Speculation about the delisting of a “part” patent from the Orange Book

After updating my Orange Book Companion® (“OBC”) Orange Book information subscription service each month, I usually first check the “What’s New” page that contains the changes in patent and exclusivity listings from the previous month. For the most recent update, Volume 40, Supplement 6, the first thing I saw at the top of the page was a patent delisting for Otsuka’s Abilify MyCite® Kit (aripiprazone oral tablets). Aripiprazole is classified by the FDA as an atypical antipsychotic.


The Abilify MyCite Kit is a very interesting product. The kit includes a tablet that contains the aripiprazole along with some circuitry that transmits an electromagnetic signal when activated by gastric juices in the patient’s stomach. Yes, each tablet is like a little radio transmitter!


The other part of the kit is a skin patch that contains a receiver for the signal sent by the tablet. The data received by the patch can be accessed via a smartphone app. In this way the patient or their caregiver can confirm that the patient had actually taken their medication. (If you have seen the movie “One Flew Over the Cuckoo’s Nest,” are you now visualizing the scene where Jack Nickolson’s character fooled Nurse Ratched into thinking he had taken his med, when he actually had not?).


The Delisted Patent


So, what was the patent that Otsuka delisted? It is 9,577,864 that is entitled:


Method and apparatus for use with received electromagnetic signal at a frequency not known exactly in advance


The apparatus claims of the ‘864 patent are directed, therefore, to the skin patch receiver part of the Abilify MyCite Kit. The independent apparatus claim preamble states:


12. Apparatus for use with respect to a received electromagnetic signal, and with respect to a reference frequency, the apparatus comprising . . .


which is then followed by a very technical description of the parts, and the function of the parts, that make up the electronics of the skin patch receiver. The USPTO shows that all of the device-related patents were assigned to Proteus Biomedical, Inc. or Proteus Digital Health, Inc., and so were likely licensed by Otuska for use in the Abilify MyCite Kit.


Based on the title of the ‘864 patent you may wonder why the frequency of the signal being sent by the Abilify MyCite tablet would not be “known exactly in advance.” That is because the best known way to send an electromagnetic signal, such as a radio signal, at a specific frequency is to use a crystal to control the frequency. Those old Citizen Band two-way radios that were such a big thing in the seventies and eighties were required to use crystals for frequency control.  However, I cannot imagine the complexity of embedding a crystal controlled transmitter in each and every Abilify MyCite tablet! So Otsuka used a simpler but less exact transmission system. That would make it important for the receiver to have greater flexibility than it would ordinarily need if the signal’s frequency was tightly controlled.  In fact, the background of the ‘864 patent describes the problem that the claimed invention is meant to overcome like this:


Suppose, for example, that the transmitter is not crystal controlled and thus the designer of the receiver is not permitted to assume that the transmitted signal is at any particular exact frequency. [Col. 1, lines 43-46].


Why was the ‘864 patent delisted?


I can only speculate about Otsuka’s reasons for delisting the ‘864 patent. I could not find any announcement from Otsuka that stated the reason. My search for the patent at the PTAB did not yield any results. Nor did my PACER search turn up any cases filed by Otsuka in which the ‘864 patent had been asserted in the complaint. That makes a finding that the patent has been held to be invalid or unenforceable unlikely.


But there was a recent 1st Circuit opinion, In re: Lantus Direct Purchaser Antitrust Litigation, 950 F.3d 1 (1stCir. 2020) (“Lantus”), that analyzed the Orange Book listing eligibility of a patent that claimed only a part of a drug delivery device that, in turn, was incorporated into the final approved drug product. You can read a nice summary of the Lantus case at Hyman, Phelps & McNamara’s excellent “FDA Law Blog.”


The drug product in Lantus was Sanofi’s Lantus® SoloSTAR® which is a disposable injector pen containing insulin glargine. The injector pen includes a drive mechanism that is claimed in 8,556,864. Sanofi had listed that patent in the Orange Book for their Lantus SoloSTAR product, but the Lantus antitrust plaintiffs argued that the patent was ineligible for listing.


The Lantus panel agreed with the plaintiffs that the patent claiming just the drive mechanism used in the Lantus SoloSTAR insulin injector pen was not eligible for listing in the Orange Book. The panel considered the statute, 21 USC 355(b)(1), which requires that the patent claim “the drug for which the applicant submitted the application.” Since the drug in question was the complete Lantus SoloSTAR, the panel concluded that the drive mechanism patent did not claim the Lantus SoloSTAR, and so was not eligible for listing in the Orange Book:


More importantly, even assuming that the drive mechanism claimed by the '864 patent is itself a drug, we still find Sanofi falling short of its goal because the drive mechanism is not the "drug for which [Sanofi] submitted" the sNDA. 21 U.S.C. § 355(b)(1). For that reason alone the patent for the drive mechanism does not qualify for listing in the Orange Book as claiming the Lantus SoloSTARId at 9.


So I can speculate that, in an abundance of cautions, Otsuka applied the Lantus opinion to its thirty-two Abilify McCite Kit patents listed in the Orange Book. Upon my review, I found that a number of the device-related patents were directed to the tablet dosage form, itself, so eligibility for listing in the Orange Book would not be likely to be a problem under Lantus.


However, when I reviewed the claims of the remaining device-related patents that are listed in the Orange Book for the Abilify MyCite Kit, I found that all but the ‘864 patent had at least one claim that could be construed to at least tangentially connect the claimed subject matter of the patent to the approved tablet dosage form, thus creating the inference, at least, of claiming the complete Abilify MyCite Kit drug product. For example, even 8,718,193, which is directed to the receiver patch, has a tenuous connection back to the tablet dosage form since it refers to the tablet in the preamble of claim 1 by describing it as an “in vivo transmitter”, as follows:


1. A signal receiver, comprising: (a) a receiver module configured to receive an encoded signal from an in vivo transmitter in a low signal to noise ratio (SNR) environment, the receiver module comprising . . . (emphasis added).


So maybe, with enough thought, Otsuka could have come to the conclusion that the ‘193 patent would pass muster under Lantus. In that case they would allow that patent to remain in the Orange Book.


That would leave the ‘864 patent as the sole remaining patent.  Unlike the claims in the Lantus drive mechanism case, the ‘864 patent’s claims for the skin patch receiver are not in any way directed to a part of a dosage form from which the drug is administered to the patient. Moreover, the ‘864 patent’s claims do not even refer to the dosage form in any way. Therefore, it seems even more difficult to construe the ‘864 patent to claim the finished Abilify MyCite Kit in light of the Lantus opinion. That realization may have provided Otsuka with their reason to select the ‘864 skin patch receiver patent for delisting.



Popular posts from this blog

Make sure that your patent exists before submitting a 3542 form for the patent to the FDA

Orange Book Vol. 42/Supp. 6 News: Watch out for the breadth of your use codes

Orange Book V43, Supp. 1 news