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Monday, 6 October 2008

Distinctive + generic = pharma brand

From European Patent Attorney Ian Hartwell comes this link to a feature in The Times on Saturday. It's an article by Science Editor Mark Henderson entitled "How drug companies try to get inside your head" and it's all about -- surprise, surprise -- the branding of pharma products.

Right: Oseltamivir poses for a friendly photo

The article rightly points out that terms such as methylphenidate, sildenafil, fluoxetine, oseltamivir and trastuzumab will be unknown to the vast number of consumers of pharmaceutical products whereas the brand names Ritalin, Viagra, Prozac, Tamiflu and Herceptin are pretty well household names (in some households, anyway). The gap between the generic term and the brand name is so vast that consumers inevitably genericise the products by referring to them only by their brand names and this article records that a group of American doctors has adduced evidence that the media is complicit in this exercise too. An analysis of US health news reporting led by Michael Hochman, of Harvard Medical School, has found that two thirds of articles described drugs mainly by their brand name rather than their 'real' name. According to Mark Henderson, while British newspapers were not studied, they refer heavily to brands.: a press database search has revealed a total of 1,174 references to Herceptin since 2003, compared with just 44 references to its generic name, trastuzumab.

According to Hochman, such reporting plays into the drug companies' hands, to the ultimate detriment of health funders and patients:

"It creates an impression that the brand is the medicine and that alternatives are inferior. This is a particular problem once drugs go out of patent and generic versions become available for a fraction of the price".
It seems to the IPKat that, if a trade mark is used generically, the risk of genericisation is that the trade mark will cease to distinguish the goods in the eyes of the relevant consumer. But from here onwards the matter becomes less clear. Terms like Herceptin or Viagra may be generic in the eyes of the average man in the street, but within the pharmaceutical products market they will still serve as trade marks in the eyes of wholesalers and retailers, not to mention the medical professions. The European Court of Justice has indicated in the Bostongurka case that a registered trade mark still fulfils its "essential function" if it enables "intermediaries" to distinguish goods, even if the ultimate consumer just sees it as a generic term. Bostongurka involved pickled cucumbers, not pharmaceutical products, though the one-size-fits-all nature of trade mark law applies equally to both. In Bostongurka the Court said:

"23 If the function of the trade mark as an indication of origin is of primary importance to the consumer or end user, it is also relevant to intermediaries who deal with the product commercially. As with consumers or end users, it will tend to influence their conduct in the market.

24 In general, the perception of consumers or end users will play a decisive role. The whole aim of the commercialisation process is the purchase of the product by those persons and the role of the intermediary consists as much in detecting and anticipating the demand for that product as in increasing or directing it.

25 Accordingly, the relevant classes of persons comprise principally consumers and end users. However, depending on the features of the product market concerned, the influence of intermediaries on decisions to purchase, and thus their perception of the trade mark, must also be taken into consideration".

The bottom line, in commercial terms, is that the trade mark covering the brand name can remain registered, thus preventing use by competitors of the brand owner, even though for the lay public the trade mark is no more than a generic term and will be used as such.

If doctors and academics use generic names where possible, to avoid favouring one product over another, Hochman suggests that the media should try to follow suit. But, as Henderson recognises, this is unrealistic: journalists use brand names simply because they are "the currency that the public understands"and stories about overprescription of Ritalin or side effects of Prozac are easily grasped.

Left: without his Ritalin to restrain him, Tiddles was literally jumping out of the window

He concludes that the real culprits are not the media but the companies that devise overcomplicated generic names which are unsuitable for lay use, as well as the regulators that allow them.

The IPKat agrees that generic terms and international non-proprietary names are generally not fit for much more than making facetious anagrams -- but those names often carry descriptive connotations for the industry that can be helpful. There's probably an ingenious solution to this problem out there somewhere: can any readers suggest it? Merpel says, how about a special type of trade mark that can't be renewed and becomes officially generic after a fixed period once the patent and any supplementary protection certificate have expired, thus giving strong initial protection but then allowing more effective competition?

5 comments:

Anonymous said...

Mr. Henderson is wrong to blame the pharmaceutical companies for devising "overcomplicated generic names". The principles of organic chemistry nomenclature dictate the generic names of drugs, not pharmaceutical companies. Such nomenclature allows for standardized drug names so those with the appropriate chemical knowledge (e.g. chemists, pharmacists, etc.) can determine a drug's chemical structure from its name, thereby enabling the prediction of the drug's properties (toxicity, side effects, etc.).

mcvooty said...

Generic products contain the same active ingredients as their formerly patented products made by the innovators, but contain different incipients, binders and other ingredients. Further, since the bio-equivalency of the generic and the innovator product is usually measured by the blood concentration rates, the generic vs original drug can differ in other ways. This is the reason that many doctors, familiar with how patients react to the innovator drug are reluctant to switch to prescribe the generic, and also explains why it is not uncommon for patients to notice the difference between the generic and originator's product. On this point, I would only add that the problem becomes even more complicated for biosimilars (follow-on biologics), which differ in subtle ways in structure and formulation from what one would like to believe are the "same." Which is a long way of saying that there are good reasons to maintain the distinction among sources.

GUY said...

The NHS solved the problem with prescription of brand names rather than generic when they introduced the British National Formulary (BNF) on the doctor's, nurse's and pharmacistst's desks. It is available on-line for public access.
This gives the generic name for all branded products. An NHS prescription that uses a brand name rather than a generic will not be dispensed under current regulations.
For a time I had a doctor who usually advised me to take some Panadol for any symptoms I presented. I would always suggest paracetamol BP and he would agree but never changed his advice. If you ask a pharmacist for a non-prescription drug by brand name he must sell you the product you asked for. Aspirin has been generic in the UK, but not Germany, for many years but many people still ask for one of the more expensive branded versions of the product.

Pamela said...

Nothing erudite to say, other than that in the aspirin case in the United States the court also discussed the two classes and prescribed two different remedies:

"The case, therefore, presents a situation in which, ignoring sporadic exceptions, the trade is divided into two classes, separated by vital differences. One, the manufacturing chemists, retail druggists, and physicians, has been educated to understand that 'Aspirin' means the plaintiff's manufacture, and has recourse to another and an intelligible name for it, actually in use among them. The other, the consumers, the plaintiff has, consciously I must assume, allowed to acquaint themselves with the drug only by the name 'Aspirin,' and has not succeeded in advising that the word means the plaintiff at all. If the defendant is allowed to continue the use of the word of the first class, certainly without any condition, there is a chance that it may get customers away from the plaintiff by deception. On the other hand, if the plaintiff is allowed a monopoly of the word as against consumers, it will deprive the defendant, and the trade in general, of the right effectually to dispose of the drug by the only description which will be understood. It appears to me that the relief granted cannot in justice to either party disregard this division; each party has won, and each has lost. . . . I will grant an injunction against direct sales of the drug under the name 'Aspirin' to manufacturing chemists, physicians, and retail druggists. This will, of course, include invoices and correspondence. . . . the defendant [i.e., a retailer] should be allowed to pack its tablets in bottles or boxes of 50 or less, bearing the name 'Aspirin' without more."

Bayer Co. v. United Drug Co., 272 F. 505 (S.D.N.Y. 1921)

Anonymous said...

"Generic products contain the same active ingredients as their formerly patented products made by the innovators, but contain different incipients, binders and other ingredients." (above)

Not always McVooty... There are plenty of examples of generic drugs that have exactly the same ingredients as their branded counterparts. Unfortunately, it is familiarity and the perception of quality that often leads patients to prefer branded drugs and thus request (or even insist on) these brand names on their prescription. Unlike in hospitals, where pharmacists can dispense a generic equivalent, community pharmacists have to go by the letter of the prescription and (for the same prescription charge)dispense a branded drug where a generic would have achieved the same result at a small fraction of the cost. The result is that the NHS (i.e the taxpayer) spends millions more on drugs than it needs to, to the detriment of other services.

But what about the private purchase of drugs by consumers? Of course, in such circumstances, the consumer is perfectly entitled to spend extra on a branded product if he/she so chooses. But it is easy for those of us with a background in science to forget that it can be hard for the average customer to understand that (in most cases) the branded and generic products contain the same active compound. Further, many customers simply don't know the generic name of a particular drug (and have probably never heard of the BNF). Thus, when the customer walks into his/her local pharmacy and asks for some [insert name of well-known anti-inflammatory painkiller], the pharmacist is only to happy to sell them a pack for a fiver, rather than inform them that they could purchase the equally effective generic for 50p.

Cleverly branded combination tablets are just as bad. Paracetamol + caffeine sold as 'Megaheadachebuster' (or something of the sort) when a paracetamol washed down with a cup of coffee would probably have the same effect. See 'lemon-flavored-paracetamol-drink' etc also.

However, the worst I have seen is a well-advertised headache cure that can be applied to the forehead. It usually retails for £4.99 and contains... menthol! That's it. Cheap as chips. Most pharmacists in fact stock it next to tubs of menthol, that retail for as little as 30p.

Clever advertising, brand value etc are all tools that a retailer is entitled to use. But when it comes to the sale of drugs, fear and uncertainty can magnify their effect and allow excessive profit to be made from public services and vulnerable members of the community alike.

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