Orange Book Insights^TM

Last week the FDA released their March 2019 (Vol. 39, Supp. 3) Orange Book raw data. Here are a few observations about Supplement 3: We had another light month of patent listings. Only 37 new patents were listed in March. Most surprising was the lack of patents claiming new compounds. Only one of the newly listed patents had traditional compound claims. Two patents were delisted in March, and unlike in February the reasons were quite obvious. The patent that was listed for Kaleo’s EVZIO (AUTOINJECTOR) as a result of a typo in the patent number has been delisted and replaced by the correct patent, 10,143,792. The other delisting was carried out because 9,085,601 that had been listed for Astellas’ LEXISCAN was reissued. Here is something to look for in the April (Supp. 4) data that will be released by the FDA in mid-May. On April 4 the FDA approved Pfizer’s IBRANCE in combination with an aromatase inhibitor or fulvestrant for HR+, HER2- advanced or metastatic breast cancer i

In mid-March the FDA released their February 2019 (Vol. 39, Supp. 2) Orange Book raw data. I updated my Orange Book Companion ® right away, but here are a few somewhat overdue observations about Supplement 2: We had another light month of patent listings. Only 36 new patents were listed in February. Are we still in a New Years hangover? Unlike last month no single product dominated the new listings. Three patents were delisted well before their expiration dates. I could not find any IPR decisions or patent listing disputes for those patents. One NDA holder delisted two of those patents from one of its products and listed them for another of its products. Maybe just a mix up during the listing process? If so, this is another example of why companies need to pay special attention to their end-to-end patent listing workflow. Pfizer received a three-year “miscellaneous” exclusivity (M-237) for CHANTIX based upon their completion of a study “to determine whether varenicline, as