United States: Pharmaceutical Taste Trade Marks - a Bitter Pill to Swallow: Strategic Points From the US Appeals Board – "In re N.V. Organon"

Like diamonds, trade marks last forever (provided that you manage them correctly). Thus, trade marks are a vital aspect of building and extending an IP monopoly in many fields, not least of which being pharmaceuticals.

Taste trade marks have been of particular interest in the past few years as another avenue of product lifecycle management. However, taste trade marks are quite susceptible to attacks based on functionality and lack of distinctiveness.

The recent US Appeal Board decision in In re N.V. Organon highlights just how damaging an applicant’s own marketing materials can be to assertions that the mark is non-functional. The case is also a good reminder that taste trade marks are extremely unlikely to be held inherently distinctive in any jurisdiction, so that it will be necessary to prove acquired distinctiveness.

On 14 June 2006 the USPTO Trademark Trial and Appeal Board handed down its decision in In re N. V. Organon concerning trademark application 76467774 for ‘an orange flavor’ for ‘pharmaceuticals for human use, namely antidepressants in quick-dissolving tablets and pills.’ (The product is Mirtazapine, marketed as RemeronSolTab®)

The mark was held not capable of trade mark protection because:

(a) Organon’s own advertising material touted functional advantages (factor 2 of the 4 part test for functionality – see below), and

(b) in this case at least, the flavor would not in fact act as a trade mark in any event.

(There are many oral pharmaceuticals with an orange taste, and by their nature, taste marks are not inherently distinctive.)

The relevant section of the US Trade Marks legislation which prohibits functionality is 15 USC 1052(e)(5).

In the landmark Qualitex case, the US Supreme Court provided further guidance by stating that in general terms, a product feature is functional if it is essential to the use or purpose of the article or if it affects the cost or quality of the article.

Back in 1982, the Federal Circuit, in In re Morton-Norwich Products, Inc. 671 F.2d 1332 referred to the following four factors to be considered when assessing functionality:

1 – the existence of a utility patent disclosing the utilitarian advantages of the design

2 – advertising materials in which the originator of the design touts the design’s utilitarian advantages

3 – the availability to competitors of functionally equivalent designs

4 – facts indicating that the design results in a comparatively simple or cheap method of manufacture

(For a more recent case, see Valu Engineering Inc., v Rexnord Corp 278 F.3d 1268.)

Organon had advertised the advantages of the Orange flavour (such as increased patient compliance) on its website and other marketing materials. This was a key factor in the Appeal Board’s decision to refuse registration of the mark.

It was also held that the applicant’s taste would not function as a trademark since there are many flavored medicines and numerous orange flavored medicines. Consequently, an orange flavor for antidepressants would not be distinct of N.V. Organon’s product.

The Appeals Board also noted that flavor is a characteristic of the goods and not their origin. Hence, in the same way as for color or scent, flavor can never be inherently distinctive. Thus, in the words of the Appeals Board, registration of a flavor mark will require a substantial showing of acquired distinctiveness.

As the Appeals Board pointed out, it is not clear how a taste would function as a trade mark since a consumer has no access to the product’s flavor prior to purchase.

This is clearly a major problem for taste marks for medicinal goods where taste testing of the product is extremely unlikely to occur.

(Although one might imagine placebo taste samples being offered by an enterprising pharmaceutical company keen to tackle this issue.)

Organon's parallel BENELUX application 1 018 650 and CTM application 3 065 539 were finally rejected in 2004 for lack of distinctiveness.

The Appeals Board relied heavily on the landmark Supreme Court decision in Qualitex Co. v. Jacobson Products Co., 514 U. S. 159 (1995), in which a green-gold colour used on dry cleaning press pads was found to be registrable as a trademark where the colour had acquired distinctiveness.

Some notable quotes from Qualitex;

‘[s]ince human beings might use as a ‘symbol’ or ‘device’ almost anything at all that is capable of carrying meaning, this language, read literally, is not restrictive.’

‘[i]t is the source-distinguishing ability of a mark – not its ontological status as colour, shape, fragrance, word, or sign that permits it to serve [as a trademark]’

In 2003, the OHIM Boards of Appeal rejected Eli Lilly’s application for a strawberry flavour as applied to pharmaceuticals – see Case R 120/2001-2. The refusal was predictably based in part on lack of distinctiveness. In the words of the Board:

‘…, it is in any event clear that such a taste cannot distinguish the pharmaceutical preparations of one undertaking from those of another.’

‘Moreover, the taste is unlikely to be perceived by consumers as a trade mark; they are far more likely to assume that it is intended to disguise the unpleasant taste of the product:..’

© Duncan Bucknell 26 July 2006

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