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Top Articles - Intellectual Property - Copyright Infringement in Computer Software
The case of Point Solutions Ltd v Focus Business Solutions Ltd and Another [2007], which was heard in the Court of Appeal, involved a claimant who carried on business as a provider of computer software services, and in particul
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
ar software for the creation and use of electronic application forms for provision to the financial services sector.
At the material time the defendants had for a number of years been the dominant supplier in that market. In A
At the material time the defendants had for a number of years been the dominant supplier in that market. In A
; 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
pril 2001, the claimant and the defendants entered into an outsourcing agreement under which the claimant carried out work for the defendants, work which included a review of a module in the defendants’ Goal software. In order
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
to carry out that work, the claimant was provided with three modules of the defendant’s Goal software.
In the course of its business the claimant supplied a product known as Acuo Software, a product which had been developed ov
In the course of its business the claimant supplied a product known as Acuo Software, a product which had been developed ov
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
r a period between 2 July 2001 and August 2002. The development of Acuo Software was in response to an approach from CMI, a well known pension provider.
In October 2001, the outsourcing agreement between the claimant and the
In October 2001, the outsourcing agreement between the claimant and the
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
defendants came to an end. Apparently, the defendants had learned that the claimant had been awarded the CMI contract, for which the defendants had made an unsuccessful bid, and that the claimant intended to bid for a different
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
contract with H (the parent company of CMI) in direct competition with the defendants.
The defendants asked for the return of the three modules of Goal software. The claimant claimed to have complied with this request. In Oct
The defendants asked for the return of the three modules of Goal software. The claimant claimed to have complied with this request. In Oct
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
ober 2002, the defendants wrote to the claimant to:
“Seek confirmation of the provenance of the software you have developed in order to compete with [the defendants]”
The defendants also sought confirmation that the claimant
“Seek confirmation of the provenance of the software you have developed in order to compete with [the defendants]”
The defendants also sought confirmation that the claimant
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ad not undertaken any copying of the defendants' Goal software or solutions. The claimant replied, confirming that it had not copied the defendants' software, and offered to make voluntary disclosure (to a mutually agreeable th
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
ird party) of material that would confirm that there had been no copyright infringement.
The parties agreed to the identity of the experts to be instructed, and terms of reference on the basis of which they should be asked to
The parties agreed to the identity of the experts to be instructed, and terms of reference on the basis of which they should be asked to
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
act. However, the matter did not progress. Eventually, in December 2004, the claimant commenced proceedings seeking a declaration of non-infringement of copyright. It was directed that an expert's report be obtained, however th
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
e parties failed to comply with that direction. The judge refused to grant the relief sought, saying that she had been asked to make a declaration that software, which she had not yet seen, did not infringe any copyright in ano
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
her software product which she had also not yet seen. She went on to hold that copyright had not yet been demonstrated with regard to such software.
The claimant appealed. It submitted on appeal:
- That the judge was wrong
The claimant appealed. It submitted on appeal:
- That the judge was wrong
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
to find that the claimant had failed to establish on the balance of probabilities that it did not copy the defendant's source code in creating the Acuo Software;
- That the judge had erred in finding that there was no utili
- That the judge had erred in finding that there was no utili
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
ty in making a declaration even if there had been no copying; and
- That her finding that she would have exercised her discretion against granting a declaration even if she had found in its favour on the issue of non-infring
- That her finding that she would have exercised her discretion against granting a declaration even if she had found in its favour on the issue of non-infring
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
ement was perverse.
The appeal would be dismissed.
The claimant had not shown that the judge was wrong in finding that it had failed to establish on the balance of probabilities that it had not copied the defendants' source c
The appeal would be dismissed.
The claimant had not shown that the judge was wrong in finding that it had failed to establish on the balance of probabilities that it had not copied the defendants' source c
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
de in creating the Acuo Software. Therefore, the other two grounds did not arise.
It is interesting to note that a judge should be slow to allow proceedings of this nature to be brought to trial in circumstances where the part
It is interesting to note that a judge should be slow to allow proceedings of this nature to be brought to trial in circumstances where the part
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ies have chosen (for tactical and forensic reasons) to disregard directions already given for the provision of the expert assistance needed if the court is to decide the real question in dispute.
If you require further informa
If you require further informa
.
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
tion contact us at enquiries@rtcoopers.com
Visit http://www.rtcoopersiplaw.com or http://www.rtcoopers.com/practice_intellectualproperty.php
© RT COOPERS, 2007. This Briefing Note does not provide a comprehensive or complete
Visit http://www.rtcoopersiplaw.com or http://www.rtcoopers.com/practice_intellectualproperty.php
© RT COOPERS, 2007. This Briefing Note does not provide a comprehensive or complete
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
statement of the law relating to the issues discussed 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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