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[cjpress]

I think that I may have discovered that a drug already in the market for a specific use can also be effective to cure another disease.  It has worked on me so far. I still need to give it time to verify such claim. This drug is already sold in its generic version.  Could I file a patent or should I try to make a deal with one of the companies which make the drug since it is sold generic?

Thank you.

[Isaac]

How does the FDA feel about your new use?

[cjpress]

FDA has not been involved.  It happens that I believe that this drug is responsible for curing my desease since I am not taking any other medication.  

[JimIvey]

I think what Isaac is suggesting is that FDA approval would be required before any marketing of your new use for the known drug is permitted.  Or perhaps he's alluding to the fact that clinical trials may be required for patent protection (in effect, excluding all but the largest drug companies from obtaining patents on drugs).

The bottom line is that bringing a new drug to market or getting an existing drug approved for a new use is extremely resource intensive and is generally infeasible for all but very large companies -- not something an individual with limited resources can generally accomplish.

Regards.

[Prakash]

I think you are referring to second medical use.  This is also called as swiss type of claims for patent. Some countries do not allow swiss type claims but many countries do.  
I think you still need to prove the drug is effective.  Also you need to know if the dosage you are taking is higher than the dosage of the drug for its first use.  If it is the same or even less, you may not have to do safety trials, but if it is higher dosage you also need to prove its dafety.

One question that arisses is how will be enforce this patent when people can buy the generic version?

[iprindia75]

Ya this what exectly ex. of swiss claim. In European contries you can not apply for the same but in US and In india it is allowable if the use is in such a huge requirement of the country. as you know that in the case like AIDS, Cancer or other life treatening disease the state can give approval for the patent but that may me for the method for manufacture of the so and so drug for the used of so and so disease. No product patent you will get. another thing is you can also get the patent on Process for the prearation of the so and so formulation in the treatment of so and so disease.

In this case if your preparation of the formulation method is different than you have o take permission of the FDA,.
One major problem of this type of patent will be a lawsuit from the company wherein innovator and generic companies are existing in the market for the same drug but for the different disease.

Best of luck.
:)

[Rajeev_Madnawat]

You may need to look closely into the patentability aspects of this "new use". Here is what MPEP section 2112 states:

I.SOMETHING WHICH IS OLD DOES NOT BECOME PATENTABLE UPON THE DIS-COVERY OF A NEW PROPERTY

“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”
Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable......

I think that I may have discovered that a drug already in the market for a specific use can also be effective to cure another disease.  It has worked on me so far. I still need to give it time to verify such claim. This drug is already sold in its generic version.  Could I file a patent or should I try to make a deal with one of the companies which make the drug since it is sold generic?

Thank you.

[Rajeev_Madnawat]

Well, it appeared that you just discovered a "hidden property" of something, you really did not invent that "something". Also, IMHO, just because it worked in a certain manner on you, is not enough to bypass the FDA approval process.

FDA has not been involved.  It happens that I believe that this drug is responsible for curing my desease since I am not taking any other medication.  

[ThinkPatent]

Yes, you can file a patent application for a new or more specifically unknown use of a known drug. But just going through your queries it seems to be that it is just your observation that drug is working to cure disease which is prima facie not indicated by the drug companies. However, to file a patent application for a new indication you have to support your contention by referring and disclosing supporting clinical data for new indication, which may be quite expensive sometimes. Otherwise it would be a reach-through claim, which may be difficult to get through examination process and can be easily revoked later on.

As already mentioned by others such type of claims are often referred as Swiss-type claims in Europe. However, in US such claims are referred as indication or method-of-use claims. To file a patent application for a new indication you need to be very careful in making disclosure, remember not to make disclosure such that it signify that a new indication is mere ‘hidden property’ which an inventor accidentally came across (which in case you did).

Patent Specialist & Analyst
Mumbai, India

[Rajeev_Madnawat]

Wouldn't this be a violation of "Duty of Disclosure, Candor, and Good Faith"?

......... To file a patent application for a new indication you need to be very careful in making disclosure, remember not to make disclosure such that it signify that a new indication is mere ‘hidden property’ which an inventor accidentally came across (which in case you did).

Patent Specialist & Analyst
Mumbai, India