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Intellectual property is an ancient principle. Not true. Intellectual property is an explicitly modern notion, having made its debut quite recently. The first patent law was enacted in 1623, and the precursor of modern copyright - the Statute of

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

Anne - came into being in 1710. These early laws were limited in scope and restricted to only a few types of information; the broader interperatation of these principles used today in the western world is quite modern, certain elements having been added only within

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

the last few years.

Intellectual property is recognized worldwide. As the US's recent standoff with China demonstrates, intellectual property is not a concept which has worldwide acceptance. Indeed, a major foreign policy objective of the Unite

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

d States has been to force other nations to comply with its own intellectual property agenda - an unwelcome form of intellectual imperialism which is all too frequently ignored by watchdog groups.

Without intellectual property, no one will produce original

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

work. Given that intellectual property law made its debut in 1623, we may correctly consider any work produced before this time to dispell the myth. Man created for millenia before the advent of intellectual property; he will create for many more milleni

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

a after it is abandoned.

Intellectual property is necessary to create incentives for the production of original works. This intellectual property myth has become the mantra of IP supporters. Often repeated, never questioned, the idea that creati

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

vity depends on a government granted monopoly needs no justification in the minds of most IP boosters. Sadly, however, they are mistaken: intellectual property "rights" are not essential to creation, and in some circumstances even deter it. Consider, for instance,

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

the software industry. Free for years from the limitations of intellectual property, the industry flourished, becoming by all accounts one of the most creative of environments in the modern world. With the recent introduction of patent law into computing, however,

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

any individual programmers live in fear of lawsuits from large corporations who claim "ownership" of techniques such as the scroll-buffer. Who benefits from this? Certainly not the creator! Intellectual property law, from its inception, has been about publishers an

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

d other powerful firms as much as it has been about creative individuals; the latter often find their interests poorly defended by IP.

Even if people DID create works without intellectual property protections, the quality of these works would be substandar

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

d. Only if "Julius Caesar", Plutarch's "Lives", "The Last Supper", and Handel's "Messiah" are "substandard"! All of these, including such pivotal creations as the Bible, the Koran, and the hundreds of Sutras were created in a world without intellectual p

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

roperty. IP boosters claim that weakening intellectual property law means giving up great literature, music, and art; in fact, history shows us that this is not the case.

The "best" creators won't work without intellectual property protections.

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

nce again, history proves this to be false. Shakespeare, Plato, Confucius, Hero, Chaucer, Handel, and many others of the finest names in world literature, music, art, and invention worked in an environment free of intellectual property restrictions. Clearly, genius

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

does not require copyright to produce!

To take away intellectual property rights is to deny creators the right to profit from their labors. This myth is based on the idea that the only way to make money off of creation is to "sell" the ideas wh

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ich are produced. In fact, this is not true. Consulting, support, performance, service: these are all ways in which creators can make money off of their abilities without appealing to intellectual property rights. Even if there were no copyright, a band could still

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

make money by charging for live performances, for instance; an even better example is found in academia, where a great deal of idea production takes place without the ideas being "sold" to the universities which sponsor their creators. Removing intellectual proper

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

y rights would not deny creators the right to profit from their labors; it would, however, allow all of society to share in the benefits of their work.

Intellectual property follows directly from the notion of physical property. Physical propert

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

y rights are derived from the basic fact that a physical object can't be in two places at once. In order to keep people from squabbling over material objects, we use a system of rights to say "who gets what". Information, however, differs from physical property in

.

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

a number of ways, one of which being that it can be in many places at the same time. Let's say that Fred gives Barney an apple; after this, Fred no longer has the apple. If, on the other hand, Fred TELLS Barney about the apple, Fred STILL knows about the apple. Fre

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

d gave the information to Barney, but Fred still has it! Clearly, then, there is no need for Fred and Barney to squabble over who "owns" the information about the apple: to do such would be to try to treat information like an object, an idea which is clearly flawed

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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