Showing posts from August, 2018

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

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 t

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 fortuito