Patentlyo Bits and Bytes by Anthony McCain

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About Anthony McCain

Anthony McCain is a law student at Mizzou where he is focusing on intellectual property; He has a background in mechanical engineering.

25 thoughts on “Patentlyo Bits and Bytes by Anthony McCain

  1. 5

    link to

    “We’re being especially cautious at this early stage, so we’re advising drivers to keep their hands on the wheel just in case. The software is very new.”

    Funny stuff. Last time I checked, it remains the driver’s responsibility in most states to control their vehicle. It’s probably wise to keep a hand on the wheel regardless of how “new” or “old” the software is, given how fast things can (and will) go wrong.

    Our robot car paradise remains a distant dream and it’s going to stay that way for a while. More junky patents on “how to drive if you’re a robot” isn’t going to change that fact.

    1. 5.1

      You are such a doosh.

      You “don’t like” a certain type of innovation, so you get “all high and mighty” about how any attempt to go down that road is filled with “junky patents”….

      Maybe you should get into an area of law that does not “upset” you so much.

      Or maybe, just avoid all this “innovation” stuff in the first place. Hence the invitation to you to join the Amish is not made flippantly.

  2. 4

    Common sense to the rescue …

    link to

    A panel of federal appeals judges has taken the unusual step of reversing a position it reached just three months ago when it decided Amazon must face a trademark lawsuit due to search results it produced related to a watch.

    In a superseding opinion (PDF) published Wednesday, the same three-judge panel from the US Court of Appeals for the 9th Circuit says that Amazon’s search results aren’t likely to produce the consumer confusion anticipated by watchmaker Multi Time Machine. “[B]ecause the page clearly labeled the name and manufacturer of each product offered for sale and even included photographs of the items, no reasonably prudent shopper accustomed to shopping online would likely be confused as to the source of the products,” wrote Judge Barry Silverman for the majority.

    1. 4.1

      common sense to the rescue

      I think the issue is far more complex than such a glib comment to survive.

      First, you are venturing into Trademark law, which I have seen no capability from you to comment upon.

      Second, the notion of “no actual confusion” is KNOWN not to be a controlling factor under trademark law FOR the notion of likelihood of confusion.

      Third, there remains serious arguments to be had about the “in commerce” portion that these Trademarks are involved with. There can be no doubt that there is in fact “in commerce” being engaged in – huge amounts of money are changing hands with this area of commerce. Whether or not this is a type of commerce that should be concerned with the trademark item and with any particular subset of “consumer” are questions not yet fully vetted.

      Fourth, your apparent lack of consistent “appreciation” for “G-g-grifters” is puzzling here, as you seem to side for a particular set of “G-g-grifters.” There are NO “white knights” in this scenario and what you have is one set of “G-g-grifters” against another set of “G-g-grifters” in a purely mercenary Money battle.

      1. 4.1.1

        you are venturing into Trademark law, which I have seen no capability from you to comment upon.

        Eff you, psych0.



          LOL, such a “reasoned” response. Maybe you want to address any of the numerous other parts of my message…? Instead of confirming the part that you don’t like?

          Gee, let’s see how long this gets by the “politeness police.”

  3. 3


    Let me modify my statement above that what Sandoz has done specifically “dodges” issues related its manufacturing process for the biosimilar which may infringe an process patents that Amgen owns. BCIPA still permits Amgen to go against Sandoz for infringement of any of Amgen’s product and use patents. But as Newman’s dissenting opinion correctly points out, the BCIPA is completely silent on whether Amgen can assert infringement under the BCIPA of any of its process patents if Sandoz simply avoids the “patent dance.” If Amgen could get that “manufacturing information” through mandatory application of the “patent dance” procedure, it would be much clearer whether or not any of Amgen’s patented processes are infringed by how Sandoz makes its biosimilar. By contrast, given the current developments to toughen the pleading requirements under the FRCP, making an “information and belief” assertion of infringement of a patented process with minimal or no knowledge of the details of the alleged infringing process, is much more risky, so what Amgen is asking for in its petition about “manufacturing details” makes complete sense.

    1. 3.1

      Certainly, from Amgen’s POV. But consider Sandoz, why would it expose itself to an infringement suit if it can avoid it?

      May I ask, does the public information necessary for approval of biological product require public disclosure of one’s manufacturing methods? If it does, I would think that it would be fair to require the same of a biosimilar.

      But if it doesn’t….

      1. 3.1.1

        And it it does not, why in the world, why in the world would anyone publish their process in the first place even if one obtains a patent on it? Keep it secret.

        Is there a way of claiming a biological product other than by specifying a particular process?


          Is there a way of claiming a biological product other than by specifying a particular process?

          Ned – look at the other thread and the danger involved in doing what you are suggesting here…


              ( s i g h )

              The thread on prior art enabled (which references a point I made in a discussion on the danger of “making admissions” and discussing others’ prior art efforts on yet another thread).

              Really Ned, this is something that you should be able to easily understand.


                anon, I am doing my best here anon.


                Way of making….

                I see. So, even if I describe a biological product and claim it, I have to disclose a method of making it. And, if I have to disclose it, why not claim it?

                Is this the point here?

  4. 2

    The last Great Patent Interference, or Why Patents and Science Mix Poorly

    link to

    “If you are a historian—” says Mario Biagioli, who is in fact a historian of science at UC Davis1—“you quickly will realize exactly how many times there are independent discoveries of the same thing.” The dispute over credit for CRISPR/Cas9 is not the result of exceptional coincidence and disagreement. In fact, it illuminates how science always works.

    1. 2.1

      Can you explicate this “poorly fit” claim?

      On patent law there is a recognition of the possibility of independent invention and that does not mean a poor fit must entail.

      Rather the opposite – spurring things to happen quicker (with reward) is the aim.

      We should not be surprised then that races develop and some of those races become hotly contested.

    2. 2.2

      A good article as far as it goes. But it is ignoring the fact that the Supremes hold that a scientific discovery itself [vs a patent application disclosing and claimed a patentable contribution by an inventor to the “useful arts”] is not patentable, while presumably a scientific discovery per se IS the basis of a Nobel Prize? So that differences in who gets what are to be expected for reasons other than parallel independent research.

  5. 1

    From Noonan,

    “Amgen had petitioned for rehearing on the panel’s decision that the District Court correctly determined that the provisions of the BPCIA requiring disclosure to the reference product sponsor of a biosimilar applicant’s application and relevant manufacturing information was optional rather than mandatory. Sandoz petitioned for rehearing on the panel’s decision that the District Court had erred in deciding that the 180-day noticed of commercial marketing for the biosimilar product could not be given to the reference product sponsor prior to FDA approval of their biosimilar application.”

    On Amgen’s petition, why is it important that the biosimilar disclose his “manufacturing information” to the sponsor?

    1. 1.1

      I may be off, but does not the sponsor bear responsibility for the drug in the market, even that made by the ge neric?

    2. 1.2

      “On Amgen’s petition, why is it important that the biosimilar disclose his “manufacturing information” to the sponsor?”


      For at least 2 reasons: (1) to establish whether the alleged “biosimilar” is truly the functional equivalent to that sponsor’s biologic as how it’s manufactured can be highly relevant to that question; and (2) to establish patent infringement, especially if the sponsor has patented methods/processes involved, but also potentially if how the biosimilar is made shows infringement of patents on the sponsor’s biologic itself, including infringement under 35 USC 271(g) if the biosimilar is imported into the U.S.

      1. 1.2.1

        EG, but

        1. is the responsibility of the government, not the sponsor; and

        2. why would anyone disclose his process to anyone else for the purposes of being accused of patent infringement? That is off-the-wall nonsense.

        Third, why in the world would anyone patent a manufacturing process where the use of the process cannot be inferred from the presence in the public domain of a product probably made by that process?

        But there might be something about biologics that requires patenting such a process. That is why I ask.



          1. The whole point is that the biosimilar requestor should be sharing that “manufacturing information” with the sponsor to establish that “bioequivalency” for the biosimilar is satisfied. The government (i.e., FDA) may have no legal obligation to share that with anyone else (i.e., Amgen, the sponsor) unless required to do so by the biosimilar statute.

          2. It isn’t “off the wall nonsense.” Sandoz has to establish “bioequivalency” for its proposed biosimilar to obtain approval from the FDA to market it, and that “manufacturing information” may be highly relevant to whether or not the proposed biosimilar is “bioequivalent.” It also may be highly relevant as to whether or not Amgen’s patent rights have been infringed, including any patent rights on the biologic.


            EG, does the government require Sponsor approval? Otherwise, I don’t understand the role of the Sponsor in all this.



              The FDA doesn’t require the sponsor (e.g., Amgen) to approve the marketing of the biosimilar . But the sponsor could certainly file objections with FDA to the approval of marketing of the biosimilar, suggesting that biosimilar requestors manufacturing practices show that the biosimilar isn’t bioequivalent to the sponsor’s biologic. That’s permitted with respect to other approvals by the FDA, such as Food Additive Petitions (FAPs).


                EG, why couldn’t the law simply allow the sponsor to hire an independent expert to come on down to the government facility and inspect the data from the petitioner, and make comments?

                I was involved in a number of trade secret case where this was actually done in order to police the settlement agreement between a trade secret owner and a company hiring an employee of the trade secret owner who allegedly had knowledge of trade secrets and who arguably would inevitably use and disclose them. Both parties hired an independent expert who had knowledge of the one party’s trade secrets and the other party’s disclosure from the concern employee. The expert would determine whether or not the subject matter of the one and the other were the same, and whether or not that subject matter was publicly known.

                I do not see from the point of view of the government why something like that should not be done with bio-similars.

                From a point of the patent law, the patent owner can sue for patent infringement based upon information and belief to the extent that they do not have actual knowledge of the manufacturing process employed by the accused infringer. So I do not see any real barrier to the sponsor filing suit if and when the bio similar is approved.

                1. Ned,

                  I don’t know what you’re experience is with FDA matters, but what you can keep “trade secret” in gaining FDA approval of a drug, food additive, or even a biosimilar is much more limited than the “trade secret” situations you note. Also, Sandoz is essentially trying to “dodge” the provisions of BPCIA that provide Amgen with information required to determine whether or not Sandoz’s biosimilar and how it’s manufactured for asserting infringement of Amgen’s patented biologic, as well as any of Amgen’s patented processes. See panel decision Amgen v. Sandoz: “Amgen argues that, by refusing to provide the required information, a subsection (k) applicant unlawfully evades the detection of process patent infringement and avoids an immediate infringement action under § 262(l)(6).” I agree with Amgen’s position in the panel decision that the so-called “patent dance” is mandatory, otherwise you have Amgen, the patent owner, without any basis under the BCIPA to assert that Sandoz is infringing these patents. “Information and belief” doesn’t help as the basis for patent infringement under the BCIPA requires the “patent dance” to proceed, there being no actual marketing of the biosimilar that would normally trigger patent infringement.

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