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Top Adding - Intellectual Property Law – Patent Law – Invalidity for Obviousness
The case of Conor Medsystems Inc v Angiotech Pharmaceuticals Inc and Another [2007], concerned a patent for a medical d
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
evice used in operations. The defendants owned a European patent for a device called a ‘stent’ used in coronary angiopl
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
asty. The ‘stent’ is inserted into a diseased artery during the procedure to keep the artery open. The claims in the pa
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
tent concerned a ‘stent’ coated with a polymer loaded with the drug taxol. This drug inhibited the development of tissu
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
which might result in the artery closing.
The defendants licensed the patent of this device to BS, a manufacturer of
The defendants licensed the patent of this device to BS, a manufacturer of
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
‘stents’. The claimant, who is a competitor of BS, sought to have the patent revoked on the grounds that the invention
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
was obvious in the light of prior art. The judge held that it was obvious to have tested taxol, and therefore the paten
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
t was invalid for obviousness. The defendant appealed.
The defendant’s appeal was dismissed.
The question to be consi
The defendant’s appeal was dismissed.
The question to be consi
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ered was whether the invention was obvious. In order to make this assessment, a number of factors had to be considered:
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
§ The attributes and common general knowledge of the skilled man;
§ The difference between the claim a
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
nd the prior art; and
§ Whether there was a motive provided or hinted by the prior art.
It was also held that:
§ Whether there was a motive provided or hinted by the prior art.
It was also held that:
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
-
§ Sometimes the commercial success of an invention could demonstrate that the idea was particularly good, whe
§ Sometimes the commercial success of an invention could demonstrate that the idea was particularly good, whe
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
eas in other situations the fact that the idea may have been ‘obvious to try’ could come into an assessment. The most i
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
mportant factor however was the nature of the invention.
§ The judge’s decision should stand.
§ This wa
§ The judge’s decision should stand.
§ This wa
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
s because the patent had not in any way demonstrated that taxol actually worked to prevent a diseased artery from closi
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
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
ng, even though it had been tested. The judge was therefore right to deem the patent invalid for obviousness.
If you r
If you r
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
quire further information contact us at enquiries@rtcoopers.com. Visit http://www.rtcoopersiplaw.com or http://www.rtc
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
oopers.com/practice_intellectualproperty.php
© RT COOPERS, 2007. This Briefing Note does not provide a comprehensive o
© RT COOPERS, 2007. This Briefing Note does not provide a comprehensive o
.
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
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
r complete statement of the law relating to the issues discussed nor does it constitute legal advice. It is intended on
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ly 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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