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A definition of software patent is hard and one may not find the definition on any patent office website. Software embodied in a physical com

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

puter readable medium and aiding an innovative process or machine is considered patentable. In order to obtain a software patent, the patent

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

Examples of combination products may in

application has to subtly claim the software as employing or performing certain function or process and as embodied in a computer readable m

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

edium.

Software patents have a very recent history as the first software patent granted was in 1981, in the legal case of Diamond v. Diehr.

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

he claimed invention is a heat treatment of rubber, wherein software code is employed to compute the optimum time duration for the treatment.

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

Combination pro

In another case of State Street Bank & Trust v. Signature Financial Group, a software business method was granted a patent in the year 1998,

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

redefining software patentability. Software patentability has been a topic of debate world over. The first question an inventor, who wishes

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

to patent his invention, asks is “Is software patentable”. The short answer is that the US patent office does grant software patents, and the

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

e has been a surge in software patenting in the US.

A classification of software patents is virtually nonexistent, although a majority of re

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

cent patents are software patents based on the above criteria and about 1400 patents are purely on computational software. Major companies li

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

ke IBM, AT&T, Siemens, HP and Microsoft boast of an extensive software patent portfolio. IBM possesses 31,995 US patents, HP possesses 21,000

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

Following aspects would a

patents worldwide as on 2003, Microsoft possesses 5000 US patents and Siemens possesses more than 10,000 issued and pending US patents. Micr

dd to the challenges in developing combination products:

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

soft and Siemens have a cross-licensing agreement to enable increased access to each others patent portfolios. In the USPTO database there ar

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

e about 25123 claimed software patents and about 284978 granted patents that disclose the use of software in their inventions.

Software pate

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

nts will surge a rise in software innovation and also enhance the quality of software protection. Cross-licensing agreements support even hig

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

her level of innovation and interaction in the software industry. Software patents not only protect marketing rights for a company but also t

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

Professional from academic institutions, pharmaceutical industries, health care indust

eir intellectual property, thereby providing a driving and inspiring force for the programmers.

Don’t even get started anyone on the advanta

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

ges of software products in day to day life. Software products range from operating systems, encryption software, web development, virtual re

.

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

ality, gaming software to customized software solutions for sectors like medical, banking, aviation, military, etc; software has been the sav

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

Companies that provide selfless information through particip

ior for many industries. Without software, humans may not have envisioned such advancement in technology and consequently the quality of life

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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