Patent protection in the pharmaceutical industry follows the 20-year expiration rule common to all patents. However, due to the exceptionally long time-to-market of a drug by virtue of the amount of research that goes into the product, the actually useful life of patent protection is drastically reduced. This protection typically lasts for only about 10 years from the time that the drug reaches the market. As soon as patent protection has expired, competitors may begin to sell products that contains the patented active substance under a different trade-name. These are commonly referred to as generic products and typically cost much less than the original product. One of the major factors in this price difference is that the generic manufacturer does not need to recoup the vast expense that goes into researching the active substance in the first place.

The interests of the original pharmaceutical producers lie in extending their monopoly position and thus delaying the commercialization of generic pharmaceuticals. On the other hand, consumer interests lie in being able to purchase pharmaceutical products that fulfil the same purpose as the patented product at a significantly lower cost.
A recent strategy employed by drug companies in their bid to extend protection is the registration of the shape of the tablet as a three-dimensional pharmaceutical trademark. The advantage of this protection is that its duration is practically unlimited, since the initial 10-year protection period may be extended by subsequent 10-year periods without limitation.

Several factors must be taken into consideration by generic manufacturers. These include :

Tablet Shape There are only so many different shapes that a tablet can assume while fulfilling it's purpose as a valid dosage form. There are also several parameters that determine the shape of a tablet which are governed by simple practicality. The size of the tablet may be determined by the amount of active agent that is required. In addition, the form that the tablet takes may influence the dissolution and speed of absorption of the particular pharmaceutical product. The tablet must also be in a size, shape and general appearance that is acceptable for a patient to swallow.

Bioequivalence Generic pharmaceutical producers must prove in the course of the registration of their pharmaceutical products that these products are 'bio-equivalent' to the original products. Therefore, generic products should be highly similar to the original product, in order to avoid potential differences arising from different dissolution/absorption considerations due to the shape of the tablet.

Certain three-dimensional pharmaceutical trademarks have already been registered for an entire class of goods of pharmaceuticals, and are not specified for certain types of drugs. The nature of the trademark documents does not take colour into consideration. Consequently, the registration of a three-dimensional pharmaceutical trademark would prevent the commercialization by other companies of pharmaceutical products which had the same shape and which belonged to the same class of goods as the protected product, even if this shape was widely used, was in a different colour and was general in nature.

Legal Framework

The Hungarian Patent Office has already granted trademark protection for certain three-dimensional pharmaceutical trademarks. According to Section 1 of the Act on the Protection of Trademarks and Geographical Marks (11/1997),
"any mark which can be graphically represented and which is suitable for distinguishing goods and services from other goods and services can be protected by trademark"
Distinctive character of the mark is thus emphasised. The official comments accompanying the Trademark Act emphasize that the monopolization of signs that do not have a distinctive character would be contrary to the interests of fair competition and consumers. Section 2(2) of the Trademark Act provides:
"A mark shall be excluded from protection by trademark if it is not suitable for making a distinction, in particular if it consists exclusively of a shape which results from the nature of the goods, which is necessary to achieve a technical result or which represents the essential value of the goods."
It is also possible to protect the shape and colour of a pharmaceutical product without having a registered trademark in Hungary. According to the Act on the Prohibition of Unfair and Restrictive Market Practices, if a company commercializes a product that has a similar external appearance, packaging, name or marking to that by which a competitor or its products is normally recognized, it may be sanctioned for committing an unfair trade practice.

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