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Have you come up with an idea, or an innovative process, or developed a neat little prototype around it? Are you totally excited about it and want to release it in the market and test it out? Hold on a

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

bit, because you need to first protect your intellectual property.

It takes years to conceptualize and develop software products. However, once the product attributes are well defined, it does not t

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

Examples of combination products may in

ke significant effort to replicate the software on a different platform or language if it has not been patented.

Can a copyright protect a new software product idea or process? A copyright on the sof

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

tware only protects the exact replication of the software code. A copyright does not protect another from replicating the core process, functional aspects, or idea of the software product. Also, a copy

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

ight provides no security if a similar code is proved to have been independently developed. Patents, on the other hand, provide an impregnable protection for software products and processes.

The grant

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

Combination pro

of a patent for a software product or process grants to the owner the right to exclude others from making, using or selling software that perform similar functions. In simplest terms, a software patent

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

protects innovative software products and processes.

The valuation of a software product company is increasingly dependent on the strength of its patent portfolio. Software patents level the playing

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

ield between small and large sized software product companies. A small software company with cutting edge patents such as Research In Motion can command a significant presence in their market or domain

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

A startup with a strong patent portfolio can carve out a niche market and securely position itself. Take the case of the Bangalore-based startup, Textual Analytics. Focused in the area of contextual

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

search in the Internet, this startup developed a strong patent portfolio. Madan Pandit, CEO of Textual Analytics says: Our filed software patent applications give us the confidence to enter the interne

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

search markets that have large and well established players.

Alan Kay, the inventor of object-oriented programming, once said, The best way to predict the future is to invent it. Organizations, big o

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

Following aspects would a

small, use patents as a means to protect their inventions. For instance, Microsoft holds about 5000 patents, and IBM about 40,000 patents. Approximately 145,000 software patents have already been gran

dd to the challenges in developing combination products:

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

ted by the US patent office and about 17,000 new patents are issued every year.

Trade secrets may be used to protect an idea in some industries. Coco Cola Inc., for example maintains its Coca-Cola pro

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

uct composition as a trade secret. However, it is difficult to maintain software processes as trade secrets primarily because the inventive idea in a software product can be reverse engineered. A signi

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

icant part of the intellectual property of a software product is exposed on the release of the new product. There is a direct and transparent relation between the functional aspect or features of softw

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

are and the software internal processes, which requires less effort to reverse engineer the product.

The breadth of intellectual property that can be captured by a software patent is significant. Soft

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

Professional from academic institutions, pharmaceutical industries, health care indust

are patents can be obtained for inventions that disclose physical components, or for function that it performs that are new and non-obvious. Software on its own is not patentable but the functions it

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

erforms are patentable. It is the machine, process, or manufacturing action utilizing the software that is patentable. Some examples of patentable software processes are editing technologies, control f

.

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

unctions, compiling functions, user interactive software and operating system technologies. Business methods and mathematical algorithms, which use new manipulation of language-specific codes to obtain

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

Companies that provide selfless information through particip

a predetermined result, are also patentable. The above mentioned software processes, business methods and mathematical algorithms covers almost anything one can think of in the high technology industry

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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