Actual - Legal

The case of KK Sony Computer Entertainment and Another v Pacific Game Technology (Holding) Ltd [2006], concerned the infringement of copyright in comp

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

uter games systems under the name of ‘PlayStation’. The first claimant was a Japanese company and the second claimant was its UK subsidiary. Both clai

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

Examples of combination products may in

mants were corporate incarnations of the well known Japanese electronics group, Sony.

One of Sony's products was the latest version of its highly suc

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

cessful family of computer game systems marketed under the name 'PlayStation' which the second claimant marketed and sold in over 100 countries, inclu

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

ing countries within the European Economic Area (“EEA”). In respect of those computer game systems Sony owned:

§ Five Community trade marks;

§ O

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

Combination pro

ne UK registered trade mark (those registrations included the word 'PlayStation');

§ Two registered designs (those being a UK registered design and

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

a Community registered design); and

§ Several copyright works (including the computer program, the menu icons, the surface design of the box and t

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

he user manual).

The defendant was a company incorporated in Hong Kong which operated a website, www.lik-sang.com. The website had been set up to off

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

r for sale a variety of commercial video games, consoles and accessories for playing music, video games and such items. The defendant also marketed an

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

d offered for sale from its website portable consoles (PSP consoles) and related games, movies and accessories.

The PSP consoles so offered were genu

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

ine products made by Sony for sale within the Japanese market only. The claimants' case was that by targeting customers in the EEA, in particular, the

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

Following aspects would a

UK, the defendant had infringed Sony's intellectual property rights associated with the PSP consoles. They also submitted that the intellectual prope

dd to the challenges in developing combination products:

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

ty rights in the items associated with the PSP (such as the packaging) had also been infringed. They sought appropriate injunctions, delivery up, disc

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

losure of names, and an enquiry as to damages, or in the alternative, an account of profits and costs.

Following an unsuccessful application by the d

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

efendant for the court to decline to exercise its jurisdiction, the action continued undefended. The issues to be considered before the court were:

§

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

Whether the claimants had consented to have the relevant products sold in the EEA; and

§ Whether by offering the goods for sale on its website,

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

Professional from academic institutions, pharmaceutical industries, health care indust

he defendant had fallen within any of the acts which gave rise to infringement under the relevant statute.

The application was allowed. The acts com

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

plained of had been perpetrated not in Hong Kong, but in the EEA, and without Sony's consent. Were these acts, complained of, committed physically wit

.

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

hin the EEA they would have been infringing acts. The electronic intermediary of a website which focussed at least in part on the EEA could not make t

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

Companies that provide selfless information through particip

hem any less so. The claimants were therefore entitled to the reliefs sought.

If you require further information contact us at enquiries@rtcoopers.co

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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