Check those Orange Book patent submissions before and after listing!

I would like to once again emphasize the need to confirm the correctness of any new patent listings in the Orange Book once they have appeared. In the Supplement 8 data a new patent was listed for an injectable drug packaged as a freeze dried powder in a vial. What drew my attention was the title of the patent: "Method and device for plasma-treating hollow bodies.” Whiskey Tango Foxtrot???
When I looked at the patent it turned out that the “plasma” was not blood plasma, but was instead an electrically generated plasma. The patent covered a device for sterilizing vials and syringes!  Not really eligible subject matter for listing the patent in the Orange Book since it did not claim a drug or a method of using a drug. It just claimed the sterilization device.
Fast forward to Supplement 9. As usual, I read through the “What’s New” page of the Orange Book Companion® to see the changes from Supplement 8. That is when I noticed that the sterilization device patent was described as “no…

And the Orange Book patent listing champion is . . .

Over my years of using the Orange Book Companion® (“OBC”), I have occasionally noticed patent listings for a product that seem to go on forever. At that time I might wonder which product of the many products in the Orange Book has the most patents listed. But other priorities would intervene, and I never did anything to satisfy my idle curiosity until now.
At first I thought that this would take a lot of coding to get the answer from the FDA’s monthly raw data. Then it came to me that the OBC’s “master” table (from which all of the tables that subscribers see are derived) could be my source rather than the FDA’s raw data. Five minutes later I had the answer. It’s a three-way tie at 36 patents per product! The champions of patent listings are:
AFREZZA (insulin recombinant human) from Mannkind Corp., BYDUREON PEN (exenatide synthetic) from AstraZeneca AB, and HYSINGLA (hydrocodone bitartrate) from Purdue Pharma LP.
Not surprisingly, the patent listings for AFREZZA (an insulin product admin…

Bumper crop of new patents in the Orange Book for July!

There were 82 new patents listed in the Orange Book during July. Usually the number of new patents range from 30-50. Is this going to be a trend? I hope not! I would have to spend a lot more time each month identifying the types of claims in each patent for the Orange Book Companion(R).

One of those "new" patents should not count, though. It is a process patent. Right now there are nine process patents listed in the Orange Book, including the new one. That is actually down from a couple years ago when there were fifteen!

Not all of the process patents in the Orange Book come right out and claim "a method of making X." No, they are a little more subtle. The new one claims "a method of enhancing the solubility of" X by mixing it with Y in certain weight ratios. Just because the claims do not say "method of making" or "process for making" does not make them any less of a process.

Another wrinkle that this new process patent presents is th…

It's best to be prepared: FDA approves a drug that no one needs (and hopefully never will)

Yes, you read that right. On July 13, 2018, the FDA approved a drug for treating a disease that no one in the entire world is suffering from. That drug is TPOXX (tecovirimat) from Siga Technologies Inc. (Siga), and it was approved for treating smallpox. Maybe you remember reading about smallpox in history books. In 1980, the World Health Organization (WHO) declared that smallpox had been eradicated from the face of the Earth. So why would any company go to the trouble of developing and then applying for approval of a drug that has no patients that need it?

That can be explained in one word: bioterrorism! While the smallpox virus, called variola, is no longer circulating among the world's populations, there is a grave concern that there are laboratory samples of the virus still in the hands of some governments or private labs. So there is the potential (however small) for the creation of a smallpox bioweapon by a government or by a terrorist group who managed to steal samples of th…

The FDA has approved an old recreational drug where an unwelcome side-effect is now the indication!

Orange Book Insights #1
Welcome to the inaugural posting of Orange Book Insights. This will hopefully be the first of many.
Not long ago I saw a headline in my local newspaper about the first approval of a cannabis-derived drug. No, this posting is not about that approval. My point is that the cannabis-related approval was considered significant enough to warrant an FDA press release and a newspaper headline.
No, this posting is about an equally well known recreational drug whose approval in December 2017 garnered, as far as I can tell, very little (if any) publicity. There was no press release from the FDA and no separate statement from the Commissioner, as there was for the cannabis-derived drug. No, this posting is about the FDA’s approval, on December 14, 2017, of (drum roll, please . . .) COCAINE!
Yes, cocaine is now an FDA approved drug (GOPRELTO (cocaine hydrochloride, 4% solution) from Genus Life Sciences Inc.). My discovery of GOPRELTO was completely fortuitous. I was lookin…