Free Letter - District Court of Delaware - Delaware

Case 1:06-cv—00071-G|\/IS Document 34 Filed 08/06/2007 Pagei 0f2
Moxkrs, NICHOLS, ARSHT & TUNNELL LLP
1201 Norvru MARKET STREET
P.O. Box 1347
WILMINGTON, DELAWARE 19899-1347
302 658 9200
.J.scx B. BLuMENEEL¤ FAX
302 351 9291
302 425 3012 FAX August 6,
[email protected]
The Honorable Gregory M. Sleet VIA ELECTRONIC FILING
United States District Court
844 King Street
Wilmington, DE 19801
Re: In re Metoprolol Succinate Direct Purchaser Antitrust Litigation
C.A. N0. 06-52 (GMS)
In re Metoprolol Succinate Ena'—Payor Antitrust Litigation
C.A. N0. 06-71 (GMS)
Dear Chief Judge Sleet:
Plaintiffs’ counsel in C.A. 06-52-GMS has advised Your Honor of the Federal
Circuit’s decision in In re Metoprolol Succinate Patent Litigation, No. 2006-1254 (Fed. Cir. July
23, 2007). In its decision, the Federal Circuit affirmed the finding of invalidity of the ‘154 patent
for double patenting by a 2-1 decision, with Judge Schall dissenting, and reversed the summary
judgment of unenforceability based upon inequitable conduct. That decision removes much of
the basis for the antitrust claims in this case. AstraZeneca intends to seek rehearing en banc with
respect to the double patenting issue. AstraZeneca has moved, in the alternative to its pending
motions to dismiss, to stay these antitrust cases pending the outcome of that patent litigation.
Under the circumstances, AstraZeneca continues to believe that these cases should be stayed
pending the resolution of the patent litigation that fonns the basis for the antitrust claims, if they
are not dismissed.
In addition, it was not until long after the District Court’s January 2006 summary
judgment decision and the filing of this litigation that any of the ANDA filers received FDA
approval and went on the market with their products. Specifically, on July 31, 2006, Sandoz
received final approval of its 25 mg product and tentative approval of its 50, 100 and 200 mg
products. Sandoz did not launch its 25 mg product until November 20, 2006 and still has not
launched its other products. KV did not receive approval of its 100 and 200 mg products until
May 2007, and has only recently launched those products. Andrx has not received any
approvals, because the FDA is not approving any Andrx products for reasons unrelated to the
litigation. Thus, it plainly was not AstraZeneca’s filing of the patent litigation that kept the
generic products of the market.

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August 6, 2007
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We are prepared to provide whatever additional facts or argument the Court may
desire on any of these matters.
Respectfully,
up /9 L!/Wl
J k B. Blumen eld (#1014)
J BB/dlb
cc: Clerk of Court (Via Hand Delivery)
Jeffrey S. Goddess, Esquire (Via Electronic Mail and Hand Delivery)
Linda P. Nussbaum, Esquire (Via Electronic Mail)
Daniel Berger, Esquire (Via Electronic Mail)
Thomas M. Sobol, Esquire (Via Electronic Mail)
Pamela S. Tikellis, Esquire (Via Electronic Mail and Hand Delivery)
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