Tuesday Patent – Smoking Is Good For You

The USPTO publishes the Official Gazette on Tuesdays, which is thus when all new patents issue.  Every Tuesday, I’ll highlight one or a few interesting patents with a focus on CPC A61K, the class where most pharmaceutical and cosmetic patents are found.

I’m making up for skipping last Tuesday and will add one from today once they are out.  Anyone who knows a smoker has heard some excuse trying to explain why smoking is actually good for them in some small, usually insignificant way.  Last Tuesday, Dignity Health received US Patent No. 9,566,273 that for at least some small group of people, suggests they may actually have a point.

Claim 1 illustrates the patent well:

1. A method of treating acute disseminated encephalomyelitis in a subject, comprising:

providing a composition comprising a nicotinic receptor agent, wherein the nicotinic receptor agent comprises one or more of nicotine, nicotine bitartrate, cytisine, nicotine polacrilex, nornicotine, nicotine 1-N-oxide, metanicotine, nicotine imine, nicotine N-glucuronide, N-methylnicotinium, N-n-decylnicotinium, 5′-cyanonicotine, 3,4-dihydrometanicotine, N’-methylnicotinium, N-octanoylnornicotine, 2,3,3a,4,5,9b-hexahydro-1-methyl-1H-pyrrolo(3,2-h)isoquinoline, 5-isothiocyanonicotine, 5-iodonicotine, 5′-hydroxycotinine-N-oxide, homoazanicotine, nicotine monomethiodide, N-4-azido-2-nitrophenylnornicotine, N-methylnornicotinium, nicotinium molybdophosphate resin, N-methyl-N’-oxonicotinium, N’-propylnornicotine, pseudooxynicotine, 4′-methylnicotine, 5-fluoronicotine, K(s-nic)5(Ga2(N,N’-bis-(2,3-dihydroxybenzoyl)-1,4-phenylenediamine)3), 5-methoxynicotine, 1-benzyl-4-phenylnicotinamidinium, 6-n-propylnicotine, SIB1663, 6-hydroxynicotine, N-methylnicotine, 6-(2-phenylethyl)nicotine, N’-formylnornicotine, N-n-octylnicotinium, N-(n-oct-3-enyl)nicotinium, N-(n-dec-9-enyl)nicotinium, 5′-acetoxy-N’-nitrosonornicotine, 4-hydroxynicotine, 4-(dimethylphenylsilyl)nicotine, N’-carbomethoxynornicotine, N-methylnicoton;

and administering a therapeutically effective dosage of the composition to enhance the activity of a compound that treats acute disseminated encephalomyelitis,

wherein the therapeutically effective dosage of the nicotinic receptor agent ranges from nicotine plasma levels of 1 ng/mL to 100 ng/mL.

In short, the patent claims using nicotine to enhance the activity of a different compound that treats acute disseminated encephalomyelitis (ADEM).  ADEM often looks like multiple sclerosis, but is a single attack and often resolves without further incident.

The specification notes that human heavy smokers have a nicotine plasma level of 15-38 ng/mL, which is within the range of the claim.  As the claim does not limit the mode of delivering the nicotine, smoking is a claimed manner of providing nicotine.  Thus, the patent seemingly covers a method of treating ADEM by smoking and taking a drug that treats ADEM.

Although it is in a spirit of light-heartedness that I chose this patent, and I haven’t studied this patent well enough to comment on the significance of the particular advancement, patents of this kind represent an important part of our patent ecosystem.  Not every advancement in medicine is a new drug for a new disease.  Many advancements are based on taking old drugs and finding new and better ways of using them.  Incentivizing this work with patents assures that the research undertaken to make these advancements can be brought to clinical reality.

This patent illustrates the point.  The disclosed mouse research shows that nicotine can help treat encephalomyelitis.  But how to best bring the advancement to patients will require examining how nicotine interacts with specific drugs to treat ADEM, best doses and modes of delivery, and research directed at complying with regulatory requirements.  This patent that will allow the pursuit of this development program with reasonable assurances that a commercially viable product could come out the other side.

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