Orange Book Insights^TM

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

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

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

  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

Orange Book Insights  No. 33 – Orange Book Vol. 42/Supp. 4 News For 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 Book, and showed the delisting of two patents.    One of the delisted patents was  7,323,463 , that had been listed for Allergan’s COMBIGAN ® . The’463 patent had been the subject of a patent delisting request. So the FDA has now acted on that request. The other delisted patent,  9,593,100 , had been listed for Array Biopharma’s MEKTOVI ®  ( binimetinib ) . The MEKTOVI ‘100 patent had not been the subject of a delisting request.   As I categorized the claims of the fifty-two newly listed patents in order to include that information in my  Orange Book Companion , I noticed one set of claims that was particularly interesting. The patent was  11,311,515  listed for an ophthalmic drug called

  I have updated the beta version of my  Purple Book Companion ™  through April 2022. The FDA's "Purple Book" contains information about approved biologic drugs. This includes patents that some BLA sponsors assert cover their biologics, as well as exclusivities that may prevent the FDA from approving competitive biosimilars of innovator biologics for a certain period of time. My  Purple Book Companion  focuses only on the listed patents and the granted exclusivities. For biologics that have patents and their expiration dates listed in the FDA's Purple Book, the  Purple Book Companion  (" PBC ") additionally provides the title of each patent, the types of claims in each patent, and further includes a link to the text of the patent at the USPTO. So there is no need to individually copy and paste patent numbers into the USPTO's search utility in order to view the patents. Just click the link. New Features : The original version of the  PBC  only had an inde