AbbVie Inc. et al v. Boehringer Ingelheim International GMBH et al, No. 1:2017cv01065 - Document 119 (D. Del. 2018)

Court Description: MEMORANDUM AND ORDER denying in part and granting in part 72 MOTION to Compel Production of Research and Development Documents filed by Boehringer Ingelheim Fremont, Inc., Boehringer Ingelheim International GMBH, Boehringer Ingelheim Pharmaceuticals, Inc. Boehringer's request for sanctions (see Doc. No. 87 ) is DENIED. (See order for further details and deadlines). Signed by Judge Richard A. Lloret on 6/7/2018. (fms)

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AbbVie Inc. et al v. Boehringer Ingelheim International GMBH et al Doc. 119 IN TH E U N ITED S TATES D ISTRICT COU RT FOR TH E D ISTRICT OF D ELAW ARE ABBVIE INC. an d ABBVIE BIOTECHNOLOGY LTD v. BOEHRINGER INGELHEIM INTERNATIONAL GMBH, BOEHRINGER INGELHEIM PHARMACEUTICALS, INC., and BOEHRINGER INGELHEIM FREMONT, INC. : : : : : : : : : : : CIVIL NO. 17-cv-0 10 65-MSG-RL MEMORAN D U M AN D ORD ER CON CERN IN G D OC. N O. 72 Defendants (collectively “Boehringer”) have m oved to com pel plain tiffs (collectively, “AbbVie”) to produce docum ents sought in Boehringer’s Second Set of Requests for Production of Docum ents and Things (RPD) concerning research and developm ent underlying AbbVie’s asserted patents. Boehringer’s Motion (BI Mot.) at 1 (Doc. No. 72). AbbVie has responded (Doc. No. 77) (AV Res.), and Boehringer has replied to the response (Doc. No. 8 7) (BI Rep.). I. Th e N atu re o f th e D is p u te . This is a discovery dispute about the scope of a request for research and developm ent docum ents concerning adalim um ab (HUMIRA), several patents for which are the subject of this case. Boehringer seeks an order directing AbbVie to “search for R&D [research and developm ent] m aterials in all custodial and non-custodial data sources reasonably likely to contain that inform ation without regard to the six-year default tem poral lim itation in Paragraph 4(e) of the Delaware Default Standard for Dockets.Justia.com Discovery [DDSD 4(e)(e)].”1 Id. Boehringer argues that “[c]ourts routinely grant discovery of this nature in patent cases because it directly im pacts the issues of prior art and patent validity.” BI Mot. at 1. AbbVie argues that DDSD 4(e) provides that discovery should be lim ited to six years before the filing of the com plaint, except for discovery related to conception and reduction to practice or asserted prior art. AV Res. at 1. AbbVie contends it has already produced m ore than DDSD 4(e) requires. Id. (describing the various categories of docum ent produced regardless of date). AbbVie com plains that Boehringer “conflates t h ir t y -s e v e n different docum ent requests as all purportedly seekin g docum ents ‘related to’ R&D underlying the inventions claim ed in the patents-in-suit.” Id. at 2 (bold and italics in AV Res.) (citing to BI Mot. at 1). As an exam ple, AbbVie points to RPD 60 , which asks for discovery about “any steps taken by AbbVie or any Third Party to increase the antibody titer of adalim um ab.” Id. AbbVie contends that this language covers a wide range of research an d developm ent relating to adalim um ab, regardless of whether the “steps” are covered by any of the contested patents, and regardless of whether the research and developm ent occurred after the ’867 patent’s effective filing date. 2 Id. AbbVie m akes the sam e point about RPD 55, which would require production of all research and developm ent relating to “the selection of the cell expression system used to express any adalim um ab[,]” regardless of whether the research had an y significance to the patents at issue in this case. Id. 1 The text of the rule reads “[a]bsent a showing of good cause, follow-up discovery shall be lim ited to a term of 6 years before the filing of the com plaint, except that discovery related to asserted prior art or the conception and reduction to practice of the in ventions claim ed in any patent-in -suit shall not be so lim ited.” 2 U.S. Patent No. 9,0 90 ,867, titled “Fed-Batch Method of Making Anti-TNF-Alpha Antibody,” which was issued by the USPTO on J uly 28 , 20 15. Com plaint at 23, ¶ 77 (Doc. No. 1). 2 AbbVie argues that the relief Boehringer seeks would force AbbVie to “search every location that potentially m ay contain decades-old docum ents unrelated to any of the patents-in -suit[,]” and that Boehringer has not dem onstrated “good cause” for exceeding the tim e lim it in DDSD 4(e). Id. at 2. AbbVie contends that m erely showing the relevance or im portance of the discovery is not enough to show “good cause,” under DDSD 4(e). Id. at 6 (citing to GlaxoSm ithKline LLC v. Teva Pharm . USA, Inc., No. CV 14-8 78 -LPS-CJ B, 20 16 WL 8 59229, at *3 (D. Del. Mar. 3, 20 16) (“if the possible existen ce of som e other relevant, non-produced docum ents was always enough to dem onstrate good cause to abandon the Default Standard’s requirem ents, the Standard would be worth little.”). Boehringer replies that DDSD 4(e) exem pts discovery concerning conception an d reduction to practice; the requested discovery is “lim ited to R&D before the filing dates of the asserted patents[;]” and the breadth of the search is a function of AbbVie asserting 157 claim s. BI Rep. at 2. Boehringer points out that “the entire scope of discovery that Boehringer seeks to com pel through this m otion would be responsive to Request No. 32, which seeks docum ents “concerning the research and developm ent of the alleged invention(s) of the patents-in-suit, including, but not lim ited to, docum ents concern ing the conception and reduction to practice of any of the alleged inventions of the patents-in -suit.” Id. at n.3. II. D is cu s s io n . At a surface level the dispute is over the delim itation of the phrases “research an d developm ent” an d “conception an d reduction to practice.” At bottom the dispute is an iteration of the usual problem of discovery: how to balance the need for inform ation against the burden of searching for the inform ation. The parties agree that the phrase 3 “research and developm ent” im plicates a larger universe of docum ents than the phrase “conception and reduction to practice.” Boehringer is concerned that a search lim ited to “conception and reduction to practice” will “exclude critical docum ents relevant to Boehringer’s invalidity defenses. For exam ple, failed experim ents that contradict the teachings of subsequent patents-in-suit or discussions relating to the state of the art that dem onstrate the obviousness of the asserted claim s.” BI Mot. at 1-2. AbbVie resists a search for broad ranging research and developm ent docum ents unrelated to the patents-in-suit, and seeks sanctuary in a m ore lim ited search for docum ents “related to the conception and reduction to practice of the inventions claim ed in the patents-insuit.” AV Res. at 1-2. The wrangle over the im plications of the two phrases also extends to whether the tim e lim it in DDSD 4(e) should be enforced or relaxed. Boehringer argues that its request for “research and developm ent” docum ents should be exem pted from DDSD 4(e)’s tim e and subject m atter constraints because there is “good cause.” BI Mot. at 1-2. The “good cause” proposed is that this case is unusual, given the num ber of patents and claim s at issue, and the evolution of a “patent thicket” over a lengthy period of tim e. Id. at 5. Boehringer also argues that research and developm ent docum en ts are routinely discovered in patent cases across the country. BI Rep. at 1. As an exam ple, Boehringer points to the Northern District of California’s local rule, which requires production of research and developm ent docum ents as part of m andatory discovery. Id. at 1 (citing to Exhibit H at 5 (a copy of the ND Ca. local rule)). The problem with the argum ent is that it am ounts to a rewrite of Delaware’s local rule. There is no obvious lim iting principle to such a “good cause” exception. Such an exception likely would com e into play any tim e a com plaint is filed m ore than a few 4 years after the conception of the patent. That is sure to be a large percentage of patent cases, regardless of whether a case is “typical” or “com plex.” AbbVie’s argum ent, that such a gen eralized search goes beyond the patents actually at issue in this case, finds a logical hom e in the text of DDSD 4(e). The rule exem pts discovery “related to asserted prior art or the conception and reduction to practice of the inventions claim ed in any patent-in-suit . . .” from the otherwise applicable tim e lim itation of six years before the filing of a com plaint. The tim e lim it exem ption does not apply to the m ore generalized category of “research and developm ent” docum ents, unless they are “related to” prior art or conception an d reduction to practice. Conception and reduction to practice are m ilestones in the larger continuum of research and developm ent. Conception m arks the point at which an invention is com plete and eligible for a patent. Pfaff v. W ells Electronics, Inc., 525 U.S. 55, 67-68 (1998 ). The date of conception inform s the tim e fram e for application of the “on-sale” bar, id., and m ay determ ine the tim e fram e for evaluating “prior art.” See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 968 (Fed. Cir. 20 14). Reduction to practice is an evidentiary signal that conception is sufficient to justify patent protection. Pfaff, 525 U.S. at 68 . Tying the tim e lim it exem ption in DDSD 4(e) to “conception and reduction to practice” has the ben efit of tethering discovery closely to the inventions actually at issue in a case. Lim itations on discovery always carry a risk of leaving behind useful inform ation. The question is the value of the discovery that m ight be m issed, weighed against the burden of searching for it. DDSD 4(e) strikes such a balance by im posing a tim e lim it on m ost discovery, but exem pting from the tim e lim it inform ation that relates to prior art, 5 conception, and reduction to practice. For evidence that does not relate to prior art, conception, or reduction to practice, the tim e lim it m ay be excused for “good cause.” Boehringer’s proposed “good cause” exception would swallow the rule. I do not agree with Boehringer that the tim e lim its under DDSD 4(e) should be disregarded. Nevertheless, the language of DDSD 4(e) lends itself to a broader scope of discovery than AbbVie seem s to acknowledge. The phrase “related to,” used in DDSD 4(e), is undefined. The phrase m ust m ean at least “relevant,” as defined under Fed. R. Evid. 40 1, although it m ay m ean m ore. Eviden ce is relevant if it has “any ten den cy to m ake a fact [of consequence to the determ ination of the action] m ore or less probable than it would be without the eviden ce.” Id. “Any tendency” is a liberal standard. “Conception” and “reduction to practice” are facts of consequence under this particular legal standard. 3 Research and developm ent inform ation that leads in a plausible and logical fashion to “conception and reduction to practice” is “related to” these two facts of consequence. It m akes the existen ce of the facts of consequence m ore likely. Inform ation that tends to contradict or disprove the existence of “conception or reduction to practice” also is “related to” those facts of consequence. 4 Events at som e rem ove from the m om ents of “conception and reduction to practice” m ay be “related to” either one, because such events m ay form part of a logical chain that tends to affirm or negate the likelihood of conception or reduction to practice. 5 3 As is “prior art,” under DDSD 4(e), but the parties’ dispute focuses for the m ost part on conception and reduction to practice. 4 An em ail in which a m anager wrote “this process is interestin g, but we will n ever be able to turn it into anythin g useful,” is “related to” conception and reduction to practice, because it has a tendency to m ake less likely the existence of either event. 5 The rule’s generality does not solve the practical problem of how to define docum ent search term s to include relevant docum ents and exclude irrelevant docum ents. The parties have n ot asked m e to rule on 6 III. Co n clu s io n a n d Ord e r. Boehringer acknowledges that RPD No. 32 defines the universe of docum ents it is asking for. RPD No. 32 asks for docum ents “concerning the research and developm ent of the alleged invention(s) of the patents-in-suit, including, but not lim ited to, docum ents concerning the conception and reduction to practice of any of the alleged inventions of the paten ts-in-suit.” I will use this request as a basis for ordering som e relief, 6 while denying Boehringer’s m otion in large part. For the reasons described above, it is on this 6 th day of J une, 20 18, ORD ERED that 1) Boehringer’s m otion (Doc. No. 72) is D EN IED , except as follows; 2) Boehringer’s m otion is GRAN TED in p art: A) For the six-year period preceding filing of the com plaint in this action, AbbVie shall prom ptly respond to RPD No. 32. B) For the tim e preceding the six-year period described in paragraph 2(A), AbbVie shall prom ptly produce docum ents concerning the research and developm ent of the alleged invention(s) of the patents-in -suit that relate to asserted prior art an d to the conception and reduction to practice of any of the alleged inventions of the patents-in-suit. C) The search shall be lim ited to the 50 custodial sources previously identified by AbbVie. disputed search term s, but have couched their dispute in term s of the lan guage of the overarching legal rule. I will order the parties to m eet and confer over search term s and an expedited tim e fram e for discovery. 6 In its reply, Boehringer for the first tim e asked that certain argum ents and evidence be precluded at sum m ary judgm ent and trial if AbbVie “can not conduct the requested search in a tim ely fashion [.]” BI Rep. at 3. I perm itted AbbVie to file a sur-reply addressing this argum ent. See Oral Order of 6/ 5/ 20 18; AbbVie sur-reply (Doc. No. 113). I will deny Boehrin ger’s request for sanctions. Siem ens Med. Solutions USA, Inc. v . Saint-Gobain Ceram ics & Plastics, Inc., 637 F.3d 1269 (Fed. Cir. 20 11), relied upon by Boehringer, does not justify such a sanction . There, the district court excluded certain proposed expert testim ony at trial because it was based on evidence not disclosed during discovery. Id. at 1286. Trial is a long way off. There has been no showin g that proposed trial evidence has been undisclosed in discovery. 7 3) Counsel shall m eet and confer on or before J une 20 , 20 18 for the purpose of (A) agreeing upon an expedited tim e fram e for the discovery required under this order, and (B) agreeing upon additional search term s, if needed to im plem ent this Order. If the parties cannot agree, they m ay schedule a conference call with m y cham bers to discuss whether a hearing is n eeded. 4) Boehringer’s request for sanctions (see Doc. No. 8 7) is D EN IED . BY TH E COU RT: s / R ich a r d A. Llo r e t RICH ARD A. LLORET U .S. MAGISTRATE JU D GE 8

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