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The FTC's new set of letters challenging patents listed in the Orange Book

 The FTC has sent out a new set of letters (dated April 30, 2024) to pharmaceutical companies in which the agency is challenging the eligibility of certain patents for listing in the FDA’s Orange Book. If you are interested in an easy way of reviewing these newly challenged patents (of which there are 125), I have created Orange Book Companion-style pages to do just that. In those custom pages each patent number is a link to the text of the challenged patent at the USPTO. Just go to the public Orange Book Companion home page ( www.orangebookcompanion.com ) and look for the section entitled “Patents disputed by the Federal Trade Commission.” There are two links in that section. One link will take you to the products that had one or more patents that were the subject of the FTC’s letters dated November 7, 2023. The other link will take you to the products that have one or more listed patents that are the subject of the FTC’s most recent letters. Clicking on the name of the product will t
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The Great Delisting! Companies delist patents in response to FTC notices.

The FTC sent letters dated November 7, 2023 to nine pharmaceutical companies stating that the FTC believes: certain patents have been improperly or inaccurately listed in the Orange Book with regard to [name of pharmaceutical company] products and that we have availed ourselves of the FDA’s regulatory process and submitted patent listing dispute communications to the FDA regarding the patents. Below, I discuss products for which the NDA holder delisted some, but not necessarily all, patents as a result of receiving the FTC letters. ARNUITY ELLIPTA, ANORO ELLIPTA ARNUITY ELLIPTA is an inhaled drug indicated for the once-daily maintenance treatment of asthma as prophylactic therapy. The FTC letter for ARNUITY ELLIPTA mentions four patents, but only mentions one strength of the drug. Strengths of a drug are identified in the Orange Book by “Product Number” (“Prod. No.”). For example, in the Orange Book, there are three product numbers for ARNUITY ELLIPTA (fluticasone furoate). Those produ
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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
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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
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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
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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
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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
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