Most of you already understand this but for those
Post# of 5066
Posted On: 09/19/2013 7:11:23 AM
Most of you already understand this but for those of you that do not, although a very important process in terms of protection of the product the company will use as their own, the trademark process has nothing to do with whether or not the FDA will approve an IND application. A company need only provide a proposed name during the IND process. During the marketing of an already approved treatment is when trademark establishment dictates the FDA's denial or approval of a product (i.e., if the name of a treatment is found to be too similar to another and there is plausibility that the names can be confused).
Conversely, if there have been unforeseen events transpire during the course of the IND application such as a specific patented process involved in creating the treatment lost its protection during the course of the consideration, the FDA may (should) require all legal steps to protect the product being considered in an IND application, or to prove its validity, are taken before authorizing the go ahead OR making the authorization public. This would be for no other reason but to protect all parties involved.
In the 31 July PR, the company stated:
"The Company has recently been informed that a patent has expired on which a license agreement was entered into and disclosed on June 6, 2012. As a result of the expiration of this patent, the Company believes that it shall no longer be bound to make certain license payments to the licensor. After extensive review, the Company does not believe this event will negatively impact the probability of the It being granted patent protection on improvements included in its own patent applications related to HemaXellerate(TM)"
Since this patented process is part of the HemXellerate treatment, the company will have to submit to several entities modifications of their applications in order to protect itself. Since it has already been established that the lapse in patent protection does not preclude them from using the process for their treatment, the treatment does not change. It is as it has been from the start. However, they discovered that they are not protected as they thought when the processes were initiated so further steps will have to be taken to rectify this.
Again, the trademark status will have no bearing on whether or not the proposed treatment will be approved or denied for clinical trials. But, from a legal standpoint, in order to protect the company and its product, paperwork must be revamped.
BMSN
Conversely, if there have been unforeseen events transpire during the course of the IND application such as a specific patented process involved in creating the treatment lost its protection during the course of the consideration, the FDA may (should) require all legal steps to protect the product being considered in an IND application, or to prove its validity, are taken before authorizing the go ahead OR making the authorization public. This would be for no other reason but to protect all parties involved.
In the 31 July PR, the company stated:
"The Company has recently been informed that a patent has expired on which a license agreement was entered into and disclosed on June 6, 2012. As a result of the expiration of this patent, the Company believes that it shall no longer be bound to make certain license payments to the licensor. After extensive review, the Company does not believe this event will negatively impact the probability of the It being granted patent protection on improvements included in its own patent applications related to HemaXellerate(TM)"
Since this patented process is part of the HemXellerate treatment, the company will have to submit to several entities modifications of their applications in order to protect itself. Since it has already been established that the lapse in patent protection does not preclude them from using the process for their treatment, the treatment does not change. It is as it has been from the start. However, they discovered that they are not protected as they thought when the processes were initiated so further steps will have to be taken to rectify this.
Again, the trademark status will have no bearing on whether or not the proposed treatment will be approved or denied for clinical trials. But, from a legal standpoint, in order to protect the company and its product, paperwork must be revamped.
BMSN
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