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Answers - DIY Domain Name Disputes: Expert Tips
This is a distillation of the wisdom acquired through years of involvement in domain name dispute proceedings. It won’t make a hopeless case winnable, but it might stop you from making a strong case un-winnable.
(1) Know your chances
Make an assessment of your chances of winning before embarking on a dispute.
You will need, at a minimum, to read and underst
(1) Know your chances
Make an assessment of your chances of winning before embarking on a dispute.
You will need, at a minimum, to read and underst
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
and the rules governing the relevant kind of complaint; learn when complaints are upheld, and when rejected. Unless the case is very clear-cut or you’re a very quick learner, your initial view may lack nuance, but you should at least know whether you have a chance of succeeding or none at all.
If you can’t form an initial view, some lawyers will be prepared to
If you can’t form an initial view, some lawyers will be prepared to
; 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
look at the papers and consider whether you have a prima facie case without charge.
(2) Write first time
It is usually worth writing to the other side about a domain dispute before making a complaint. There are two main reasons. First, the cost and aggravation of a domain name dispute can sometimes be avoided by a simple exchange of letters. Second, even if
(2) Write first time
It is usually worth writing to the other side about a domain dispute before making a complaint. There are two main reasons. First, the cost and aggravation of a domain name dispute can sometimes be avoided by a simple exchange of letters. Second, even if
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 dispute isn’t resolved by correspondence, the fact that you have tried to resolve the dispute without recourse to arbitration proceedings will create a favourable impression with some panellists.
Neither goal is likely to be achieved if the correspondence is disproportionately aggressive or sarcastic: your letters should be lucid, polite and concise.
The p
Neither goal is likely to be achieved if the correspondence is disproportionately aggressive or sarcastic: your letters should be lucid, polite and concise.
The p
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
roblem with writing before filing a complaint is that the domain registrant could transfer the domain to another person before you get a chance to file - possibly to a person with better rights in the domain name than the registrant. You should assess this risk carefully before deciding whether to write first. In making this assessment, one important considerat
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
on will be the cost of filing a complaint and thereby blocking transfers. In Nominet (.uk) proceedings, it costs nothing to file a complaint and have domain transfers blocked until the dispute is resolved; however in most other kinds of domain name proceedings, the complaint fee is payable upon filing.
(3) Know your limits
Time limits, that is – and word limi
(3) Know your limits
Time limits, that is – and word limi
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
ts. In domain name disputes both time limits and word limits can be short. It’s important not to contravene either: missing time limits can be fatal to your case, and looks careless at best; exceeding word limits will annoy the panel.
Panellists will tell you that they don’t get paid enough to read what they don't have to read, when they don't have to read it.
Panellists will tell you that they don’t get paid enough to read what they don't have to read, when they don't have to read it.
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
(4) Tell a story
The “pleadings” of domain name arbitration proceedings – complaints, responses and (in Nominet proceedings) replies – are never going to make great reading. The formal requirements of these documents make them tedious, even for readers professionally acclimatised to tedium.
The easiest way to make the document more interesting is to write i
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
as you would a simple story. Insofar as the document recounts facts, these should usually be in chronological order. You also need to be clear about which person or entity is undertaking which action. This is obvious in the case of natural persons, but can be unclear where you are dealing with legal entities such as companies and partnerships.
Even the non-fa
Even the non-fa
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
ctual, argumentative sections of your pleadings can be organised in the same way as a story, with a clear beginning, middle and end - although the order an argument will be logical rather than chronological.
(5) Keep cool
Your Complaint or Response should be dispassionate and measured - and give the appearance of objectivity. Remember who is likely to be maki
(5) Keep cool
Your Complaint or Response should be dispassionate and measured - and give the appearance of objectivity. Remember who is likely to be maki
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
g the decision, and where: a middle-aged lawyer in an air-conditioned office. Although you need the sympathy of that lawyer, you it's best not to be seen to be asking for it.
(6) Fit the facts to the rules, the rules to the facts
Rarely, if ever, will the rules fit the facts like a glove. More commonly, you’ll find that the facts have an extra finger, or the
(6) Fit the facts to the rules, the rules to the facts
Rarely, if ever, will the rules fit the facts like a glove. More commonly, you’ll find that the facts have an extra finger, or the
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
glove is too tight, or too capacious.
Your handling of the tensions between the facts and the rules will be a key factor in the success or failure of your argument. By careful presentation of both the facts and the law, it is possible to make it look like the latter was made to fit the former. In this way, weaker arguments can be made stronger, and stronger ar
Your handling of the tensions between the facts and the rules will be a key factor in the success or failure of your argument. By careful presentation of both the facts and the law, it is possible to make it look like the latter was made to fit the former. In this way, weaker arguments can be made stronger, and stronger ar
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
guments can be made compelling.
(7) Weight your evidence
One kilo of evidence is too much; one gram too little. To reiterate: panellists will tell you that they don’t get paid enough to spend their weekends reviewing your appendices. However, a certain quantity of documentary support is necessary in all cases, to demonstrate the prior dealings of the parties,
(7) Weight your evidence
One kilo of evidence is too much; one gram too little. To reiterate: panellists will tell you that they don’t get paid enough to spend their weekends reviewing your appendices. However, a certain quantity of documentary support is necessary in all cases, to demonstrate the prior dealings of the parties,
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
the use of the domain name in dispute, the rights of the parties, and so on.
As a rule of thumb, you should not include more than one file of evidence and, if possible, that file should be slim enough to allow the panellist to review its contents in less than 15 minutes. (Of course, you may need to break this rule in some cases.)
(8) Find a precedent or two
As a rule of thumb, you should not include more than one file of evidence and, if possible, that file should be slim enough to allow the panellist to review its contents in less than 15 minutes. (Of course, you may need to break this rule in some cases.)
(8) Find a precedent or two
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
The major dispute resolution services have now built up a substantial body of case law. Few if any panellists read every decision; most read only a small percentage of the decisions issued.
Panellists don’t want to make decisions that are inconsistent with previous case law: they don’t want to invite the criticism of their colleagues or academic commentators;
Panellists don’t want to make decisions that are inconsistent with previous case law: they don’t want to invite the criticism of their colleagues or academic commentators;
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
or do they want to have their decisions overturned on appeal. You can help the panellist avoid these ignominies by pointing him or her in the direction of a decision or two which supports your interpretation of the rules.
Don’t however go overboard with the authorities. Generally, you should cite only one or two authorities in each case. However, in some circu
Don’t however go overboard with the authorities. Generally, you should cite only one or two authorities in each case. However, in some circu
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
mstances - for example, where there is a well-known case, or your opponent has cited a case, which contradicts your “case theory” - then you may need additional authorities to establish your case.
Sometimes it may be necessary to cite a court judgment; only do so if it really is necessary.
(9) Be a pedant
Panellists are usually lawyers; lawyers are professio
Sometimes it may be necessary to cite a court judgment; only do so if it really is necessary.
(9) Be a pedant
Panellists are usually lawyers; lawyers are professio
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
nal pedants. You don’t want the condescension of the panellist, so try to avoid typos, inconsistent usage, and errors of grammar and spelling. Once your document is prepared, proof read it; then have a friend proof read it; then proof read it again.
(10) Read, re-read and re-re-read the rules
Read the applicable rules before drafting your complaint (or respon
(10) Read, re-read and re-re-read the rules
Read the applicable rules before drafting your complaint (or respon
.
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
e); and during; and after. Check that your document meets all the formal requirements.
(11) Use your service provider
You’re the customer and, although you cannot be always right when the service is dispute resolution, you can be a little bit always right. They won’t give you much in the way of substantive advice, but most will help clear up procedural issues
(11) Use your service provider
You’re the customer and, although you cannot be always right when the service is dispute resolution, you can be a little bit always right. They won’t give you much in the way of substantive advice, but most will help clear up procedural issues
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
.
(12) Stay relevant
Irrelevant material is most unwelcome to the panellist. You may think you can make your opponent look bad by telling the panel how he or she stole your money, or killed your cat. Resist that urge: it will only make you look bad. Ensure all of your arguments and evidence are directed to the rules upon which the panel must make its decision
(12) Stay relevant
Irrelevant material is most unwelcome to the panellist. You may think you can make your opponent look bad by telling the panel how he or she stole your money, or killed your cat. Resist that urge: it will only make you look bad. Ensure all of your arguments and evidence are directed to the rules upon which the panel must make its decision
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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