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In this third article on business method patents we're going to continue our discussion with legal requirements for getting a business method patent.

In order for a comp

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

any or individual to get a business method patent, the business method or software must meet the following requirements:

1. The method or software must be on a subject

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

Examples of combination products may in

atter that the patent office defines as patentable. This is said to be anything created by humans that falls into two classes; laws of nature, natural phenomena and abst

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

act ideas.

2. The method or software developed must be of some practical use. This is fairly easy to satisfy because any functional purpose will be good enough. A bus

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

iness only needs to demonstrate that its method or software produces some tangible result. For example; Amazon.com with their 1-click purchase produces a tangible result

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

Combination pro

an expected purchase.

3. The method or software must be novel. In other words, this method or software must be noticeably different from anything else that has come b

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

fore it.

4. The method or software must be what they call "non obvious." What this means is that somebody who has ordinary skill in that specific technology would not h

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

ave been able to think of it.

The cost of getting a business method patent depends on a number of factors, including the actual subject matter of the patent, how complex

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

the examination process needs to be to determine if it is a new idea and whether or not the process goes through a lawyer. The cost for getting a business method patent

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

an be anywhere from $3,000 to $15,000 unless you go through the process yourself without hiring a lawyer. After the patent is issued, the owner of the patent must pay ma

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

ntenance fees to the U.S. Patent and Trademark Office after 3.5, 7.5 and 11.5 years. If the patent should be challenged, and many are, costs for getting the patent can g

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

Following aspects would a

o through the roof.

The next legal requirement for getting a patent is novelty. An application for a business method patent will fail the novelty test if the method was

dd to the challenges in developing combination products:

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

in use for more than 1 year before the patent was applied for. It is because of this novelty requirement that a company must research whether this method already exists

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

nd if not, file for a patent as quickly as possible.

A business method is considered to be novel when it is different in at least one area from all prior methods. This

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

is known as "prior art." Prior art consists of the following as per the USPTO in these exact terms.

1. "Any published writing (including any patent) that was made publi

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

ly available either: (1) before the date of invention of the business method or (2) more than one year before the patent application for the business method is filed."

2

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

Professional from academic institutions, pharmaceutical industries, health care indust

"Any U.S. patent that has a filing date earlier than the date of invention of the business method."

3. "Any relevant method or process (whether described in writing o

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

r not) existing publicly before the business method was conceived."

4. "Any public or commercial use, sale, or knowledge of the business method more than one year befor

.

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

the patent application for the business method is filed."

Finally, as to the timeline for obtaining a business method patent, it takes two and a half to three years to

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

Companies that provide selfless information through particip

et a business method patent from the date it was filed. The patent is valid for 20 years after filing. After that it becomes public domain and anyone can use the method

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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