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Top Adding - Five Key Questions About IP Help Increase Market Value and Improve Bottom Line Results
Intellectual assets are critical to business success in today's global market.
If you are a CEO, CFO, GC or other business leader, asking questions about these assets will help you to bring added value
If you are a CEO, CFO, GC or other business leader, asking questions about these assets will help you to bring added value
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
to your company.
Failure to consider these issues yields adverse business consequences, including unrealized value, unnecessary expense and legal risk.
Routine attention to intellectual asset managem
Failure to consider these issues yields adverse business consequences, including unrealized value, unnecessary expense and legal risk.
Routine attention to intellectual asset managem
; 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
ent can avoid these consequences, yet many businesses miss this opportunity simply for lack of knowledge and attention.
Intellectual Assets
What are intellectual assets? Essentially these encompass al
Intellectual Assets
What are intellectual assets? Essentially these encompass al
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
l of the intangible assets of an enterprise.
From the business point of view, we're talking about brands, logos, packaging, corporate identity, ideas, business methods, marketing information, published
From the business point of view, we're talking about brands, logos, packaging, corporate identity, ideas, business methods, marketing information, published
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
content, secrets and inventions.
From the legal point of view, they are trademarks, copyrights, trade secrets and patents.
Five Key Questions
1. Maximize IP Assets.
"Have you established a clear cl
From the legal point of view, they are trademarks, copyrights, trade secrets and patents.
Five Key Questions
1. Maximize IP Assets.
"Have you established a clear cl
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
aim to your IP rights through registration?"
Brands, packaging, ideas, inventions and content have greater value to investors and purchasers if they are secured by registrations. Companies with strong
Brands, packaging, ideas, inventions and content have greater value to investors and purchasers if they are secured by registrations. Companies with strong
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
portfolios of registered rights are worth more. For example, the S&P 500 traded at a market-to-book ratio of 4.7 in 2003. At that rate, tangible assets amount to less than 24% of market value, with int
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
angible assets such as brand and goodwill accounting for more than 75% of market value. This fact presents an significant opportunity for companies with low valuations to create market value.
2. Domain
2. Domain
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
Name Registrations.
"Do you have domain names properly registered to avoid inadvertent expiration or improper transfer by former employees or ISPs?"
In our practice, we routinely deal with companies
"Do you have domain names properly registered to avoid inadvertent expiration or improper transfer by former employees or ISPs?"
In our practice, we routinely deal with companies
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
that have lost domain names because they failed to maintain registrations in their own names or lacked a sound system for managing renewals. It can happen to anyone, large and small, as illustrated by M
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
icrosoft's well-publicized loss of the domain name hotmail.co.uk. The cost of prevention is small, while the expense of recovering lost domain names can be high.
3. Content Protection.
"Is the content
3. Content Protection.
"Is the content
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
of your website, manuals, publications and other materials adequately protected?"
Copyright registration and notice is not a prerequisite to protection, but early registration is required to benefit f
Copyright registration and notice is not a prerequisite to protection, but early registration is required to benefit f
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
ully from the remedies provided under copyright law. The failure to register copyrights before infringement occurs results in the loss of the right to recover statutory damages and attorneys fees. Many
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
small clients find that enforcement is an unrealistic expense without the benefit of those remedies, yet registration of copyrights is simple and inexpensive.
4. Enforcement.
"Have you allowed third p
4. Enforcement.
"Have you allowed third p
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
arties to steal or erode your intellectual assets?"
The failure to take action against infringers results in loss of revenue and rights. Haphazard enforcement efforts can be expensive and ineffective.
The failure to take action against infringers results in loss of revenue and rights. Haphazard enforcement efforts can be expensive and ineffective.
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
Companies that practice effective intellectual asset management will work with counsel to create a strategic enforcement plan that reduces overall legal expense while maximizing IP rights and avoiding t
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
he loss of rights through inaction.
5. Insurance coverage.
"Do you have insurance coverage for IP claims against the company?"
Many companies have coverage for IP claims and don't realize. Many comp
5. Insurance coverage.
"Do you have insurance coverage for IP claims against the company?"
Many companies have coverage for IP claims and don't realize. Many comp
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
anies do not, and should. Coverage is often hidden away in an "advertising injury" clause. Courts have often read these clauses more broadly than they appear on their face. As a result, coverage can ea
.
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
sily be overlooked. When a prominent New York law firm famously failed to advise its client about coverage and tender a timely claim, defense coverage was later denied, costing the company millions in l
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
egal fees.
Added Value
Asking questions about intellectual capital issues can increase company value and avoid risk. Effective management of these rights is the key to success in the information age.
Added Value
Asking questions about intellectual capital issues can increase company value and avoid risk. Effective management of these rights is the key to success in the information age.
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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