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Top Articles - Business Method Patents, Part II
Since the flood of applications to the Patent Office, various online companies have applied for and been grant
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
ed patents on a wide variety of methods, many of those involving Internet shopping or Web commerce advertising
; 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
In order to qualify for a business method patent there are various criteria that must be met. First of all,
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
business method patent is granted for a method or type of business software that is practical in its purpose.
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
This is a criterion which is common for granting of all patents.
Another criterion is that the business metho
Another criterion is that the business metho
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
must not be obvious. The Patent Office will not approve applications for methods that they have deemed to be
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
ntirely obvious. It is easy to prove that a method is practical, but a little harder to prove it is not obviou
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
.
A third criterion a business method patent must fulfill is that it should be something that is worth patent
A third criterion a business method patent must fulfill is that it should be something that is worth patent
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ng. The Patent and Trademark Office will not just approve almost anything that comes through their office, but
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
will scrutinize the applications to make sure they are worthy of being patented. This is the most subjective o
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the criteria that are applied, but it is not generally difficult to demonstrate that an idea is worthwhile, i
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
f it actually is.
Lastly, the method to be patented should be something that is new to the industry. The Pate
Lastly, the method to be patented should be something that is new to the industry. The Pate
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
t Office will not patent anything that has been in use for a long time. The method or software must have been
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
n use no more than one prior to the date of the patent application.
Like the other patent applications, the c
Like the other patent applications, the c
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
sts of the business method patent can vary from $2,000 to $10,000 or more depending on the costs of the patent
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
lawyer’s fees (if you use one). Since the business method patent is a form of a utility patent, the patent own
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 must pay maintenance fees for the patent. These fees are approximately three times the application fee, spre
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
d over the course of the life of the patent. Usually the business method patent is valid for an average of twe
.
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
ty years. However, with the popularity of this type of patent, expect at least a two to three years’ wait befo
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
e the patent is approved.
Make sure you consider a business method patent if you have unique business methods
Make sure you consider a business method patent if you have unique business methods
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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