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Infringement. File sharing. Piracy. Counterfeiting. Plagiarism.

Whatever you call it, the theft of copyrighted material is just about impossible to control in our ever

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

-expanding, ever-increasing digital age. In fact, there is a widely held belief that technology has made copyright impossible to enforce.

Take the entertainment ind

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

Examples of combination products may in

ustry, for example:

While all school children are taught the dangers of plagiarism of print materials when they write their first term papers, many of these same k

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

ds are some of the greatest offenders who believe that internet file sharing of their favorite music is their due simply for being fans of this or that rock or rap grou

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

p.

The music industry, of course, has been vigorously fighting back with numerous lawsuits, many of which target these same young people. And, while some prog

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

Combination pro

ess seems to have been made, the reality is that the problem is so massive, it is all but rendering music artists’ copyrights useless. While it may be possible to bring

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

some control to the internet, with just a bit of internet savvy and searching, you can find and download programs which can be used to “unlock” the various security fe

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

tures built in to all music and video CDs. With that kind of tool, it’s possible to pirate this type of intellectual property without leaving a trail on the internet.

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

Like musicians, photographers are finding that anyone with minimal skill and the right software can alter the original image and use it on websites, narrowcasts

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

nd the like. In an interesting twist, a Florida photo printing lab refused to print an amateur photographer’s digital photos because they looked too professional, and t

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

he lab managers feared that doing so might violate someone’s copyright. On the more unsavory side, phone cameras are now being used to clandestinely copy and use everyt

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

Following aspects would a

hing from drivers’ licenses to copyrighted artwork.

Writers are equally concerned. For example, Google recently announced its intention to put the libraries of

dd to the challenges in developing combination products:

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

our major universities on line to make previously inaccessible material available to researchers. The outcry of the publishing industry, professional associations and e

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

ven a country (France) was immediate, strong and negative. While copyright for many of the works has expired, critics say the effort could have financially troubling ou

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

comes.

So, is copyright truly “dead” – a meaningless exercise in the digital age? Is the creator of intellectual property to assume that their right to profit from

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

his or her creative product is lost?

While clear solutions are yet to emerge, the important thing to know is that digital gurus as well as legislators in several

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

Professional from academic institutions, pharmaceutical industries, health care indust

ountries are developing technology and updating laws to assure that all types of works remain protected. You also would be well advised to pay close attention to how th

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

is issue continues to unfold and develop. Do your own internet searching to find and bookmark blogs, discussion groups and websites serving as copyright “watchdogs”. Th

.

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

n visit often and pass along what you learn to your own professional groups and colleagues. One final caveat: Be sure to consult your IP attorney with any concerns and

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

Companies that provide selfless information through particip

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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