Free Letter - District Court of Delaware - Delaware

Case 1 :06-cv-00033-SLR Document 74 Filed 11/17/2006 Page 1 ot 4
w 525.*d,;9;EE€_E€?,l’,En!:..$2P,£i'·i.§,....8_;*;',E’;,ji;`,E,,hl;l"L..
A l W Arronwnvs AT Law .
witnmeron, ne -
The Nemours Building
t007 Noun Orange St.
Arthur G. Connolly, EEI **-9- B=>>< 2207
Pgymgy Wllmlngmfl, DE 19899
TEL (302) ess-eels tru (2022 eee ann
FM (302) 658-¤3¤¤ nun; isozn ess sem
swan. [email protected] WE8; Wwwpcbm cam
xeetv ro Wilmington Ofnce
November 17, 2006
By Electronic Filing
The Honorable Sue L. Robinson
United States District Court
844 King Street
Wilmington, DE 19801
Re: Takeda Pharmaceutical Co. Ltal arial TAP Pharmaceutical Products Inc. v. Teva
Pharmaceuticals USA, Jrtc. and Teva Pharmaceutical Industries, Ltd.,
C.A. No. O6—33»SLR
Dear Chief Judge Robinson:
We represent Plaintiffs Takeda Pharmaceutical Co. Ltd ("Taiceda") and TAP
Pharmaceutical Products lnc. ("TAP") in the above-referenced action. We respectfully submit
this letter in response to Defendants Teva Pharmaceuticals USA, Incfs and Teva Pharmaceutical
Industries, Ltdfs (collectively “Teva") letter dated November 9, 2006. This letter responds to
Part A of Teva’s letter regarding Teva’s Request Nos. 10, 1 l, 15~l9 and 38-39. TAP and Teva
are iiirther discussing the issues raised in Part B of Teva’s letter. Therefore, we do not address
that portion of Teva's letter and ask the Court to allow the parties to resolve these issues.
As an initial matter, Plaintiffs stress that Teva’s inquiry focuses on the ‘098 patent
directed to the compotmd lansoprazole per se, the active pharmaceutical ingredient in Prevacid®.
That patent issued on December 9, l986, while the last of the asserted formulation patents issued
on July 18, l995. Thus, Plaintiffs have already produced R&D documents relating to
lansoprazole dating more than eight and a half years after issuance of the ‘O98 patent. But
Plaintiffs have quite reasonably drawn the line at July 18, l995. `
ln its quest for a theory of obviousness, Teva is engaged in a fishing expedition seeking
to obtain every R&D document, including all tests, data and analyses carried out by Takeda ——
regardless of when they were created. That is simply unreasonable. Just as post-grant testing
and data have no bearing on Takeda’s entitlement to a patent term extension as explained below,
they are similarly irrelevant to any issue raised by Teva. Obviousness is measured at the time the
invention was made —— not two decades after the fact as Teva would have it.
WILMINGTON, me wnsuiueron, oc tos Annales, cn

Case 1 :06-cv-00033-SLR Document 74 Filed 11/17/2006 Page 2 of 4
LAW OFFSCES
Comsveiw Bova Lewes & Herz LLP
The Honorable Sue L. Robinson
November 17, 2006
Page 2
Teva is simiiexiy mistaken in its interpretation ofthe duty of disclosure with respect to
patent term extension proceedings. Teva asserts that "infom1ation that called into question the
veiidiiy of the ‘O98 Patent" would be relevant to the patent term extension proceeding. But the
plain language of the PTO’s wie states that the duty of diseiosure in a patent term extension
proceeding applies solely to "materiel information adverse to zz determination of entitlement to
the extension sought .... " 37 C.F.R. § I.765(e.) (emphasis added). The ruie specifically states
that there is "rzo duty to transmit information which is not material E0 the determination of
emiriement to the extension sought? 37 CBR. § 1.765(b) (emphasis added). The duty of
disclosure does not, as Teva argues, extend to infomation regarding posr—grant testing. See 35
U.S.C. § 156 (2000) (stating the requirements for a patent term extension); 37 C.F.R. § 1.710,
1.720 (same).1
Teva oontlates a patent applicant ’s duty to disclose information materiai to patemability
with aparentee ’s duiy of disclosure of information material to za, deterrninetion of erititiement to
the teym extension sought. Under H&tCh~W&Xm&H, patent term extensions were meant es e
reasonable means for pharmaceutical pateritees to restore some ofthe patent term lost te the FDA
approval process. Extensions were net designed as a vehicle to reopen prosecution em the merits,
re—examine patent validity, or impose on zi patentee an ongoing duty of disclosure of information
material to patentczbiliiy for an aiready issued patent. That is evident from the different language
used by the PTO in its respective regulations. Rule 56 defines 21 pete11tapp1icaz1‘a’s duty of
disclosure as follows: "[e]ech individual associated with the idling and prosecution of a1 patent
application has a duty of candor and good faith in dealing with the Office, which inciudes e duty
to disclose te the Office all information known to that individual to be material to paterzmbiliry
as deHned in this sectio11." 37 C.F.R. § 156(ei) (emphasis added). But for patent term
extensions, the PTO limited the duty of disclosure to "mate=:ial information adverse to a
determination of entirlement to the extension sought .... ” 37 CFR. § 1.765(e) (emphasis
added). This difference in standards is meaningful and consistent with the general purpose of
patent term restoration: “to further encourage new drug research by restoring some ef the parent
term lost while drug products undergo testing and await FSA pre-·me.rket approve}? Glaxo
Operations UK Ltd. v. Quigg, 894 F.2d 392, 396 (Fed. Ci;. 1990) (citing HR. Rep. No. 98-857,
at l4—»l5 (1984), reprinted in 1984 U.S.C.C.A.N. 26-47, 2647-48).
The PTO’s comments in connection with its rulemaking also support this different duty
for patent term extensions. The PTO noted that "Congress expected that it wouid be an
administratively simple proeeedirigf and "[s]i¤ee the determination as to Whether a patent is
I The basic requirements for E1 patent term extension are: (a.) “[t]he patent claims él product or 21 method of using or
manufacturing a prociuct" as defined; (b}"[t}hetem1 ofthe patent has never been previously extended"; (0) a.
compliant application has been submitted; (ci) “{t]he product has been subject to a regulatory review period . . .
before its commercial marketing or use"; (e) "[t]he product has received permission for commercial marketing or
use . . ."; (t) the application is submitted within sixty days ofthe grant of permission; (g) the application is submitted
before the term ofthe patent expires; and (P1) "[n}0 other patent term has been extended for the same reguiatory
review period for the product? 37 C.F.R. § 1.720. There is no requirement concerning patent validity.

Case 1 :06-cv-00033-SLR Document 74 Filed 11/17/2006 Page 3 of 4
Law Orricas
Conuottv Bova Loose & Hur; tra
The Honorable Sue L. Robinson
November 17, 2006
Page 3
eligible for extension . . . may be made solely on the basis of the representations made in the
application for extension, a iinal determination to refuse a patent term extension because of fraud
or a violation ofthe duty of disclosure is expected to be rare." Rules for Extension of Patent
Term, 52 PIR. 9386, 9392 (Mar. 24, 1987). Further, in answering a comment of whether the
duty of disclosure extends to prior art discovered since the issuance of the patent, the Office
simply reiterated the rule: "Section 1.765(b) specifically states that an attorney, agent or patent
owner has no duty to transmit information which is not material to the determination of
enttzf/ernent to the extension soug/u‘." Id (emphasis added). The plain language ofthe rule and
the PTO’s comments support the conclusion that the duty of disclosure for patent term
extensions is limited to information relevant to the requirements ofthe extension, and does not
include, as Teva suggests, a reexamination of patent validity.
Teva’s reliance on Pfizer, Inc. v. Ronbuxy Labs., Ltd, 405 ii`. Supp. 2d ¢i95 (D. Del.
2005), rev ’d in part on other grounds, 457 §.3d 1284 (Fed. Cir. 2006) is also misplaced. First,
the main issue with respect to the patent term extension in Pfizer was whether the patent~at-issue
in fact covered the product, Lipitor®. Id at 511. Here, Teva admits that the extended ‘098
patent covers lansoprazole, the active ingredient in Prevacid®. Second, Ranbaxy argued that the
. patent term extension was invalid because during the term extension proceeding, Piizer failed to
disclose statements made in connection with the prosecution of foreign counterparts and a
subsequent U.S. patent. Id at 512. These statements allegedly related to construction of the
claims ofthe extended patent. The Court evaluated these statements in its claim construction and
found them to be irrelevant to the patent’s scope. Id. at 506. Thus, they were similarly irrelevant
to Piizer’s entitlement to a patent term extension. Id. at 512. Here, subsequent test data
allegedly relating to potentdbility are, oforriori, irrelevant to a Takeda’s entitlement to a patent
term extension.
On a separate note, we write in response to Your Honor’s request at the teleconference
today with respect to Plaintiffs’ discovery of Teva’s Board of Directors meeting minutes. (Doc.
Rec,. No. 34.) We believe that these notes may shed light on Teva’s decision to tile ANDA 77-
255 and its Paragraph IV certification that, in Tevasopinicn, the patents-in-suit are invalid,
unenforceable or will not be infringed by Teva’s proposed lansoprazole product. Accordingly,
these materials squarely pertain to Plaintiffs’ allegations that (i) Teva acted "without a
reasonable basis for a good faith belief that it would not be liable for infringing" the patents—in—
suit and (2) Teva’s disregard of its duty to exercise due care by making baseless assertions of
invalidity. Plaintiffs are not seeking wholesale production of such minutes, only those portions
concerning the ANDA and other issues involved in this case.

Case 1 :06-cv-00033-SLR Document 74 Filed 11/17/2006 Page 4 of 4
L/wv Orsnces
Commottv Bov Loooa & Het; LLP
The Honorable Sue L. Robinson
November E7, 2006
Page 4
Thank you for your consideration.
Respectfully submitted, __V
_’[ /% a //t1///1aaaa/1 . b13a/;1 1a 7//17b14/b_ E RG . »1/1 /1~:7=/ J 7—// · ~//7 t //· »/e/ J /e7/11/b /»~ ’ u /1‘e//
Axthur G. Com1 ily,IIl (#2667) ``J.
ec: Jeffrey D. Blake, Esq.
William F. Cavanaugh, Jr., Esq.
Arlene L. Chow, Esq.
Eric J. Lobenfeid, Esq.
John L. North, Esq.
Karen L. Pascale, Esq.
Chad J. Peterman, Esq.
Stuart E. Pollack, Esq.
Philippe Y. Riesen, Esq.
Jeffrey J. Toney, Esq.
Tedd W. Van Buskirk, Esq.