Actual - Legal

In the case of QR Sciences Ltd v BTG International Ltd [2005], the defendant company, BTG, (a purchaser of in

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

tellectual property and technology rights, particularly patents) granted an exclusive licence to QR Sciences

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

Examples of combination products may in

an Australian Company), in September 2002 to use a large number of its patents subsisting in many different c

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

untries.

A clause in the licence agreement granted QR Sciences the right to assign the patents in certain ci

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

cumstances. Clause 14.4 of the licence stated that: “throughout the term of the licence BTG will not assign a

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

Combination pro

y patent without first offering to assign such patent to QRS”.

In March 2004, BTG informed QR Sciences that

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

it was negotiating an assignment of the patents to a third party. QR Sciences began proceedings against BTG.

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

R Sciences argued that clause 14.4 applied when BTG proposed an assignment of the patents as well as when BTG

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

abandoned the patents and the Court should construe the clause to have this meaning.

The following issues ar

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

se during the action:-

whether BTG's negotiations triggered QR Science's rights under clause 14.4; and wheth

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

r BTG's proposals to QR Sciences in March 2004 discharged BTG's duty to offer the patents to QRS first. The C

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

Following aspects would a

ourt ruled:-

BTG's negotiations with the third party to assign the patents did not trigger QR Sciences' righ

dd to the challenges in developing combination products:

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

s under clause 14.4. If the negotiations had involved abandoning the patents, QR Sciences could have enforced

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

its rights under the clause; BTG's proposals were made subject to contract and were therefore not contractual

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

offers but only invitations to treat; BTG had not yet satisfied its contractual obligations to first make an

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

ffer to QR Sciences; and any offer by BTG to QR Sciences must be a contractual offer whereby QR Sciences had

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

Professional from academic institutions, pharmaceutical industries, health care indust

a reasonable time to consider the offer and respond.

If you require further information contact us at enquir

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

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

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

Companies that provide selfless information through particip

light 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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