Top Articles

Licensing is a key business strategy. It's a way to maximize the earnings from inventions and creative works, which are called intellectual property or "IP.".

What is licensing?

Licensing is when you grant some rights to intellectucal property "IP" that you

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

own. It is really a partnership of mutual cooperation between the licensor, who owns the IP, and the licensee, who is given the right to use it for certain purposes.

Question: What are royalties?

Royalties are a way of calculating compensation for use of int

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

llectual property. The licensee is granted the right to use it for a royalty. Royalties are usually based on a percentage of the revenues that are generated. For instance, if I license my course to a company and say, “For every subsequent use of this course,

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

I get 5% of the revenue,” that’s the royalty — 5% of the revenue would be the royalty/payment that I would receive.

Question: Are there rules of thumb for royalty amounts?

Figuring out what royalty to ask for is always a challenge. As sort of a really rough

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

rule of thumb, the allocation of the revenue generated can be 25% for the licensor and 75% for the licensee. This is because the licensee is usually doing all the sales and marketing related to generating revenue. It varies greatly from industry to industry.

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

Question: What are some examples of the types of works that can be licensed?

Many types of IP can be licensed. For example, copyright-protected works, trademarks, and patented inventions can be licensed. Materials and know-how may be licensed and generate

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

dditional income. Other examples include images, photographs, music, a recording – on any kind of media.

It’s very difficult to license something that has not been reduced to writing or some kind of tangible form. Just trying to license “know-how,” for insta

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

nce, is very difficult. Someone could have a lot of expertise, but unless they turn it into something concrete or tangible, it’s difficult to license it.

Question: What are the pitfalls of licensing?

A classic pitfall is that the licensee does not pay royal

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ies. The licensor gives rights to a licensee and the licensee doesn’t do anything with them. So the licensor’s IP rights are tied up in the license agreement, but the licensor isn’t getting any money for the IP. I recommend that a licensee be required to pay

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

at least a “minimum” royalty or forfeit the license. That way, the licensor is guaranteed a certain level of revenue. That’s also motivating for licensees because they’re going to have to pay that money in order to keep the license, so they’re going to focus

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

n using your IP.

Another pitfall is granting an exclusive license, or giving away way too many rights. The scope of the license grant is extremely important. For example, one situation that I’m familiar with involved a patent for a chemical process. It was

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

licensed to a very large pharmaceutical company. But in that license, we were very careful to limit it to medical applications. We turned around two years later and licensed that same patent to a paint company. Had we granted all the rights in the first lice

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

se, we wouldn’t have been able to do the second licensing agreement, which was a very different market and a very different application.

Question: What if I want to use someone else’s work?

Using someone else’s work is sometimes called “licensing in.” That’

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

a very good business strategy as well. Why recreate the wheel if you can use materials that are out there or content that’s already been created? Usually, what I suggest is that you approach the owner of the IP and say, “I’d like permission to use some of yo

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

ur materials,” and you negotiate an agreement.

It’s OK to use other people’s works (without payment) if the work is in the public domain or if the use is considered to be within the “fair use doctrine.” (See enews archives for further discussion).

Question:

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

What if someone copies my work?

Registering copyrights is an important step. If an infringement occurs after the copyright is registered, you can recover statutory damages per infringement and attorney fees. If an infringement occurs prior to registration, y

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

u can only recover actual damages, which are extremely difficult to prove.

Question: What is a territory?

Licensors try to specify territories for authorized use. Say, for instance, you have a way to fix cars and you were going to deliver a training program

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

and it required on-site training to show people how to do this particular type of repair – fix the paint or fix the dents. That’s a service that would probably be delivered in person, so it makes sense to carve that up geographically.

But, if you market on 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

e Internet, it’s really hard to specify a geographic territory. For example, if you’re developing an e-learning kind of program and it is going to be marketed over the Internet, then it’s very difficult to restrict geographies, just because you could have pote

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

tial customers coming from anywhere in the world.

In conclusion, these are just a few of the frequently asked questions about licensing. Licensing is a great way to generate revenue from IP. Is licensing a strategy that you want to explore for 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

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/130180/toparticles-FAQs--Licensing-Intellectual-Property-IP.html">FAQs - Licensing Intellectual Property (IP)</a>

BB link (for phorums):
[url=http://www.toparticles.org.ua/article/130180/toparticles-FAQs--Licensing-Intellectual-Property-IP.html]FAQs - Licensing Intellectual Property (IP)[/url]

EMBROIDERING ON WOMEN'S APPAREL
Women represent more than 50 percent of the workforce today and are taking their place in upper level management positions in growing numbers. As women advance in the business world, promotional apparel is reflecting that move. The “unisex” treatment of promotional garments, using the same standard grade rules for both men’s and women’s sizing, is being replaced with designs sized to fit that make a fashion statement appropriate for each gender. With this evolution, women’s promotional business apparel can be an interesting and welcome addition to a woman’s wardrobe rather than a functional waste of billions of business dollars.

Here’s a resume benefit that most resumes – even professionally written ones – don’t have: a description blurb for your employers. Unless it’s Macy’s, UPS, IBM or a similar company, the company names on your resume mean nothing. Here’s why it works in your favor to include a blurb.

Ten ways you can improve the usability and look of your blog's comments section.

Tags

Links

Top Articles - FAQs - Licensing Intellectual Property (IP)

Related Articles: