Replies to post #3430 on Biotech Values

[rkrw]

<<Eventually, there will not be any gain -- no gain whatsoever -- and we will be left with no patent challenges," Rakoczy said. "You're talking about an industrywide change.">>

Quite an exaggeration. Maybe a minimum sales threshold to make the challenge worth it.

Per a recent PR, Teva has 50+ current patent challenges. I found this to be an astounding figure. Whole generic industry has become challenge first, understand the patent later. Big Rx is under enormous pressure, should only help innovative bio's....

Incidentally, authorized generics have been around for at least 10 years.

[DewDiligence]

Mylan withdraws lawsuit in order to file a stronger one:

[Following is the letter from Mylan’s outside attorney to the presiding judge in the “authorized generics” case. Clearly, Mylan believes this case has broad ramifications for the generic-drug industry.]

http://www.sec.gov/Archives/edgar/data/69499/000095015204006557/j0938401exv99w2.htm

> >
August 30, 2004
VIA HAND-DELIVERY

The Honorable Irene M. Keeley
Chief Judge
United States District Court
500 West Pike Street
P.O. Box 2808
Clarksburg, West Virginia 26302-2808

Re: Mylan Pharmaceuticals Inc. v. FDA et al.,
Civil Action No. 1:04cv00174 (N.D. W. Va.)

Dear Judge Keeley:

On behalf of Mylan Pharmaceuticals Inc., the purpose of this letter is to notify the Court of, and explain to the Court the reason for, the attached notice of voluntary dismissal without prejudice that Mylan has today filed with the Clerk.

During the proceedings at the preliminary injunction hearing, counsel for both FDA and P&G disclosed facts and positions that have a significant bearing on related aspects of the “authorized generic” question and the considerable anticompetitive effects of authorized generics on the industry. The importance of these issues to Mylan and the entire generic pharmaceutical industry has led Mylan to conclude that all potential claims and aspects of the problems raised by authorized generics should be presented for review together in one action. In these circumstances, and because of potential preclusion concerns, Mylan feels compelled to withdraw its action without prejudice at this time in order to evaluate all of the potential issues and claims concerning authorized generics arising out of the recent hearing.

Mylan is, of course, aware that the Court has committed significant time and effort to the issues raised to date. Mylan is deeply appreciative of those efforts and thankful for the Court’s continuing courtesy and cooperation.

Very truly yours,

William A. Rakoczy
RAKOCZY MOLINO MAZZOCHI LLP
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