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A patent is a right granted to an individual or group (such as a company) which permits the grantee the knack to avoid others from making, using, or selling the invention, for a fixed period of time in exch

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

ange for the regulated, public disclosure of certain details of a device, method, process or composition of matter (substance) (known as an invention) which is new, inventive, and useful or industrially app

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

Examples of combination products may in

licable.

Patents by their techno-legal nature are written in a specific format, thus enabling it difficult to read and understand by a lay man. The focus of this paper is to provide very basic informat

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

ion of a patent document, so that a lay man can easily understand a patent.

There are three main types of patents:

Utility patents: are patents on invention

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

which function in a new way or to provide a new result

Design patents: is a patent on the aesthetic design or ornamentation of something that already exists. A design patent is grant

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

Combination pro

ed when the design in question does not change the functionality of the object, only gives it a novel appearance. Design patents primarily contain drawings

Plant patents: are patents

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

on types of plants that may be reproduced by grafts and cuttings. Note that patents related to genetic engineering of plants are normally considered utility patents.

Utility patents are the most common

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

type of patents, and are what people in general indicate when they just say "patent."

Parts of a patent document

Patents with their techno-legal nature are written in a standard f

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

ormat. A patent document contains following parts:

Bibliographic information

The front page of the patent bibliographic information including patent/publication number, inventor n

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

ame, the entity to whom patent rights are assigned (generally an inventor assigns a patent to his employer if the invention was conceived as part of his work for that employer), patent number, filing or app

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

ication date, date of issue, classes and subclasses under which the patent was classified, and the classes searched by the examiner during determination of novelty of the invention, abstract, representative

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

Following aspects would a

drawing and the title. Sometimes the front page also includes patents and non-patent. They can provide good leads for a patent search.

Description

The description possibly will conta

dd to the challenges in developing combination products:

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

in several parts, including:

Field of the invention: briefly describes the field of technology to which the patent is applicable and about invention.

Background of th

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

e invention: describes prior, similar inventions (patents and research publications), and the problems which remained unresolved. It provides why this invention is new and useful and how it is able

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

to solve those problems.

Summary of the invention: describes the objective of the present invention

Brief description of the drawings: lists all the drawings that

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

are part of the patent, and

Detailed description: describes in very detail about exactly how the invention works, refers to each diagram, and repeatedly attempts to broaden the scope

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

Professional from academic institutions, pharmaceutical industries, health care indust

of the patent by suggesting other ways that the invention could be used or implemented other than just what is presented in the figures.

Claims
Claims in a patent are very import

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

nt section as it legally determines exactly what the patent covers and what it does not. Claims are critical, both for validity and clearance searches, and for writing a patent application.

Claims are

.

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

generally of two types “independent claims" and "dependent claims". Dependent claims are those that rely to a previous claim, and thereby may require that previous claim to be valid for themselves to be val

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

Companies that provide selfless information through particip

id. This is a very important concept in validity searches, where it is a common strategy to attempt to invalidate mainly the independent claims, to potentially invalidate the dependent claims in the process

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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