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Top Articles - Data Protection - Database Right For Sales Agencies
A ruling by the High Court has resulted in new case law governing sales agencies with regard to database rights. Where a sales agency has built up a database of cu
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
stomer details, they will now own a database right in that database in the event that there is not an agreement with another party as to the ownership of that data
; 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
base.
What this means in practice is that it is now important to ensure that agency or distribution agreements include an express assignment of any database right
What this means in practice is that it is now important to ensure that agency or distribution agreements include an express assignment of any database right
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to the supplier of the information (or principal), rather than relying on a general IP assignment clause. She says:
"The maker of a database is the first owner o
"The maker of a database is the first owner o
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
f database right in it. The claimant in the case tried to argue that the agent was a self employed consultant and therefore could not have the status of "maker" of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
the database - this was rejected by the court".
The case was decided with regards to the EC Database Directive and its implementation in the UK through the Copyr
The case was decided with regards to the EC Database Directive and its implementation in the UK through the Copyr
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
ght and Rights in Databases Regulations 1997. The facts of the case involved an agent selling home insulation which the principal manufactured. The agent sold the
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
principal's insulation to customers and used the principal's name and business cards when doing so. The agent also created a database of customers to whom it had s
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
old the insulation, however, the principal then began using this database to sell its other products.
Once the matter came into dispute, the agent issued a counte
Once the matter came into dispute, the agent issued a counte
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
-claim for delivery up of the database claiming to be the rightful owner of it.
"The court held that the agent had created the database of customer names - they w
"The court held that the agent had created the database of customer names - they w
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ere, after all, customers of the agent, and accordingly the database belonged to the agent”.
The case was reasonably clear cut as there was no employment relation
The case was reasonably clear cut as there was no employment relation
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
ship, and there was no express agreement regarding the ownership of the intellectual property rights in the database. Consequently, the ownership of the database r
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
ght was vested in the sales agent.
It means that Sales agents and distributors will be in a strong position on termination of the arrangement if ownership of the
It means that Sales agents and distributors will be in a strong position on termination of the arrangement if ownership of the
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
intellectual property rights including the database right has not been made expressly stated in an agency or distribution agreement. This case is consistent with t
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
he customer lists belonging to the agent, distributor or franchisee as part of their confidential information. Here there is an issue regarding the distinction be
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
ween the database right and the copyright in the content of the database.
The William Hill case made a distinction between the rights in the database itself and r
The William Hill case made a distinction between the rights in the database itself and r
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
ights in the contents and it is unclear whether the judge took this into account in deciding that the database (which presumably included the customer information
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
contained within it), belongs to the sales agent.
Comment: In the future, agency and distribution agreements will have to deal with the ownership of any customer
Comment: In the future, agency and distribution agreements will have to deal with the ownership of any customer
.
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
atabase i.e. customer list as well as other intellectual property rights. Not many agents or distributors would want to give us their customer lists. If not the pr
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
incipal/supplier may lose control of the customer database on termination, as well as paying potential compensation to the agent on termination to obtain the list
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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