Litigation

Hoffmann-La Roche, Inc. et al. v. Promega Corporation

judgment

93-1748

Filed
1992-10-27

Patents at issue (3)

Summary

Roche sued Promega for infringement of US 4,889,818 and breach of the Cetus–Promega license agreement covering Roche's PCR process patents. The district court found the '818 patent unenforceable for inequitable conduct; the Federal Circuit vacated in part and remanded, and on remand the district court again held the patent unenforceable.

Case overview & background

Plain-language overview of the case: parties, accused product, patents at issue, and why the suit matters.

I'll research this case across docket sources, opinions, and industry coverage.

Good material on the merits. Now let me pin down docket details, the remand decision, and the ultimate resolution.

Now let me verify the 2005 settlement and the role of the PCR process patents ('195/'202).

Case Overview — Hoffmann-La Roche, Inc. v. Promega Corp., No. C 93-1748 VRW (N.D. Cal.)

The parties. This is an operating-company-versus-operating-company licensing fight, not an NPE/PAE assertion — both sides make and sell the technology at issue. Plaintiffs Hoffmann-La Roche, Inc. (Nutley, N.J.) and Roche Molecular Systems, Inc. (Pleasanton, Cal.) are the U.S. pharmaceutical/diagnostics arms of Swiss-based Roche, which in 1991 paid Cetus Corporation roughly $300 million for the polymerase chain reaction (PCR) patent estate, including the patents-in-suit. Defendant Promega Corporation (Madison, Wis.) is a life-science reagents supplier that had taken a June 1990 license from Cetus to manufacture and sell Taq DNA polymerase for non-PCR/research uses; when Roche acquired the portfolio it demanded that Promega stop selling Taq and pay higher royalties, Promega refused, and Roche sued in late 1992 for breach of the license and patent infringement (Roche's September 2005 press release describes the suit as "the original lawsuit initiated by Roche Diagnostics in 1992"). Promega counterclaimed that the Taq patent was unenforceable for inequitable conduct — a counterclaim that became the center of gravity of the case and ultimately consumed 13 years of litigation. [Nature Biotechnology 18:7 (Jan. 2000); Nature 403 (2000) coverage; UNCTAD case summary of Hoffmann-La Roche v. Promega, No. 00-1372 (Fed. Cir. 2003); Roche settlement press release, Sept. 13, 2005]

The technology and patents. The accused technology is Taq DNA polymerase — the thermostable enzyme isolated from Thermus aquaticus that made PCR practical by surviving the high-temperature denaturation step of each amplification cycle — and Promega's sales of Taq and PCR-related reagents that Roche contended exceeded the scope of Promega's non-PCR license (Roche at one point asserted that roughly 200 researchers who published with Promega-supplied Taq were infringing). Three patents were asserted, all originating with Cetus and invented by Nobel laureate Kary Mullis and Cetus colleagues: U.S. 4,683,202 ("Process for amplifying nucleic acid sequences," issued July 28, 1987) — the core Mullis PCR method claim covering repeated cycles of denaturation, primer annealing and extension; U.S. 4,683,195 ("Process for amplifying, detecting, and/or cloning nucleic acid sequences," issued Dec. 15, 1987) — PCR coupled with detection (e.g., labeled probes) and cloning embodiments; and U.S. 4,889,818 ("Purified thermostable enzyme," issued Dec. 26, 1989, to Gelfand and Stoffel) — purified native/recombinant Taq polymerase. The '818 patent was the commercially critical one, since Roche and its PCR licensing partner (Perkin-Elmer/Applera) monetized PCR through Taq royalties; the '195 and '202 process patents, by contrast, expired in the mid-2000s (Roche noted in September 2005 that its "foundational PCR patents recently expired in the US"). [Hoffmann-La Roche v. Promega, 323 F.3d 1354, 1357–59 (Fed. Cir. 2003); 319 F. Supp. 2d 1011 (N.D. Cal. 2004)]

Procedural posture and significance. The case was filed in the U.S. District Court for the Northern District of California, San Francisco Division, and assigned to Judge Vaughn R. Walker (docket No. C 93-1748 VRW) — a venue consistent with Roche Molecular Systems' Bay Area presence and the parties' license relationship, and one that put a science-heavy case before a judge experienced in complex technology litigation. The path was: a 1994 summary-judgment ruling that several prosecution misstatements were material as a matter of law, 33 U.S.P.Q.2d 1641 (N.D. Cal. 1994); a four-week bench trial in February 1999 (Arthur Kornberg testified); Judge Walker's December 7, 1999 order holding all claims of the '818 patent unenforceable for inequitable conduct based on eight material misstatements made with intent to deceive the PTO, 1999 WL 1797330; affirmance in part and reversal in part by the Federal Circuit (Bryson, J.; Newman, J., dissenting), 323 F.3d 1354 (Fed. Cir. Mar. 31, 2003) (No. 00-1372), which rejected the molecular-weight theory but sustained the "prophetic Example VI written in the past tense" and fidelity/template-dependence findings and remanded for the equitable sanction determination; and Judge Walker's May 2004 remand decision reaffirming unenforceability, 319 F. Supp. 2d 1011, while declining on the then-existing record to extend the taint to the '195 and '202 patents under "infectious unenforceability"/unclean hands (the court said it was "quite troubled by the apparently contradictory positions taken before the PTO"). The case is notable on several axes: it is a canonical — and much-criticized — inequitable conduct decision (the verb-tense/Example VI holding is a staple of patent-drafting commentary, and Judge Newman's dissent warned the majority had revived a "plague" of inequitable-conduct charges); it had direct market consequences in a Taq reagent market estimated at roughly $200 million worldwide, with per-unit royalties reported at 15–17 cents; it spawned follow-on antitrust exposure, including the direct-purchaser Walker Process class action in D.D.C. that settled for $33 million in 2008 with $11 million in fees; and it stands in contrast to Roche/Applera's successful enforcement of the '195/'202 PCR process patents against MJ Research (D. Conn. jury verdict 2004; damages enhanced to $35.4 million). There is no IPR linkage — inter partes review did not exist until 2012 and these patents had expired — though the '

Key legal developments & outcome

Major rulings, motions, claim construction, settlements, and the present posture or final disposition.

I'll research this case thoroughly, starting with the core docket and appellate history.

Excellent leads. Now let me pin down the post-2003 remand proceedings, the docket, and final disposition.

Now let me open the later N.D. Cal. remand opinion and check for any further appeal or final judgment.

Hoffmann-La Roche, Inc. v. Promega Corp., No. C-93-1748 VRW (N.D. Cal.) — Chronology and Outcome

Bottom line: This is the "Taq polymerase" case. Roche's infringement and contract claims were ultimately lost not on claim construction or infringement, but because Judge Vaughn R. Walker held U.S. Patent 4,889,818 (the native/recombinant Taq patent) unenforceable for inequitable conduct committed by Cetus's inventors during prosecution. The Federal Circuit affirmed the core findings in 2003 (over a sharp Newman dissent) and remanded for the equitable-sanction determination; on remand the district court again held the patent unenforceable and dismissed Roche's related breach-of-contract claims. The '195 and '202 PCR process patents were never adjudicated on the merits — the inequitable-conduct phase effectively consumed the case, and those patents expired in 2004.

Note on sourcing: the parties, court, case number and patents in this prompt are treated as authoritative. Docket-entry numbers below come from the opinions as cited; where I could not independently confirm a docket entry or date, I say so.


1. Filing and initial pleadings

Date Event
1989-12-26 U.S. 4,889,818 ("Purified Thermostable Enzyme," Taq DNA polymerase) issues to Cetus Corp.
1990-06 Cetus licenses the '818 patent to Promega (research/non-PCR Taq uses).
1991 Cetus sells the '818 patent and PCR rights to Roche (~$300 million, per contemporaneous Nature reporting).
1992-10-27 Roche (Hoffmann-La Roche, Inc. and Roche Molecular Systems, Inc.) files suit in N.D. Cal. against Promega, alleging infringement of the PCR patents ('195, '202, '818) and breach of the Cetus–Promega license agreement. Assigned to Judge Vaughn R. Walker as No. C-93-1748 VRW.
1993 (exact date not verified) Promega answers and counterclaims, seeking declaratory judgment that the '818 patent is invalid and **unenforce

Plaintiff representatives

Counsel of record for the plaintiff(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research the docket and counsel appearances for this case.

Good initial anchor. Let me pull the full opinion text and earlier rulings to track counsel over time.

Now let me find the earlier-stage counsel (1990s) and verify firm affiliations.

Bottom line

The PACER docket sheet for N.D. Cal. No. C‑93‑1748 VRW is not retrievable through the open sources I could reach (a 1992‑filed case; the early docket is paper/archived), so I could not compile an appearance‑by‑appearance list. What I can document with precision are the plaintiffs' counsel blocks printed in the published opinions — the Federal Circuit's 2003 decision (Roche II) and Judge Walker's 1999 and 2004 orders. Those show a stable three‑firm structure for Roche: Pennie & Edmonds (N.Y.) as the patent‑litigation lead, Orrick, Herrington & Sutcliffe (San Francisco/N.Y.) as co‑counsel, and later Bingham McCutchen (S.F.) and Crummy, Del Deo (Newark) adding local/N.J. support.

Because the roster changed between 1999 and 2004 (Pennie & Edmonds dissolved in 2003), I've separated the two snapshots.


1. Counsel as recorded at the Federal Circuit (Roche II, 323 F.3d 1354 (Fed. Cir. Mar. 31, 2003))

Attorney Role Firm / office Note
Jennifer Gordon Lead counsel — argued the appeal for plaintiffs‑appellants Pennie & Edmonds LLP, New York, NY (later Orrick) Pennie & Edmonds was one of the premier U.S. IP boutiques; Gordon was Roche's principal PCR/Taq advocate through trial, appeal and remand. Per the Chilean science journal Biological Research, Roche's outside patent counsel (Pennie & Edmonds, N.Y.) had retained experts in this very action since early 1994, confirming Pennie's lead role from the mid‑1990s.
Todd A. Wagner On the brief (core trial/appellate team) Pennie & Edmonds LLP, New York, NY Appears again in Judge Walker's 2004 order, so he spanned the entire life of the case.
Todd L. Krause On the brief Pennie & Edmonds LLP, New York, NY Appellate‑stage team member.
Barbara A. Caulfield Of counsel on the brief; San Francisco co‑counsel Orrick, Herrington & Sutcliffe LLP, San Francisco Senior Orrick patent litigator; also listed in the 2004 district court order, i.e., she was on the case for the entire post‑remand phase.
S. Leslie Misrock Of counsel Pennie & Edmonds Legendary patent‑litigation name partner at Pennie & Edmonds, best known for biotechnology/pharmaceutical patent trials.
Heidi Keefe Of counsel Orrick, Herrington & Sutcliffe LLP Orrick side of the team.
Myra J. Pasek Of counsel Orrick, Herrington & Sutcliffe LLP Orrick side of the team.

Source: 323 F.3d 1354, counsel block (reproduced at https://caselaw.findlaw.com/summary/opinion/us-federal-circuit/2003/03/31/[115597](/patent/115597).html and http://www.worldlii.org/us/cases/federal/USCAFED/2003/71.html).

2. Counsel as recorded in Judge Walker's post‑remand order (Hoffmann‑La Roche, Inc. v. Promega Corp., No. C 93‑1748 VRW, 319 F. Supp. 2d 1011 (N.D. Cal. May 13, 2004))

Plaintiffs' side, verbatim from the opinion's advocate list:

  • James B. Lewis — Bingham McCutchen LLP (San Francisco). San Francisco litigation counsel; Bingham McCutchen was formed in 2001 when McCutchen, Doyle, Brown & Enersen combined with Bingham Dana, so Lewis's appearance is consistent with McCutchen Doyle having been Roche's S.F. local counsel earlier in the case. (The McCutchen Doyle → Bingham McCutchen succession is firm history; I did not find a docket entry confirming Lewis's pre‑2001 affiliation — treat as inference.)
  • Barbara A. Caulfield and Denise M. Alter — Orrick, Herrington & Sutcliffe LLP, San Francisco (co‑counsel).
  • Jennifer Gordon and Scott B. Familant — Orrick, Herrington & Sutcliffe LLP, New York (the Pennie & Edmonds team landed at Orrick after Pennie dissolved in 2003; the 2004 order therefore shows Gordon under the Orrick banner).
  • John A. Ridley — Crummy, Del Deo, Dolan, Griffinger & Vecchione, Newark, N.J. Most plausibly Roche's New Jersey counsel, given that Hoffmann‑La Roche Inc. and Roche Molecular Systems are Nutley/Branchburg, N.J. entities. (Role characterization is my inference from the firm's Newark location; the record only shows the appearance.)
  • Todd Wagner — Pennie & Edmonds LLP, New York.

Source: https://www.casemine.com/judgement/us/5914b72cadd7b0493477d876 (order of May 13, 2004, No. C 93‑1748 VRW); 319 F. Supp. 2d 1011.

Caution on that source: the Casemine "Advocates" block lists Jennifer Gordon (Orrick, N.Y.) in both the plaintiffs' and defendant's lists, which is almost certainly a transcription artifact rather than a dual appearance. Everything else in the plaintiffs' list is internally consistent with the 2003 Federal Circuit counsel block.


3. Role summary

  • Lead / first‑chair (trial and appeal): Jennifer Gordon (Pennie & Edmonds → Orrick, N.Y.).
  • Of counsel / brief‑writers: Todd A. Wagner, Todd L. Krause, S. Leslie Misrock (Pennie & Edmonds); Barbara A. Caulfield, Heidi Keefe, Myra J. Pasek, Denise M. Alter (Orrick); Scott B. Familant (Orrick, later stage).
  • Local / regional counsel: James B. Lewis (Bingham McCutchen, S.F.); John A. Ridley (Crummy, Del Deo, Newark).
  • In‑house: no in‑house attorney appears in any published counsel listing. Roche Molecular Systems' general counsel at the time, Melinda Griffith, is quoted publicly as the company spokesperson (Nature Biotechnology, Jan. 2000, "Roche's Taq patent invalid"), but she is not recorded as counsel of record — so I would not list her as such.

4. What I could not verify — stated explicitly

  1. No PACER/docket pull. I could not access a docket sheet for C‑93‑1748, so I cannot give filing dates for the appearances (e.g., when Bingham or Crummy, Del Deo first entered), and I cannot rule out additional attorneys who appeared on discovery motions or who withdrew before the opinion‑stage counsel blocks were printed.
  2. Early‑period counsel (1992–1996) are not independently documented. The summary‑judgment ruling of August 1996 and the 1996–1997 orders are not available in full text through the sources I reached; the earliest firm‑level confirmation I have of Pennie & Edmonds' role is the 1994 retention of an expert "for the law firm Pennie and Edmonds of New York" in Civil Action No. C‑93‑1748 (https://scielo.conicyt.cl/scielo.php?pid=s0716-97602000000100005&script=sci_arttext).
  3. No sealed‑filing inference. Nothing suggests plaintiffs' counsel was sealed or under protective order; the appearance lists are public in the opinions.
  4. Defendant's side (for completeness, not requested): Gary A. Ahrens and John C. Scheller (Michael, Best & Friedrich, Milwaukee/Madison), Peter G. Carroll and Virginia S. Medlen (Haverstock, Medler & Carroll, S.F.), Leslie B. Posnock (Schwartz & Posnock, Sausalito), and Russell L. Johnson (Skjerven Morrill, San Jose); Promega's public spokesperson/attorney in the press was James Troupis (Nature, Jan. 1998).

Defendant representatives

Counsel of record for the defendant(s): attorneys, firms, and roles (lead counsel, of counsel, local counsel).

I'll research this docket and the counsel appearances.

Good — I found a counsel list in a 2004 opinion. Let me verify and dig deeper, including earlier appearances and the docket.

Now let me pin down the earlier appearances (1992–1999) and the later appeal, plus check for a docket record.

Defendant's counsel of record — Promega Corporation

Sourcing note up front: I could not retrieve the PACER docket sheet for No. C 93‑1748 VRW (a 1992‑filed N.D. Cal. case; the N.D. Cal. docket is not in CourtListener's RECAP archive and PACER's historical docket for that case is not web-indexed). What is verifiable are the counsel listings printed in the court's own opinions and the Federal Circuit's opinion, which I've used as the primary basis below. No counsel in this matter appears to have appeared under seal.

Verified counsel list

Attorney Role Firm / office Note
James R. Troupis Lead trial and appellate counsel (argued the Fed. Cir. appeal, No. 00‑1372) Michael Best & Friedrich LLP, Madison, WI 22‑year Michael Best litigator; left in June 2010 to found Troupis Law Office LLC (Middleton, WI). Long‑running outside patent counsel to Promega — later lead counsel in Promega v. Life Technologies (W.D. Wis.), where he won a $52M verdict (2012) that was subsequently overturned. Named "Promega attorney James Troupis" in contemporaneous Nature coverage of the 1999 inequitable‑conduct ruling.
J. Donald Best Counsel on the Federal Circuit brief Michael Best & Friedrich LLP, Madison, WI Name partner of the firm; senior Wisconsin commercial/IP litigator.
Michael E. Husmann Counsel on the Federal Circuit brief Michael Best & Friedrich LLP, Madison, WI Patent/IP litigator; part of the Promega appellate team.
John C. Scheller Counsel — trial team and Federal Circuit brief; appeared at the 2003–04 remand stage Michael Best & Friedrich LLP, Madison, WI Filed declarations in the district court (e.g., supporting Promega's motion to stay/strike Roche's renewed summary‑judgment motion). Later a named partner at Scheller Legal Solutions LLC.
Gary A. Ahrens Counsel of record at the 2004 remand stage Michael Best & Friedrich LLP, Milwaukee, WI Listed "for defendant" in Judge Walker's 2004 remand order (No. C 93‑1748 VRW).
Karla M. Davis Counsel on the Federal Circuit brief Michael Best & Friedrich (per brief listing; firm affiliation not stated in the FindLaw caption) Listed among the five attorneys "on the brief" for defendant‑appellee.
Peter G. Carroll Local counsel (trial) / of counsel on appeal Haverstock, Medlen & Carroll LLP (later Medlen & Carroll LLP), San Francisco, CA Listed "for defendant" in the 2004 order and as of counsel on the Fed. Cir. brief; San Francisco IP boutique.
Virginia S. Medlen Local counsel Haverstock, Medlen & Carroll LLP, San Francisco, CA Listed "for defendant" in the 2004 order; Ph.D. patent attorney; her declaration is part of the record exhibits.
Kamrin T. MacKnight Of counsel on the Federal Circuit brief Medlen & Carroll LLP, San Francisco, CA Appellate briefing role.
Russell L. Johnson Of counsel on appeal / local counsel Skjerven, Morrill, MacPherson, Franklin & Friel LLP, San Jose, CA Listed both as of counsel on the Fed. Cir. brief and "for defendant" in the 2004 district court order; Skjerven Morrill was a leading Silicon Valley IP boutique.
Leslie B. Posnock Local counsel Schwartz & Posnock, Sausalito, CA Listed "for defendant" in the 2004 remand order.

Key citations

  • Hoffmann‑La Roche, Inc. v. Promega Corp., 323 F.3d 1354 (Fed. Cir. 2003) (No. 00‑1372): "James R. Troupis, Michael Best & Friedrich LLP, of Madison, WI, argued for defendant‑appellee. With him on the brief were Michael E. Husmann, J. Donald Best, John C. Scheller, and Karla M. Davis. Of counsel on the brief were Peter G. Carroll and Kamrin T. MacKnight, Medlen & Carroll LLP, of San Francisco, CA; and Russell L. Johnson, Skjerven, Morrill, MacPherson, Franklin & Friel LLP, of San Jose, CA." — FindLaw; full text at law.resource.org and Justia.
  • Hoffmann‑La Roche, Inc. v. Promega Corp., No. C 93‑1748 VRW (N.D. Cal. 2004) (Walker, J., remand order on the equities): "Gary A. Ahrens, Michael, Best Friedrich, Milwaukee, WI, Peter G. Carroll, Virginia S. Medlen, Haverstock, Medler Carroll, San Francisco, CA, John C. Scheller, Michael, Best Friedrich, Madison, WI, Leslie B. Posnock, Schwartz Posnock, Sausalito, CA, Russell L. Johnson, Skjerven Morrill LLP, San Jose, CA, for defendant." — Casemine.
  • Docket‑event chronology (orders of 6/13/1994, 8/9/1996, 12/31/1997, 12/7/1999, 4/4/2000 judgment, 4/12/2000 stay, 5/8/2000 administrative closing, 1/28/2005 order) appears in the exhibit index reproduced at the front of the '818 patent litigation record — US 4,889,818 file/exhibit compilation.

Caveats and things I could not verify

  1. No in‑house counsel appears of record. Promega's public statements in the case were made by CEO William Linton, not by legal staff; I found no Promega in‑house attorney on any filing or in any opinion. (On the plaintiff side, Melinda Griffith is identified as general counsel of Roche Molecular Systems — not counsel of record.)
  2. The 2004 Casemine "Advocates" block is a reporter compilation, not a per‑document signature list. It lists Jennifer Gordon (Orrick, Herrington & Sutcliffe, New York) under both plaintiffs and defendant; she was unquestionably Roche's counsel (Promega moved to strike her declaration in 1994). I have therefore excluded her from the defendant table — treat that entry as an artifact of the compilation.
  3. Counsel for the first years of the case (1992–1996) is not independently documented in any source I could pull. Troupis was clearly on the team by the February 1999 bench trial (his examination of Dr. Gelfand appears in the Fed. Cir. joint appendix at 323 F.3d 1354), and Michael Best appears to have been Promega's Wisconsin firm throughout, but I cannot confirm who signed the 1993 answer without the docket.
  4. Firm names appear in the opinions with garbled punctuation ("Michael, Best Friedrich" = Michael Best & Friedrich LLP; "Haverstock, Medler Carroll" = Haverstock, Medlen & Carroll LLP; "Skjerven Morrill LLP" = Skjerven, Morrill, MacPherson, Franklin & Friel LLP). Several of these firms no longer exist under those names (Skjerven Morrill dissolved in 2003; Medlen & Carroll's practice was absorbed elsewhere), so current contact information is not meaningful.
  5. I did not find a PTAB/IPR counterpart — unsurprising given the 1989 issuance date and the pre‑AIA posture of the case. The later Taq disputes ran through Molecular Diagnostics Labs. v. Hoffmann‑La Roche (D.D.C.) and parallel foreign nullity actions (German Federal Patent Court, 2005), not the PTAB.