Showing posts from July, 2019

A disappearing Pediatric Exclusivity and other musings about the June 2019 Orange Book supplement

In mid-July the FDA released their June 2019 (Vol. 39, Supp. 6) Orange Book raw data. Here are a few observations about Supplement 6: There were 47 new patents listed in June. Only four of the newly listed patents had traditional compound claims which does not include new polymorphs, salts or hydrates. One patent was delisted in June. The patent, 8,759,316, had been listed for KENGREAL ® (cangrelor) from Chiesi USA. The claims are directed to a method of transitioning a patient from administration of cangrelor during percutaneous coronary intervention (“PCI”, which is the more modern name for angioplasty with stent) to administration of cangrelor in preparation for surgery, or vice versa. Cangrelor is not in the latest Patent Listing Disputes list, nor is it in the July 16, 2019 “Paragraph IV Patent Certifications” list. The NCE-1 date occurred on June 22. So why was the patent delisted? One thought that I had was based upon the lack of any mention in the KENGREAL label of

Now you see them, now you don’t: Catch those expiration date issues before your patent or exclusivity disappears!

This blog entry is not so much about Orange Book Supplement 5 (May 2019) (see the end of this posting for that). Instead, it is a warning about the ramifications of not seeing expiration date issues, regardless of whether they were created by you or the FDA, in the Orange Book. What brought this issue to my attention ? I was making needed changes to the computer code that generates the Orange Book Archive™ (“ OBA ”) section of my  Orange Book Companion ® (“ OBC ”). Over the last few years, whenever the FDA made changes to its raw data files I would take the lazy route of making minor changes to the computer code which would make the new data files look like the old data files. In that way I did not have to make major changes to the downstream computer code. For my update of the  OBA  to include 2018 expirations I decided to bite the bullet and make the major revisions that would allow my code to use the FDA’s current data file format directly. No more retrofitting of the new