Replies to post #25492 on Intellipharmaceutics International Inc. (IPCI)

[Amigo Mike]

Angelo,

I often wonder why IPCI isn't saying when they provided the paragraph IV notification.

Has anyone gotten that outta Della Penna ?

Amigo Mike

[Samsa]

Angelo......In my opinion its a non-issue. remember, rules changed as of December 6th. if a challenge is made or patent is in question , the applicant gets to submit a 250 word brief in support of the claim. The FDA can make an arbitrary ruling to either proceed or stall the application. I think the fact the Supreme court has already ruled on this makes it pretty clear. regardless of what Weasel was trying to say, there is a huge difference between a generic and an NDA and the patent numbers being challenged. you can not make a generic version of Oxy as it is indeed still under patent protection. as the latest version of Oxy was just granted patent in 2012 with is so called abuse deterrence. any true generic must be based off that. These NDA's however, like IPCI's and COLL's didnt base their drug off the new patent they based it off the OLD Oxy patents and the old non abuse formula and then added their own abuse formula (nPODDDs etc) and thats what makes it a New drug rather than a generic. the original claims by Purdue in court was that the new patents they received for their abuse drug and for which the FDA stated all new drugs must be equivalent too, tried to argue that the patent protection protecting them was part and parcel to the old original Oxy patents and therefore those older patents were protected as well as they were now extended through the newer patents. Thats where the courts ruled the original Oxy patents were indeed expired and only the new patents with the abuse deterrence were valid. thereby allowing New drugs to come onto the market but keeping a true generic of the 2012 Oxy off the market until patent expires. That's about the easiest way I can explain it.

Now, can they still file a frivolous lawsuit? yes, they can. but again the new rules that went into effect Dec.6th all IPCI has to do is submit a 250 word brief in support of the application and the FDA can allow the application to move on. I personally see Purdue as a non issue at this point so go enjoy your fishing trip LOL. I'm heading to the mountains next Thursday myself! but no R&R, a tree limb came down and messed up the back porch roof.