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Patent family is a group of patents which, are all related to each other, in this case by way of the priority or priorities of a particular patent do

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

cument. Since patents protection is territorial, thus if a company or an individual that wants to protect its invention in a particular or multiple c

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

Examples of combination products may in

ountries must apply for patent protection in those countries -- either by filing national patent applications, or by making the application via one o

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

f the multi-national routes (EP or PCT application).

The Paris convention for the protection of Intellectual Property in 1883 directs that:

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

bsequent filing must be made within 1 year (6 months for design patents), to seek protection back to the priority application date.

Subsequent

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

Combination pro

filing will include the priority application number and date, in addition to the new filing application number and date.

The earliest publicati

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 (generally a published application) for public inspection will be 18 months from the priority date.

All publications related by a common pri

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

ority number are defines as equivalents and members of a closely related patent family. In some case more complex relationships between publications

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

can exits. This results in multiple, but related priority application from other countries or from divisions, continuations or continuations in part.

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

Differences in the patent families

STN: The Patent family information from CAplus, WPINDEX and INPADOC files of

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

STN is very comprehensive. Difference may occur based on country courage, patent kind codes coverage, and timing of file updates. But these also are

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

Following aspects would a

not very accurate, as we have checked for few patents and compared the information from specific country registry database. Especially EP register is

dd to the challenges in developing combination products:

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

most updates.

INPADOC: INPADOC patent family is defined as comprising all the documents sharing directly or indirectly (e.g. via a

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

third document) at least one priority. This includes all the patent documents resulting from a patent application submitted as a first filing with a

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

patent office and from the same patent application filed within the priority year with a patent office in any other country.

Derwent
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
g>: Derwent patent family uses other mechanism, they gathers all of the patent documents relating to an invention into a single database record. In g
ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust
eneral, one record in Derwent WPI (Files 350/351/352) on Dialog represents one invention and shows you all the patent documents that Derwent has coll
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ected relating to that invention.

In conclusion, presently there is not a single platform and mechanism for gathering patent families. Best source i
.

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
s the individual country registry database, but most of the countries don’t have online access to these registry system. Thus a patent professional,
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip
must have to consult individual patent database to get more accurate patent family and legal status information, before making any critical decision.

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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