Pharmaceutical taste trade marks – a bitter pill to swallow

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

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.


The Organon

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 US
law on functionality

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

Back in
1982, the Federal Circuit, in In re
Morton-Norwich Products, Inc.
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

Lack of

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

Can a taste act as a trade mark?

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.)


No luck elsewhere either

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

Qualitex case

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.

notable quotes from Qualitex;

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.’

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]’

strawberry failure

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

‘…, 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:..’

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