Actual - Legal

In the case of Merz Pharma GmbH and Co KGaA v Allergan Inc [2006], a dispute arose as to the validity of a patent for the use of Botulinium toxins in a type of medical treatm

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

ent.

Both the claimant and defendant companies were involved in the manufacture, marketing and development of pharmaceuticals. The defendant was the holder of a patent which

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

Examples of combination products may in

concerned the use of ‘the neurotoxin component’ of Botulinium toxins in the treatment of pain caused by muscular activity and contracture. The Botulunium toxins were a compou

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

d of ‘the neurotoxin component’ and ‘neurotoxin associated proteins’.

The defendant filed their patent on 14 July 2003. It was a second generation divisional patent, the ori

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

inal having been filed on 16 December 1994. By the priority date there were two formulations of Botulinium toxins available commercially. On of those was BOTOX. The defendant

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

Combination pro

marketed BOTOX, but both were used to treat muscle conditions.

Issues arose concerning the validity of the patent in respect of two of the claims which provided:

* Claim

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

: ‘Use of the neurotoxin component of Botulinium toxin for the manufacture of a medicament for the treatment of pain associated with muscle activity or contracture’.

* Cla

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

m 5: 'Use according to any one of the preceding claims, wherein the neurotoxin component of Botulinium type A, B, C, D, E, F or G'.

The claimant sought the revocation of the

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

patent on the grounds that it was invalid. They argued that the patent disclosed additional matters that were not in the original application, namely that the original applic

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

tion concerned the use of Botulinium toxins to treat various disorders. By contrast, the patent specifications referred to the use of the neurotoxin component stripped of the

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

neurotoxin associated proteins.

The defendant submitted that the neurotoxin component had been referred to in the original application in the technical background to the inv

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

Following aspects would a

ntion. They therefore argued that the matter had been sufficiently disclosed both implicitly and explicitly by the original application.

The revocation was be allowed on the

dd to the challenges in developing combination products:

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

basis that:-

* It was settled law that a patent would be revoked in the event that any additional matters relevant to the invention were added to it.

*

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

This would require consideration by a skilled addressee of the original application with regards to what was implicitly and explicitly disclosed by it.

*

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

In this case, a skilled addressee would have understood claim 1 to cover the use of the neurotoxin component whether or not it formed part of the toxin complex.

*

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

Therefore the original application disclosed only the use of the Botulinium toxin and not the neurotoxin component stripped of the neurotoxin associated prote

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

Professional from academic institutions, pharmaceutical industries, health care indust

ns.

* There was no implicit or explicit disclosure of the use of the neurotoxin component on its own.

* The patent, having referred to the

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

neurotoxin component explicitly, was invalid on the ground that it had disclosed additional matters.

The patent was revoked.

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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

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

Companies that provide selfless information through particip

nor does it 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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