Comments on: Is the Use of a Patented Formulation or Delivery Technology Safe under the FDA Research Exemption “Safe Harbor”? http://www.patentbaristas.com/archives/2007/08/03/is-the-use-of-a-patented-formulation-or-delivery-technology-safe-under-the-fda-research-exemption-safe-harbor/ Freshly Brewed Bio/Pharma Chat. Served Up Daily. Wed, 10 Mar 2010 16:00:30 -0500 http://wordpress.org/?v=2.9.2 hourly 1 By: Is patent gridlock keeping drugs off the market? http://www.patentbaristas.com/archives/2007/08/03/is-the-use-of-a-patented-formulation-or-delivery-technology-safe-under-the-fda-research-exemption-safe-harbor/comment-page-1/#comment-58153 Is patent gridlock keeping drugs off the market? Fri, 25 Jul 2008 12:44:46 +0000 http://www.patentbaristas.com/archives/2007/08/03/is-the-use-of-a-patented-formulation-or-delivery-technology-safe-under-the-fda-research-exemption-safe-harbor/#comment-58153 [...] regulatory filings. And the language of the ruling makes it look like it’s intended to cover all sorts of patented technologies as [...] [...] regulatory filings. And the language of the ruling makes it look like it’s intended to cover all sorts of patented technologies as [...]

]]> By: Diala http://www.patentbaristas.com/archives/2007/08/03/is-the-use-of-a-patented-formulation-or-delivery-technology-safe-under-the-fda-research-exemption-safe-harbor/comment-page-1/#comment-45325 Diala Sat, 15 Mar 2008 04:00:54 +0000 http://www.patentbaristas.com/archives/2007/08/03/is-the-use-of-a-patented-formulation-or-delivery-technology-safe-under-the-fda-research-exemption-safe-harbor/#comment-45325 Hi, I read this article with interest and have a couple of questions which I'm wondering if you have an answer to: 1. does the research exemption safe harbor extend beyond pre-clinical studies to clinical studies ? do the same terms apply for clinical studies ? 2. does this safe harbor apply to biologics submitted via a BLA ? the article talks about INDs and NDAs submitted under the FDCA only. If it applies to biologics, how was Amgen able to sue TKT for infringement at the IND stage ? Thanks, Diala Hi,

I read this article with interest and have a couple of questions which I’m wondering if you have an answer to:

1. does the research exemption safe harbor extend beyond pre-clinical studies to clinical studies ? do the same terms apply for clinical studies ?

2. does this safe harbor apply to biologics submitted via a BLA ? the article talks about INDs and NDAs submitted under the FDCA only. If it applies to biologics, how was Amgen able to sue TKT for infringement at the IND stage ?

Thanks,

Diala

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