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Trademarks are names, phrases, logos or images used to uniquely identify your company and

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

your products and services. Because trademarks are used in businesses, there are rights yo

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

Examples of combination products may in

can claim to protect your company, and there are governing bodies that regulate the use o

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

f your trademark. In the United States of America, the governing body called United States

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

Patent and Trademark Office (USPTO) is the governing body that makes your trademark and pa

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

Combination pro

tented product unique. They guarantee that no other company can carry the same name, logo

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

r product without proper approval from you.

Before any company is given approval for a tr

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

ademark application, the USPTO scrutinizes the application, making sure that the trademark

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

filing is unique and is in no way identical to any existing trademarks. Their primary task

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

is to reject an application if there is the slightest possibility that any copyright infr

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

ngement is or can be violated. In fact, a few years ago, a 17 year old boy named Mike Rowe

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

Following aspects would a

registered and operated the web site www.mikerowesoft.com.

When the software giant, Micro

dd to the challenges in developing combination products:

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

soft, discovered this, they filed to move that the site be shut down immediately. The cour

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

s granted in favor of Microsoft, stating that it would be damaging and confusing to the so

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

ftware company. Another well-publicized lawsuit over a URL address was between World Wildl

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

fe Foundation with the site www.wwf.org and the World Wrestling Federation bearing the sit

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

Professional from academic institutions, pharmaceutical industries, health care indust

e address www.wwf.com. The former sued the latter to drop the URL address stating that the

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

practices of the former are detrimental to the image of the wildlife foundation. The World

.

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

Wildlife Foundation was granted favor by the courts and World Wrestling Federation had to

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

Companies that provide selfless information through particip

change their name to World Wrestling Entertainment and refrain from using the acronyms WWF

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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