Free Letter - District Court of Delaware - Delaware

Case 1 :04-cv—00940-JJF Document 108 Filed 07/12/2007 Page 1 of 2
YOUNG CoNAwAY STARGATT & TAYLOR, LLP
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p July 12, 2007
BY E-FILING
The Honorable Joseph J. Farnan, Jr.
United States District Court
844 King Street
Wilmington, DE 19801
Re: The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Irzc.,
C.A. No. 04-940-JJF
Dear Judge Farnan:
This is in response to Mr. Fineman’s letter to your Honor of July 6, 2007 (DJ. 107), with
respect to the Federal Circuit’s decision in Takeda Chemical Indus., Irzc. v. Ahuhapharm Pty.,
Ltd, No. 06-1329 (June 28, 2007). That case involved the obviousness of a chemical compound,
"piog1itazone," in view of a structurally related compound, referred to in the opinion as
"compound b." The Federal Circuit affirmed the district court’s conclusion that the defendant
had not demonstrated that pioglitazone was prima facie obvious.
The Federal Circuit noted that °‘Alphapharm’s obviousness argument rested entirely on
` the court making a preliminary finding that the prior art would have led to the selection of
compound b as the lead compound? (Slip op. at 16). The district court, however, rejected that
argument and found as a fact that compound b would not have been a "lead compound" because
the prior art did not suggest that it would be any more useful as a treatment for diabetes than a
myriad of other compounds. In particular, the district court found "nothing in the prior art to
narrow the possibilities of a lead compound to compound b." (Id). The Federal Circuit held that
this threshold fmding was not clearly erroneous, and that pioglitazone was not prima facie
obvious.
The rationale for the district eourt’s "lead compound" finding in Takeda and its
affirmance by the Federal Circuit does not apply here. The claims of P&G’s ’406 patent, in
particular claim 15, made clear that 2-pyr EHDP was much more potent for the inhibition of
bone resorption than any other compound known at the time. Resort to the specification of the
’406 patent confirms the strikingly greater activity and better therapeutic ratio of 2-pyr EHDP
compared to other known bisphosphonates. Thus, 2-pyr EHDP was certainly a lead compound.
In addition to its lead compormd discussion, the Federal Circuit referred to the structural
differences between the molecules of the two compounds. That discussion is not applicable here.
DE02;611s110.1 0589561021

Case 1 :04-cv—00940-JJF Document 108 Filed 07/12/2007 Page 2 of 2
Youmc CoNAwAv STARGATT & TAYLOR, LLP
The Honorable Joseph J. Farnan, Jr.
July 12, 2007
Page 2
2-pyr EHDP and risedronate are isomers, and a comparison of their structural formulas shows
that they are more closely structurally related than compound b and pioglitazone.
Teva remains available at the Court’s convenience should the Court have any questions
about this or any other aspect of the issues before the Court.
Respectfully submitted,
%a J. {M2
Karen L. Pascale (No. 2903)
ce: Frederick L. Cottrell, Ill, Esquire (by CM/ECF and hand delivery)
Steven J. Fineman, Esquire (by CM/ECF and hand delivery)
William F. Lee, Esquire (by e-mail)
Vinita Ferrera, Esquire (by e-mail)
James Galbraith, Esquire (by e-mail)
‘ DB02:6l18110.1 058956.102l