Tuesday Patent – A Method

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.

The styling of the claim in US Patent No. 9,616,136 is the reason for this weeks choice.  Usually, this would be the part of the post where I describe the invention, but the noteworthy aspect of the claim is that it is a method of treatment claims that does not specify what is being treated.

1. A method comprising administering to a mammal a compound having the following structure:  [genus including PEGylated lacosamide] wherein: Ar is aryl, optionally substituted with halo; R.sup.1 is lower alkyl; the dotted line (“—“) represents a covalent bond; X.sup.1 is a spacer moiety; and POLY.sup.1 is a poly(alkylene oxide), and pharmaceutically acceptable salts thereof.

Compare this to claim 1 from US Patent No. 9,566,273, which was the subject of my first Tuesday Patent post :

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.

 

Notice the big difference, today’s patent does not identify the goal of the method.  Although patent skeptics may criticize this omission, it is not necessarily a problem.  A method claim is composed of steps, and as long as the steps can be actually performed (and not unfortunate and unclear add-ons as in Mayo v. Prometheus), it is possible to analyze the claim for both infringement and patentability.

For the patent skeptics, the horror of this claim is its breadth.  Any administration of the drug to a patient for any reason is infringing.  How can someone possibly claim all administrations of this compound?  Particularly when the specification is limited?  The written description only describes two plausible reasons, epilepsy and pain.  Of those two, only pain is supported with experimental data.

Recent arguments about Section 101 would lead most people to say a claim like this is ineligible. This is non-sensical.  Processes are eligible, and this is clearly a method of treating.  It is unfortunate that patent policy has degraded to the point where Section 101 eligibility is the focus of fights about these claims, when the very breadth a patent skeptic would criticize creates obvious vulnerabilities for the claims under the normal rules of novelty, obviousness, written description and enablement.

Novelty: Any stated administration of a compound in the genus would render the claims unpatentable.  Lack of novelty of a claim like this is usually easy to search and detect, so I presume there is no missing art out there.  But the wide sweep of the claim runs the risk of hitting a stray remark from another patent application.

Obviousness: Again, any suggestion of administering compounds like these could render the claims obvious.  The patent itself states that non-linked/PEGylated lacosamide was suggested for pain.  But any reason to PEGylated and administer lacosamide would render the claim obvious.

Written Description/Enablement: Although separate doctrines, they would likely follow each other in this patent.  Does a working example of one species (pain) enable across and show possession of the full scope?  Does the description of the chemical genus as possibly addressing epilepsy add anything? What is the scope to be measured when it is not recited in the claim?

All of these doctrines can protect against overbreadth without needing to resort to the vagueness of Section 101.

One last point, it should not be difficult to meaningfully add a limitation to the claim to address what the administration is for.  Although some claim drafters include an extra step specifically for this purpose (e.g., identifying a patient having the disease), one can also name the disease in the preamble and the limit the patient in the administering step.  There are pros and cons to each method.  However, I say “should be” in the first sentence because even the nicotine example above makes this aspect of claim construction tricky.

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