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The case of Celem SA and Another v Alcon Electronics PVT Ltd [2006] concerned jurisdictional issues relating to pa

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

tent infringement. The claimant companies were engaged in the manufacture of components for the electrical inducti

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

Examples of combination products may in

n heating market, and were the holders of a European patent in relation to certain capacitors.

The defendant was

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

n Indian company also engaged in the manufacture of products for the electrical induction heating market. The clai

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

ants had alleged various breaches of their UK intellectual property rights by the defendant. They argued that the

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

Combination pro

manufacture of certain capacitors by the defendants infringed the UK patent. Furthermore, the claimants' particula

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

s of claims made numerous allegations in relation to the importation and distribution of the infringing articles w

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

thin the United Kingdom.

The claimants were granted permission to serve their proceedings on the defendant in Ind

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

a. The defendant made an application which challenged the jurisdiction of the English courts. As a result, two que

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

stions fell to be determined:

- Whether there was a serious issue to be tried; and

- If so, whether the cour

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

had been right to exercise its discretion in accepting jurisdiction.

The application was dismissed.

In the inst

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

Following aspects would a

nt case, the documentary evidence connected to the parties had demonstrated a number of serious issues to be tried

dd to the challenges in developing combination products:

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

in relation to the alleged infringements occurring within the United Kingdom. In addition, given the Indian court'

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

s reluctance to entertain a claim which sought to protect UK intellectual property rights, it appeared that the on

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

y forum in which the claimants could protect those rights was the English courts.

In those circumstances, it was

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

eld that the court had been right to exercise its discretion in accepting jurisdiction.

If you require further in

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

Professional from academic institutions, pharmaceutical industries, health care indust

ormation contact us at enquiries@rtcoopers.com

Visit http://www.rtcoopersiplaw.com or http://www.rtcoopers.com/pr

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

.

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

e statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended only t

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

Companies that provide selfless information through particip

highlight general issues. Specialist legal advice should always be sought in relation to particular circumstances

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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