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In the case of CeWe Color AG and Co v Office for Harmonisation in the Internal Market (Trade Marks and Designs) (T-178/03 and T-179/0

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

3), the Court of First Instance rejected CeWe's trade mark applications on the grounds that the marks were merely descriptive and lac

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

Examples of combination products may in

ked distinctiveness.

In 2001, CeWe applied for registration of the Community Trade Marks for the names DIGIFILM and DIGIFILMMAKER in

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

Classes 9, 16 and 42 in respect of apparatus and automatic machines for recording data carriers, in particular apparatus for the tran

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

sfer of digital data onto data carriers.

The examiner rejected the applications in respect of Classes 9 and 42 in accordance with Ar

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

Combination pro

7(1)(b) and (c) of Council Regulation (EC) 40/94. The examiner concluded that:- - the trade marks sought were simply descriptive of

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

the relevant goods and services; and - the terms 'Digi', 'Film' and 'Maker' did not have the sufficient level of distinctiveness fo

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

registration.

CeWe appealed and the Board of Appeal upheld the examiner's decision. CeWe further appealed to the Court of First Ins

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

tance and contended that:- although the terms 'digi', 'film' and 'maker' are known to refer in the English language to respectively

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

'digital', 'film' and 'manufacturer', the marks were not descriptive but were rather technical terms which the general public underst

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

ood; the combination of the terms 'digi', 'film' and 'maker' was unique; and although the marks for which registration was sought

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

Following aspects would a

may appear on the internet, they are not listed in the dictionary and are therefore capable of registration.

The Court of First Ins

dd to the challenges in developing combination products:

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

ance held that:- the terms 'digi', 'film' and 'maker' in DigiFilm and DigiFlimMaker form combinations capable of being dissociated

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

and these juxtapositions are neither unusual nor striking; DigiFilm and DigiFlimMaker would be understood immediately by the public

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

as referring to the processing of digital data; in the absence of any additional element whether graphic or another distinctive fea

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

ture, the marks sought lacked the necessary distinctiveness for registration; the terms DigiFilm and DigiFlimMaker would be perceiv

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

Professional from academic institutions, pharmaceutical industries, health care indust

d by the average consumer as terms simply descriptive of the goods and services they provide; and CeWe's appeal would be rejected.

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

.

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

ot provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal advice. It

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

Companies that provide selfless information through particip

is intended only to highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances

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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