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Photographers often submit photos to publishers for inclusion in a book or magazine. But what happens to the copyright for t

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

hat photo? Does it transfer to the publisher? What is the publisher allowed to do with the copyright?

Unless the copyrigh

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

Examples of combination products may in

t to a photo is specifically transferred in total to a publisher, the publisher’s use of that photo is limited by the usage

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

agreement. The publisher, however, creates a new copyright, called a “collective work,” when your photo is combined with ot

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

her photos, text, illustrations, etc. Your photo then is covered by two copyrights – one for the photo itself, and the oth

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

Combination pro

er as part of a collective work.

As the owner of the copyright to a collective work, the publisher may reproduce and distri

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

ute your contribution as part of that particular collective work, but not as a separate item. The publisher also may distr

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

ibute any “revision” of that collective work and any later collective work in the same series. "Revision" also is thought to

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

be a new "version," which still is considered to be one work.

Revision became an issue with some photographers who had c

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

ntributed work for National Geographic magazine. There, National Geographic distributed via CDs previously published magazin

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

e issues almost exactly as they appeared in print, except that National Geographic added a search engine and index. The ph

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

Following aspects would a

otographers argued it was a new use of their images and wanted to be paid for it. National Geographic argued that the CDs

dd to the challenges in developing combination products:

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

ere a revision of the collective work (the magazines) so that the usage was included in the initial grant. Because the pho

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

tographers were located in different parts of the United States, they filed their lawsuits in separate courts and both cas

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

es were appealed. While the reasons why aren’t covered here, in sum, the 2nd and 11th Circuit Court of Appeals came to diffe

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

ent conclusions about whether the CDs were a revision or a new product. This inconsistency in the law will have to be reso

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

Professional from academic institutions, pharmaceutical industries, health care indust

lved later.

While hindsight is 20-20, we can learn from this experience that the best way to protect your copyrights is to

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

be as specific as possible when granting usage rights. If you don’t want your photos used for certain purposes, say so. Bu

.

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

if your agreement doesn’t address a usage, a court that might not agree with your position just may be the one that deter

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

Companies that provide selfless information through particip

mines your rights.

Take my advice; get professional help.

PhotoAttorney

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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