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One of the hot topics in the IP world today is IPC reform. Due to be published on 1 July 2005, and to come into effect on 1 Jan

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

uary 2006, the eighth version of the IPC classification system (also referred to as IPC 2006) may not seem radically different

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

Examples of combination products may in

from the previous IPC7, on first blush. But there are important benefits for patent searchers, attorneys, examiners and IP mana

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

er.

What is the IPC system?

The IPC classification system grew out of the Strasbourg Agreement of 1971 as an internati

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

onally acknowledged method of classifying patents for inventions, including published patent applications, utility models and u

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

Combination pro

tility certificates. Currently used in more than 100 countries as the major, or the only, form of classifying these documents,

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

he purpose of the IPC system is to group patent documents according to the technical field in which they lie, independent of bo

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

th language and terminology. As such, it is indispensable for retrieving patent documents to establish the novelty of an invent

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

ion, or to determine the state of the art in a particular field.

What is IPC reform?

The IPC classification system is

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

eriodically reviewed in order to improve the system and to take into account technical and electronic developments. The IPC ref

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

orm incorporates a number of key changes over and above the regular IPC revision. These include the addition of new entries (su

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

Following aspects would a

ch as ‘traditional herbal medicines’), and a new two-level structure. This new structure divides the system into a ‘Core’ level

dd to the challenges in developing combination products:

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

which satisfies the needs of small and medium-sized IP Offices, and an ‘Advanced’ level for those providing and searching larg

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

er patent collections. The rules, purpose and structure of the IPC symbols used for searching will not fundamentally change in

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

the new edition, but the IPC will be more responsive to keep track of, and up with, recent explosions in technology.

Patent cl

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

ssifications (previous, current, and future) for those patents occurring in the major patent collections, ‘PCT Minimum Document

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

Professional from academic institutions, pharmaceutical industries, health care indust

ation’, will be kept up-to-date with the latest edition of the IPC. Searchers will no longer need to use different versions of

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

the IPC to ensure a full coverage search of the major patent collections. Classifications will be maintained in a Master Classi

.

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

ication Database (MCD) that will be accessible via esp@cenet. Finally, over time, useful background data will be added to a new

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

Companies that provide selfless information through particip

‘electronic layer’, containing supplementary online information, to help you search the IPC system effectively and efficiently

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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