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Thursday, 23 August 2012

Patents and publication of dose regimes: can you help?

And now for something completely serious ... An Anxious Reader has contacted the IPKat in conditions of the direst secrecy, since millions (or tens of millions) of euros are at stake.  Can you help?  Says Anxious Reader:

The EMA's logo ... 
"The European Medicines Agency (EMA) has created a clinical trial database (known as the EudraCT Database) whose mission is to provide an overview of clinical trials being conducted in the EU (see EU Clinical Trials Register here). 
The information published on this site is loaded by the national Medicines Agency from which authorisation for the trial is sought, and posted within 24 hours from trial authorisation. 
Confusingly similar?
We have found that information concerning the dose regime for a new drug to be tried out in an upcoming trial has been published on this site. After many emails and phone calls (with both the EMA and the Spanish authorities), we have been informed by the Spanish Medicine Agency that all information introduced in what is called the clinical trial authorisation (CTA), including dose regimes which are mandatory, are published on this website upon authorisation. And there is no way we can preserve the confidentiality of this information.

This mandatory publication is clearly in conflict with the possibility of filing patent applications on dose regimes, given that we would have to file these applications before conducting the dose finding study. Is there anyone out there who can offer any suggestions or advice as to how to deal with this situation?"
The IPKat is, as usual, certain that he knows the answer, but he doesn't want to spoil it for all those experts in the field who so enjoy writing in, so he has acceded to Merpel's request to give them a chance to show how clever they are too.  Please post your comments below or, if that doesn't work, email them to the IPKat here.

7 comments:

Gareth said...

Presumably the mere fact of a trial isn't in itself an enabling disclosure of the treatment effect, nor does it provide a reasonable expectation of success. Other prior art may of course mean there is such an expectation, or the finding of a preferred dose may in some circumstances be considered routine.

CanItBeThatObvious said...

I assume that since the dosage regimes are submitted to the EMA, then the scientific personnel of the Anxious Reader have some data, rationale and/or logical basis. Therefore, if you want to protect these dosage regimes, why not file a patent application prior to the disclosure? Or am I missing something...?!

Anonymous said...

It's not quite clear whether you would like comments on the specific
disclosure that has already occurred or a general strategy on what to do on future cases. I'm a patent attorney, not an IP lawyer, so my perspective might not include all possible options. However these are my brief
thoughts.

1. For any disclosure originating from inventors there are of course grace periods available in many territories. You'll need to contact local attorneys in each territory to find out how each grace period works. They
are different in terms of what you need to make use of it, e.g. whether the deadline for filing from the disclosure is from the filing date or priority date, whether the PCT route is still available, what the criteria are for being able to use it etc. For this first disclosure which came as a surprise there may be more chance to meet the criteria (although the 'evident abuse' hurdle at the EPO and the confidentiality test in the UK
probably won't be met). Clearly all of this will increase costs.

2. For future cases the applicant will need to consider strategies to
minimise damage. You could try filing a priority application before submitting the data, and then adding the date to the Convention case, if
time-frames permit. There is a risk that the priority case will be
considered unsupported/ insufficient.

3. You could ensure that the data submitted to the database is in a form where it causes minimal damage as prior art. So if several dosages are being tested, then perhaps that could be given as a broad range, so that a
claim to a specific dosage would still be novel.

4. Depending on the factual situation more complex strategies involve filing more than one application, each directed to a different dosage range,
and then you choose which one to carry on with depending on the results of the trial. If the data was not available at the time of Convention filing then you would file it as post-filing data and hope for the best.

In general prior art problems tend to be more serious than
support/sufficiency problems (although this very much depends on the factual situation). So in general I would advise a strategy of trying to get a priority application on file before the database discloses the dosage
information. Clearly though a very thoughtful approach is needed looking at all the time-frames and how these will interact with grace period provisions.

Hope this is helpful.

Anonymous said...

I'm a patent attorney, not an IP lawyer, so my perspective might not include all possible options. However these are my brief thoughts:

1. For any disclosure originating from inventors there are of course grace periods available in many territories. You'll need to contact local attorneys in each territory to find out how each grace period works. They are different in terms of what you need to make use of it, whether the deadline for filing from the disclosure is from the filing date or priority date, whether the PCT route is still available, what the criteria are for being able to use it etc. For this first disclosure which came as a surprise there may be more chance to meet the criteria (although the 'evident abuse' hurdle at the EPO and the confidentiality test in the UK probably won't be met). Clearly all of this will increase costs.

2. For future cases the applicant will need to consider strategies to minimise damage. You could try filing a priority application before submitting the data, and then adding the date to the Convention case, if time-frames permit. There is a risk that the priority case will be considered unsupported/insufficient.

3. You could ensure that the data submitted to the database is in a form where is causes minimal damage as prior art. So if several dosages are being tested, then perhaps that could be given as a broad range, so that a claim to a specific dosage would still be novel.

4. Depending on the factual situation more complex strategies involve filing more than one application, each directed to a different dosage range, and then you choose which one to carry on with depending on the results of the trial. If the data was not available at the time of Convention filing then you would file it as post-filing data and hope for the best.

In general prior art problems tend to be more serious than support/sufficiency problems (although this very much depends on the factual situation). So in general I would advise a strategy of trying to get a priority application on file before the database discloses the dosage information. Clearly though a very thoughtful approach is needed looking at all the time-frames and how these will interact with grace period provisions.

Hope this is helpful!

Anonymous said...

If the Spanish Medicine Agency (SMA) are free to put the dosage information on the EudraCT database for publication on the internet, disclosure happens at the time of giving the information to the SMA, doesn't it? While the publication on the database is much more visible, something doesn't need to be available to ALL the public in order to be a public disclosure, the person told just needs to not be under an obligation to keep it confidential, which the SMA presumably is not.

Giovanni Guglielmetti said...

I believe you will have to file the patent application before being authorised to start the clinical trials. This is not at odds with patent practice since it is usual that you file before starting the trias which put the invention at risk of being disclosed, you just need to file a little bit earlier (before getting the authorisation or immediately therefter).

Anonymous said...

T158/96

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