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Top Articles - The Intellectual Property Audit - Finding What You Have (Part I of V)
The Intellectual Property Audit Measures an Organization’s Intellectual Assets
With the advent of easy and ever-less
With the advent of easy and ever-less
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
-expensive computer access throughout the industrialized world, we live more and more in an economy based not on agrarian activities
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
or industrial strength but on knowledge and the management of knowledge. Managing this new economy requires different tools than di
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d agrarian or industrial economies. The agrarian economy demanded farming skill from the workers, and transportation and storage 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
crops. The industrial economy demanded manufacturing skills from the workers, transportation and a consumer market for manufactured
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
items. Our new knowledge economy demands that organizations have in place the tools to manage the knowledge contained within them:
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 examples of this knowledge are contracts with employees, contractors, strategic partners, and consumers to protect the organiza
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
tion’s knowledge base, patents to protect inventions, trademarks and service marks to protect organizational goodwill, copyright to
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
protect publications, and a well-designed licensing program to allow the organization to commercialize and capitalize on its intelle
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
ctual property.
This knowledge — the collective intellectual understanding of everyone who works for the organization — co
This knowledge — the collective intellectual understanding of everyone who works for the organization — co
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
tained within an organization is the organization’s intellectual capital. Intellectual capital makes up approximately 80% of the val
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
ue of the S&P Fortune 500 companies. Probably the best-known example of an organization’s intellectual capital is the Coca-Cola lo
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
go, which is valued at approximately U.S. $10 billion. However, the books of these organizations do not reflect these assets; they
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
are “hidden resources.” “Book values of publicly traded companies mainly reflect the value of tangible and capital assets of the or
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ganization.... This is hardly an accurate reflection of the intangible assets as [good will] is created to balance the books followi
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
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
ng an acquisition. The market value of a organization reflects the value of a hidden resource that is recognized and valued by the m
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
arket....”
Clearly, if an organization fails to account for 80% of its assets on its ledger books, that organization canno
Clearly, if an organization fails to account for 80% of its assets on its ledger books, that organization canno
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
t provide an accurate valuation figure for investors, partners or consumers. Therefore, an organization must account for those intan
.
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
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
gible assets that do not appear on the ledger books but which make up so much of the organization’s market worth. It does so through
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
an intellectual property audit.
Continued in Part II
Copyright 2003, 2007, Nancy Baum Delain. All rights reserved
Continued in Part II
Copyright 2003, 2007, Nancy Baum Delain. All rights reserved
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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