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The U.S. Supreme Court is considering whether software companies can be liable for their products that enable illegal sharing of music and video files

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

. The case of M.G.M. v. Grokster has the attention of major and diverse players. Over 55 amicus briefs – statements by those who are not directly invo

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

Examples of combination products may in

ved in the case – have been submitted to the Court for consideration. These include the NFL, the NBA, the Christian Coalition, Senators Leahy and Hatc

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

h, and two photography groups - the PPA and the ASMP, which specifically note that the “illegal file-sharing poses particularly significant risks for

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

ublication photographers and other small copyright owners whose livelihoods depend to a substantial degree upon commercial exploitation of their creat

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

Combination pro

ive works.” Some of the materials can be viewed here: http://news.findlaw.com/legalnews/lit/mpaa/index.html

The issue is not whether file sharing 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

opyrighted materials is illegal – it is. The issue is whether a manufacturer can sell a device that allows customers to commit copyright infringement.

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

It is based on the legal theory of secondary liability. Computers or the internet likewise could be considered devices that enable someone to steal o

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

hers’ work. But since those items also can be used for legal activity, the benefit of doubt goes in their favor. On the contrary, anyone caught with i

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

tems that have no legal use – such as burglar’s tools that can be used only to break into a house – can be prosecuted without more.

The individuals w

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

o use Grokster’s service to illegally download music will not get the same benefit of doubt. They commit the infringement and are subject to civil and

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

Following aspects would a

criminal prosecution. Case closed.

How can we stop the infringement? Even if the Supreme Court outlaws Grokster’s software, infringing activities won

dd to the challenges in developing combination products:

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

’t stop. We must find other ways to at least minimize it. There are things we can do.

First, we can educate the infringers. Some people don’t realize

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

that sharing files of copyrighted work is illegal. The recording industry increased its public awareness program and found a significant rise in the p

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

ercentage of persons aware that it is illegal to make copyrighted music available online for others to download. When some people know that an activit

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

is illegal, they don’t do it. Second, we can develop and use technology and other features that make it difficult for others to steal our work. Some

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

Professional from academic institutions, pharmaceutical industries, health care indust

thieves are lazy and won't steal anything that takes effort. Third, we can make it easier for potential infringers to purchase the product they want.

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

he recording industry has learned that consumers will purchase one song when they don’t want to buy the entire album. Last, we can sue those who steal

.

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

the work so that they and others learn that the theft will not be tolerated. Going to jail or paying a fine is a deterrent.

So don’t blame the messe

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

Companies that provide selfless information through particip

ger. Change the message. Follow the course of our fellow recording artists and protect your work.

Copyright 2005 Carolyn E. Wright All Rights Reserve

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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