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Biotech / Medical : Sepracor-Looks very promising

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To: rkrw who wrote ()8/16/1999 11:59:00 PM
From: rkrw  Read Replies (1) of 10280
 
Sorry to post actual potentially impacting stuff.

Juice from the 10K.

8. Litigation:
On February 12, 1999, the Federal Trade Commission ("FTC") issued a request for additional information or documentary materials relating to the Company's exclusive license agreement with Eli Lilly and Company (the "Lilly Agreement"). The purpose of the request was to investigate whether or not the Lilly Agreement constitutes a violation of Section 5 of the Federal Trade Commission Act and
Section 7 of the Clayton Act. The Company is in the process of responding to the request. At the conclusion of its investigation, the FTC could institute proceedings seeking to modify the Lilly Agreement or to prevent it from becoming
effective. While the Company believes that the Lilly Agreement does not constitute a violation of the above-mentioned laws, the Company is unable to predict the outcome of the proceeding.

**Anyone care to look up Section 5 of the FTC Act and Section 7 of the Clayton Act? I assume its something along the lines of restraint of trade and unfair competition.**

In May 1998, HMRI filed an action in Belgium alleging that Sepracor's European patent relating to fexofenadine is invalid in Belgium, or is not infringed by HMRI's sales of fexofenadine in Belgium and Germany. In September 1998, Sepracor commenced infringement proceedings in the United Kingdom against HMRI and related companies for infringement of Sepracor's European patent relating to fexofenadine.

**This is a critical part of Sepracor's negotiating leverage with HMR over Allegra royalties. Will be huge if they can seal a good deal.**

And very new juice:

On June 30, 1999, the PTO declared an interference between certain claims of Sepracor's issued method-of-use patent relating to (+)-zopiclone, and a claim in a Rhone-Poulenc Rorer S.A. ("RPR") patent application relating to a method
of improving sleep quality or time in a human by the administration of (+)-zopiclone. If Sepracor prevails in the interference, Sepracor will retain all of its claims in its issued patent. If, however, Sepracor loses the interference, RPR will be issued a U.S. patent containing its claim involved in the interference, and Sepracor will lose its claims involved in the interference but retain the claims in its issued patents that are not involved in the interference. The interference proceeding is in the early
stages. While the Company is unable to predict the outcome, it believes that the interference will have no effect on its development of (+)-zopiclone metabolites.

**So just what they need, another interference <g>
Based on Allegra, this will probably won't be decided for several years. The key aspect in an interference is first to discover, so there is no point in speculating who will win. Like the disputed allegra patent, it looks like Sepracor's claims are far broader than the innovator.
Different this time with no deal in place. Also claim it will have no effect on the development of the drug. But a stronger patent will give them better leverage to cut a deal
with RPR if that's the route they choose to go. And of course lest anyone not know, HMR and RPR are merging.
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