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Answers - When Circumvention is Necessary for Fair Use
Copyright law was carved out of our fundamental rights system in order to provide artists, writers, and others with a mechanism by which they would be rewarded for their creations by pre
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
venting others from copying them for a period of time. This "copyright" has always been coupled with the consumer/user's right of "fair use" which, among other things, provides for user
; 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
to make copies of the work for non commercial archival purposes, and recently, for the right to make a copy of works in order to "timeshift," or enjoy the works at times more convenient
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
than the original performance.
Various distributors of copyrighted materials, notably the software, music and entertainment industries, have added mechanisms by which the user can no lo
Various distributors of copyrighted materials, notably the software, music and entertainment industries, have added mechanisms by which the user can no lo
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
ger exercise their fair use rights by making archival copies or timeshifting performances. The Copyright office is now requesting comments regarding whether or not giving the user the r
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ght to circumvent these mechanisms is appropriate.
There is substantial evidence produced by software creators, music producers and the rest of the entertainment industry that copying a
There is substantial evidence produced by software creators, music producers and the rest of the entertainment industry that copying a
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
d re-distributing copyrighted works causes harm to those industries in lost sales opportunities. However, that is not necessarily the real issue. The Copyright Office is attempting to
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
determine whether or not as a user who has provided the producer with fees or other consideration, has the right to then make use of the product in accordance with current copyright laws
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
An example that is close to my heart is timeshifting and archiving of high definition television signals. I pay DirecTV a substantial amount each month in order to watch high definiti
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
n signals. DirecTV allows me to download these signals to timeshift via their digital video recorder device. However, the device will not allow me to archive the signals in the same fo
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
mat which they were saved. In order to archive the programming, it must be downgraded unless I circumvent the technology barriers to enjoy my fair use right.
A similar issue occurs whe
A similar issue occurs whe
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
purchasing a DVD. The user pays a fee to view the content of the disc, but is prevented from viewing that content if they leave the country and use a DVD player that is native to thei
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
new country. They are also prevented from making an archival copy of the DVD that they have already paid for. The user would have to use circumvention technology in that case to even
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
iew the DVD that they have already paid for.
These industries have essentially "taken the law into their own hands" by denying the consumer the right to use fully paid up products as th
These industries have essentially "taken the law into their own hands" by denying the consumer the right to use fully paid up products as th
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
e law allows. While there is no doubt that circumvention technology COULD be used to make and distribute illegal copies of copyrighted materials, that is not the issue that is being add
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
essed by this request for comments. Laws against illegal copying and distribution are already on the books, and are being enforced by harsh civil and criminal sanctions. Yet the consum
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
r's use to unimpeded fair use of products they have paid for is ignored.
Once a consumer has complied with the fees required by the distributor, the consumer should then have all rights
Once a consumer has complied with the fees required by the distributor, the consumer should then have all rights
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
to use the product, including fair use rights. While the distributor should be allowed reasonable means to protect their investment from illegal copying, the consumer should be guarante
.
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
d their fair use rights that emanate from the very same Copyright Act that provides protection for the distributor. If circumvention technology is necessary to exercise those fair use r
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
ghts, the consumer should have the right to use it, but only to the extent that s/he needs to archive, timeshift, or even (in the case of regional prohibitions with DVDs) use the product
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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