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Judge Robinson denies defendant’s request to claw back documents in ANDA litigation


Judge Sue L. Robinson denied defendant’s request to claw back certain documents that defendant initially produced “without claiming protection from disclosure under either the attorney-client privilege or the work product doctrine.” Pfizer Inc., et al. v. Lupin Pharm., Inc., et al., C.A. No. 12-808-SLR, slip. op. at 1 (D. Del. Dec. 2, 2013). Defendant produced “100 documents related to experiments conducted by scientists in [defendant’s] Intellectual Property Management Group,” and defendant sought to claw back those documents as protected under the attorney-client privilege or the work product doctrine. Id. at 2. Judge Robinson found it clear that these documents were not protected under the attorney-client privilege, as “they were neither created with the knowledge of . . . counsel, nor were they shared with . . . counsel contemporaneously.” Id.

The “harder question,” as Judge Robinson explained, was whether these documents were protected under the work product doctrine, which does not require attorney involvement for document protection. Id. at 3. Judge Robinson recognized that “the documents at issue were generated under the complex administrative paradigm created under the Hatch-Waxman Act,” and that “litigating the validity of patents is contemplated under the statute.” Id. at 3-4. However, Judge Robinson “decline[d] to equate the ordinary course of business of a generic manufacturer (testing compounds in order to develop bioequivalent drugs) with the more specific conduct associated with anticipation of litigation (e.g., testing the compounds of the prior art in order to invalidate a patent), especially where, as here, there [was] no indication that the [defendant] scientists were doing anything other than pursuing general scientific research on [defendant’s] prospective drug(s).” Id. at 4. Judge Robinson therefore found that defendant failed to meet its burden to demonstrate the documents at issue were protected from disclosure and denied defendant’s requested claw back. Id.

Pfizer Inc., et al. v. Lupin Pharm., Inc., et al., C.A. No. 12-808-SLR (D. Del. Dec. 2, 2013).

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