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Top Articles - How Do You File A Patent
You got a great invention, and you don't want others to create or use the same invention (or at least nobody can claim they invented it). That's the kind o
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
f protection a patent offers. It gives you exclusivity to create, reproduce and sell the product or process to the public for a particular length of time (
; 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
ost patents nowadays offer protection for a minimum of 17 years). If you want to protect your product, device or process under a patent, then read on.
The
The
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
United States Patent and Trademark Office (PTO) has its own website where it stores a database of all US patents and trademarks. If your invention is not
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
et on the list, then you can submit an application for a patent addressed to the Director of the US PTO, which includes a written document of the specifica
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ion of the invention and a signed declaration. The written document will usually list down the attributes of the invention that sets apart from other relat
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
ed inventions that have been patented already, and the claims of the patent (why the invention is patentable). A drawing of the invention (whenever applica
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
le) is also needed. It can be a simple sketch or a set of formal drawings showing the invention’s parts and/or aspects. For more information about these do
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
cuments, you can go to http://www.uspto.gov/web/offices/pac/doc/general/index.html#app
Fees will depend on the invention you're trying to patent. The PTO
Fees will depend on the invention you're trying to patent. The PTO
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
ebsite has a list of all applicable filing fees and the schedule on filing them. If you're an independent inventor or if your company (with less than 500 p
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
ople) created the patent, the filing fee is $380; for larger companies it will be $760. Depending on the patent maintenance, you may be required to pay add
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
itional fees as well, sometimes exceeding more than $3000.
The assistant commissioner for patents at PTO will process your patent application, after which
The assistant commissioner for patents at PTO will process your patent application, after which
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
he/she will inform you when the patent will be issued. Once the patent is issued, you have to pay an issue fee of $605 for small entities, and $1210 for la
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
rge entities. You will then be given a patent number, where you can put on your product label to show that your invention is protected.
The above process
The above process
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
onstitutes a non-provisional patent application. Because it takes longer for regular non-provisional patent applications to get approved (some may take eve
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
years), the PTO has provided another way of protecting your invention at a much earlier date. It's called a Provisional Patent Application (PPA). The appl
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
ication process is somewhat the same, but it's much faster and need not to submit that much documents. You just pay a minimal amount of $75 to get a PATENT
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
PENDING mark for your invention. For the next 12 months from the time you file a PPA, you must file the regular patent application to fully protect your i
.
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
nvention.
This article does not offer all-inclusive information about patent application, but just a general overview of what happens during the process.
This article does not offer all-inclusive information about patent application, but just a general overview of what happens during the process.
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
t is strongly recommended that you consult with a patent lawyer to give you an explanation of all applicable patent laws and regulations for your invention
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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