Free Letter - District Court of Delaware - Delaware

Case 1 :06-cv-00033-SLR Document 72 Filed 1 1/O9/2006 Page 1 of 3
Youno CoNAwAY STARGATT & TAYLOR, LLP
THE Biz-xunvwma Burrorwo
1000 WEST STREET, 17TH Frooiz
KAREN L- PASCALE VVILMINGTON, DEL.-wana 19801 (302) 571*5600
DrRi2crD1AL; (302)57l—500l (302)57l-125312-xx
Dinner mx; (302) 576-3516 p_O_ Boxggl (800)253-2234(DE ONLY)
[email protected] \NrLLiTNoroN, Drar.-xwxruz 19899-0391 )““V-Y9¤¤§°9¤¤‘V¤Ywm
November 9, 2006
By E—FiIi11g
The Honorable Sue L. Robinson
United States District Court
844 King Street
Wilmington, DE 19801
Re: Takeda Pharmaceutical C0. Ltd and TAP Pharmaceutical
Products Inc. v. Teva Pharmaceuticals USA, [nc. and Teva
Pharmaceutical Industries, Ltd, Civil Action No. 06-33-SLR
Pursuant to the Courts order during the September 20, 2006 Discovery Status
Conference (see D.I. 59 at 39-40), Defendants Teva Pharmaceuticals USA, Inc. and Teva
Pharmaceutical Industries Ltd. (collectively "Teva") respectfully submit this letter concerning
the date restrictions imposed by the Plaintiffs in connection with documents produced in the
referenced matter.
A. Teva’s Requests Nos. 10. 11. 15-19 and 38-39
These requests seek documents relating to the research, development and testing of
lansoprazole, the drug at issue in this matter, and related compounds ("R&D Documents").
Plaintiffs produced only documents dated on or before July 18, 1995, the date of issuance of the
last of the patents—in-suit. There are two components to this dispute.
(1) Regarding R&D Documents as a whole, Teva respectfully submits that Plaintiffs
should be required to produce such Documents dated on or before January 6. 1997, the date on
which Takeda was granted a patent term extension on United States Patent No. 4,628,098 ("the
‘098 patent”), which Takeda asserts in this action.
Takeda was subject to a duty to disclose "material information adverse to a determination
of entitlement to the extension sought .... " 37 C.F.R. § 1.765(a); see also Pfizer Inc. v.
Ranbaxv Labs. Ltd., 405 F. Supp. 2d 495, 511 (D. Del. 2005). But for that extension, the ‘098
patent would have expired on July 29, 2005, before this action was filed. If Takeda had
information that called into question the validity of the ‘098 Patent, that patent would not have _
been eligible for the extension: "No patent will be determined eligible for extension and no -
extension will be issued if it is determined that fraud on the [Patent and Trademark] Office or the
Secretary [of Health and Human Services] was practiced or attempted or the duty of disclosure
was violated through bad faith or gross negligence in connection with the patent term extension
proceeding? 37 C.F.R. § 1.765(c).
DB02:56013l4.l 0589561020

Case 1:06-cv-00033-SLR Document 72 Filed 11/O9/2006 Page 2 of 3
Yourvo CONAWAY STARGATT & TAYLOR, LLP
The Honorable Sue L. Robinson
November 9, 2006
Page 2
Takeda argued during prosecution of the ‘098 patent that lansoprazole possessed
"surprising" efficacy that demonstrated that the compound was novel and non-obvious. After the
patents were issued but before Takeda obtained the extension of the ‘098 patent term, however,
Plaintiffs continued to test the compounds described in the ‘098 patent and obtained data that
was inconsistent with those representations. For example, Takeda published at least two articles
in 1996 indicating that the relative efficacy of lansoprazole was much smaller than Plaintiffs
represented to the PTO in connection with prosecution of the ‘098 patent}
Teva respectfully submits that Takeda produce all such Testing Documents, as well as
any documents that contradict or fail to support its assertions, without date restriction.
(2) Teva believes Plaintiffs are likely to rely on research, development, or testing
documents, or underlying data or analysis, that demonstrate the efficacy of lansoprazole
("Testing Documents") as purported evidence of secondary indicia of non-obviousness. Testing
Documents may include testing that compares lansoprazole to other Substituted Benzimidazoles.
Teva submits that Takeda should produce all Testing Documents, even those dated after
July 18, 1995. Moreover, to the extent Plaintiffs are in possession of documents — such as the
two 1996 publications discussed above —— that contradict any assertions of secondary indicia,
Teva submits that Takeda should produce such Testing Documents regardless of date.
B. Teva’s Request Nos. 26. 28 and 43
These requests seek documents concerning TAP’s New Drug Application ("NDA") No.
20-406, including the application file for the NDA and for package labeling, and any
communications with the FDA concerning the foregoing (collectively, "NDA Documents").
Plaintiffs refused to produce documents dated after May 10, 1995, the date of approval of 'l`AP’s
NDA by the PDA.
The NDA was approved months before the last patent issued, and two years before
Takeda sought the patent term extension. As pointed out above, representations to the FDA
concerning efficacy of lansoprazole, whenever made, are relevant to the validity of the patents in
suit. Further, the FDA website contains copies of letters indicating that TAP submitted multiple
amendments and supplements to its NDA and package labeling between 1999-2002. Such
documents are relevant, at least, to the question the issue of secondary indicia of non-
obviousness, such as Plaintiffs’ claims regarding unexpected efficacy of lansoprazole products.
Respectfully Submitted,
jélirp. gg/2234,,, _ _
Karen L. Pascale (#2903)
I Efects of lartsoprazole on indomethacin-induced gastric bleeding and mucosal lesions in rats, Murakami l. et al.,
Nippon Yakurigaku Zasshi , 1996, vol. 108, no. 6, pp. 323-332; Effects of intravenous lansoprazole on acute gastric
mucosal lesions and acid secretion, Murakami I. et al., Japanese Pharmacology & Therapeutics, 1996, vol. 24, no. 8,
pp. 129-144.
ns02;s60r314.1 0ss9s6.1020

Case 1:06-cv-00033-SLR Document 72 Filed 11/O9/2006 Page 3 of 3
Youno CONAWAY STARGATT & TAYLOR, LLP
The Honorable Sue L. Robinson
November 9, 2006
Page 3
cc: Arthur G. Connolly, lll, Esq.
Eric J. Lobenfeld, Esq.
Arlene L. Chow, Esq.
Tedd W. Van Buskirk, Esq.
Phillipe Y. Riesen, Esq.
William F. Cavanaugh, Jr., Esq.
Stuart E. Pollack, Esq.
Chad J. Peterman, Esq.
John L. North, Esq.
Jeffrey J. Toney, Esq.
Jeffrey D. Blake, Esq.
DB02:560l3l4.l 0589561020