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.

If You Can’t Find It Publicly, It’s Probably Not Publicly Available

The title of this post slightly overstates the opinion, but that sentiment was the clear undercurrent in a recent order from the PTAB.  Alkermes Pharma Ireland Ltd. v. Otsuka Pharma. Co., Ltd. (IPR2017-00287, April 5, 2017).  In the order, the PTAB denied pre-institution discovery to the petitioner to establish the date of public accessibility of certain references.

US Patent No. 9,125,939 has a priority date of May 23, 2003.  Thus, anything published prior May 23, 2002, is prior art under pre-AIA 35 U.S.C. § 102(b).

Petitioner alleged that two meeting abstracts authored by the Patent Owner, Keck and Citrome, were publicly available by May 18, 2002, the first date of the conference where the abstracts were due to be presented.  In order to support this date, petitioner relied on the cover page of the meeting abstract book and a declaration from one of their experts that such abstracts were usually distributed at the conference.  Petitioner also relied a on a press release, BMS/Otsuka, from the patent owner, where the date listed on an online resource for news releases was May 22, 2002.

The Patent Owner challenged the evidence of the publication date in its preliminary response.  The details of the challenge are not particularly important, except to note that it isn’t a slam dunk even with the dates on the pages. Petitioner’s evidence may not be sufficient based on cases like Norian Corp. v. Stryker Corp.

In order to shore up the evidence of publication, Petitioner sought discovery from the Patent Owner about the dates Patent Owner was involved in submitting the documents for publication.  The PTAB rejected the discovery, noting that Petitioner “could, and should, have obtained [the information] by other means.”

By focusing on when the public could have received the publications, instead of when Patent Owner authorized the publications, the PTAB hit on something important.  If the documents were, in fact, publicly available at the time Petitioner contends, then there should be evidence of this availability.

There are many ways to find this information.  For example, library date stamps show at least the date that one entity received a publication.

This case underscores something that is going to become more important as electronic only resources increase.  Dates listed may not reflect actual dates of publication.  Differing content may exist between the epub ahead of print and the print version of an article.  Archives may estimate a date, particularly if document retrieval is automated, and therefore may simply have an incorrect date.  It is nice to see the PTAB being attuned to these issues, but we will need to see how PTAB reacts to the evidence that is currently of record in the proceeding.

Calm Before The Storm

Workshop + Brazil means that between previous post and the end of the month, my only blogging will be next week.  So in the meantime, this reminder that pharmaceutical patents fuel R&D, and the R&D means jobs and the drugs of the future.

It is not always as clear as as cutting workforce after a patent loss, but the economics are always the same.

 

Tuesday Patent – Specificity In Getting Rid Of Red Wine Stains

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.

This week, I am looking at US Patent No. 9,585,816, which is a product to get rid of red wine stains on teeth.  I chose this just to continue with the theme of interesting patents related to items purchased with a drivers license.

Of course, if I wanted to enter this field, it seems like it would be easy to design a competing product without infringing the following claim.

1. An effervescent tablet composition for eliminating red wine discoloration of mouth, offensive odor of the mouth and for cleaning a palate comprises an excipient, a disintegrating agent, a flavoring agent, a sweetener, an active agent, and a lubricant;

wherein the excipient comprises a malic acid, a combination comprising a rice starch and a di-basic calcium phosphate, a sorbitol, a sodium bicarbonate, a potassium bicarbonate, a microcrystalline cellulose, a sodium chloride, a sodium carbonate and a magnesium oxide;
wherein the malic acid is present in the composition in a range of 25-35% w/w,
the combination comprising the rice starch and the di-basic calcium phosphate is present in the composition in a range of 15-25% w/w,
the sorbitol is present in the composition in a range of 10-15% w/w,
the sodium bicarbonate is present in the composition in a range of 3-8% w/w,
the potassium bicarbonate is present in the composition in a range of 3-8% w/w,
the microcrystalline cellulose is present in the composition in a range of 2-7% w/w,
the sodium chloride is present in the composition at less than or equal to 5% w/w,
the sodium carbonate is present in the composition at less than or equal to 3% w/w,
the magnesium oxide is present in the composition at less than or equal to 1% w/w,
the flavoring agent is a natural flavoring agent and is present in the composition is 3-8% w/w,
the lubricant is a magnesium stearate and is present in the composition at less than or equal to 3% w/w,
the sweetener comprises a stevia leaf extract and a sucralose, and the stevia leaf extract is present in the composition in a range of 2-7% w/w and the sucralose is present in the composition is in a range of 0.1-3% w/w; and
wherein the malic acid reacts with potassium bicarbonate or sodium bicarbonate or sodium carbonate to form an effervescence reaction to induce tablet disintegration, to provide a pleasant sensation in the mouth when dissolved, and to clean a wine stain in the mouth.

All patentees need to balance the amount of detail included in a claim against the prior art, but this seems excessive. Just to pick on one point, if you only sweeten with sucralose, but not stevia, then you are outside the literal scope of this claim.

It is important to remember that there are times that claims such as this make strategic sense.   Narrow claims are easier to get issued, and some protection is better than no protection. However, it is equally important to remember the multitudinous issues that go into that strategic choice, and whether a patent covering a specific effervescent tablet really aids those strategic goals. I’d be curious to know what the value of this claim is to the patentee.

All of that said, I could have really used this product last weekend. Incentives!

A Foregone Conclusion – Life Tech. v. Promega

I’ll probably have something more to say on the SCOTUS decision after reading and discussing some of the details of the reasoning.  But the core claim was that Taq was somehow “substantial” in the context of PCR kit.  The only way to get to that result is that every necessary component is “substantial,” which would make nearly all components of any invention “substantial.  Even a small bolt in a large harvesting machine may be necessary to hold the thing together.

Ultimately, the  decision can be summed up in a sentence at the end of the opinion: “[w]e are persuaded, however, that when as in this case a product is made abroad and all components but a single commodity article are supplied from abroad, this activity is outside the scope of the statute.” (emphasis added).  With that accurate factual description in place, there was only one result possible.  I’ll write more on reasoning to get there some other day.