Free Letter - District Court of Delaware - Delaware

Case 1 :05-cv-00854-JJF Document 43 Filed 08/26/2008 Page 1 of 3
O1`1`lS JHITIGS LLP
M '
Mary B. Matterer
$02888.6960
mmatterer@morrisjamescom
August 26, 2008
VIA ELECTRONIC FILING
The Honorable Joseph J. Faman, Jr.
United States District Court
844 King Street
Wilmington, DE 19801
Re: Boehringer Ingelheim Int’l GmbIL et al. v. Barr Labs., Inc.,
Civil Action N0. 05-700 (JJF) (Consolidated) and
Boehringer Ingelheim Int’l Gmbli et al. v. Mylan Pharms. Inc.,
Civil Action No. 05-854 (JJF)
Your Honor:
I write as counsel for Defendant Mylan Pharmaceuticals Inc. ("Mylan") in response to
Plaintiffs Boehringer Ingelheim International GmbH’s and Boehringer Ingelheim
Pharmaceuticals, Inc.’s (collectively "Boehringer") August 25, 2008 letter to Your Honor about
the proposed Final Judgment Order that Mylan submitted to the Court on August 25.
Boehringer asserts that Mylan’s proposed Final Judgment Order “‘contains certain errors
and ambiguities." Mylan respectfully submits that there is nothing ambiguous or erroneous in
Mylan’s August 25 proposed Final Judgment Order, and that Boehringer’s [Proposed] Final
Judgment is incomplete, incorrect and mischaracterizes the Court’s June 26, 2008 Memorandum
Opinion (D.I. 250) and Order (D.I. 251).
The first "WHEREAS" clause of Mylan’s proposed Final Judgment Order accurately
reflects the facts that Boehringer charged Defendant Barr Laboratories, Inc. ("Barr") with
infringement of certain claims in U.S. Patents Nos. 4,843,086 ("the ‘086 patent) and 4,886,812
("the ‘8 12 patent") in Civil Action No. 05-700 (JJF), that Boehringer charged Mylan with
infringement of certain claims of the ‘8l2 patent in Civil Action No. 05-854 (JJF), and that the
actions against Barr and Mylan were consolidated for trial.
The second "WI-IEREAS" clause of Mylan’s proposal correctly states that the ‘086 patent
expired on June 27, 2006. Mylan’s third "WHEREAS" clause correctly states that Barr’s
counterclaim that the ‘8l2 patent is unenforceable was dismissed by stipulation on November 5,
2007.
The fourth "WHEREAS" clause of Mylan’s proposal correctly states that the
consolidated actions against Barr and Mylan were tried in March 2008 before Your Honor, and
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Case 1:05-cv-00854-JJF Document 43 Filed 08/26/2008 Page 2 of 3
Morrrsjamesrrp
The Honorable Joseph J. Farnan, Jr.
August 26, 2008
Page 2
that the Court issued a Memorandum Opinion and Order on June 26, 2008. Mylan’s fifth
"WHEREAS" clause correctly states that Boehringer and Barr agreed to settle Civil Action No.
05-700 (JJF) and filed a Stipulation and Order of Dismissal after the Court tried both actions and
issued its Memorandum Opinion and Order.
Nothing in any of the "WHEREAS" clauses or in the three numbered paragraphs of
Mylan’s proposed Final Judgment Order suggests that a final judgment is being entered by the
Court on Civil Action No. 05-700 (JJ F) against Barr. The fifth "WHEREAS" clause and the
numbered paragraphs of the proposed Final Judgment Order make it absolutely clear that final
judgment is being entered in favor of Mylan against Boehringer, and that Civil Action No. 05-
700 (JJ F) between Boehringer and Barr was settled by way of a Stipulation and Order of
Dismissal filed with the Court after the Court’s June 26, 2008 Memorandum Opinion and Order.
Unlike Mylan’s proposal, Boehringer’s August 25, 2008 [Proposed] Final Judgment fails
to provide any indication at all that its settlement with Barr occurred after Your Honor’s June 26,
2008 Memorandum Opinion and Order. Boehringer’s omission clearly creates ambiguity in
connection with the question of whether the findings and conclusions reflected in Your Honor’s
Memorandum Opinion and Order should have any collateral estoppel effect with respect to both
actions against the two defendants. The fact that more than two paragraphs of Boehringer’s letter
to the Court are devoted to summarizing the case confirms that a full appreciation of the posture
of the proceedings is necessary to put the Court’s Final Judgment into proper context, and
reveals that Boehringer’s [Proposed] Final Judgment is incomplete.
Your Honor’s June 26, 2008 Memorandum Opinion and Order expressly state that certain
claims of the ‘812 patent are "invalid on the grounds of nonstatutory double patenting." (D.l.
250 at 43 and D.I. 251). Boehringer’s [Proposed] Final Judgment substitutes in numbered
paragraphs two and three the phrase "obviousness-type double patenting" for the Court’s finding
of "nonstatutory double patenting." Boehringer’s attempt to give a new construction to the
Court’s findings — and in so doing revisit the issue of whether objective indicia of non-
obviousness are legally irrelevant in this case — is incorrect and mischaracterizes the Court’s
decision. Paragraphs one, two and three of My1an’s proposal accurately reflects the Court’s
determination and should be entered.
Boehringer’s objection to Mylan’s proposed paragraph two is unfounded. Worse,
Boehringer’s proposal incorrectly suggests that nonstatutory double patenting invalidity, which
arises because "claims in a later patent . . . are not patentably distinct from claims in a commonly
owned earlier patent" (Eli Lilly & C0. v. Barr Labs., Inc., 251 F.3d 955, 967 (Fed. Cir. 2001)) is
unrelated to My1an’s counterclaim directed to invalidity “for failure to meet one or more of the
conditions of patentability specified in Title 35 of the United States code" (D.l. 6 at 6 1] 13). This
Court found that the claims at issue at trial were invalid on the ground of nonstatutory double
patenting — a determination necessarily based on either an obviousness or an anticipation

Case 1:05-cv-00854-JJF Document 43 Filed 08/26/2008 Page 3 of 3
Morrisjamesrrp
The Honorable Joseph J. Farnan, Jr.
August 26, 2008
Page 3
analysis under Title 35. Boehringer’s omission of any reference in its [Proposed] Final
Judgment to Mylan’s counterclaim renders Boehringer’s proposal incomplete and erroneous.
Paragraph two of Mylan’s proposed Final Judgment Order accurately reflects the Court’s
determination and should be entered.
Boehringer’s misrepresentation of this Court’s infringement finding also should not be
memorialized in the manner suggested in Boehringer’s [Proposed] Final Judgment. The Court’s
June 26, 2008 Memorandum Opinion states: "Because an invalid patent cannot be infringed, the
Court will enter judgment in favor of Defendants on both issues [noninfringement and
invalidity]? (D.1. 250 at 43-44). Boehringer’s attempt to rewrite the Court’s clear decision into
a finding of infringement should be rejected. Paragraph three of Mylan’s proposed Final
Judgment Order accurately reflects the Court’s decision and should be entered.
Finally, Boehringer’s [Proposed] Final Judgment oddly singles out and includes a
reference to the Court’s conclusion about Boehringer’s belated and ineffective terminal
disclaimer, but says nothing about the import of 35 U.S.C. § 121 on the Court’s double patenting
determination or about any of a number of the Court’s other specific findings underlying the
June 26, 2008 Memorandum Opinion and Order. The inclusion of a provision in the Court’s
Final Judgment about the terminal disclaimer filed by Boehringer, coupled with the exclusion of
other specific findings made by the Court, could erroneously give rise to a negative implication
that the Court’s decision with respect to invalidity was based solely on the Court’s findings about
Boehringer’s untimely and ineffective terminal disclaimer. Mylan accordingly believes that only
the Court’s final conclusions — that certain claims of the ‘812 patent are invalid on the ground of
nonstatutory double patenting and that Mylan does not infringe those invalid claims — should be
included in the Final Judgment Order.
Mylan appreciates Your Honor’s attention to this matter and regrets the need to involve
the Court in this dispute. Mylan respectfully submits that Boehringer’s arguments do not add
clarity to the Court’s rulings, but instead serve only to delay the entry of final judgment.
[V_, j Very tru,l/y rf U ‘— l
Mary B. tterer
cc: All counsel of record via email