an entity is evil/the bad guy/the enemy and then put themselves into a reality distortion field where laws (natural and man made) warp and change meaning around that enemy, so that they can’t see reality.

        1. 1.1.1.1

          You implied that it was a bad decision, which implies in turn it was not transformative. It was a completely logical decision within the law.

          Copyright did not ‘take a hit’ as you put it, which shows a bias. Saying it took a hit implies it’s been weakened, when it hasn’t. The decisions simply upholds copyright law, including fair use, as it has been. A major point of the ruling of fair use was that it was transformative. To say it caused copyright to ‘take a hit’ implies the decision was faulty, and that it was not transformative.

          1. 1.1.1.1.1

            I did not imply that transformation was not obtained. In the least.

            You read too much into the direct statement.

            Yes, (objectively), copyright DOES take a hit. Do you deny that? Apparently so, and apparently you do not understand the traditional sense of copyright and ENTIRE works (quite in fact – t h e entire work, and not a snippetized databse version as you may think) is in fact – MUST BE in fact – copied.

            So NO, you are quite wrong in that I say or even imply that transformation was absent.

            1. 1.1.1.1.1.1

              Yes, (objectively), copyright DOES take a hit. Do you deny that? Apparently so, and apparently you do not understand the traditional sense of copyright and ENTIRE works (quite in fact – t h e entire work, and not a snippetized databse version as you may think) is in fact – MUST BE in fact – copied.

              Even when “anon” tries to say something — and it’s pretty clear he’s desperately trying here — it comes out as incomprehensible garbage.

              Take a remedial English course already. And please stop using the phrase “quite in fact”. It makes you sound like a thirteen year old doosh.

              1. 1.1.1.1.1.1.1

                For all your whining here Malcolm, you fail to actually state a specific complaint of poor English.

                Quite in fact, the doosh is you.

                Do you want me to repost what Prof. Crouch himself had to say about the “penchant” for like totally proper English? – Funny too, you don’t have what it takes for the right stuff to be proper (the law).

            2. 1.1.1.1.1.2

              Anon, you do not seem to understand what a copyright is. It is not the right to keep someone from using your work. It is a right to keep someone from using your work to duplicate how you used it.

              They cannot make copies that infringe your right. Full stop.

              It doesn’t say they can’t make copies. It says they cannot make copies that infringe any rights you have with regards to making copies.

              For your argument to hold water (hint, it doesn’t), the copyright owner would have had to have been granted a specific right to license information about the work. They were not.

              Ergo, no, copyright did not, objectively, take a hit. You use that word, and it does not mean what you think it means. You really mean, subjectively, it took a hit. Subjectively, you feel it took a hit because you feel that somehow, fair use is not part of the equation, because subjectively, you feel somehow someone should always have to pay a license no matter what.

              That is wrong. Fair Use is part of Copyright. If you don’t like that, to use your own words against you, go talk to a legislator. Get the law changed. But don’t post that ‘copyright took a hit’ because it didn’t. The exact same laws applied before the decision. The famous VCR case allowed people to copy a tv show in it’s entirety to time shift it and it was fair use, and not infringing (Sony Corp of America vs Universal Studios). You somehow seem to miss that precedent in your analysis that ‘copying the entire work is copying and violating copy right’. I suggest you learn more on what copyright rights actually are (Hint, you might want to read the judges opinion in this case, and the Supreme Court’s opinion in Sony vs Universal Studios, and do the follow up on the cited cases).

              1. 1.1.1.1.1.2.1

                You are over- reading and under-understanding again by attempting to portray my comment for something other than what it is.

                I understand copyright perfectly well thank you. My comment is – and remains – accurate.

      1. 1.1.3

        It sometimes amazes me how some people decide an entity is evil/the bad guy/the enemy and then put themselves into a reality distortion field where laws (natural and man made) warp and change meaning around that enemy, so that they can’t see reality.

        The best part is when people who engage in that activity (like “anon” and his cohorts) reveal themselves to be kinda obsessed with World War II. Surprise!

        1. 1.1.3.1

          There is no “obsession” with a healthy understanding of history, Malcolm.

          And in fact, my understanding spans far more than just World War II.

          Funny though, that you would impliedly take issue with the lessons available from that era.

          Gee, I wonder why that is (wait, no I don’t).

    2. 1.2

      I do take issue with this statement in the opinion (a common mis-statement among people who see “computer” and revert immediately to infancy):

      The search engine also makes possible new forms of research, known as “text mining” and “data mining.”

      Analyzing texts for word repetitions and patterns is not a “new form of research” and search engines did not “make it possible”. Search engines only made it easier.

      Why is it so hard for people to understand and acknowledge that information processing is as old as the ability of the human brain to process information?

      1. 1.2.1

        You do get the difference between a person doing something and a machine doing somersetting, right?

        Remember that word:

        Anthromorphication

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