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Top Adding - Intellectual Property Considerations
Intellectual Property is one of the hardest things to protect. If yo
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
u file a patent it becomes public information and if someone copies
; 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
it and changes one thing, they basically stole your idea for free th
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
en it is your duty to try to sue them; that costs you thousands. Ano
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 huge issue in trying to protect your intellectual property comes
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
when filing forms with various City, State, Federal or Counties, th
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
at becomes an easy target giving away pieces to the puzzle to compet
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
itors too.
But that is not all, these days corporate espionage is a
But that is not all, these days corporate espionage is a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
big thing. They actually teach it in many Universities. You therefor
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
e need to shred your trash, pass-word protect your systems and preve
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nt hackers or computer intrusions. Still how can you be safe with qu
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
estionable employees out to sell your data to your competitors, as l
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
ose lips sink ships and the more money involved, as they often say;
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
the loser the lips will be.
Even our own US military dealing in Top
Even our own US military dealing in Top
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
Secret information, usually knows that it is only top secret for 6-
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
months and then forget it; everyone knows and you may as well let th
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
defense contractors go have a hay day with their press releases to
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
boost their stock. Suffice it to say if you do not have a good strat
.
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
egy in place to protect your intellectual property then you are doin
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
g more harm to your company than good. So, consider all this in 2006
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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