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shannu
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Posts: 13
Opposition
« on: Oct 19th, 2007, 5:35am »
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All:
 
Here is a small query for all to revert back:
 
There is one European Patent "A" which claims an amorphous form of a substance "S1" prepared using spray drying method. There is an another EP Patent "B" which claims an amorphous form of a substance "S2" using Spray drying method. The Patent "B" published much before the patent "A" was filed. Substance "S1" and substance "S2" are of same the****utic area and are also chemically similar to each other.
 
Is it possible to file an opposition on the ground of obviosness.
 
Note: The inventors of both the patents acknowledge that amorphous form improves the bioavailability.
 
Regards    
 
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alconada
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Posts: 14
Re: Opposition
« Reply #1 on: Oct 20th, 2007, 11:51am »
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I think this thread should belong to the "European Patents" forum.
 
Anyway, I give you my opinion.
 
For deciding on whether a claimed subject-matter is obvious over a prior art, the EPO uses the problem-solution approach.
 
If A does not provide any evidence that S1 has any unexpected or surprising effect over S2, then the problem A aims to solve is to provide an alternative to S2. Altrernatives are usually not inventive if they result  from a minor structural modification of the prior art of the kind that a person of ordinary skills in the art would regard as arbitrary.
 
If A teaches a surprising or unexpected effect of S1 over S2, then the problem to be solved by A is to achieve said effect. The solution provided in A is prima facie not obvious even if both S1 and S2 are highly related structurally unless you find a second document suggesting that said structural difference may cause such effect in a different family of compunds.
 
Please note that said unexpected effect need not be in the form of experiments but that a mention in the description is usually enough. Moreover, evidence of said tehcnicas effect may be provided during opposition proceedings (only if the effect one intends to show is already mentioned in the application as filed).
 
I hope this helps. Should you need further assistance in  the opposition, send me a PM.
 
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shannu
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Posts: 13
Re: Opposition
« Reply #2 on: Oct 22nd, 2007, 6:01am »
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Thanks alconada for your valuable inputs.
 
I totally agree with you however I have some points to highlights and seek your inputs.
 
The prior art ref A teaches that an amorphous form has improved bioavailabily compare to crystalline form of active ingredient S1. The ref A further teaches that such an amorphous form is prepared using spray drying method.
 
Therefore, according to me:
 
It is quite obvious for a person skilled in the art to use and try the prior art teaching to solve the same problem of a crystalline form of a substance S2 using the exact method (SPRAY DYING) described in ref A and to achieve the same the****utic goal.
 
Please let me know if my understanding is correct.
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alconada
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Posts: 14
Re: Opposition
« Reply #3 on: Oct 23rd, 2007, 12:39pm »
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I forgot to mention in my previous post that opposition proceedings can only be initiated within 9 months of the date the publication of the patent is mentioned in the European Patent Bulletin.
 
Going back to your question, it seems that the key point is whether crystalline S1 was known in the prior art or decribed in A for the first time.  
 
If crystalline S1 has been described in A for the first time, it should be first  established whether S1 is inventive over crystalline S2 or over other documents of the prior art. If S1 was known, then it should be established whether applying spray drying to obtain the amorphous S1 is inventive over the analogous process in B.
 
In the first case, the situation mentioned in my previous post applies, ie is S1 an alternative to S2 or is there an improvemente in whatever property (for example, it might be that crystalline S1 is better medicament than crystalline S2)? If this is the case, then, probably crystalline S1 would be inventive and so it would be to spray dry it and the amorphous product obtained thereby.
 
If S1 is not inventive, then its modification by spray drying and the product derived therefrom would also lack inventive step.
 
Best regards
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