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Top Adding - Patenting - An Overview For New Inventors
If you are serious about an idea and want to see it turned into a fully fledged invention, it is essential to obtain some form of patent protection, at least to the 'patent pending' status. Without that, it is unwise to advertise or promote the idea, as it is easily stolen. More than that, businesses you approach will not take you seriously - as without the patent pending status your idea is just that - an idea.
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
1. When does an idea become an invention?
Whenever an idea becomes patentable it is referred to as an invention. In practice, this is not always clear-cut and may require external advice.
2. Do I have to discuss my invention idea with anyone ?
Yes, you do. Here are a few reasons why: first, in order to find out whether your idea is patentable or not, whether there is a similar invent
; 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
ion anywhere in the world, whether there is sufficient commercial potential in order to warrant the cost of patenting, finally, in order to prepare the patents themselves.
3. How can I safely discuss my ideas without the risk of losing them ?
This is a point where many would-be inventors stop short following up their idea, as it seems terribly complicated and full of dangers, not counting the cost a
3. How can I safely discuss my ideas without the risk of losing them ?
This is a point where many would-be inventors stop short following up their idea, as it seems terribly complicated and full of dangers, not counting the cost a
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
d trouble. There are two ways out: (i) by directly approaching a reputable patent attorney who, by the nature of his office, will keep your invention confidential. However, this is an expensive option. (ii) by approaching professionals dealing with invention promotion. While most reputable promotion companies/ persons will keep your confidence, it is best to insist on a Confidentiality Agreement, a legally binding
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
document, in which the person solemnly promises to keep your confidence in matters relating to your invention which were not known beforehand. This is a reasonably secure and cheap way out and, for financial reasons, it is the only way open to the majority of new inventors.
4. About the Confidentiality Agreement
The Confidentiality Agreement (or Non-Disclosure Agreement) is a legally binding agre
4. About the Confidentiality Agreement
The Confidentiality Agreement (or Non-Disclosure Agreement) is a legally binding agre
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
ment between two parties, where one party is the inventor or a delegate of the inventor, while the other party is a person or entity (such as a business) to whom the confidential information is imparted. Clearly, this form of agreement has only limited use, as it is not suitable for advertising or publicizing the invention, nor is it designed for that purpose. One other point to realize is that the Confidentiality
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
Agreement has no standard form or content, it is often drafted by the parties in question or acquired from other resources, such as the Internet. In a case of a dispute, the courts will honor such an agreement in most countries, provided they find that the wording and content of the agreement is legally acceptable.
5. When is an invention fit for patenting ?
There are two main aspects to this: fir
5. When is an invention fit for patenting ?
There are two main aspects to this: fir
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
st, your invention should have the necessary attributes for it to be patentable (e.g.: novelty, inventive step, potential usefulness, etc.), secondly, there should be a definite need for the idea and a probable market for taking up the invention.
6. About patents.
Patents are documents which publicly and fully disclose an invention and, if properly designed, will provide the inventor legal protectio
6. About patents.
Patents are documents which publicly and fully disclose an invention and, if properly designed, will provide the inventor legal protectio
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
against unauthorized use (note: a Confidentiality Agreement is a personal disclosure, while a patent is public disclosure). Patents can be bought and sold, so that the owner of a patent may not be the inventor. Also, it is possible to retain the patent while selling the right to use it. This is the meaning of the phrase : 'manufactured under license'.
The following are the main patent types:
• Provisional Pa
The following are the main patent types:
• Provisional Pa
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
tent Application
• Final (Utility) Patents
• Design Patents
• Plant Patents
• International Application *
* The so-called International Applications (or PCT applications) are applications for Utility Patents simultaneously in several countries. There are certain savings compared to making separate applications in taking out individual patents for the countries in question, but the result is
• Final (Utility) Patents
• Design Patents
• Plant Patents
• International Application *
* The so-called International Applications (or PCT applications) are applications for Utility Patents simultaneously in several countries. There are certain savings compared to making separate applications in taking out individual patents for the countries in question, but the result is
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
the same, the applicant ends up with individual patents for each of the countries in question and has to pay the individual patenting and renewal fees. There is no such thing as an International Patent
A few of the above patent types will be briefly discussed:
7. What is a Provisional Patent?
It is a simplified version of a final (or Utility) patent and offers you complete international priority prot
7. What is a Provisional Patent?
It is a simplified version of a final (or Utility) patent and offers you complete international priority prot
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
ection for 1 year. After that, you must proceed to the final patent, or you will lose the protection gained from the Provisional. The Provisional Specification is the cheapest form of total legal protection around the world and was designed with starting-out inventors in mind. An important aspect of a provisional patent is, that on lodging it with a patent office it will stay 'dormant' and will not be examined un
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
til there is a legal challenge, e.g.: someone patents a similar invention and there is doubt which of the two were first. Here is an important point: on examining the two patent documents, it sometimes happens that the earliest applicant loses out due to the poor way his Provisional is written. While it is perfectly legal to write and lodge your own patents in order to save on the cost of preparing it (you would st
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
ll have to pay a lodgment fee), it is generally a very foolish thing to do, as you will not be sure whether your invention is protected or not. This goes for both Provisional and Final patents. While it is not essential to lodge a provisional specification, as you are entitled to go for the final patent straight away, this is not usually recommended.
The advantages of this type of patent procedure are as follows:
The advantages of this type of patent procedure are as follows:
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
(i) a provisional specification allows you to modify it within the one-year period, without affecting its validity. This is very convenient as it allows one to protect the invention while it is still developing. This is not possible with the final patent.
(ii) the Provisional Patent Application provides priority protection Internationally for one year, this aspect is superior to other types of patenting w
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
ich only apply for a specific country.
(iii) the provisional patent application allows for a 'breathing space' - a full year to look around for a potential backer, someone who may even be prepared to pay for the final patenting.
(iv) There are considerable savings, as the Provisional Patent Application costs 10 to 12 times less than other forms of patenting.
When contemplating this form of patenting, i
(iii) the provisional patent application allows for a 'breathing space' - a full year to look around for a potential backer, someone who may even be prepared to pay for the final patenting.
(iv) There are considerable savings, as the Provisional Patent Application costs 10 to 12 times less than other forms of patenting.
When contemplating this form of patenting, i
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
t is advisable to turn to agencies experienced in this type of procedure (for instance http://www.newinvent.com)
8. About the Final Patent (‘Utility Patent’)
This is the final unchangeable form of your invention. Most usually, it will have a formal structure involving such things as background literature, disclosure of invention, claims, embodiments, practical examples for use, detailed figures and draw
8. About the Final Patent (‘Utility Patent’)
This is the final unchangeable form of your invention. Most usually, it will have a formal structure involving such things as background literature, disclosure of invention, claims, embodiments, practical examples for use, detailed figures and draw
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ings, etc. It will protect your invention for 20 years from the date of filing and you will get a formal Patent Document once it has been fully examined and accepted. Usually, it takes from 12 to 18 months to obtain a final patent after application. It is approximately 10 to 12 times as expensive to prepare as a provisional patent and has to be taken out for each country separately, which makes it a very expensive
.
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
rocess, as lodgment fees must be paid in each case. It becomes especially expensive if protection is sought. In more then one country. Therefore, a final patent should only be taken out where it is highly warranted, e.g.: when someone wants to develop your invention and would like to buy the patent rights.
9. Following the Patent Procedure
After a patent protection was obtained, whether in the f
9. Following the Patent Procedure
After a patent protection was obtained, whether in the f
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
orm of a Utility Patent or a Provisional Patent Application, it is advisable to advertise it as widely as possible in order to make it stand out from the large body of currently valid patented inventions (some 50 million at present). The web site “Patent Showcase” as well as other agencies specialize in this and will be able to advise once this matter comes up.
Author: Dr. Stephen G. Szirmai
ivnet@yahoo.co
Author: Dr. Stephen G. Szirmai
ivnet@yahoo.co
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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