Tags |
|
|
Links |
|
|
Answers - Intellectual Property: Patent Infringement
In the case of Agilent Technologies Deutschland GmbH v Waters Ltd (2005), the claimant, the proprietor of a European patent for a pump and co
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
ntrol system, brought proceedings against the defendant for patent infringement. The patent is for a pump for delivering solvent under pressu
; 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
re to high-pressure liquid chromatography columns. In particular, the patent relates to the control of the flow rate of the pump by altering
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
he stroke volume and the frequency of reciprocation of the pistons.
In earlier proceedings, the court had found that an earlier version of t
In earlier proceedings, the court had found that an earlier version of t
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
he defendant's device (the 'automatic device') infringed the claimant's patent and held the patent valid. The defendant modified its device t
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
create a new device (the 'manual device') which was the subject matter of the patent infringement claim. The pump and control system of the
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
manual device operated in what was referred to as 'manual mode', in which flow rate and stroke length were independently selected by the oper
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
tor. The result was that the manual device no longer maintained any predetermined relationship between stroke length and flow rate other than
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
that imposed by maximum and minimum possible frequencies and stroke lengths.
The judge held that the defendant's manual device did not infr
The judge held that the defendant's manual device did not infr
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
nge the claimant's patent because it was not within the scope of the patent.
The claimant appealed against the decision and contended that t
The claimant appealed against the decision and contended that t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
he patent covered the defendant's manual device as a matter of plain language as 'Control Means (i) coupled to the drive means; (ii) for adju
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
sting the stroke length of the pistons; (iii) in response to the desired flow rate of the liquid delivered (iv with the stroke volume being d
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
creased when the flow rate is decreased and vice versa; (v) such that pulsations in the flow of liquid delivered to the output of the pumping
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
apparatus are reduced'.
The appeal was dismissed and the Court of Appeal held that:
Patent claims were to be construed as if read by the
Patent claims were to be construed as if read by the
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
otional skilled man in context;
In the instant case, it was the 'control means' which was to adjust the stroke length 'in response to the d
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
esired flow rate' not the operator;
The operator was not part of the 'control means' of the claim, and the response called for by claim (ii
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
) was not present in the defendant's device; and
The judge had been entitled to find that the defendant's device did not infringe, being ou
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
tside the scope of the patent.
If you require further information contact us.
Email: enquiries@rtcoopers.com
© RT COOPERS, 2005. This Bri
Email: enquiries@rtcoopers.com
© RT COOPERS, 2005. This Bri
.
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
fing Note does not provide a comprehensive or complete statement of the law relating to the issues discussed nor does it constitute legal adv
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
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
HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.answers.org.ua/article/130188/answers-Intellectual-Property-Patent-Infringement.html">Intellectual Property: Patent Infringement</a>
BB link (for phorums):
[url=http://www.answers.org.ua/article/130188/answers-Intellectual-Property-Patent-Infringement.html]Intellectual Property: Patent Infringement[/url]
Related Articles:
Struggling as an Online Marketer opr Business
Bookmark it:
|