The Chicken Sandwich Conundrum: Parts is Parts . . . or Not

 Orange Book Insights No. 43 (revised Feb. 24, 2024): The Chicken Sandwich Conundrum: Parts is Parts . . . or Not Parts may be parts (thinking back to that old Wendy’s commercial where they compared their chicken sandwich made solely from chicken breast meat to their competitor’s chicken sandwich that was allegedly made from various unknown parts of a chicken). However, all of the claims of Pat. No. 7500444 (‘444 patent) that Glaxo had listed in the Orange Book for their ADVAIR HFA (fluticasone propionate; salmeterol xinafoate) product, are directed to something called an “actuation indicator” which is nothing more than  a mechanical part of the ADVAIR HFA device rather than a drug! Steve Auten had previously shared news about a November 7 FTC announcement that the FTC had submitted patent disputes to the FDA under 21 CFR 314.53(f) for patents that the FTC believes do not qualify for listing in the Orange Book. The FTC also sent the responsible drug manufacturers letters informing th

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

 So, you received an “Issue Notification” from the USPTO for an allowed patent application. Yay! But be careful! The “Issue Notification” document that the USPTO sent you says that it merely contains a “ projected ” patent number and issue date.  In the case of MC2 Therapeutics’ WYNZORA, a patent with the projected patent number that the Issue Notification contained did not issue on the projected issue date, and, in fact, never issued! However, MC2 must have submitted a 3542 form to the FDA for patent number 11638711 (‘711 patent) that was contained in an Issue Notification that had been sent to them on April 12, 2023. That Issue Notification said that the patent would issue on May 2, 2023. The Electronic Orange Book shows that information for the ‘711 patent was received by the FDA for WYNZORA on May 31. However, in my preparation for the Vol. 43/ Supplement 6 version of my Orange Book Companion® I discovered that one of the text files of basic data that my algorithms had generated fo

Orange Book V43, Supp. 1 news

  Happy Orange Book New Year! Volume 43, Supp. 1 added 41 new patents to the FDA’s Orange Book. That includes three new patents for the current patent listing champ, AUVELITY® which now has 103 patents listed. You can see all of the changes to the Orange Book that occurred in Vol. 43/Supp. 1 by going to the Orange Book Companion® public home page and clicking on the prominent “What’s New” link.  If are a gluten for punishment, can also see all 103 AUVELITY patents by clicking the sample link for trademarks that begin with "A" and then scrolling down to AUVELITY. A device for making a drug does not claim the drug, itself Three particularly interesting patents were listed in the Orange Book as part of Volume 43/Supplement 1. All three patents claim devices for making the approved drug. They do not claim the approved drug, itself, or a method of using the approved drug. Yet all three were listed as “drug product” patents.  In each case, the approved product is a gas that is con

A New Patent Listing Champion!

First, if you haven’t seen it yet, the USPTO has replaced their old patent search interface of  “Quick Search”, “Advanced Search” and “Patent Number Search” with a new system called Patent Public Search (“PPS)”. The former “Quick Search” is no longer available where you could use a dropdown to select sections of patents to search (such as the ever popular “Claims”). For patent number searching in PPS, just type the patent numbers (each separated by a space) in the search field and click the “PN” button. Other searches are similar to the old Advanced Search, except that you may have a whole new set of codes to learn. One problem for Mac users is that PPS does not work with Apple’s Safari browser. So Mac users will need to install Google Chrome or Mozilla Firefox. This change at the USPTO broke the patent number links in my Orange Book Companion ® (“OBC”). I had barely gotten off my flight to Phoenix to visit family on October 1 when I discovered that none of the patent number links in

Orange Book Vol. 42/Supps. 7 and 8 News, Plus an Interesting Type of Claim for VASCEPA

The Vol. 42/Supp. 7 of the FDA’s Orange Book contained only 36 newly listed patents. Maybe July is a slow month? Also, there were no patent delistings.  The Vol. 42/Supp. 8 of the FDA’s Orange Book contained only 33 new patents. Two months in a row with less than forty new patents? Maybe it’s the summer doldrums? There was a delisting request for a patent that was reissued. Ho hum! However, if you are a fan (or not a fan) of listing patents that claim a mechanical part of a drug administration device, there is something for you. Teva Branded Pharmaceutical Products listed 11,395,889 for several of their metered dose asthma inhalers. The ‘889 patent claims a dosage counter for the inhalers. You can see all of the changes by looking at the free “What’s New” for Supp. 8 that is available from a link on my Orange Book Companion home page. “Interesting” Method Claims I have been looking into the Paragraph IV certifications and Section viii statements that Hikma made in their ANDA for Amari

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

This posting is late since I am talking about Vol. 42, Supp. 6 of the Orange Book. The data for Supp. 6 was released by the FDA in mid-July. However, I updated my  Orange Book Companion  immediately when the data was released, so my subscribers received the new data on time. Similarly, if you are not a subscriber but enjoy checking out my free  Orange Book Companion  “ What’s New ” each month, that was also ready to view in mid-July. So, what is late? It’s this Supp. 6 news where I discuss a mass delisting of patents for a single product   in which all of the patents had what appears to be overly broad use codes . Please read on.   Supp. 6 added 52 new patents to the FDA’s Orange Book. However, unlike Supp. 5, there were a number of patents that were delisted or were newly tagged as being the subject of a delisting request. Two of four patents listed for Serenity Pharmaceuticals’ NOCTIVA ( desmopressin acetate)   were delisted. Both strengths of NOCTIVA are shown in the Orange Book as

Orange Book Vol. 42/Supp. 5 News

  For those who are interested in month-by-month changes to the patents listed in the Orange Book, and interested in new awards of exclusivity, I posted a link on my public  Orange Book Companion  home page to the free Orange Book Companion “ What’s New ” for Vol. 42, Supp. 5.  Supp. 5 added 44 new patents to the FDA’s Orange Book, and no patents were delisted. However, there was a bumper crop of Patent Term Extensions under 35 USC 156 (eleven, not including one patent that received its second one-year PTE under Sec. 156(e)(2)).  The extended patents have not yet been added to the list of  Sec. 156 extensions  shown at the USPTO. If you want to review the extended patents, just search for the phrase “new expiration date” (without the quotes) in the  What’s New  using your web browser. News has come out recently that Amarin, the Orange Book patent listing champion with 68 patents listed for its 1 gram strength of VASCEPA (icosapent ethyl), is planning a major downsizing in response to s