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A Coalition of music industry bodies, including the MCPRS Alliance and the Association of Independent Music, is lobbying to have intellectual property law amended to allow In

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

ternet Service Providers (ISPs) to be sued for allowing illegal file-sharing on their networks. Commentators have said that their efforts are misguided and commercially impra

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

Examples of combination products may in

tical. Currently, ISP’s are not required to police the content of their networks much in the same way that telephone companies are not liable for obscene calls.

The problem

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

arises because file-sharing is the primary reason for an increasing number of users using broadband, and is responsible for much of the bandwidth that ISP’s sell to their cus

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

omers. If file-sharing was outlawed, ISP’s would lose a substantial proportion of their revenue. The crucial point is that trying to police content used by millions of custom

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

Combination pro

rs would be difficult and very expensive.

Up until now, the music industry has tried to combat file-sharing by pursuing individual users who share vast libraries of copyrigh

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

t material. File-sharing is only illegal when it is copyright material being shared. Recently, the British Phonographic Industry tried to convince two ISP’s – Tiscali and Cab

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

e & Wireless – to suspend the accounts of 59 users, but without success.

It should also be noted that under the Data Protection Act ISP’s are prevented from disclosing to a

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

hird party the names of users without their permission or an order from the court. This means that a copyright owner will usually only be able to identify offenders by an IP

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

address. If a copyright owner wants to sue an offender, they have to first force the ISP to disclose the name of the offender who operates from the specific IP address. There

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

is a precedent derived from the 1970’s Norwich Pharmacal case which could be applicable in these circumstances. The precedent states that it is permissible for A (who may be

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

Following aspects would a

copyright owner) to sue B (who may be wholly innocent ISP) in order to force B to identify wrongdoer C (who may be a file-sharer). This precedent has successfully been relie

dd to the challenges in developing combination products:

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

d on in online defamation cases, and can potentially be used to identify particularly active file-sharers.

There have also been suggestions that ISP’s could become licensed

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

usic providers. However, this also seems commercially impractical. Firstly it is not part of an ISP’s core business and secondly, ISP’s working with the music industry to try

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

to agree licensing fees has proved impossible to date.

Comment: As far as the law is concerned, it would be far better for the music industry to recognise that technology ha

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

s improved to a point where a change in music distribution is now necessary. They should be looking to exploit the internet rather than policing it – a fledgling example of t

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

Professional from academic institutions, pharmaceutical industries, health care indust

is being Apple’s i-Tunes. If it is possible to download properly licensed, good quality versions (perhaps with bundled ‘extras’) for an affordable fee, illegal file-sharing m

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

y become less attractive.

Please contact us for more information on music copyright at enquiries@rtcoopers.com

Visit http://www.rtcoopersiplaw.com or http://www.rtcoopers.c

.

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

om/practice_intellectualproperty.php

© RT COOPERS, 2006. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discusse

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

Companies that provide selfless information through particip

nor does it constitute legal advice. 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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