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In the case of Unilin Beheer BV v Berry Floor NV & Ors, Information Management Consultancy Ltd, B&Q plc (2005), the courts ruled that the fau

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

lty drafting of a patent application did not amount to lack of reasonable care and skill.

Unilin, the claimant, applied for a patent for a f

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

Examples of combination products may in

oor covering and the application succeeded. Unilin then became aware of prior art which made it necessary for it to amend the patent applica

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

ion by reducing the scope of the main claim. Unilin also amended the body of the specification so that the text and drawings conformed to the

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

main claim.

After grant of the patent, Unilin sued three defendants for patent infringement. The defendants counterclaimed, arguing that a p

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

Combination pro

ece of prior art (Yoichi) had not been cited against the patent.

On 26 September 2003, the court held that Claims 1-19 of the patent were in

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

valid in respect of the prior art Yoichi but Claims 20 and 21 were valid and infringed by the defendant. Unilin claimed damages for past infr

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

ngements and costs.

The defendants contended that Unilin could not claim damages by way of s.63 (2) of the Patents Act 1977 whereby a court

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

annot grant any relief if a patent is only partially valid unless it is proven that the patent was framed in good faith and with reasonable c

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

re and skill. The defendants argued that Unilin did not frame the patent with reasonable care and skill.

Unilin’s patent contained a limitat

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

on that the floor covering panels substantially consist of HDF or MDF board and that there should be a snap together connection. These limita

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

Following aspects would a

tions were not essential when the patent was first applied for, so the amendments that Unilin made were to make MDF/HDF and snap-fit essentia

dd to the challenges in developing combination products:

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

. Unilin also amended the description so it conformed to the amended claim. The defendants said that Unilin failed to exercise reasonable car

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

and skill in amending the description.

The Court of Appeal held that:

▪ the specification as a whole was drafted with reasonable

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

are and skill;

▪ if there was some irrelevant but harmless information in the specification this did not mean it was not drafted wi

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

hout reasonable care and skill; and

▪ the specifications were not misleading.

The appeal was therefore dismissed and Unilin and it

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

Professional from academic institutions, pharmaceutical industries, health care indust

was ruled that would be paid damages and costs.

Comment: Please contact us for more information on applying for a patent.

Email: enquiries

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

rtcoopers.com

Visit http://www.rtcoopersiplaw.com or http://www.rtcoopers.com/practice_intellectualproperty.php

© RT COOPERS, 2005. This Br

.

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

efing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal ad

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

Companies that provide selfless information through particip

ice. 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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