Magistrate Judge Mary Pat Thynge: Inequitable Conduct: Pleading and Discovery

This opinion follows a series of discovery disputes between the parties surrounding requests for production of documents concerning drugs other than the drug that is the subject of the plaintiffs’ NDA, defendant Mylan’s ANDA and the patent-in-suit. Eurand, Inc. v. Mylan Pharmaceuticals, Inc., C.A. No. 08-889-SLR, Memo. Order (D. Del. Apr. 13, 2010) (Thynge, Magistrate) (see prior opinion and post here). As part of its Second Amended Answer, defendant Mylan asserted the affirmative defense and counterclaim of inequitable conduct alleging that Mylan failed to disclose another material patent during the examination of the patent-in-suit. Mylan sought to discovery documents “evidencing the two inventors’ awareness of and understanding of” certain pieces of prior art during the period prior to and during the filing and prosecution of the patent-in-suit. Id. at 3.

Mylan’s Second Amended Answer asserted a claim of inequitable conduct solely based on one piece of prior art, a U.S. patent. Mylan also sought documents, however, related to two other references that were not mentioned in its Answer, but Mylan argued were relevant to plaintiffs’ subjective intent. Id. at 8-10. Such discovery was necessary, Mylan argued, before it could assert additional claims of inequitable conduct under Rules 9 and 11. Judge Thynge held that “[i]t is improper to use discovery in search of a factual predicate required to be pled in the first instance.” Id. at 10.

However, as to the documents sought to establish knowledge and intent related to the U.S. patent that Mylan did plead in its counterclaim and affirmative defense, those documents are relevant and should be produced. Plaintiffs argued that they conducted a thorough search of all relevant files including all development and product files related to the drug claimed in the patent-in-suit and those files would have encompassed the prior art sought by Mylan. Id. at 5, 11. They further argued that the proposed search by Mylan of the emails of the two inventors would “involve review of a large number of potential emails and substantial expense…and contains terms that have nothing to do with the present inequitable conduct claim.” Id. at 11. Noting the hesitancy of the court to opine on such “mysteries of keyword search techniques,” the court stated that it in determining the “adequacy” of search terms or methodology, a reasonableness test is applied. It further found that plaintiffs’ search of materials related to the drug claimed in the patent-in-suit “did not include keywords on the inventors’ knowledge or awareness of the materiality of the [prior art] patent” and that “[s]uch knowledge under the circumstances…would most likely be found in the emails of the inventors.” Id. at 13. Therefore, the court ordered plaintiffs to search and produce all emails that “are relevant to the inventors’ knowledge and materiality of the [prior art] patent to the [patent-in-suit] and failure to disclose the [prior art] patent during the prosection of the [patent-in-suit]” during the period from the filing of the [prior art] patent to the date of issuance of the [patent-in-suit].” Id. at 14.

Eurand, Inc. v. Mylan Pharmaceuticals, Inc., C.A. No. 08-889-SLR, Memo. Order (D. Del. Apr. 13, 2010) (Thynge, Magistrate)

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