In re Novartis and Par Antitrust Litigation

Background

This order concerns plaintiffs’ motion under Federal Rule of Civil Procedure 45 to compel nonparties Lupin Limited and Lupin Pharmaceuticals, Inc., collectively called Lupin, to produce documents responsive to a subpoena.

The underlying civil antitrust case alleges that Novartis Pharmaceuticals Corporation and Novartis AG, together called Novartis, and Par Pharmaceutical, Inc. entered an unlawful agreement concerning the generic version of Exforge, a prescription drug used to treat hypertension. According to the allegations described in the order, Par agreed not to launch a generic version until September 30, 2014, and Novartis agreed not to compete with Par during the 180-day regulatory exclusivity period after Par’s launch. Plaintiffs contend that the agreement delayed generic competition and kept prices higher than they otherwise would have been.

Plaintiffs argued that Lupin’s records could show whether Lupin had the ability, plans, and economic incentive to enter the generic Exforge market before March 30, 2015, when Par’s exclusivity period actually ended. Plaintiffs served the subpoena on February 11, 2019. After extensive discussions, Lupin produced more than 1,100 documents totaling more than 20,000 pages, but it maintained that it had found no other nonprivileged responsive documents.

Disputed discovery

Plaintiffs identified nine categories they said remained deficient, including process-validation reports and manufacturing records; launch-meeting minutes; inventory and manufacturing dates; launch timelines; purchases of active ingredients, other ingredients, and packaging; evidence of possible earlier-launch efforts; manufacturing difficulties; and the timing of equipment purchases or availability.

Lupin argued that its existing production—including forecasts, its abbreviated new drug application file, launch-meeting minutes, transactional data, and launch-preparation documents—was sufficient. It also argued that the nine requests were overly broad and imposed an undue burden after more than 18 months of searches. The order noted that some requested manufacturing documents were held at a facility in India that was inaccessible during a COVID-19 lockdown.

Court’s analysis

The court explained that discovery from a nonparty must concern nonprivileged material relevant to a claim or defense and proportional to the needs of the case. Once the subpoenaing party shows relevance, the nonparty must justify limiting discovery by showing undue burden. Courts also give particular consideration to the expense and inconvenience imposed on nonparties.

The court found the requested materials relevant because Lupin’s launch plans, manufacturing capacity, and ability to enter the market earlier could bear directly on plaintiffs’ theory that the Novartis/Par agreement delayed generic competition. The court acknowledged that the requests were broad and that compliance would burden Lupin. It determined that the competing concerns could be addressed by shifting the costs of further production to plaintiffs.

Ruling

Judge Alvin K. Hellerstein granted the motion to compel discovery. Lupin was ordered to comply with the narrowed Requests 4 and 5 by producing documents fitting the nine categories identified by plaintiffs. Lupin must produce the documents within 45 days from issuance of the order.

The order requires plaintiffs to pay Lupin’s reasonable expenses and attorneys’ fees incurred in complying with the motion going forward. The Clerk was instructed to close the open motion, ECF No. 244.