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One of my hobbies is wine tasting. So it’s no surprise that an article from the Wall Street Journal recently grabbed my attention. It said: “U.S. Investigates Counterfeiting of Rare Wines.”

The very i

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

dea assaults the senses.

According to the article, the targets of the counterfeiters include France’s great Chateau Mouton Rothschild. How distasteful!

Chateau Mouton, of course, enjoys an exalted and

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

well earned reputation as one of the great Bordeaux wines of France. In The World Atlas of Wine, the historian, Hugh Johnson, describes the wines of the region this way:

“. . . a combination of fresh s

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ft-fruit, oak, dryness, subtlety combined with substance, a touch of cigar-box, a suggestion of sweetness and, above all, vigor.”

Chateau Mouton elevates these characteristics to Olympian heights. Mr.

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

Johnson sings its praise. Close your eyes and imagine. According to Johnson the wine is:

“. . . strong, dark, full of the savour of ripe black currants. Given the ten or often even 20 years they need

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

to mature, these wines reach into realms of perfection where they are rarely followed. But millionaires tend to be impatient: too much is drunk far too young.”

Can you taste it?

Chateau Mouton also fe

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ds the eyes with its artistic labels. Since 1945 the beauty of the wine has been enhanced with the designs of famous artists of the day, Picasso, Warhol, Miro, Kadinsky, to name only a few.

I received

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

my first bottle of Mouton from my father when I graduated from college, a 1970 with a Chagall label, a simple line drawing enhanced with pink, yellow and blue. It was quite a change from our usual house

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

wine today: Two Buck Chuck from Trader Joes.

I think about that bottle of Mouton when I read about counterfeit wine. Imagine the anticipation upon opening the bottle, the expectation of cherries, raspb

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

rries, black currants, only to discover . . . what? The smell of dirty gym socks, perhaps, or moldy cheese? Who knows.

And who knows where it’s from.

That thought leads me back to my role as a tradem

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

rk lawyer. Dealing with trademarks may sound rather genteel, well removed from jail cells and guns. But not always so.

As trademark lawyers, we learn that counterfeiting involves more than wine or fif

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

ty dollar bills. Sometimes it involves Pine-Sol, at least my first counterfeiting case did. In the late 80s, customer complaints caused our client to discover that phony Pine-Sol was on sale in Chicago.

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

The chase was on.

A counterfeiting case proceeds without notice to the sellers. Armed with a court order and accompanied by U.S. Marshals and our private investigators, we invaded a series of small so

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

th-side Chicago stores like Elliot Ness after Al Capone.

I can picture the uncooperative store owner made compliant when the Marshall took him aside to introduce his friends Smith and Wesson.

I can hea

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

r the violent barking of the mangy mutts left behind to guard the abandon dentist’s office on South Ashland Avenue where the counterfeits were filled.

I can see the barrels of chemicals, iridescent yell

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

w beneath the glow of a bare bulb pulling electricity from a cord extended to an outside outlet behind a neighboring building.

I can smell the sharp pungent odor of the pine tar used to turn these caust

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

c chemicals into ersatz Pine-Sol.

Mostly I can feel the anger rising in me when I learn from the lab report that kids accidentally drinking the counterfeit Pine-Sol could die or go blind. And I can fee

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

l the relief when the counterfeiter, Mr. Banda, was arrested and jailed after selling more of the stuff to stores in Detroit.

I think about all this when I contemplate the counterfeit Mouton, brewed per

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

aps in a back alley in France, a place where the light from a street lamp glistens on wet cobble stones, small bistros fill the air with the smells of butter, onion and garlic, and a small man smoking a

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

aulois cigarette funnels Two Buck Chuck into bottles bearing copies of labels drawn by Salvadore Dali.

Chateau Mouton 1958.

And I wonder: will Hugh Johnson’s impatient millionaires taste the difference

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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