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Top Articles - How to Work With Your Intellectual Property Lawyer
In many small businesses, intellectual property is an overlooked asset. The goodwill from your company name, computer programs you have written, articles, manuals, or books that you have written, logos, advertisi
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
ng copy, methods you have used or processes to create your products or services, all should be closely examined in conjunction with a qualified intellectual property attorney, to decide how much value they are to
; 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
our business, and how they should be properly protected.
There are many different disciplines under which your intellectual property can be protected. These include copyright, trademark, trade secret, method pat
There are many different disciplines under which your intellectual property can be protected. These include copyright, trademark, trade secret, method pat
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ents, design patents, product patents, and others. You can also consult with your intellectual property attorney to decide whether or not to extend your intellectual property protection world wide, or just keep i
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
national.
If your business could be impacted by competitors copying your name, your logo, your products, your services, or anything else integral to your business' success, you owe it to yourself, your employees
If your business could be impacted by competitors copying your name, your logo, your products, your services, or anything else integral to your business' success, you owe it to yourself, your employees
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
and your shareholders to protect it in the strongest way possible. Fine yourself a good intellectual property attorney with specific knowledge of your particular business genre who can help you "lock down" your i
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
nvestment.
What Should You Look For in an Intellectual Property Attorney?
Intellectual property is a field in which an attorney has to know not only the law, but must also have a sense about the potential client
What Should You Look For in an Intellectual Property Attorney?
Intellectual property is a field in which an attorney has to know not only the law, but must also have a sense about the potential client
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
s business goals, practices, and ethical stance. These elements are not always obvious, so it is in the client's best interest to inquire in an initial interview not only how long s/he has been practicing this pa
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ticular type of law, but also what type of businesses the intellectual property attorney has had experience with, as well as how "gung ho" the attorney is. For example, if your business wishes to take a balanced
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
view of protection, going after only infringers that you feel are causing serious damage, if your intellectual property attorney delights in dropping nuclear bomb style threat letters on indigent college students
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nd little old ladies, perhaps you would do better with an attorney more in line with your personal ethical structure.
Other things to look for in an attorney include whether or not your personal communications st
Other things to look for in an attorney include whether or not your personal communications st
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
le meshes with that of the intellectual property lawyer. A good example is email communication. Email, for many business owners, is a much more efficient and usually cheaper method of communication. As an added
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
bonus, you have a written record of the exchange in case of later misunderstanding. If your business runs on email contact and your attorney uses pen and paper, this may not work out in your best interests.
Onc
Onc
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
You Find an Intellectual Property Attorney, Then What?
What do you do once you've found your intellectual property attorney? Communicate clearly what your objectives are and let the attorney make suggestions to
What do you do once you've found your intellectual property attorney? Communicate clearly what your objectives are and let the attorney make suggestions to
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
you as to how to reach those objectives. Intellectual property law is often highly complex and legally technical. If you have questions, ask the intellectual property attorney. If they don't communicate with yo
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
u, their client, in clear English terms, ask them to. Oftentimes, lawyers forget that they are dealing with non-lawyers and may fall back on legal jargon. If they can't explain concepts to you in a way you under
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
tand, perhaps you should find an attorney who will.
On the other hand, you should not expect your intellectual property lawyer to boil 3 years of law school and decades of experience into a fifteen minute "Cliff
On the other hand, you should not expect your intellectual property lawyer to boil 3 years of law school and decades of experience into a fifteen minute "Cliff
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
otes" summary. As with all things, finding a balance where both of you are comfortable is of great importance.
As a legal client, do not forget that you are in the driver's seat. Your intellectual property atto
As a legal client, do not forget that you are in the driver's seat. Your intellectual property atto
.
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
rney can't make business decisions for you. You must weigh his or her advice carefully, then make your decisions as an informed consumer of legal services. Your decisions should feel "right" to you. Insist that
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
your intellectual property lawyer lay out the scenario to you and give you appropriate cost estimates, time estimates, and how the attorney thinks that this action (or inaction) will be of benefit to your business
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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