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genisi

11/07/12 3:35 PM

#151893 RE: JohnWayne #151892

Novartis has guided in recent calls that the base patent (I would presume the composition of matter patent, but I haven't really looked into it) for Gleevec expires in the US in late 2015.

Correct, the COM patent #5521184 runs until July 2015 (including pediatric exclusivity).

However, they also have a variety of patents on other isoforms/polymorphs/crstalline formulations that they will try to use to defend against generics beyond the base patent expiry.

These are patents #7544799 and #6894051, beta crystal form of Gleevec expiring in 2019. I think Sun Pharma attacked those patents and they got a tentative approval for generic Gleevec from the FDA.

DewDiligence

11/07/12 4:06 PM

#151895 RE: JohnWayne #151892

[NVS] also have a variety of patents on other isoforms/polymorphs/crstalline formulations that they will try to use to defend against generics beyond the base patent expiry.

Almost all drugs have such patents, and the statement above on defending IP against generics is boilerplate stuff that every company says in response to questions from analysts.

The clue to what NVS actually expects vis-à-vis generic Gleevec is that NVS has guided analysts not to include large Gleevec sales in the analysts’ post-2015 models.