Actual - Legal

The Government of India has met the December 31 deadline for complying with its obli

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

gation to World Trade Organisation (WTO) under TRIPs agreement, by promulgating an O

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

Examples of combination products may in

rdinance – The Patent (Amendment) Ordinance, 2004 followed by the Act – Patent (Amen

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

dment) Act, 2005.

Under TRIPS, India was required to introduce product patent where

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

only process patent was permitted. Procedural changes were also required to be made

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

Combination pro

as per Patent Co-operation Treaty (PCT). The new Act ensures adequate safeguards ag

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

ainst misuse of patent rights and vests enough power with the Government to interven

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

and ensure that patented inventions are available for the public at an affordable p

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

rice.

In nutshell, the most important changes are:

· Product Patent can be issued

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

in respect of food, drugs and chemicals. Provisions of 'process patent' for these go

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

ods abolished.

· Provisions in respect of EMR (Exclusive Marketing Rights) abolishe

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

Following aspects would a

d.

· Computer software per se is not patentable, but in combination with or embedde

dd to the challenges in developing combination products:

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

d in hardware is patentable.

· Provision of 'acceptance of specification' and its a

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

dvertisement have been deleted.

· Provision for pre-grant and post-grant opposition

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

to the granting of a patent.

· Application for patent will be published in Official

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

Journal. At that time opposition can be made on limited grounds but hearing is not

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

Professional from academic institutions, pharmaceutical industries, health care indust

mandatory.

· After grant of patent, opposition can be made within 12 months.

· Pro

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

vision of sealing of patent omitted.

· Provision for acquisition of patent for publ

.

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

ic health purposes.

· Suit for infringement of patent cannot commence before date o

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

Companies that provide selfless information through particip

f publication of publication of the application.

· Penalties enhanced substantially

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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