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
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The Great Delisting! Companies delist patents in response to FTC notices.
By Bruce Pokras
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…
The Chicken Sandwich Conundrum: Parts is Parts . . . or Not
By Bruce Pokras
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
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Make sure that your patent exists before submitting a 3542 form for the patent to the FDA
By Bruce Pokras
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…
Orange Book V43, Supp. 1 news
By Bruce Pokras
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…
A New Patent Listing Champion!
By Bruce Pokras
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
…
Orange Book Vol. 42/Supps. 7 and 8 News, Plus an Interesting Type of Claim for VASCEPA
By Bruce Pokras
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…
Orange Book Vol. 42/Supp. 6 News: Watch out for the breadth of your use codes
By Bruce Pokras
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…
Orange Book Vol. 42/Supp. 5 News
By Bruce Pokras
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…
Orange Book Vol. 42/Supp. 4 News
By Bruce Pokras
Orange Book Insights No. 33 – Orange Book Vol. 42/Supp. 4 NewsFor those who have not checked yet, in mid-May I posted a link to my free Orange Book Companion “What’s New” for Orange Book Vol. 42, Supp. 4 on my public Orange Book Companion home page. Supp. 4 added 52 new patents to the FDA’s Orange…