Free Letter - District Court of Delaware - Delaware

Case 1:04-cv—OO179—SLR Document 137 Filed O1/O9/2007 Page 1 of 2
Rica-1ARz>s, LAYTON 8. FWMGER
A PROFESSIONAL ASSOCIATION
ONE RODNEY SQUARE l
920 NORTH KING STREET .
WILMINGTON, DELAWARE isaoi _
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FM (302} esa-vvon Z
WWW.RLF.COM
January 9, 2007
BY E-FILING and HAND DELIVERY
The Honorable Sue L. Robinson
Chief Judge
U.S. District Court for the District of Delaware ‘
J. Caleb Boggs Federal Building
844 N. King Street
Wilmington, DE 19801
Re: Bayer AG, et al. v. Dr. Reddfs Laboratories, Ltd., et al.,
C.A. N0. 04-0179 J
Dear Chief Judge Robinson:
Pursuant to Local Rule 7.l.2(c), we write on behalf of Plaintiffs Bayer AG, Bayer
HealthCare AG, and Bayer Pharmaceuticals Corporation (collectively "Bayer") to bring to the J
Court’s attention a recent Federal Circuit case which was decided after post-trial briefing was
completed in the above—referenced matter. ln its opening and responsive post—trial briefs, Bayer
cited Eli Lilly & C0. v. Zenith Goldline Phczrrns., Inc., 364 F. Supp. 2d 820 (S.D. Ind. 2005). On
December 26, 2006, the Federal Circuit affirmed the district court’s ruling in that case. Eli Lilly
& Co. v Zenith Goldline Pharms, Inc., —- F.3d --, 2006 WL 3792689 (Dec. 26, 2006). A copy of
the Federal Circuit’s opinion is attached as Exhibit A.
Of particular relevance to this case is the Federal Circuit’s discussion in affirming the l
district court’s ruling that the claims—in—suit were not obvious, located at pages *4-8 of the -
Federal Circuit’s opinion. Discussing with approval its prior decision in Yamanonchi Pharm.
Co., Ltd v. Danbury Pharmacczl, [nc. 231 F.3d 1339 (Fed. Cir. 2000), the Federal Circuit held
that the defendants had not proven that the compound at issue was obvious because, inter alia,
they had not proven that the compound which was the beginning compound of their obviousness
theory would have been a "lead compound" for the person of ordinary skill in the art. Eli Lilly,
2006 WL 3792689 at *6 ("Likewise, in this case, the defendants have not shown that a person
ordinarily skilled in this art would have selected Compound 222 as a lead compound .... "). The I
RLF1-3102326-1 ?

Case 1:04-cv—OO179—SLR Document 137 Filed O1/O9/2007 Page 2 of 2
The Hon. Sue L. Robinson (
January 9, 2007
Page 2 .
Federal Circuit further held that the art in fact taught away from the defendants’ theory, as the art
taught that substituents other than that used in the defendants’ beginning compound were
preferred. Id. (compound defendants started with would not have been "a lead compound
because it contained hydrogen rather than tluorine or chlorine. At the time of invention, the state
of the art would have directed the person of ordinary skill in the art away from unfluorinated
compounds like Compound 222."). The Court also reiterated that merely identifying teachings
in the prior art of the use of particular substituents used in a compound is insufficient to render a
- compound obvious. Id. at *7 ("As taught by Yamcznouchf Pharm C0. and other precedent, mere
identification in the prior art of each component of a composition does not show that the
combination as a whole lacks the necessary attributes for patentability."). (
Finally, in affirming the district court’s rejection of the defendants’ inequitable conduct
charges, the Federal Circuit reiterated that to prove inequitable conduct based on the omission of v
a reference, "the record must contain clear and convincing evidence that the applicant made a {
deliberate decision to withhold a known material reference. Beyond that, the applicant must
have withheld the material subject matter with the intent to deceive." Id. at *9 (citations
omitted).
We thank the Court for its consideration of these matters.
Respectful - submitted,
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Jrivmh p_ . ?
Encl. ‘ · ._ _____,__,.. . A»--ee‘i‘`
cc: Richard L. Horwitz, Esq. (by e-filing and hand delivery)
David E. Moore, Esq. (by e-filing and hand delivery)
RLF1-srozszs-1

Case 1:04-cv-00179-SLR

Document 137

Filed 01/09/2007

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Case 1:04-cv-00179-SLR

Document 137

Filed 01/09/2007

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