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  • Actual - Patents & Inventions: So You Have An Idea -- So What?

    Okay, you have come up with a fantastic idea that will solve all the woes of the universe - or at least make you $millions$ - what do you do? How do you start?

    Well, the first thing to do is get all your ducks in a row. Start a hard-bound journal and put everything in writing. Draw pictures or diagrams of how your invention works. Date and sign each page, and get someone you trust to look at it and date and sign too.

    Then, get ready to spend some m
    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
    oney. Sorry, but it takes money to get things going. If your idea is worth anything - which you can find out through the process - you should file for a patent.

    A patent gives you 20 years from the filing date the right to keep others from making or selling your invention without your permission. That gives you time to develop and sell your invention in the marketplace. Believe me or not, getting the patent may be the easiest part. About 99% is in
    ; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

    Examples of combination products may in
    the development and marketing of the idea.

    To get a patent it is best to find a registered patent attorney or agent. I know, attorneys are sharks. But in this case, their knowledge will get through the government bureaucracy a lot faster and easier than you can by yourself.

    To give you an idea of what you are going to face when getting into the patent process, here are some FAQ’s to help you understand better - maybe.

    PATENT FAQ’s

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

    the terms “patent pending” and “patent applied for” mean?

    A: They are used by the inventor - or his manufacturer or seller of his product - to inform the public that a patent application has been filed with the Patent and Trademark Office (“USPTO”). You can be fined if you use these terms falsely and deceive the public.

    Q: Is there any danger that the USPTO will give others information contained in my patent application while it is pending?

    A: No.
    here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
    All patent applications are kept in strictest secrecy until the patent is issued. After the patent is issued your file is made available in the USPTO Files Information Room for inspection by anyone and copies of the files may be purchased from the USPTO. (The Files Information Room is where searchers go to prepare their patent searches - which are needed to complete a patent application)

    Q: May I write directly to the USPTO about my application afte
    d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

    Combination pro
    it is filed?

    A: The USPTO will answer questions regarding the status of the application, whether it has been rejected, allowed, or pending action. BUT, if you have an attorney representing you, the Office will not correspond with both of you. The best practice is for all comments be forwarded through your attorney. Another thing - it can take some time before your application will be assigned to an examiner, and what is called an “office action” w
    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
    ill happen. Patience is needed.

    Q: Do you actually have to go to the USPTO to do business with them?

    No. Most business with the USPTO is done in writing and through correspondence. Interviews with Examiners are sometimes necessary (and sometimes helpful) but a lot of them are done by phone by your attorney. The expense of a trip to D. C. is seldom necessary.

    Q: If two or more persons work together to make an invention, who gets the patent?

    A: I
    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
    f each person had a share in the ideas forming the invention, they are considered joint inventors and a patent will be issued jointly if they make it through the application process. BUT, if one person provided all the ideas for the invention - and the other person(s) has only followed instructions in making the invention, the person with the ideas would be considered the sole inventor - meaning the patent application and the patent itself shall be in
    nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
    is/her name alone.

    Q: What if one person supplies all the ideas to make an invention - and another person either employs him and/or comes up with the money to build and test the invention - should the patent application be filed jointly?

    A: NO. The application MUST be signed by the TRUE INVENTOR - and filed with the USPTO in the true inventor’s name. This is one time money doesn’t count. It is the person with the ideas - not the employer - not 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
    money man - that gets the patent. If the greedy, blood-sucking, viperous, money-grubbing, creatively non- contributing money man or boss wants any part of the invention, he would have to get his hold through a contract or license on the invention - not the patent itself.

    Q: Does the USPTO control the fees charged by patent attorneys and agents for their services?

    A: No. This is strictly a matter between you and the attorney or agent. Fees vary - a
    ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
    do attorneys and agents. You should feel comfortable with your choice. It would be best to ask up front for estimates on charges for: (a) a patent search; (b) The preparation of a patent application; (c) drawings to accompany the application; and, (d) the prosecution of the application before the USPTO. (NOTE: an attorney can only give you estimates. The cost of a search, and the application with drawings is pretty well determinable up fro
    ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

    Following aspects would a
    nt. But the prosecution step depends on the Examiner and what he does and doesn’t like about your application. There may be amendments that have to be made (expect at least one), and negotiations to transpire, which all take time and effort from the attorney)

    Q: Will the USPTO help me pick an attorney or agent to do my search or prepare my application?

    A: No. The USPTO cannot make this choice for you. The Office does maintain a list of registere
    dd to the challenges in developing combination products:

    Which markets to tap where the combination products can do fairly well?
    Which combination prod
    d attorneys and agents. Also some bar associations have lawyer referral services that may help you. If you have a general attorney, although he can’t help you directly if he isn’t a registered attorney with the USPTO, he may help you with a referral.

    Q: Will the USPTO advise me about whether or not a certain promotion firm is reliable and trustworthy?

    A: No. The USPTO has no direct control over such organizations. While the USPTO does not invest
    cts are meaningful and rational?
    Which therapeutic categories to select?
    Which Combinations can address unmet needs of the patients?
    Do combin
    gate complaints about invention promoters or promotion firms - or get involved in any legal proceedings relating to such firms - there is a public forum to publish complaints against such firms. The protections you have from patent promotion firms is spelled out in laws passed in 1999. These promotion firms have specific duties of disclosure under this act. [See http://www.gadgets-gizmos- inventions.com for more info]

    Q: Are there any organizations
    tions increase the patient compliance?
    What would be the developing cost?
    How to tackle the risks encountered during combination product developmen
    that can tell me how and where I may be able to get some assistance in developing and marketing my invention?

    A: Yes. Organizations in your community - such as Chambers of Commerce and banks - may be able to help. Many communities have locally financed “business incubators” or industrial development organizations that can help you locate manufacturers and vulture (I mean Venture) capitalists that might be interested in helping you. Do your homework
    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
    - check, check, check - and be careful. Q: Are there any state government agencies that can help in developing and marketing my invention?

    A: Yes. Nearly all states have state planning and development agencies or departments of commerce and industry that seek new products and articles to manufacture, or processes to assist existing manufacturers and communities in the state. A lot of these agencies are online - or at least have listings in telephone
    ping new procedures for reviewing their safety, efficacy and quality.

    Professional from academic institutions, pharmaceutical industries, health care indust
    books. If all else fails - write your state governor’s office.

    Q: Can the USPTO help me in developing and marketing my invention?

    A: No. the USPTO cannot act or advise concerning any business transactions or arrangements that are involved in the development and marketing of an invention. They will publish the fact that your patent is available for licensing or sale in the Official Gazette - at your request and for a fee.

    Q: How do I start?

    A:
    y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
    First, of course, you have to have an idea. Then that idea has to be put down in a form so that it can be understood at least by a person that is experienced in the field of endeavor that concerns the invention. This usually is a written description and a drawing. Whatever it takes to explain the invention.

    The next step is a patent search - to see if someone else has come up with a similar idea. A lot of times this is the case. And, a lot of times
    .

    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
    your idea may be enough of an improvement to be unique enough for a new patent. There are search firms available - and most patent attorneys have access to their own favorites. It is best to commit only to the patent search at first. Do not sign a contract for anything else just in case the search finds your invention with no way to find “novelty” and “non- obviousness.”

    If the search report looks good (watch out for the hype artists), it is time for
    elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

    Companies that provide selfless information through particip
    commitment. Choose your attorney and let it fly.

    It is possible to file a patent application by yourself - but really - it is like you going into a restaurant in Paris, France that is, and trying to order from the menu. unless you know and speak the language, you won’t get what you want. In the case of a patent, the USPTO will throw you out - even if your invention is great - because the application does not speak their language.

    © 2006 Gary Cogle


    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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