According to some observers, the US Patent system is undermining innovation. In KSR International versus Teleflex Inc., the US Supreme Court ruled that patents must be “more than the predictable use of prior art elements according to their established functions” or in my layman’s words, you can’t patent something that should have been obvious. The drug [...]
Archive for May 2nd, 2008
In our webinar last week on Patent & Marketing Exclusivity we received an interesting question that I would like to pass along to readers of this blog.
Q: If there are two RLDs, one with IP and one without IP, does a Sponsor have to certify against both RLDs?
A: If you reference a RLD, you always [...]
I was recently asked how you can have a 505(b)(2) application for an Orphan drug. The reasoning behind the query was that Orphan drugs are new chemical entities (NCE). This perpetuates the misconception that 505(b)(2) cannot be used for NCEs, which by now readers of this blog know is wrong. We have discussed the use [...]
