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Top Articles - Twelve Steps To Filing A U.S. Patent Application
Inventing is a challenging task. Before you bring the invention to market, it is wise to take the appropriate steps to insure that you protect your invention. The most important protection that you can get is
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
a patent. Intellectual property law is complex. Obtaining a patent can be expensive and usually requires the services of a patent attorney, who can walk you through the steps of evaluating your product, and as
; 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
sist you in the patent acquisition process. This guide is intended to give you an overview of the steps needed to acquire a U.S. patent.
1. Preparation and submission of a disclosure in written form to design
1. Preparation and submission of a disclosure in written form to design
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ated company managers of the idea or innovation by its creator(s) for initial review and summary evaluation [Estimated Time: 1-2 hours; Cost: company time].
2. Review by designated company mangers of the disc
2. Review by designated company mangers of the disc
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
losed idea or innovation for potential commercial worth and value [Estimated Time: 1-2 hours; Cost: company time].
3. Summary evaluation of the disclosed idea or innovation by patent counsel to identify its t
3. Summary evaluation of the disclosed idea or innovation by patent counsel to identify its t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
echnical working essentials and to assess whether these essentials might meet the patent merit requirements of utility, novelty, and non –obviousness in view of the relevant prior art [Estimated Time: 2- 4 hou
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
rs; Cost: $195.00 per hour]
4. Review and decision by designated company managers whether and how to proceed with commercial development of the idea or innovation and also whether or not to seek patent protec
4. Review and decision by designated company managers whether and how to proceed with commercial development of the idea or innovation and also whether or not to seek patent protec
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
tion for the innovation based on patent counsel’s summary evaluation [Estimated Time: 3- 6 hours; Cost: company time].
5. Holding an in-person (if possible) meeting of the creator/inventors, patent counsel, a
5. Holding an in-person (if possible) meeting of the creator/inventors, patent counsel, a
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
nd company mangers in order to determine and decide what is or should be the broadest possible scope for the innovation in commercial and non-commercial terms; and to detail and characterize inventorship, the
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
number and types of commercial formats, kinds of variations, preferred embodiments and minimum essential parts, operation limits and optimal use ranges, and the like which are or might come to be within the de
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
fined limits of the innovation [Estimated Time 2- 3 hours; Cost: patent counsel @ $195.00 per hour & company time].
6. Preparation and submission to patent counsel of a complete and full written description o
6. Preparation and submission to patent counsel of a complete and full written description o
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 the innovation/invention prepared by the creators/inventors (in one or more documents) which provides sufficient technical detail, relevant drawings, useful background information, a listing of unexpected be
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
nefits and desirable advantages, and the relevant prior art for patent text purposes [Estimated Time: 8-24 hours; Cost: company time].
7. Preparation and distribution of a first draft text of the patent appli
7. Preparation and distribution of a first draft text of the patent appli
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
cation by patent counsel to the named inventors and designated company managers [Estimated Time: 30-35 hours; Cost: $195.00 per hour]
8. Review and substantive revision of the first draft patent application t
8. Review and substantive revision of the first draft patent application t
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
ext by the named inventors and designated company managers and return of the revised first draft text to patent counsel [Estimated Time: 5-10 hours; Cost: company time].
9. Preparation and distribution of a
9. Preparation and distribution of a
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
second (and presumably last) draft text of the patent application by patent counsel to the named inventors and designated company managers for final comments and changes to the text [Estimated Time: 10-14 hour
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
s; Cost: $195.00 per hour].
10. Receipt by patent counsel of final desired or needed changes to the patent application text from the named inventors and designated company managers and preparation of a fully
10. Receipt by patent counsel of final desired or needed changes to the patent application text from the named inventors and designated company managers and preparation of a fully
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
approved text ready to be submitted to the U. S. Patent Office [Estimated Time 2-4 hours; Cost: $195.00 per hour].
11. Preparation by patent counsel of required supporting formal documents and fee payments t
11. Preparation by patent counsel of required supporting formal documents and fee payments t
.
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
o accompany the fully approved patent application manuscript [Estimated Time: 2-3 hours; Cost: $195.00 per hour].
12. Submission, with or without prior signature by the named inventors, of the fully approved
12. Submission, with or without prior signature by the named inventors, of the fully approved
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
patent application manuscript, supporting formal documents and requisite fee payments to the U.S. Patent office and obtaining an official serial number and filing date sufficient for patent pending purposes.
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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