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 take you to a list of the challenged patents for that product. Each patent number is a link to the patent at the USPTO. By reviewing the patent’s claims you can judge for yourself if the FTC is correct in concluding that the patent is not eligible for listing in the Orange Book.

Following the FTC’s challenge letters dated November 7, 2023, several companies delisted one or more of their challenged patents. It will be interesting to see if the April 30 letters will similarly cause companies to delist patents. Stay tuned!


Comments

Post a Comment

Popular posts from this blog

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
Read more

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
Read more

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
Read more