Pharma News Briefs

• FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website.  The comments come in response to FDA's request last month.  A summary of the new comments is in the works.
• FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues.  This too follows an FDA request made last month.
• Yesterday, the WSJ Health Blog had two pessimistic reports on the pharmaceutical industry: "Drug Drought Deepens as FDA Approvals Lag" and "Pharma Woes Won't Let Up Soon."
• On a happier note, Wednesday, the U.S. District Court for the Eastern District of Virginia granted GSK's motion for a preliminary injunction against the USPTO, halting implementation of the PTO's new claims and continuation rules (see Patent Docs).
• Also on Halloween, the New York Time published a spooky article entitled "Chinese Chemicals Flow Unchecked Onto World Drug Market."  Reuters published a similar article the next day.  This can't be good publicity for pharmaceutical companies--both innovators and generics alike--who are increasingly outsourcing production of key ingredients to China.
• On Tuesday, the Federal Circuit denied rehearing of BIO and PhRMA v. District of Columbia, in which the court previously found Washington, D.C.'s drug price control law to be unconstitutional (see Patently-O).
• Last week, Sen. Bernie Sanders (D-VT) introduced a new bill that would scrap patent and market exclusivity for drugs and replace it with a "medical innovation prize fund" (see FDA Law Blog and Pharmalot).  I suspect that this bill is DOA, and therefore nothing to fear.
• Also last week, the WSJ Health Blog reported on Amgen's big win in its patent infringement suit against Roche's Mircera drug.
• A couple weeks ago, BioPharma Reporter published an interesting article, "U.S. Dragging its Heels on Biosimilars, Report Says."

Comments

[Sandeep K. Rathod]

Dear Aaron,

I have put up a very brief summary of all the comments on my blog here:
http://genericpharmaceuticals.blogspot.com/2007/11/ramipril-documents-recd-at-fda.html

Hope you find them a good start.
I know, your analysis as a US Attorney will be much more cogent and focussed.

Sincerely,
Sandeep,
Matrix.