Actual - Legal

In September 2006, Nike agreed to pay Hackney Council ?300,000 for the unlawful use of the Council’s ‘H’ logo. Nike had not obtained Hackney Co

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

uncil’s permission to use the logo. The settlement figure was calculated by taking into account the total global sales of Nike merchandise, and

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

Examples of combination products may in

an appropriate percentage was established.

Logos, such as the ‘H’ logo, can be registered as trade marks or registered designs and copyright m

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

y also subsists in a logo as ‘artistic works’ governed by the Copyrights, Designs and Patents Act 1988 as amended. This particular case was int

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

resting as Hackney is a public sector organisation, and usually these types of disputes are between companies. Most public sector organisations

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

Combination pro

do not see the need to register logos as trade marks or registered designs, especially as many of their designs are quite old. This case shows

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

hat it can be in their financial interest to ensure that their intellectual property rights (IPRs) are protected.

Due to the advent of the Int

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

ernet, cases involving disputes over IPRs are on the increase. This is due to the fact that when someone creates some material which infringes

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

he rights of another, the infringing material can be found relatively easily. Many companies now invest a substantial portion of their capital

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

n assets which are protected by intellectual property, and this is the main contributing factor to the increase in the formal assertion of IPRs

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

A company that does not actively police its rights is potentially losing a large amount of income through the exploitation of assets which sho

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

Following aspects would a

ld really be licensed out. Many companies simply do not realise this.

Copyright law protects works from being copied without permission. Not e

dd to the challenges in developing combination products:

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

erything is capable of being protected by copyright, and it is important to note that copyright cannot protect an idea, a name, a title or an a

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

vertising slogan. An expression of an idea can only be protected if it meets the necessary requirements.

For instance, if you consider a magaz

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

ine title – there is no copyright protection in a title. However, the work may be protected as a registered trade mark and/or under the common

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

law action of passing-off. In order for there to be passing of in this case, there has to be evidence of a misrepresentation, a likelihood of c

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

Professional from academic institutions, pharmaceutical industries, health care indust

nfusion on the part of the public and the likelihood of damage such as to the goodwill of the better known magazine.

Comment: It is very expe

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

sive to collate evidence of confusion which is usually done by survey evidence.

Contact us at enquiries@rtcoopers.com

© RT COOPERS, 2006. Thi

.

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

Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal

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

Companies that provide selfless information through particip

dvice. It 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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