Opinion ID: 4190033
Heading Depth: 4
Heading Rank: 1

Heading: All documents of any kind from the files of Dr.

Text: Jones and others with whom he worked on the prosecution of the ’018 Patent regarding whether or not to disclose prior art to the PTO. All docu- ments of any kind from the files of anyone else who was involved (directly or indirectly) in the 28 REGENERON PHARMACEUTICALS v. MERUS N.V. prosecution of the ’018 Patent and who may not be captured in paragraph 1 above, who gave consid- eration to the relevance or applicability of prior art to the ’018 Patent. Id. at 589. Regeneron confirmed it had produced what was required. 3 These events lead up to trial. A bench trial on Mer- us’s claim of inequitable conduct was scheduled to commence on June 8, 2015. Under the local rules, the district court required the parties’ witnesses to testify by declaration/affidavit on direct examination. Regeneron submitted trial affidavits from Drs. Smeland and Jones, both attorneys acting as attorneys. At this time, Regeneron’s privilege log indicated that it had withheld many documents from Dr. Smeland’s files that he had authored or received on the basis of the attorney/client privilege and/or work product doctrine. The same was true for Dr. Jones except for the binder of documents that Regeneron had earlier disclosed pursuant to the district court’s Order. Merus cried foul. Merus argued that Regeneron was again engaging in a sword/shield use of the attorney client privilege and moved to strike these affidavits based on, inter alia, the assertion that Regeneron had shielded privileged documents from disclosure that were now directly implicated by the trial declarations. According to Merus, Dr. Jones’s trial affidavit relied heavily on information that Regeneron failed to disclose during fact discovery and in response to the district court’s prior Order. In particular, Merus cited Dr. Jones’s deposition testimony that apart from a phone call that he had made to the PTO to schedule a meeting, he could not recall a single other communication with the Examiner during the ’018 patent prosecution. Late-produced billing records REGENERON PHARMACEUTICALS v. MERUS N.V. 29 referenced in Dr. Jones’s trial affidavit, however, suggested otherwise. Things were worse with respect to Dr. Smeland. Merus argued that Dr. Smeland was proposing to testify about his views on the meaning of claim language and his subjective understanding of the Withheld References. During discovery, however, Regeneron had withheld numerous documents on precisely those topics on the basis of privilege. The district court reviewed each of the trial affidavits and concluded that a comparison of these affidavits with entries on Regeneron’s privilege logs raised a number of concerns. In his affidavit, Dr. Smeland made dozens of assertions regarding topics about which Regeneron had not disclosed documents by placing those documents on its privilege log. In particular, Dr. Smeland made statements about his understanding of the scope of the invention in the ’176 application, his state of mind, and what he knew and thought about each of the Withheld References at the time of patent prosecution continuing up to the present. The district court provided a lengthy list of Dr. Smeland’s problematic assertions to emphasize the seriousness of the issue. In particular, Dr. Smeland stated that: • “I firmly believed—and still believe today— that Brüggemann, Taki, Zou and Wood were not material to patentability because they were substantially different from the mice claimed in the ’176 application . . . and were cumulative of other information before the Pa- tent Examiner.” • Dr. Smeland’s description of his understand- ing of what a materiality analysis for inequi- table conduct involves: “Regardless of whether I satisfied the minimum requirements of being an ordinary skilled artisan, I felt comfortable 30 REGENERON PHARMACEUTICALS v. MERUS N.V. evaluating the art from that perspective dur- ing the prosecution of the ’176 application. When I did have questions, however, I did not hesitate to reach out to those with more expe- rience and knowledge.” • “I routinely made Regeneron inventors aware of the foregoing obligations when providing them with invention declarations.” • With regards to Brüggemann and Zou, “I was generally familiar with the subject matter of those two references . . . [a]t no time did I con- sider these references to be material to pa- tentability to the claims pending in the ’176 application.” • “Because of this experience [prosecuting the ’176 application as well as the ’287 Patent], I was readily familiar with both prior art that was before the Examiner in the ’176 applica- tion and the pending claims of the ’176 appli- cation.” • “I viewed the analysis [relating to the With- held References] as straightforward.” • “I concluded that [the Withheld References], alone or combined with other prior art of which I was aware, were cumulative of infor- mation already before the Examiner. Fur- thermore, it was my view that the skilled artisan would not have viewed them as teach- ing the reverse chimeric inventions that the Examiner had allowed in the ’176 applica- tion.” REGENERON PHARMACEUTICALS v. MERUS N.V. 31 Id. at 590–93. 5 These statements and others implicated Dr. Smeland’s knowledge and state of mind regarding the Withheld References directly—both during prosecution and continuing through to trial. During litigation, Regeneron made a choice to maintain the attorney-client privilege as to Dr. Smeland’s knowledge and thoughts about the Withheld References during prosecution of the ’176 application. In maintaining its assertion of privilege, Regeneron shielded Dr. Smeland’s documents relating to his knowledge and thoughts about the Withheld References during prosecution from disclosure. As with any affirmative disclosure of information otherwise protected by the attorney-client privilege, however, once the disclosure of the trial affidavit was made, as it was not inadvertent, the waiver was complete. See In re von Bulow, 828 F.2d 94, 102–03 (2d Cir. 1987) (“‘[S]ubject matter waiver’ . . . allows the attacking party to reach all privileged conversations regarding a particular subject once one privileged conversation on that topic has been disclosed.”); see also Fort James Corp. v. Solo Cup Co., 412 F.3d 1340, 1349 (Fed. Cir. 2005) (“The widely applied standard for determining the scope of a waiver of attorney-client privilege is that the waiver applies to all other communications relating to the same subject matter.”). Thus, on the day that Regeneron disclosed Dr. Smeland’s trial affidavit, it waived the privilege as to the subject matter of each of the topics the affidavit addressed. In particular, Regeneron waived privilege as to Dr. Smeland’s views on the broadest reasonable construction of the claim language, understanding of the technolo- 5 The full list of problematic assertions the district court highlighted can be found in Regeneron I, 144 F. Supp. 3d at 590–93. 32 REGENERON PHARMACEUTICALS v. MERUS N.V. gy, and materiality (including cumulativeness) of each of the Withheld References. Regeneron argued that it had fully complied with its disclosure requirements throughout litigation. Merus, on the other hand, pointed to entries on Regeneron’s privilege log that seemed inconsistent with Regeneron’s representations. To resolve this dispute, the district court conducted an in camera review of a subset of the “many thousands” of documents on Regeneron’s log. Regeneron I, 144 F. Supp. 3d at 594. According to the district court, the log turned out to be a “Pandora’s Box.” Id. The district court’s in camera review revealed that there were dozens of “Smeland documents” that were not disclosed during litigation but as to which privilege had now been waived. The district court’s in camera review revealed additional serious discovery issues including a number of relevant non-privileged documents that had been withheld on the basis of privilege and documents that should have been produced pursuant to the Order regarding the Jones Memo issue that had not been disclosed. In all, the district court concluded that there were three categories of documents that presented serious concerns of discovery misconduct: 1. Non-privileged documents that were not pro- duced and instead resided throughout litiga- tion on the privilege log (e.g., numerous Excel spreadsheets with scientific test results, third party filings to the PTO, and fact statements by non-lawyers not seeking legal advice). 2. Previously privileged documents as to which Regeneron affirmatively waived the privilege by disclosing the “Jones Memo” and that the district court ordered be produced pursuant to its Order. REGENERON PHARMACEUTICALS v. MERUS N.V. 33