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Author Topic: Was this drug D ever patentable, and if so, how?  (Read 224 times)

memekit

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Was this drug D ever patentable, and if so, how?
« on: 02-07-18 at 07:27 am »

The following is based on a tried-and-failed attempt, and now pondering a Continuation. 
Say prior art by Smith et al tests a refined crude plant extract yet claims the  drug D within blocks enzyme Z at IC50=50 ug/ml and that drug D completely blocks receptor R.  Blocking receptor R is very toxic so Smith et al propose use of drug D for topical use only.
But Inventor  discovers with far better top university analysis data using pure drug D compound that drug D blocks enzyme Z at concentrations of 20 ug/ml achievable by systemic dosing and does not block receptor R at all even up to saturation levels.
So Applicant has discovered drug D has >double the potency and no receptor R blockage and no evil side effects.  So drug D could be used to maintain receptor R while treating diseases responsive to blocking enzyme Z.   
How could a method (would it be a new use?) claim be written for drug D to treat diseases X in patients who do not want receptor anti-R side effects? 
“Applicant’s” claim idea:  A method for maintaining receptor R by administering to patients afflicted with diseases X the pure drug D….
But Examiner argues that Smith’s and Applicant’s drug D both block enzyme Z and so just because Smith doesn’t claim drug D for systemic diseases it would be prima facie obvious to do so.  How could this be when Smith acknowledges the systemic toxicity of the drug?
Applicant argues no ancient suggestions, superior assay gave unexpected results which teach away with opposite conclusions, that no-receptor blockage is surprising, invention not predicted, inoperative prior art (testing crude extract), false conclusion/wrong substance, different patient population, no overlap in claimed treatment populations, structural differences due to different test substance and different patient populations, means plus function is physical recitation under 112, different method claim, invention is nonobvious because of skepticism of experts, no prior anticipation, inoperative prior art/non-enabling (Morsa), inobviousness of systemic dosing, process of use (new and unobvious use of old structures), no modification possible since conclusions opposite, long-felt/importan need, nexus of evidence between declaration and claim/outcomes of use differ due to different patient population, drug D treats a subpopulation with unexpected results of no receptor blockages (Promethius v Roxane), Applicant can extrapolate receptor concentration to different dose than prior art…

Examiner rejected all of these arguments, stating meets all structural limitation of claimed method and would achieve same intended results.  "Not the same!" stresses Applicant.
Applicant proposed a method claim to maintains receptor R while treating diseases responsive to blocking enzyme Z by administering drug D to patients in need thereof who must NOT block receptor R.  Examiner argues that this is only a dosing/observing claim, i.e. no active step and rejects claim.  Applicant believes that ‘maintaining receptor’ is an active in the preamble, it's in the spec.  Since when does Applicant have to prove their data to Examiner?

Was drug D ever newly-patentable and if so, how?
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NJ Patent1

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Re: Was this drug D ever patentable, and if so, how?
« Reply #1 on: 02-07-18 at 09:47 am »

I don’t know what support you have in your application or precisely what Smith et al. disclose, and if Examiner won’t budge on some of those arguments you may be headed for appeal anyway.  I might try a claim along lines of: 

1) A method of treating disease X in a mammal suffering from disease X comprising the step of:
   administering to the mammal a therapeutically effective amount of drug D in a solid oral dosage form, wherein, after administration, clinical indication of inhibition of receptor R is not observed. 

2) The method of claim 1 wherein, after administration, the peak plasma concentration of drug D is about ?? ug/ml or less [or some other pharmacokinetic limitation]. 

You may need separate claim for injectable.  And don’t overlook claims to the dosage forms(s) itself / themselves.
 
Is D, a product of nature, ever patentable?  Resounding “sometimes”.  There is case law here.  How is D changed?  Do you know what was in the extract that caused inhibition of R?  “Purity” or “free of” claims get allowed (my batting average is about .500 here) if the analysis method, with detection limits, is disclosed in the application and referenced in the claim. 
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memekit

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Re: Was this drug D ever patentable, and if so, how?
« Reply #2 on: 02-07-18 at 07:11 pm »

Thank-you very much.  Smith's data stems from interference by phytochemicals in this class found in the whole plant well-known to block R, but we only tested pure compound from supplier and only referred to pure compound and submitted drawing of molecule.  This was shown/argued with Examiner stating not found persuasive.
Good ideas wrt your 1) and 2).  The achieved allowable is --A method to treat enzyme-Z responsive diseases comprising administering drug D and measuring receptor inhibition."  "Clinically observing" would've been better but our data was wet-lab.  Usefulness of this claim is very iffy, or as you lawyers say maybe a "Pyrrhic victory". 
Again thank-you for the ideas. 


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