Top Adding - Legal

The different types of patents are provisional patents, utility patents, plant patents

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

and design patents.

Provisional Patents (PP)

A provisional patent applicat

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

Examples of combination products may in

on (PPA) allows filing without a formal patent claim. It establishes a filing date fo

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

you. So, if you have an idea, and if you do not have the time and resources needed for f

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

ling a patent, you can go for a provisional patent. This will establish your date of appli

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

Combination pro

ation. Beware though - the actual patent should not differ significantly from the provisi

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

nal patent description.

Utility Patents

Utility patents are the most comm

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

on types of patents. They are usually valid for around twenty years, except in the case of

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

drugs, medical devices, etc.

Plant Patents

Plant patents can be taken fo

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

the plant varieties which have been asexually reproduced. These patents may include mutan

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

s, hybrids, seedlings, etc. They are also valid for around 20 years.

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

Following aspects would a

Design patents refer to new original ornamental design for an article to be man
dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod
factured. The USPTO definition follows:

“A design consists of the visual ornamental chara
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
teristics embodied in, or applied to, an article of manufacture. Since a design is manifes
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
ted in appearance, the subject matter of a design patent application may relate to the con
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
iguration or shape of an article, to the surface ornamentation applied to an article, or t
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
the combination of configuration and surface ornamentation. A design for surface ornament
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tion is inseparable from the article to which it is applied and cannot exist alone. It mus
.

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
be a definite pattern of surface ornamentation, applied to an article of manufacture.”

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

Companies that provide selfless information through particip
ease send your feedback to: info at intellectualvillage.com - we will really appreciate it

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

Tags

Links

Top Adding - What Are The Different Types Of Patents?

Related Articles: