Document 239-3
Filed 06/12/2006
Page 1 of 27
EXHIBIT 2
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 2 of 27
IN THE UNffED
STATES DISTRICT COURT
OF DELAWARE
FOR THE DISTRICT
PHARMACIA & UPJOHN COMPANY, Plaintiff, v. SICOR, ~C. and SICOR PHARMACEUTICALS, INC., Defendants. ) ) C.A. No. 04-833-KkT
DEFENDANTS'
RESPONSES
TO
PHARMACIA
& UPJOHN'S
FOURTH
SET OF INTER1ROGATORIES
IINEOUITABLE
CONDUCT CONTENTIONS)
Defendants Sicor Inc. and SICOR Pharmaceuticals, Inc. (collectively "Defendants" or
"Sicoi?, by and throughtheirundersigned counsel,for theirresponses the FourthSet of to
Interrogatoriesby Plaintiff Pharmacia & Upjohn Company L;LC("Plaintiff' or "Pharmacci"),
state as follows:
GENERAL
OBJECTIONS
The following general objections ("General Objections") apply to all of Plaintiffs Interrogatories in this Fourth Set of Interrogatories and are incosporatedby reference into each
speci~eresponsemadeherein. The assertionof the same,similar,or additional objections the or provisionofpartialanswersin the individual responsesto theseInterrogatories not waive does
any of Sieor's General Objections as set forth below:
i.
Defendants object generally to the Interrogatories to the extent that they purport to
imposeburdens or obligationsbeyond'those required by the Federal Rules of Civil Procedure
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 3 of 27
and the Local Rules of Civil Practice
and Proeedure
of the United
States District
Court for the
District of Delaware (the 'Zocal Rules"). 2. Defendants object generally to the Interrogatories to the extent they seek
privileged information, including, without limitation, information which was developed for or in ~inticipation of litigation, orwhich constitutes the work product of counsel or coI~den~ial
attorney-client communications.
3.
Defendants object generally to the Interrogatories to the extent that: (a) they are
overbroad, vague, ambiguous, :indefinite, compound, or cumulative, (b) compliance would be oppressive and unduly burdensome, (c) they are harassin& (d) they seek informati~n that is neither relevant to the subject matter of this litigation nor reasonably calculated to lead to the discovery of admissible evidence and exceed the bounds of the legitimate purposes of discovery; (e) they seek information not in Defendants' possession; and/or (f) they seek information that is equally available to Defendants and Plaintiff. 4. reserving: i) the right to amend or supplement any and all responses or other information provided herein at any thne upon receipt of additiotal
information; and
These responses are submitted without waiving in any way, and on the contrary
(ii)
the right to object on any grounds to the use in evidence or other use of these Responses or other information provided herein in this or any other proceeding by these parties or any other parties or nonparties.
5.
Defendants object to the Interrogatories to the extent they purport to require the
identi~cation of "all" persons or documents relating to broad categories of various subjects on ·aheground that such requests are overly broad ~mduly~burdensome, and not reasonably calculated to leadto `the discovery of admissible evidence. In most cases, it simply is not reasoI~ib~ly possible to search for and identify all such persons and/or documents. Subject to
-2-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 4 of 27
Local Rule 26.1 and without waiving the foregoing, or their other general or specific objections, Defendants will identify and locate after a reasonable search such persons or documents sufficient to provide the information sought.
6. Defendants anticipate that Pharmacia and its agents as well as non-parties
(including the inventors of the patent-in-suit) may have information and/or documents and things in their possession, custody and control that relate to the issues raised by Pharmacia's contention interrogatories. The responses provided to these contention interrogatories at this stage are preliminary, and Defendants expressly reserve the right to supplement each of their responses to each ofPharmacia's contention interrogatories as discovery proceeds.
7.
These General ~bjections and any future responses are made for the sole purpose
of this action. By providing aresponse to these Interrogatories, Defendants do not concede that the information provided is discoverable, relevant, or admissible, and reserve the right to challenge further discovery into the subject matter of any of the individual requests. Defendants also reserve the right to challenge the competency, relevance, materiality, privilege, and/or admissibility into evidence of any documents, information, or material produced in response to these Interrogatories in this or any ·subseqaent proceeding, -or at the trial of this or any other
action.
8.
Responses provided to specific Interrogatories are subject to, and without waiver
of,the General Objections and those specific objections raised with respect to particular Interrogatories. Accordingly, the provision of substantive responses to anyInterrogatory shall
not be construed as an admission or used as the basis for a contention that Plaintiff is entitledto
:any response more specific than that provided.
-3-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 5 of 27
SPECIFIC
INTERROGATORY NO. 20
RESPONSES
AND OBJECTIONS
State in detail all factual and legal bases for Sicor's contentions @led dr unpled) that any individual associated with the filing or prosecution of any patent application underlying the '285 patent violated the Duty of Candor including (but not limited to) the identity of each individual whom Sicor contends violated the Duty of Candor; a description of how each such individual violated the Duty of Candor; the identity of every reference, document, or fact allegedly not disclosed to from the PTO; the identity of every reference, document, or fact allegedly misrepresented to the PTO; the identity of every reference, document, or fact allegedly withheld or effectively withheld from the PTO; a description of how such action(s) or omission(s) violated the Duty of Candor; the identity of all documents relating to Sicor's contentions of any violation 6f the Duty of Candor, and the identity of all individuals with knowledge of any alleged violation of the Duty of Candor.
RESPONSE TO ~ZNTERROGATORY NO. 20
Defendants object to this interrogatory as being ambiguous with respect to the amount of "detail" necessary to comply with this request. Defendants have made a good faith attempt to describe all factual bases of which they are aware at this juncture in the proceedings for their contention that the Duty of Candor was violated with respect to the '285 patent. Defendants
further object to the extent this interrogatoryseeks their contentions of the "law" ofinequitable
conduct as opposed to the application of the applicable law to the factual bases for Sicor's contention that any individual associated with the filing or prosecution of anypatent application underlying the '285 patent violated the Duty ofCandor. Additionally, the legal standards that apply to allegations ofizlequitable conduct are equally available to Pharmacia as to Defendants. Further, as the law on inequitable conduct (and the Duty of Candor) is constantly evolving, Sicor reserves the right to rely on the state of the law as it evolves throughout the litigation, including but not limited to legal developments occurnbg after the close of discovery. Subject:to.and without waiver;of:anv ·of the foregoing objectionslor-the Genersil
Objections, ·atthis time, Defendants respond as follows:
-4-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 6 of 27
Defendants' contentions are set forth in their Amended Counterclaimpreviously filed
with the Court. Defendants reaffirm the contentions set forth therein and set forth further
explanationof those contentionshereinbelow with the expectationthat the following response be read in conjunctionwith that pleading. Furthermore, to aid in Pharmacialsunderstanding of
Defendants' contentions, Defendants have provided document production numbers for various
citations. These document production numbers do not necessarily constitute an exhaustivelist of instances of the cited documents. Moreover, other documents that Defendants have not directly
cited to in this response may further prove or illustrate the factual contentions made herein. At all times during the pendency of a patent application, all individuals associated with the filing or prosecution of a patent application have a duty of candor and good faith to meaninrrfully and truthfully disclose to the U.S. Patent and Trademark Office (hereinaRer'ZT.S. Patent Of3~ce'3material information of which they are aware (the "Duty of Candor''). Each individual associated with the ~ling or prosecution of what ultimately became the '285 patent who was aware of material information was required by U.S. Patent Office practice to submit, or cause-to submit, such information to the U.S. Patent Office as part of an rzlformation Disclosure Statement ('?DS~ as early in prosecution of the '285 patent as it was known. According to 37 C.F.R. Section 1.56(c): Individuals associated with the filing or prosecutionof a patent application withinthe meaning of this section are: (1) Each inventor named in the application; (2) Each attorney or agent who prepares or prosecutes the application; and (3) Every other person who is substantively involved in the preparation or prosecution of the application and who is associated with the inventor, with the
assignee or with anyone to whom there is an obligation to assign
the application.
During the course .ofthe prosecution of the '285 patent Sicor contendsthat:the ''tindividuals"with a Duty of Candor included at'least the named inventors: Gaetano Gatti, Diego
'Oldani, Giuseppe Bottoni, Carlo Confa;lonieri, Luciano Gambini, and Rciberto De Ponti;.and the
-5-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 7 of 27
patent attorneys of record including, but not limited to: Daniel Boehnen, Richard Kelly, and Emily Miao. To date, Sicor has only been able to depose Messrs De Ponti and Gambini regarding their roles in the invention and prosecution of the '2%5patent. Consequently,Sicor's
investigation into these issues is continuing.
Even without all of the depositions, it is still clear that each of the above-mentioned individuals knew that they had a Duty of Candor to the U.S. Patent Of~ce. Each named inventor
executed a "Deccaratton, Power of Attorney and Petition" in which they specifically
ac~owledged, under penalty ofpejury (18 U.S.C. ~1001)"the duty to disclose information material to the examinationof this application in accordancewith Section 1.56Ca) Title 37 of
Code Federal of Regulations." 0014905PU0014907). CPU Surely Boehnen, Kelly, Mr. Mr.
and Ms. Miao are well aware of their Duty of Candor. Mr. BoeZlnen, Kelly, and Ms. Miao Mr.
are eachregistered practicebeforethe U.S. PatentOfficeand as suchtheir actionsin to association the prosecution anypatentapplication governed the Dutyof Candor. with of are by Moreover, membersof the PatentBar, Mr. Boehnen, Kelly,andMs. Miao's actionsin as Mr. association the prosecution anypatentapplication also governed the Cannonsof with of are by Professional Responsibility, codi~edat 37 C.F;R.~10.20et seq.,whichincludesthe admonition that "Ca] practitioner shouldavoideventhe appearance professional of impropriety." Sicoralsopresentlycontends otheragentsand employees that ofPharmaciaactedin
connection with the ~ling and prosecution of the '285 patent and, thus, had a Duty of Candor to
the U.S. Patent Of~ce in association withthe '285 patent. In 1995, notwithstanding the
erpirationof the basic drugpatentsnearly a decadeearlierand onlytwo yearsafterPharmacia ~B -acquired Farmitalia'schemotherapy frandhise(including '285 psitent the rest of drug the and the ·Gatti patentfamily),;4driamydin ·stillone of Phannac'ia was i9B''stop tenproducts. Given
the commerci~ significance of·theiGattipatent family and the '285 patent to the highly
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 8 of 27
profitable continuation of this chemotherapy drug frsmchise, Sicor believes that other individuals were actively and substantially involved in the prosecution of the '285 patent land its siblings, parents and counterparts) as well as the assertions of the Gatti patents throughout the world. Sicor's investigation is still continuing in this regard, but at this time, Sicor contends that other agents and employees having a Duty of Candor with respect to the '285 patent include, but are not limited to: Geof~ey Woods (a European patent lawyer at J.A. Kemp & Co. whom according to Pharmacia's recent discovery letters to Court: is responsible for coordinating worldwide patent prosecution related to the '285 patent and the Oath patent family); Viftorino Ferrario (characterized in Pharmacia's privilege log as an attorney in Pharmacia's Documentation and Patent Department in Milan, Italy); and R Metelli (characterized in Pharmacia's privilege log
as an attorney Pharnacia's Documentation PatentDepartment Milan,Italy). Sicor in and in
believes that the depositions of the named inventors and U.S. prosecuting attorneys Boehnen and Miao will shed light on the specific activities of all of the specifically known individuals as well as the identities of other individuals involved in violating the Duty of Candor to the U.S. Patent Of~ce in association with the '285 patent. For purposes of the Duty of Candor, information is material "where there is a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow
the application to issue as a patent." 37 C.F.R. Section 1.56(b)(1991). In some cases, a stricter
standard of materiality has been cited wherein, information is "material to patentability when it is not cumulative -to information already of record or being made of-record in the application, and (1) It establishes, by itse'lf~r in combination with other Information, a prima ·facie case ofunpatentability ofa claim; or (2) It refutes, or is inconsistent with-a positionthe applicant takes
(i) Opposing:an argument of unpatent~ib;ilit~relied on'by
the Of~ee,-ar
-7-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 9 of 27
O Asserting an argument ofpatentability... 37 C.F.R. Section 1.56(b)(1992).
"
During the course of the prosecution of the '285 patent, ZT.S. Patent Office practice and the Duty of Candor dictated that the Applicants should avoidthe submission of long lists of
references in an IDS, and fUrther that if such a long list of references was submitted, the Applicants submitting the IDS should highlight those references which were known to be of
sign~cance, particularly those references that might refute, or were inconsistentwith, positions
taken by the inventors or assignees, or theii attorneys or agents, before the U.S. Patent Office.
The Duty of Candor further required, among other things, that each Applicant disclose to the U.S. Patent Office material information arising from related foreign applications and related
litigation, and from communications with competitors or other potential i~I~ingers. According to Section 2001.06 of the ~lanuaI of Patent ExamiainP Procedure (MPEP)(emphasis
added):
Such individuals may be or become aware of material information ~om various sources such as, for exa~ple, co-workers, trade shows, communications from or with competitors, poten~ial infringers, or other third parties, related foreign applications (see MPEP Section 2001,06(a)), prior or copending United States patent applications (see MPEP Section 2001.061b~, related litigation (see MPEP Section 2001.06(c)) and preliminary
examination searches.
The Duty of Candor further required ~thatthe Applicants avoid dumping reams of
informationupon the U.S. Patent Office late in the course of the prosecution of fhe '285 patent, which belated dumpinginvolved burying key references within long lists of documentsin hopes
ofbiding information from-the -srttention ofU.S, Patent-O~f~ce.
Based on.discovery to.date, 'Sicor.contends that at bast:Gaetano Gatti, Diego Oldani,
GiuseppeBottoni, ~Carlo Confalonieri, Islciano Gambini,RobertoDe Ponti, Daniel Boehnen, Dr. ·Carlo;Confaloliieri, Vittorino Ferrario j Richard Ke~y, R. Metelli,_ Emily ~liao, ·andGeof~ey
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 10 of 27
Woods eachjointly and severally violated their Duty of Candor to the 'U.S.Patent Office in
association with the '285 patent.
Gaetano Gatti, Diego Oldani, Giuseppe Bottoni, Carlo Confalonieri, Luciano Gambini, and Roberto De Ponti jointly and severally violated their Duty of Candor to the U.S. Patent Office in association with the '285 patent by falsely communicating in the '285 patent
application that actual stability tests had been conducted prior to the ~ing of the priority
document for the '285 patent application (i~e. the UK '452 patent application) for analogous
solutions containing~ either doxorubicinhydrochloride at 5 mg/ml concentration,or 4'-epidoxarubicin, 4'-desoxy-doxorubicin, 4'-desoxy-4'-iodo-doxorubicin, danuorubicin or 4-
demethoxy-daunorubicin, hydrochloride salts, at both 2 mghmland 5 mg/ml. 03eiLjnen as Deposition, 3/1/2006, ~1:19 - 96:7). No stability tests were conducted and no data actually existed at the time of filing for any of the molecules (other than doxorubicinhydrochloride at 1 mg/ml, 2 mgJml and 20 mg/ml). This is particularly and highly material for idarubicin ~i.e.4demethoxy-daunorubicin) hydrochloride and epirubicin ~.e. 4'-epi-doxorubicin)hydrochloside, bath of which are within the scope of the claims of'285 patent. Consequently, Sicor contends that Gaetano Gatti,Diego Oldani, Giuseppe Bottom Carlo Confalonieri,Luciano Gambini, and Roberto De Ponti violated their Duty of Candor to:the U.S. Patent Office by, among other things, knowingly misrepresentingthat they had in fact conducted actual stability testing on idarubicin and epinrbicinmolecules, when in fact at the time of filing of the patent applicationneither the
named inventors nor anyone else at Pharmacia had conducted such stabiltS testing. As a result,
the:inventors were not in actualpossession of the fuillscope of the invention claimed in the '285 patent.at thetime the patent applicationwas filed This niisrepresentationis higlily material to the patent~ibility-oftheclaims of·the ~'285 patent under 35 U.S;C. ~112. Giventhe hig% materia~a~a~a~a~a~a~a~a~a~a~a~. of this misrepresentation,'Sicar dso:believes that one or more patent attorneys Irnew
-9-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 11 of 27
or should have known of this knowing misrepresentation and, thus, violated their Duty of Candor
to the U.S. Patent Of~ce.
Dr. Carlo Confalonieri further violated his Duty of Candor in association with the '285
patent by submittingknowingly false statementsto the U.S. Patent Office regarding the prior art
Wassermann reference. (PI 1190 - PT 1194). In particular, in a declaration dated May 27, 1991 land resubmitted to the U.S. Patent Ofi~ce as an Exhibit to Dr. Confalonieri's December 9, 1992 Declaration ~U 0016632 - PU 0016785)), Dr. Confalonieri falsely stated that Wasserman
provided "no information" that would allow one skilled in the art to produce storage stable
doxorubicin solutions. (PU 0016638 - PU 0016639). Dr. Confalonie~i also falsely stated in that same declaration that "one skilled in the art would not have been lead by the Wassermann
reference to have recognized the unique advantages to be achieved by adjusting Adriamycin [doxorubicin]solutionsto apH of from 2.5 to 5.0 with hydrochloric acid" and that 'Yhereis nothing in Wassermannwhich would suggest that solutions would have long term storage stable
characteristics..;". ~U 0016640 - PU 0016641) Contrary to Confalonieri"s misrepresentations, using the data disclosed in Wassermann and standard chemical kinetics equa~tionsthat were known in the prior art, disclosed by Wasserman and well known to the named inventors (including Dr. Confalonieri), Wassermann
provides all of the information necessary for determiningthe estimated shelf-life stabiIity of
doxorubicin in acidic solution containing hydrochloric acid. (See Expert Report of Douglas S. Clark PhD,:pp. 18-20). Dr. Confalonieri l~new (or should have lolown) -that the degradation of doxorubicin in acidic solution. was described by the kinetic equations disclosed in Wasserman
.andthat the shelf-life (stability) could be readily:estimated~·omtire degradationrate of
aoxorub;idin which, in turn, cocild be rou~tinelycalculated. ~Dr.:Confalonieri's knowledge is evidenced by a declarationhe prepared and s~ibmittea to the Swedish Patent Oftice on December
-10-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 12 of 27
14, 1994 in a foreign application related to the '285 patent. In that Swedish Confalonieri Declaration, Dr. Confalonieri stated that "L~lnpractice the Kobs value [observed rate of degradation for doxorubicin at acidic pH] is calculated on a scientific calculator," that "Ct]his is a routine procedure for those skilled in the art", and that "once Kobs is known the t90 [shelf-life] is lolown" and aclcnowledged that he had been using these standard techniques since before the foreign priority date of the '285 patent. (PU 0028154). Dr. Confalonieri also stated that '"[t]he relationship between reaction rates and temperature is well estabhshed" by the Arrhenius
equation. (PU 0028155). Thus; contrary to the material statements he made in his May 27, 1991
declaration about Wassermann's alleged failure to suggest to one of ordinary skill that Wassermann's solutions would`haue long term storage stable characteristics, Dr. Confalonieri actually knew that storage stability could be routinely calculated on a scientific calculator from the rate equations, rate constant values and activation energy disclosed in the Wassernann reference for the disclosed doxorubicin degradation reaction. Dr. Confalonieri also had lrnowledge of the standard prior art chemical equations for estimating shelf-life of the doxorubicin solution disclosed in Wassernarn. Dr. Confalonieri's misrepresentation to the U.S.
Patent Of~ice of the teachings of Wassermann was highly material. The U.S. Patent Examiner had rej ected the claims over the m7assermann reference, which rejection was only removed because of the arguments supported by Dr. Confalonieri's misrepresentations. Given the high materiality of the misrepresentations, Sicor alsobelieves that one or more patent attorneys knew or should have known of these la~owing misrepresentations and, ·thus, violated their Duty of
Candor-to ·the U.S. Patent Of~ice.
Dr. Carlo ·Confalonieri and ~Mr. Richard ~Ke~lyjointly.ana severally violated their Duty of :Candor to the U;S. Patent Oflice in -assodiation with the`'285 patent by submitting ~knowingly false comparative testing data ~to U.S. Patent Cfhce2 regarding the prior art Wassermann the
-I~-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 13 of 27
reference. Based on the submission of false comparative data prepared at the direction of at least Dr. Confalonieri, in an Amendment and Communication signed by Mr. Kelly and submitted to the U.S. Patent Office on January 6, 1993, (PU 0014992 - PU 0015000), Phannacia further misrepresented that Wassermann's teaching of an aqueous doxorubicin solution adjusted to a pH of 2.13 with hydrochloric acid had storage stability inferior to the claimed invention. In particular, Mr. Kelly compared data in Exhibit C of tab 2 of the Confalonieri Declaration ~U 0015197 - PU 0015201) to support the conclusion that cloxorubicin hydrochloride solution which
has its pH adjusted to 2.5 with hydrochloric acid has superior storage stability to doxorubicin
hydrochloride solutions whose pH has been adjusted to 2.0 with hydrochloric acid. (PU 0014997 - pU 0014998). Yet, upon close examination of tab 2 within that Exhibit C the only data set forth for pH 2.0 and 2.5 were for aqueous solutions ofdoxorubicin adjusted with-glycine-~a~ a physiologically acceptable buffer, not a physiologically acceptable acid tin particular, HCI
(hydrochloricacid)) as argued to the U.S. Patent Office. This false comparative data and the
false conclusions resulting there~om, which allowed Pharmacia to improperly overcome the rej ection of the claims over the m7assermann prior art, are highly material, particularly given the distinctions that Pharmacia drew prior to this submission and throughout the patent prosecution between using unpatentable buffers to adjust the pH of the solution and the allegedly unexpected properties provided bythe claimed invention of using only acids to adjust the pH of an aqueous doxorubicin solution. Given the high materialityof this violation of the Duty of Candor, Sicor also believes that additionalpatent attorneys knew or should have hnown of these prior false testing data and misrepresentations, but violatedtheir Duty of Candor to'the U.S. Patent Office by failing to affinnatively~ing
~f~the U;S. Patent iOffice.
.at least this prior Yiolation-of the Duty of Candor to the attention
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 14 of 27
Daniel Boehnen, Dr. Carlo Confalonieri,Vittorino Ferrario, Richard Kelly, R Metelli, Emily Miao, and Geo~fli·ey Woodsjointly and severally violated their individual Duties of Candor to the U.S. Patent Office in association with the '285 patent by failing to timely disclose
material information associated with the related Australian patent i~ingement accusation and
litigation. InAugust 1991,Farmitalia sought assurances from Upjohn that its dealings with Delta West would not i~inge Australian Patent No. 598,197 (the "australian '197 Patent") to which Upjohn wrote Farmitalia on February 7, 1992, stating that each of the claims of the Australian '197 Patent was invalid based on a non-exhaustive list of sixteen (16) publications
and nine (9) patent publications. CPU0034802 - PU 0034803). (The Australian '197 Patent also claims its priority ~om the UK '452 Application and thus, has the same written description as the '285 patent, making it another related foreign application to the 2285 patent). Both Fannitalia and Upjohn are predecessors-in-interest to Pharmacia, becoming part ofPharmacia during the prosecution of the '285 patent. Yet no one involved in the prosecution of the '285 patent disclosed this hirrhlv material Upjohn invalidity letter to the U.S. Patent Office during the prosecution ofthe '285 patent.
Mr. RichardKelly was clearly aware of the existence of this February 1992 Upjohn
invalidity letter. During the prosecution of U.S. Patent No. 5,124,3 17 (the "'3 17 patent", which is -the parent patent of the '285 patent), Mr. Relly supervised his associate's attempt to submit to the U.S. Patent O~Bcethe Upjohninvali
consideredthe Upjohn invalidityletter before issuing the '317,patent, yet Mr. Kelly did nothing
to withdraw '317 patentfromissuance. @efenaanf'sExhibitNo.91 at RidhardKelly's the
11/21)/05 Deposition). iMoreover, one:ever (inclui~ing-but no not'limited to Mr. Kelly, Mr.
Boehnen and Ms. Miao):associated with the prosecution ofthe '285 patent submitted the
-13 -
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 15 of 27
February 1992 Upjohn invalidity letter to the U.S. Patent Off~ce in connection with the prosecution ofthe '285 patent.
Daniel Boehnen, Dr. Carlo Confalonieri,Vittorino Ferrario, Richard Kelly, R. Metelli, Emily Miao, and Geoffrey Woodsjointly and ·severallyviolated their individual Duties of Candor to the U.S. Patent Of~ce in associationwith the '285 patent by burying the U.S. Patent Examiner with an exceedingly long list of prior art references - two hundred and twenty-eight
(228) separate references -- on July 1, 1998 ("Ninth Supplemental Information Disclosure Statement'3(PU 0015323 - PU 0015339) including many references at issue in the related ~ustralian litigation, which had been settled almost three years earlier. Moreover, this Ninth Supplemental information Disclosure Statement was ~led after the'U.S; Patent Examiner had
already given Phannacia indication theclaims the '285patent an that of application were
allowable, knowing full well that at this late stage of the prosecution, and after six years of dealing with the '285 patent application, the U.S. Patent Examiner would give this new
information little or no scrutiny. Some ofthe references cited for-the first time that would have
beennaterial
to the patentabilityofthe
claims of the '285 patent, but were buried in the list of
two hundred and twenty-eight (228) late-~ed references, were: Sv. Aage Schou ~ V. Gaun Jensen (1959) (PU 0076838 - PU 0076840); J. Windheuser (1963) (SICOR-PNU 006409 SICOR-PNU 006416); E. Sandell (1967) ~U 0076858 - PU 0076860); K. liver (1971) CPU 0076829 -PU 0076834); Lachman (1976 edition) CPU0011777 - PU 0011809); Mori et al.
(1980) (Plaintiffs ExhibitNo. 64 at Doug Clark's 11/1/05 deposition). Five of these references (Schou, Windheuser, Sandell, liver andlachman) contradictedPharnacia's seriatim arguments -forpatentabilityregarding Mihat df.ordinary skill would have understood regarding, among one other things, (a) differences`betweenacids.andbuffers in sdlution;:Cb) prior art sdlutionsnot being ·ailjusted with hydrocfiloric acid las claimed),~but instead adjusted with -buffers;and (C)
- I~t-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 16 of 27
using a buffer instead of an acid to adjust the pH of a solution above about pH 2. Mori discloses stable solutions of anthracyclineglycosides. Hence, in addition to violating their duty to timely submit references and to Idghlightthose references which were known to be of significance, these individuals also violated their duty to correct earlier inconsistent arguments refUtedby these late ~ed references. Con~ary to that duty, Mr. Boehnen and Ms. Miao, among others,
elected to remain silent about the inconsistencies and buried these five references.
Pharmacia' s privilege log produced in this litigation shows that Dr. Confalonieri, Vittorino Ferrario, Richard Kelly and R. Metelli were significantly involved in at least the related Australian litigation. Notwithstanding their Imowledge of the related Australian litigation and its significance, and the high materiality of the expert analyses, prior art references and opinions expressed therein, Dr. Confalonieri, Vittorino Ferrario,·Richard Kelly and R. Metelli still
~owingly failed to disclose to the U.S. Patent Office:
(1) the analyses of two experts in the pharmaceutical field, Dr. William'Neil Charman ~U 0011682 - PU 0011717) and Mr. Rabert Laurence Weston (PU 0014464 0014491), that find and explainin detail that the claims of the Australian '197 Patent are invalid in view of many of the same references set forth in Upjohn's February 1992 invalidityletter, and
(2) at least a half-dozen of the references that were raised during the related Australian litigation.
The Charman and Weston expert reports ~filedchrtlng the related Australian litigation werehi~vmaterial. For example, paragraphs 80-~T ofDr. Charman's report discuss the
fnethod ~bywhidh Dr.:Charman gra~hea -the data (see ·Exhibit WNCIO) provided ·in Wassermann (1983) i(PI 1190 - pi 1193) and two other prior art references ~ewska (PU 0063154 - PU
-aS-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 17 of 27
0069162) and Benvenuto ~U 0008943 - PU 0008947), which information would have enabled a person skilled in the art in 1985 to make the anthracycline glycoside solutions of either doxorubicin or idarubicin in a pH range of approximately 2.5 to 5. This aspect ofDr. Charman's withheld report directly contradicts the sworn statements in the Confalonieri Declaration concerning Wassermann ~It is my opinion that Wassermann provides no information which
wouldallowone skilledin the art to producea storagestableAdriamUcin solution.)? (PU
0015199). Notwithstanding Dr. Channan's April 1995 report which refuted and is inconsistent with the position statements in the Confalonieri Declaration, Pharmacia's patent lawyers, Daniel Boehnen and Emily Miao, resubmitted that same Confalonieri Declaration on July 12, 1996 (PU 0015155 - PU 0015168; PU 0015197 - PU 0015201), to oppose the U.S. Patent Examiner's argument of.unpatentability, without ever providing Dr. Charnan's report to the U.S. Patent
Examiner.
Among the half-dozen references that Dr. Confalonieri, Vittorino Ferrario, Richard Kelly and R. Metelli failed to disclose from the related Australian Litigation to the U.S. Patent Of~ee
was the complete copy of portions of Lachman, The Theory and Practice of Industrial Pharmacy
(2"dEd. Lea & Feb-iger 1976)~U 0011812- PU 0011860) producedas exhibitWNCSto Dr.
Charnan's expert report (PU 0011695). While Applicants did disdlose a number of selected
pagesfromthe 3'd Edition(1986)of Lachman, third editionwas not priorart to the '285 that
patent and, more importantly, the omitted pages taught, among other things, the potentially deleterious effect a buffer could have on the stability of a ~nal drug product and the experimental method whereby one of ordinary skill in the art would identify buffers having stlch.an effect.
Anoth-er.ofthe material, non-cumulativ~ references ·that Dr. Confalonieri, Vittorino Ferrario,
Richard ~lly
and R. Metelli failed to disdlose from the Tdatea Austrdlian ~Z;itigation the U.S. ·to The ~Y1S
Patent Office during the ~osecution of:the '285 patent was U.S. Patent No.4,310;515.
- 1:6 -
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 18 of 27
patent was discussed in Dr. C~arman's expert report (PU 0011704~. In particular, the '515 patent disclosed an injectable, water-based solution having a pi-I in the range of2.3 to 2.7 adjusted and stabilized by the presence of the appropriate amount ofhydrochloric acid, not a
buffer.
Sicor believes from their late submission of so many of the prior art references underlying the related Australian litigation that Mr. Boehnen and Ms. Miao were aware or should have been aware of the related Australian litigation. Because Sicor has not been allowed to depose n~. Boehnen or Ms. Miao it does not lonow when they became aware of the related Australian litigation, but given that the withheld Australian references refuted earlier arguments supported by Mr. Boehnen, these lawyers also violated their duty to correct earlier inconsistent arguments refutedby these expert reports. Contrary to that duty, Mr. Boehnen, and;Msz Miao, among others, elected to remain silent. Finally, Sicor's investigation is still continuing on whether Daniel Bo~hnen and Emily
Miao further violated their individual Duties of Candor to the U.S; Patent O~Btice in association
withthe '285 patent by intentionally misrepresenting the true scope and teachings of the Janssen reference (PU 0013746 - PU 0013756) at page 4 of an Amendment signed by Mr. Boehnen on or about May 6, 1997 ~U 0015277 - PU 0015281). Sicor believes that the depositions of the named inventors and U.S. prosecuting attorneys Mr.'Boehnen and Ms. Miao will shed light on
this issue.
INTERROGATORY'NO.
21
State in detail all factual and:legal bases for Sicor's contentions @led or unpled) that any individual associated with the filing or prosecution of any patent application underlying the '285 patent.intended to -;violatethe Duty of Candor indluding (but not limited to) the identity of eac~
individ~il·whom ·Sicor.contends intentiona~y -vidlated:the Duty of Candor; -a.description how of
.each such individual intended to vio:late the Duty ofiCandor; ·the identity of.~ill evidence.of:an intent to vidlate the Duty of Candori :the:identity ·of~all documents ~ating to or concerning any
- 17-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 19 of 27
contention of any intentional violation of the Duty of Candor, and the identity of all individuals with l~nowledge relating to or concerning any alleged intent to violate the Duty of Candor.
RESPONSE TO INTERROGATORY NO. 21
Defendants object to this intenrogatory as being ambiguous with respect to the amount of "detail" necessary to comply with this request. Defendants have made a good faith attempt to describe all factualbases of which they are aware at this juncture in the proceedings for their contention that the Duty of Candor was violated with respect to the '285 patent. Defendants fUrther object to the extent this interrogatory seeks their contentions of the 'law" of inequitable conduct as opposed to the ayplication of the applicable law to the factual bases for Sicor's contention that any individual associated with the filing or prosecution Of any patent application underlying the '285 patent intentionally violated the Duty of Candor. Additionally, the legal standards that apply to allegations ofinequitable conduct are equally available to Phanzlacia as to Defendants. Further, as the law on inequitable conduct land intent to violate the Duty of Candor) is constantly evolving Sicor reserves the right to rely on the state of the law as it evolves ~throughoutthe Litigation, including but not limited to legal developments occurring after the close of discovery. Subiect to and without waive of any of the foregoing objections or the General Objections, at this time, Defendants respond as follows:
The "intent to deceive" reqt~ired to prove inequitable conduct need not be proven by
direct evidence. It canbe established based upon the inference created by the totality of circumstances surrounding an applicant's conduct, and is most often proven:by a showing of acts, the natural consequences of which:are presumslb!y intendedby the actor. So, while -intent cannot be simply presumed fiom materiality, the degree ofmaterialitv of.awitbheld reference or misstatement may lead to .an infernce of intent In the absence of a credible good faith .e~Iilanatioa
-a8-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 20 of 27
A credible good faith explanationrequires more than a mere denial ofany intent to
mislead Moreover, affirmative misrepresentations -- which comprise a significant aspect of the
violation of the Duty of Candor in this case - are typieany accorded a relatively high degree of
materiality, ~om which intent may easily be inferred. Each of the violations of the Duty of Candor set forth in interrogatory No. 21 involved a
significantto very high degree of materiality. Some of the violations further involved af~firmative misrepresentationsof the existence of experimentaldata, the conduct of experiments and general teachings in the art. An Examiner would be unable to satisfactorilyinvestigate these aspects of a prosecution and ~e~uently relies upon the candor of patent applicants. Yet, as discussed above, various individuals including~ainiel Boehnen,Dr. Carlo ConfB~onieri, Vittorino Ferrario, Richard Kelly, R Metelli, EmilfrMiao, and Geoffrey Woods withheld
material information, mischaracterized information and delayed the disclosure of other
information. None of these improprietiesis particularly surprisingin view of the value of
Pharnacia's hi~zlypro~tablechemotherapy ~anchiseandits statedmotivation keepthat drug to
~anchise running beyond the expiration date of the basic patents. The high materiality of the vio~atiansas well as the totality of the circumstances leads to the clear and convincing conclusionthat a plurality of the actors identified above each had an intent to deceive the U.S. Patent Office in order to obtain the '285 patent land the other U.S. patents in the Gatti family).
n\TTERROGATORY NO. 22
State in detail all factual and legal bases for Sicor's contentions @led or unpled) that the ''285:patent is unenforceable including (but not limited to) the identity of each individual whose acts or:omissions Sicor contends render the "285patent unenforceable; a description of each act
or omission that Sicor contends renders the-'285 patent unenforce~ble; -the identity of all
documentsrelating to any acts or omissions'Sicor contendsrender ~the:(285 patent unenforceable; .andthe identity of.allinditiiduals with knowledge:relating -to:or concerning any alleged acts or
omissions:Sicor contends render-the"285 patent :unenforceable.
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 21 of 27
RESPONSE
TO INTERROGATORY
NO.
22
Defendants object to this interrogatory as being ambiguous with respect to the amount of "detail" necessary to comply with this request. Defendants have made a good faith attempt to describe all factualbases of which they are aware at this juncture in the proceedings for their contention that the '285 patent is unenforceable. Defendants further object to the extent this interrogatory seeks their contentions of the "law" of inequitable conduct as opposed to the application of the applicable law to the factual bases for Sicor's contention that the '285 patent is unenforceable. Additionally, the legal standards that apply to allegations ofinequitable conduct are equally available to Pharmacia as to Defendants. Further, as the law on inequitable conduct land unenforceability) is constantly evolving, Sicor reserves the right to rely on the state of the
law as it evolves throughout the litigation, including but not limited to legal developments
occurring after the close of discovery. Sicor further objects to Interrogatory No. 22 as being duplicative of Interrogatory No. 21. Subject to and without waiver of any of-the foregoing objections or the General Objections, at this time, Defendants respond as follows:
The '285 patent is unenforceable as a result ofanv one of the plurality of intentional
violations of the Duty of Candor set forth above. The people with knowledge of the acts described:herein include, among others: Daniel Boehnen, Dr. Carlo Confalonieri, Vittorino
Fer;ario, Richard Kelly, R Metelli, Emily Miao, and Geof~ey Woods. Sicor has not yet had the
opportunity to depose.any of these individuals due to the Protective Order Pharmacia sought to protect its lawyers, and due to serious discovery deficiencies in Pharmacia'sproduction .delayed the depositions of the +emaining ·named:inventors, including Dr. Confalonieri. that
-20-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 22 of 27
ASHBY
gt GEDDES
steven J. B~ck (I;D. #2114) John G. Day (I.D. #2403) Tiffany Geyer Lydon O.D. # 3950)
222 Delaware Avenue,17" Floor
P.O.BoxllSO
Wilmington, DE 19899
302-654-1888
Attonteysfor Defendants Of Counsel:
Reid Ashinoff David R. Baum
SONNENSCHEIN 1221 Avenue NATH $ ROSENTHAL ofthe Americas LLP
New York, New York 10020
(232) 768-6700 Dated: April 11, 2006
168460.1
-21-
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 23 of 27
CERTIFICATE
OF SERMCE
I hereby certify onthe 11"dayofApril,2006,theattached that DEFENDANTS"
RESPONSES TO PHARMACIA & UPJOHN'S FOURTH SET OF INTERROGATORIES
(INEQUITABLE
of record
CONDUCT CONTENTIONS)
and in the manner indicated:
was served upon the below-named counsel
at the address
Jack B. Blumenfeld, Esquire
Morris, ~ichols, Arsht & Tunnell
1201 North Market Street
HAND DELIVERY
P.O. Box 1347
~ilmington, DE 19899 Joshua R Rich, Esquire McDonnell Boehnen Hullrert & Berghoff VLA ELECTRONIC MAIL
390 SouthWackerDrive
Suite 3200
Chicago, IL 60606
- g~
Steven J.
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 24 of 27
IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE
PHARMAC~A & UPJOHN COMPANY, Plaintif~
v.
)
C.A. No. 04-833-KkT
SICOR nNC. and SICOR
PHARMACEUTICALS, ING,,
Defendants.
NOTICE OE"SERVICE
Theundersigned hereby certifies on the 1Ithdayof April,2006,DEFENDANTS' that
RESPONSES TO PHARMACIA & UPJOHN"S FOURTH SET OF INTERROGATORIES
~NEQUITABLE
CONDUCT
CONTENTIONS)
was served upon the following counsel of
record at the address and in the manner indicated:
Jack B. Blumenfeld, Esquire Morris, Nichols, Arsht & Tunnell
1201 North P.O. Box Market 1347 Street
HAND DELIVERY
PTilmington, DE 19899
Joshua R. Rich, Esquire
McDonnell Boehnen Hulbert & Berghoff
300 South Suite 3200 Wacker Drive
VIA ELECTRONIC MAIL
Chicago, IL 60606
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 25 of 27
ASHBY
& GEDDES
/S/ Steven J. Balick
Steven J. Balick (LD. #2'114)
John G. Day (I.D. #2403)
Tiffany Geyer Lydon (LD. #3950) 222 Delaware Avenue, 17" Floor
P.O. Box 1150
Wilmington, DE 19899
302-654-1888
sbalick(i~ashbv-ne~des.com idav~i~,,ashbv-aeddes,con tlvdoncii~,,ashbv-nedds .com Attomeysfor Defendants OfCounsel:
Reid David Ashinoff R. Baum
Michael S. Gugig
Mirella Moshe Siskindovich Sonnenschein Nath & Rosent~al
1221 Avenue ofthe Americas
LLP
New York, New York 10020
(212) 768-6700
Dated: April 11, 2006
149886.1
Case 1:04-cv-00833-KAJ
Document 239-3
Filed 06/12/2006
Page 26 of 27
CERTIFICATE
OF
SERVICE
I herebycertifythat on the 1Ithdayof April,2006,the attached NOTICEOF SERVICE
was served upon the below-named counsel of record at the address and in the manner indicated:
Jack B. Blumenfeld, Esquire
Morris, Nichols, Arsht & Tunnell
1201 North Market
P.O. Box 1347
HAND DELIVERY
Street
Wilmington, DE 19&99
Joshua R. Rich, Esquire McDonnell Boehnen Huroert & Berghoff
300 South Wacker Drive
VIA ELECTRONIC MAIL
Suite 3200
Chicago, IL 60606
is/Steven
J. BaEick
Steven J. Balick
Case 1:04-cv-00833-KAJ Document 239-3 CM/ECFLNE - U.S. District Court:ded Discovery Documents
Filed 06/12/2006
Page 27 of 27 Page 1 of 1
i:04-cv-00833-KAJ
Pharmacia & UDiohn v. Sicor Inc.. ct al
U.S. District
District
Conrt
of Delaware
Notice ofElectronic Filing The following transaction was received ~omBalick, Steven entered on 4/11/2006 at 11:19 PM EDT and
filed on 4/11/2006
Case Name:
Case Filer: Number:
Phannacia & Upjohn v. Sicar Inc., ct al
1:04-cv-833 Sicor Inc.
Sicor Pharmaceuticals
Document ]occket Number: Te9t: 220
Inc.
NOTICE OF SERVICE ofDefendants' Responses to Pharmacia & Upjohn's Fourth Set of Interrogatories Ohequitable Conduct Contentions) by Sicor Inc., Sicor Pharmaceuticals Inc..(Balick,
Steven)
The followingdocument(s)are associatedwith this transaction:
Document description:Main Document Original filename:n/a
Electronic document Stampr
[STAMP dcecf;Stamp_I~~=1079733 [Date=L/11/2006] FileNumber=l 98784-0] 196 [49296bf/293 373 160b3 el 9b39792e4baec267b067c626a62963 ff4db5 891 f6ecd784
i~2340e9ecb4aa7890d7c5 ab51197521 5430195 aff9;88f66f4a7a291 530f8]1
1:04-cv-833 Notice will be electronically mailed to: Steven J. Balick [email protected], [email protected]; [email protected]; ~ioravanti@ashby-geddesicom; nlopez@ashby-ged~es.com; [email protected]; [email protected]; [email protected] John G. Day [email protected], [email protected]; [email protected]; dfioravanti@ashby-geddes .com; nlopez@ashby-geddes,com; tlydon@ashby-geddes .com; [email protected]; [email protected] Maryellen Noreika [email protected]
by other means to:
1:04-ev-833 Notice will be delivered
https:/eecfded.uscourts. gov/cgi-bin/Dispatch.p1?83 842970263 3919
4/11/2006
United States Free Forms
Canada Free Forms
United Kingdom Free Forms
Australia Free Forms