Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_03-cv-00597/USCOURTS-azd-2_03-cv-00597-2/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 35:271 Patent Infringement

---

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

WO

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

Bard Peripheral Vascular, Inc.; David

Goldfarb, M.D., 

Plaintiffs, 

vs.

W.L. Gore & Associates, Inc., 

Defendant. _________________________________

W.L. Gore & Associates, Inc.,

Counterclaimant,

vs.

Bard Peripheral Vascular, Inc.,David

Goldfarb, M.D., and C.R. Bard, Inc.,

Counterdefendants.

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

)

No. CIV 03-0597–PHX-MHM

ORDER

Defendant W.L. Gore & Associates, Inc. ("Gore"), has filed a renewed motion to

pierce the privilege/work product claims relating to the work of Dr. J.G.R. Volder. (Doc.

324). Plaintiffs (collectively referred to as "Bard") have filed a response opposing the motion

(Doc. 325) and Gore has filed a reply. (Doc. 326). The parties have provided supplemental

briefing by way of Bard's sur-reply (Doc. 327) and Gore's response to Bard's sur-reply. (Doc.

328). The Court has considered all briefing filed by the parties. The Court heard oral

argument on Gore's renewed motion on May 12, 2006 and now enters this Order.

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 1 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 2 -

By way of background, Gore as part of its counterclaim has asserted that the Goldfarb

patent is unenforceable as a result of alleged inequitable conduct during the patent

application process. Gore alleges that this inequitable conduct includes knowingly and

deliberately failing to name the proper inventors in at least some claims of the Goldfarb

patent application. In an Order dated March 25, 2004 (Doc. 91), the Court granted in part

Gore's motion to compel discovery regarding the inventorship issue within the time frame

of a September 9, 1974 meeting allegedly held to discuss the identity of the inventor through

October 24, 1974, the date of the patent application. 

In an Order filed September 30, 2005 (Doc. 311), the Court considered Gore's motion

to expand the scope of the waiver and pierce the privilege/work product immunity on the

issue of inventorship. As discussed in that Order, Gore had developed the ePTFE tubes and

was engaged in research with surgeons across the country to develop the tubes for use as

vascular grafts. The surgeons Gore supplied with ePTFE tube samples included Dr. J.G.R.

Volder of the University of Utah and Plaintiff Dr. Goldfarb of the Arizona Heart Institute

("AHI"), among others. According to Gore, Dr. Volder's work involving the ePTFE tubes

began in 1972 and in November 1973 Volder published an article that described his work.

In mid-1974, several present or former Gore and AHI employees formed a new company to

manufacture and sell ePTFE vascular grafts in competition with Gore. These persons

included Drs. Goldfarb and Volder, among others, and this new company was initially known

as Impra, now known as Bard Peripheral Vascular, a Plaintiff in the present action. (Doc.

311, at pp. 14-15). 

Gore contends that Dr. Volder achieved successful results with other ePTFE tubing

before Dr. Goldfarb and that Volder's work was recorded in a laboratory notebook. A copy

of Dr. Volder's notebook was entrusted to Impra's then attorney, Samuel Sutton, but the copy

of the notebook was allegedly "destroyed" or "discarded" by Mr. Sutton between 1989 and

1995 in conjunction with Mr. Sutton's winding down of his legal practice. Gore contends

that at a meeting in September 1974, Dr. Goldfarb allegedly was "elected" inventor and that

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 2 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 3 -

Plaintiffs suppressed Dr. Volder's notebook from the U.S. Patent and Trademark Office

("PTO"). 

Previously before the Court was Gore's motion to expand the scope of the waiver from

the original time frame of the September 9, 1974 meeting to the October 24, 1974 patent

application to further include May 1974 through issuance of the patent in August 2002. Gore

sought an Order compelling Bard to produce all documents relating to Dr. Volder withheld

on the basis of attorney-client privilege or attorney work product. The Court determined in

the September 30, 2005 Order that on the basis of the record then before it, Gore had failed

to make a sufficient showing to invoke the crime-fraud exception. Gore also had not made

a sufficient demonstration by an adverse party of substantial need for the materials and

undue hardship in obtaining the substantial equivalent of the materials by other means. The

Court found it significant that Dr. Volder had not taken any steps to withdraw his 1974

statement that Dr. Goldfarb was responsible for the invention or to withdraw or recant his

1976 affidavit to that effect filed with the PTO. Dr. Volder also had not made a formal claim

of inventorship in legal proceedings. In addition, Gore had not provided sufficient

information as to the nature or extent of Dr. Volder's "serious health crisis" that allegedly had

occurred during the year preceding September 2005. The Court therefore denied without

prejudice Gore's motion for production of the withheld documents relating to Dr. Volder.

The Court did find that Gore had shown a sufficient basis for a limited expansion of the

waiver to include the time frame of June 1974 to September 9, 1974 based on the deposition

testimony of Messrs. Mendenhall and Sutton regarding a meeting and investigation on the

issue of inventorship that occurred in or about June 1974.

Gore has now filed a renewed motion seeking an Order to compel Plaintiffs and their

attorneys to produce all documents referring to Dr. Volder which have previously been

withheld on grounds of work product and/or attorney-client privilege. Gore re-asserts that

Dr. Goldfarb was chosen the inventor because he was the "safest" choice, that is, he was

considered the one with the least chance of an ownership claim by a previous employer. In

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 3 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 4 -

contrast, Harold Green, who became President of Impra, was ruled out due to his ties with

Gore. Dr. Volder at the time had an employment contract with the University of Utah. 

Gore argues that Dr. Volder's notebook contained fairly accurate and complete records

of his conception, reduction to practice and diligence relating to artificial blood vessels and

that Mr. Sutton has confirmed that the notebook contained detailed and fully witnessed

entries which evidence Volder's work on expanded ePTFE structures dating back to the early

1970's. Dr. Lenox Baker, then chairman of Impra, testified in 1979 that he had seen and

"thumbed through" a book of experimental data that has been alleged to be Dr. Volder's

logbook. Gore also cites statements made on behalf of Impra in 1980 litigation and by

Impra's counsel in 1978 regarding Dr. Volder's alleged "better" right and claim to the

inventorship. Gore cites a statement by Mr. Sutton in a 1980 letter that it was his

understanding that the content of Dr. Volder's notebook was instrumental in precipitating

Impra's decision to stop paying royalties on Dr. Goldfarb's alleged invention and to

reassigning the patent application back to Goldfarb. Gore also points to hearsay testimony

from the deposition of Dr. John Johnson in 1978, when Johnson was a director of Impra, that

Dr. Volder had expressed the opinion that Volder was the true inventor of the graft. The

Court discussed in some detail in its previous Order of September 30, 2005 statements,

affidavits and deposition testimony of others associated with Impra, Bard and Gore over the

course of many years regarding the claim or repudiation of Dr. Volder as the true inventor.

As mentioned above, the copy of the notebook entrusted to Mr. Sutton has been

"destroyed" or "discarded." In addition, it appears that Dr. Volder, who presently lives in the

Netherlands, has provided to Gore's counsel "all documents that [Volder] had in his

possession relating to e-PTFE vascular graft work in the United States in the 1970's." (Doc.

311, at p. 17). The alleged notebook was not among these documents. Gore has attached to

its present renewed motion as Appendix A an excerpt from Plaintiffs' privilege logs that

shows some thirty documents that have been withheld and which are the subject of Gore's

renewed motion. Gore also notes that commencing in October 1996, one of Plaintiffs'

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 4 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 5 -

attorneys (Mr. Polese) had written to Dr. Volder and asked for access to the notebook from

Mr. Sutton. 

Gore contends in support of its renewed motion that it made attempts to procure Dr.

Volder's testimony but was unsuccessful. Gore contends that Dr. Volder became seriously

ill following a series of alleged threatening communications from one of Plaintiffs' lawyers.

Gore has submitted a medical certificate from Dr. Volder's physician stating that as of

October 2005, Dr. Volder is not able to assist in this action due to illness. Gore also contends

that Mr. Sutton destroyed the best evidence of Dr. Volder's early work and that Plaintiffs

should not be permitted to benefit from that destruction. 

In their response opposing Gore's renewed motion, Plaintiffs contend that the medical

certificate Gore has submitted is a conclusory, one-sentence "medical statement" which is

unsupported. Plaintiffs further argue that Dr. Volder was available during the fact discovery

period but Gore did nothing to obtain his testimony. Plaintiffs point out that Gore hired

Dutch counsel to speak with Dr. Volder, Gore's general counsel interviewed Dr. Volder

several times, Gore received historical documents from Dr. Volder, and that Gore has paid

Dr. Volder $10,000.00 to act as a "consultant." According to Plaintiffs, Gore has claimed

that its conversations with Dr. Volder are privileged and not discoverable. Plaintiffs have

challenged Gore as waiting until Dr. Volder allegedly became "unavailable" as justification

for its attempt to gain access to Plaintiffs' attorney work product. Plaintiffs also contend that

Gore had the opportunity to obtain from Dr. Volder a prior signed statement or affidavit

attesting to his claim as true inventor but failed to do so. Plaintiffs argue that Gore knew

about the "destruction" of the copy of Dr. Volder's notebook long ago but did nothing about

it, including asking Dr. Volder for the original. Plaintiffs point out that Gore claimed that

Peter Cooper was the inventor during the twenty-year interference before the PTO. 

Plaintiffs state that some twenty of the withheld documents have not been produced

based on a claim of attorney-client communications and some seven of the documents have

been withheld based on "opinion work product." Plaintiffs claim that these latter seven

documents may be produced only upon a far stronger showing than the substantial need and

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 5 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 6 -

undue hardship standard relied upon by Gore. Plaintiffs contend that only Item 30, referred

to as "Handwritten attorney notes re: telephone conference with Gerald North re: Dr. Jay

Volder and Interference No. 101,100" authored by attorney Lawrence M. Green, is

potentially discoverable based on Gore's renewed motion. Plaintiffs state that they have

provided Items 6 and 8, which are communications between Bard/Goldfarb's counsel and

Impra representatives during the time between 1977 and 1996 when Impra was adverse to

the Goldfarb patent. (Doc. 325, n. 1). 

The parties have advanced additional and supplemental arguments in their reply and

post-reply submissions. Gore claims it asked Dr. Volder for the notebook but was told he

did not have it. Gore contends that Plaintiffs have not provided sufficient foundation for

their claim of attorney-client privilege or work product doctrine regarding the withheld

documents. Gore also argues that Plaintiffs' contention that Bard cannot be bound by

admissions by Impra's officers and attorneys that Dr. Volder's inventorship rights are superior

to Dr. Goldfarb's is unfounded because the Impra of 1978-80 is the same corporation known

today as Bard Peripheral Vascular. Gore further contends that it had designated Dr. Volder

as a possible trial witness as early as August 6, 2003 but has been thwarted by his inability

to testify due to illness. Gore also points to Dr. Volder's alleged statements to two Impra

executives in 1977-78 that he, not Dr. Goldfarb, was the inventor.

The Court has considered the numerous facts and arguments advanced by the parties

on the issue. The fact discovery in this case was completed on October 30, 2004 [parties

took a deposition on November 11, 2004]. Plaintiffs have submitted correspondence

indicating that one of their lawyers (Mr. Polese) was communicating with Dr. Volder and

Mrs. Volder between April and August 2004 in an attempt to interview Dr. Volder about the

present litigation. Gore's counsel or representative also was communicating with Dr. Volder

about this same time. According to the correspondence, Dr. Volder, who had been a

shareholder of Impra, indicated that he wished to remain neutral regarding the litigation. It

therefore appears that Dr. Volder had not agreed to be a witness for either party. It further

appears that Gore made no attempt to depose Dr. Volder or obtain his sworn statement before

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 6 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 7 -

the close of fact discovery. The Court reiterates that there is no indication that Dr. Volder

has ever claimed to be the inventor based on his own sworn statement or deposition

testimony. As the record now stands, Dr. Volder submitted a letter in September 1974 and

a sworn affidavit to the PTO in 1976 supporting Dr. Goldfarb's application to obtain the '135

patent. 

The parties are in dispute over the past relationship between Impra and Bard. As

discussed above, Impra was formed about the time of the patent application in September

1974. From approximately mid-1977 to mid-1996, Impra was adverse to the patent

application and was involved in a lawsuit against Dr. Goldfarb concerning rights to the

application. From 1980 on, C.R. Bard was the exclusive licensee of the '135 patent. In 1996,

C.R. Bard acquired Impra. Plaintiffs contend that Impra is the predecessor-in-interest of C.R.

Bard and that statements of a predecessor-in-interest are inadmissible and cannot be

considered admissions under the hearsay rule. Fed.R.Evid. 801(d)(2). Gore, on the other

hand, contends that Impra remained intact following acquisition of its stock by C.R. Bard

based on the terms of the acquisition agreement. The entity C.R. Bard is not a plaintiff in this

lawsuit and therefore admissions made by Impra's officers and attorneys are admissible

against it. The Court finds it unnecessary to resolve this factual dispute bearing on the

relationship between C.R. Bard and Impra in order to resolve the issues before it. 

Under Fed.R.Civ.P. 26(b)(3), documents and tangible things prepared by a party or

his representative in anticipation of litigation, may not be ordered produced unless the party

seeking them demonstrates "substantial need [for] the materials in the preparation of the

party's case and that the party is unable without undue hardship to obtain the substantial

equivalent of the materials by other means." As the Court has previously observed, the

attorney-client privilege applies to confidential communications between attorney and client

for the purpose of securing legal advice concerning preparation of prosecution of a patent

application. Advanced Cardiovascular Systems, Inc. v. C.R. Bard, Inc., 144 F.R.D. 373 (N.D.

Cal. 1992). "Because the attorney-client privilege is in derogation of the search for truth, it

is 'narrowly and strictly construed.'" Verizon California Inc. v. Ronald A. Katz Tech.

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 7 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 8 -

Licensing, L.P., 266 F. Supp. 2d 1144, 1147 (C.D. Cal. 2003). The work product doctrine,

codified in Fed.R.Civ.P. 26(b)(3), "protects 'from discovery documents and tangible things

prepared by a party or his representative in anticipation of litigation,' ... Such documents may

only be ordered produced upon an adverse party's demonstration of 'substantial need [for] the

materials' and 'undue hardship [in obtaining] the substantial equivalent of the materials by

other means.'" In re Grand Jury Subpoena [Mark Torf/Torf Environmental Management], 357

F.3d 900, 906 (9th Cir. 2004). 

The following facts lead this Court to deny Gore's present renewed motion. On

September 10, 1974, Dr. Volder signed a letter expressing his belief that the '135 patent

application "should be filed in the name of Dr. Goldfarb" not his own. (Doc. 325, Exh. 5 at

page 3). In an affidavit dated July 27, 1976 and which was submitted to the U.S. Patent and

Trademark Office supporting Dr. Goldfarb's application to obtain the '135 patent, Dr. Volder

stated that he was "of the unqualified opinion that the prosthetic vascular structure conceived

and developed by [Goldfarb], while seemingly apparent when viewed with the aid of

hindsight, was by no means obvious to those actively conducting research on [e]PTFE

vascular structures during 1972 and 1973." (Doc. 325, Exh. 6 at ¶¶ 5, 10-11). Dr. Volder

has had his own patent counsel but has never made a formal claim of ownership regarding

the '135 patent with the PTO. 

Dr. Volder was available to provide a sworn statement during the fact discovery

period in this case. It appears that counsel for both parties to this lawsuit were

communicating with Dr. Volder between April and August 2004. As an attachment to their

sur-reply, Plaintiffs have submitted a letter from Dr. Volder to Plaintiffs' attorney James

Polese which states in pertinent part as follows: 

Sorry I missed your call, but my wife has informed me about the

message. ... As a matter of fact I am aware that Gore is fighting

the Goldfarb patent. Last year I have been contacted with W.L.

Gore & Ass., according this matter and had a meeting with its

lawyers in the Netherlands, discussing my work in the early

70's. Although I prefer not to be involved in this matter for

personal reasons, they kept on calling me with result that I am

receiving representatives of Gore next week in the Netherlands

to discuss my work in the early 70's again. They are also very

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 8 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 9 -

interested in my archive. They asked me to be an expert witness

as well. So I'm very sorry that things are in progress right now,

I don't think I can be of any help for you.

(Doc. 327, Exh. B). This letter contains a fax transmission date of July 4, 2004. (id). Gore

therefore had been communicating with Dr. Volder during 2003 and thus had ample

opportunity to obtain his sworn statement on the issue of any previous inventorship

discussions. Moreover, as discussed above, Gore retained Dutch counsel to meet with Dr.

Volder, Gore's general counsel and Dutch lawyer met with Dr. Volder, and Gore's general

counsel spoke with Dr. Volder. Gore has received documents from Dr. Volder and has paid

Dr. Volder $10,000.00 as a "consultant." (Doc. 325, at page 2). 

There has been some discussion by Gore in its reply that it planned to bring Dr.

Volder to trial as a witness. (Doc. 326, page 9). In their sur-reply, Plaintiffs state that

Plaintiffs' counsel asked Gore to explain this assertion and Plaintiffs have attached a letter

dated February 6, 2006 from Gore's counsel to Plaintiffs' counsel Mr. Polese that states as

follows: "Until your personal interference, Dr. Volder was cooperating with Gore counsel

and we believed that he would be willing to attend the trial to make clear his key role in the

development of ePTFE vascular graft." (Doc. 327, Exh. 13). Gore, however, never obtained

a sworn statement from Dr. Volder during the time it was communicating with him. In

another faxed communication from Dr. Volder to Plaintiffs' counsel Mr. Polese dated August

4, 2004, Dr. Volder stated: "I would like to point out again that my standpoint in this case is

neutral."

It seems logical that Gore would have sought to prove its claim that Dr. Volder was

the true inventor through evidence provided by Dr. Volder. It further seems that it would

have been necessary for Dr. Volder to repudiate or at least explain his prior statements

affirming Dr. Goldfarb's inventor status. However, Dr. Volder has indicated that he desired

to remain neutral. Dr. Volder allegedly is now unavailable due to health reasons. However,

Dr. Volder was available during fact discovery and during that time was cooperating with

Gore but Gore failed to obtain his testimony or affidavit disputing his prior statements,

including his own sworn statement, affirming Dr. Goldfarb's inventor status. Under these

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 9 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 10 -

circumstances, it does not seem that Gore should now be permitted to obtain from Plaintiffs

documents which Plaintiffs claim are privileged or protected under the work product doctrine

in order to prove the claim. Gore's belated attempt does not satisfy the Court that Gore has

shown a "substantial need [for] the materials" in the preparation of its case and that Gore was

"unable without undue hardship to obtain the substantial equivalent of the materials by other

means." Gore's renewed motion to pierce privilege/work product claims relating to the work

of Dr. Volder is denied.

In its reply, Gore raised for the first time its argument that Plaintiffs had not justified

or substantiated their designation based on either attorney-client privilege or work product

as to certain identified documents on Plaintiffs' privilege log. (Doc. 326, at pages 3-5, 7-8).

It does not appear that Plaintiffs responded to this argument in their sur-reply briefing. (Doc.

327). At the oral argument hearing, in response to the Court's question about this issue,

Plaintiffs' counsel indicated that more detailed descriptions relevant to the privilege log could

be provided. The issue that Gore raised for the first time in its reply has not been adequately

briefed by the parties and the Court has declined to consider it. Arguments raised for the first

time in a reply are generally not considered because to do so may unfairly deprive the

opposing party of the opportunity to make a meaningful response. See, e.g., Pacific Coast

Federation of Fisherman's Ass'n. v. U.S. Bureau of Reclamation, 138 F. Supp.2d 1228, 1248,

n.17 (N.D. Cal. 2001).

Certain of the parties' submissions relevant to the issues discussed in this Order have

been filed under seal. It does not appear to the Court, however, that it is necessary to file this

Order under seal. The Court will permit the parties to jointly notify the Court within five

days of the filing date of this Order of any request to file this Order under seal upon a

showing of good cause. 

Accordingly, 

IT IS ORDERED that Gore's renewed motion to pierce the privilege/work product

claims relating to the work of Dr. Volder (Doc. 324) is denied.

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 10 of 11
1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

- 11 -

IT IS FURTHER ORDERED that the parties may jointly notify the Court within

five days of the filing date of this Order of any request to file this Order under seal upon a

showing of good cause. 

DATED this 29th day of September, 2006.

Case 2:03-cv-00597-MHM Document 343 Filed 09/29/06 Page 11 of 11