One notion for how to best use the OptiDose patent would be to literally take over the market for pediatric drugs. It is a little hard to imagine that dosing by weight would be such a marketing advantage that this would be possible, but bear with me.

Starting point? Hmmm. In the OTC market, Tylenol/acetaminophen would be tempting. Even though the sales are over the counter, the infant part of that market is largely driven by pediatrician recommendations.

To win the pediatricians over, I think we need to borrow a page out of Mead Johnson’s old playbook. If you already know their “no instructions” story, you can skip the next page or two.

Source – “A glimpse of Mead Johnson” page 6

(~1961 pub by Mead Johnson, I got mine from lib at ISU, Evansville, IN.)

“Today’s mother who finds herself with an infant feeding problem knows where to get help – from her pediatrician.

But it wasn’t always that simple around the turn of the century. Then many a distraught mother, not knowing where to turn, accepted the advice of her grocer or a self-styled neighborhood expert. She was lucky if the mixture of misinformation didn’t make her baby worse.

Edward Mead Johnson gave the problem much thought and arrived at these conclusions: “not all babies are alike” and “physicians’ babies are better babies.” These two truisms – the need for an individual formula for each baby and the necessity of the physician prescribing the formula – became his guides when he marketed a dietary product for infants.”

Pg 7

“Mead Johnson’s policy was to promote his products exclusively to physicians, using no consumer advertising and putting no dosage directions on the packages.”

Pg 12

“One of the many service items distributed by the company was the “Feeding Calculator”, which enabled general practitioners to figure out formulas for a host of individual situations.”

(Earlier – before Mead - baby formulas and their advertising to mothers and doctors both – see The infant formula industry 1870-1910, Apple R, J His Med 1986, 41:3.) Best single quotes are from Apple R, Bull His Med 1980; 54(3):402-17. Commercial infant feeding and medical practice 1870-1940.)

“Manufacturers, who in the nineteenth century had directed their advertising to both the public and physicians, realized by the twentieth century that their continued success in marketing these products lay in cultivating the physicians’ self-interest. By the 1930’s infant-food companies and physicians had established a mutually advantageous relationship. This paper traces the development of this association and the ways in which it increased medical control in an area not previously within the physicians’ domain.”

Pg 409: “…Mead Johnson unveiled Dextri-Maltose at the 1912 AMA convention and promoted this milk modifier, as well as its later infant-feeding products, exclusively to the medical profession.

Although Dextri-Maltose was not a prescription item, the physician advised the mother to buy it and explained how to prepare it; no directions appeared on the package. To make the physician’s job easier, Mead Johnson provided a series of free aids. Feeding calculators were especially popular….By dialing the infant’s age and weight, the doctor could see at a glance the recommended amounts of milk, water and Dextri-Maltose to use, as well as the size and number of feedings per day. ….[Mead Johnson supplied physicians with formula blanks that] told the mother how to mix the formula and feed it to her child, reminded her to bring the baby back to the physician for a checkup and a new formula on a specified date. …. The company frequently stressed that “when Dextri-Maltose is used …the physician himself controls the feeding problem”, and in later years it claimed that this policy was “responsible in large measure for the advancement of the profession of pediatrics in this country because it brought control of infant feeding under the direction of the medical profession”.

(Later, in the 1930’s, the AMA created a Seal of Acceptance for infant foods, then created rules that said that putting the feeding directions anywhere but under the control of the attending physician was not permitted. – pg 413-414. No story on how it later changed, etc.)

OK, back to us adopting a similar strategy for dosing by weight. I hope it is painfully obvious that if we just slap a body weight scale on existing acetaminophen we are going in the wrong direction. Right now there are no dosage instructions for under 2 years. The label says see your doctor. (I am only looking at business angles here, but it is probably also in the babies’ best interest to not have parents giving them OTC medications without a doctor’s OK.)

There are at least two ways we could use our dosing by weight patent to go in the right direction.

1. Multiple dosages. If we require the licensee to produce at least 2 variations on dosage, with no indications on how to make the choice, it would nudge parents into asking their doctors which variation to buy. In the acetaminophen example, three dosage choices could be placebo (very weak, main effect would be to calm the parent), median (similar to today’s doses), and thermal (a relatively high dose for bringing down dangerous fevers).
2. BSA. One of our patent variations is dosing by body surface area. The scale gradations would be in square meters. If we require the licensee to use a BSA scale, and not provide any instructions on how to come up with a child’s BSA, parents would almost have to see their doctors to get their BSA. The “prescription” would say something like “Baby Johnny, Menatol M (our median version), fill to .40 m² BSA and give orally twice per day until fever subsides”.

From our first OTC product, we could then colonize cough and cold meds, vitamins, iron drops, etc.

In the prescription area, our first product could be an off-patent antibiotic, or something else relatively non-controversial and non-costly for us. Once we get a little success under our belts and in our wallets, go for my favorite, infant fluoride-vitamins. There we will truly make a difference in the outcomes (less cavities, nicer looking teeth), but we will run smack into being different from AAP recs, and not having clinical proof that our way is better, etc.

OK, so that is the takeover vision as far as I have it. Now, who would be a good candidate to be our licensee? I have a whole list, but let me give you one. Celgene.

There is a great story about them in the WSJ on 11-15-04, front page. In a nutshell, they originated as an early biotech (late 70’s). Their first real commercial success came with a patent strategy we just have to love. They started with an old off-patent drug, thalidomide, with a tragic history (causing birth defects), but a powerful biology (suppresses some matrix proteins) that was emerging as a treatment for AIDS wasting. To get it approved by the FDA they developed a method to keep it away from pregnant women. They eventually patented this method. That patent had the effect of giving them exclusive rights to thalidomide. They then found thalidomide was useful in some cancer treatments, and raised the price as sales soared. They are now selling over $200 million a year of a drug that costs very little to produce, and have a sweet patent situation to keep it all their own. If anybody could appreciate what a new drug delivery patent like ours could do, it is these guys. And, as a kicker they are still pretty sharp in the biotech area, and we could at least look to see if they have any expertise that could help with our old osteo work.  And they have some new drugs under clinical trials. If nothing else, they may want to have our help setting up the new drugs with fancy dosing syringes, and just get a  cheap OptiDose license for these new drugs.

That’s it for now. If you want to see more, here are a few sources.

Here are the first 2 claims out of their first patent on their delivery system. 6,045,501

What is claimed:  (emphasis mine)

1. A method for delivering a teratogenic drug to patients in need of the drug while avoiding the delivery of said drug to a foetus comprising:

a. registering in a computer readable storage medium prescribers who are qualified to prescribe said drug;

b. registering in said medium pharmacies to fill prescriptions for said drug;

c. registering said patients in said medium, including information concerning the ability of female patients to become pregnant and the ability of male patients to impregnate females;

d. retrieving from said medium information identifying a subpopulation of said female patients who are capable of becoming pregnant and male patients who are capable of impregnating females;

e. providing to the subpopulation, counseling information concerning the risks attendant to fetal exposure to said drug;

f. determining whether patients comprising said subpopulation are pregnant; and

g. in response to a determination of non-pregnancy for said patients, authorizing said registered pharmacies to fill prescriptions from said registered prescribers for said non-pregnant registered patients.

2. The method of claim 1 wherein said drug is thalidomide.