Answers - Legal

In the case of Bolton Pharmaceutical Co 100 Limited -v- Swinghope Limited and Others [2005], the claimant was the new owner of a trade mark registered in respect

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

of a pharmaceutical product which was commonly used to treat hypertension. It acquired the product from AZ, another pharmaceutical company, in September 2004, who

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

Examples of combination products may in

had previously sold its trade mark rights to a Spanish company.

The claimant acquired the trade mark in the United Kingdom, and later realised that the product w

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

as being imported into the UK by certain third parties, including the defendant, and bearing its trade mark. They had not sought the claimant's consent and the cl

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

imant therefore commenced proceedings alleging that the defendants were illegally impinging on its market and as a result, they were causing the claimant 'harm'.

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

Combination pro

The claimant applied for summary judgment.

The defendants argued that:

The doctrine of exhaustion of rights applied, which provided that where a product had bee

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

put on the market in a member state by the trade mark owner or with his consent, there could be no question of infringement of that mark; and

Estoppel applied,

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

on the basis that the claimant had failed to assert his rights under the trade mark in the preceding five months. The court held that the claimant's application

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

for summary judgment would be allowed on the grounds that:

"For the doctrine of exhaustion of rights to apply, the owner of the rights in an importing state had

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

to be able to determine the products to which the mark might be applied in the exporting state and to be able to control the quality of the product. That power wo

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

ld be lost if, as the result of an assignment, control over the trade mark was surrendered to a third party which was not economically linked to the assignor. In

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

Following aspects would a

this case, there was no evidence to support the claim that AZ was linked to either the claimant, or that the claimant and T were linked".

It followed therefore t

dd to the challenges in developing combination products:

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

at any defence based on the doctrine of the exhaustion of rights had no real prospect of succeeding1.

The defendant's argument that estoppel should bar the claim

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

ant from obtaining the relief sought, was inconsistent with section 10(4) Trade Marks Act 1994, which imposes strict liability for trade mark infringement. The co

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

rt went on to find that the defendant's argument was inconsistent with the law of acquiescence, which provides that in order for estoppel to apply the claimant mu

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

st have carried out some act or omission, beyond mere delay in commencing proceedings, which would have led the defendant to reasonably believe that the claimant

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

Professional from academic institutions, pharmaceutical industries, health care indust

ould not enforce its rights under the trade mark. On this reasoning, the defence had no real prospect of success. The claimant was granted the relief sought.

T

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

his is the test that must be satisfied in order for an applicant to obtain a summary judgment.

If you require further information contact us.

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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

coopers.com

© RT COOPERS, 2005. This Briefing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it

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

Companies that provide selfless information through particip

constitute legal advice. It is intended only to 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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