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From Antitrust Law Daily, November 30, 2017

Pharmaceutical company compelled to produce contested documents in ‘pay-for-delay’ case

By Gregory Kane, J.D., M.B.A.

Plaintiffs in a multidistrict litigation against Boehringer Ingelheim Pharmaceuticals, Humana, Inc. and Louisiana Health Service Indemnity Co. (collectively, "Humana") successfully moved to force the production of documents relevant to the drug in dispute, Aggrenox, by the federal district court in Bridgeport, Connecticut. Boehringer previously produced the 52 documents at issue to the FTC in response to an order of the United States District Court for the District of Columbia in a related multidistrict proceeding (In re Aggrenox Antitrust Litigation, November 29, 2017, Underhill, S.).

Boehringer obtained a patent on an anti-coagulant drug marketed under the name Aggrenox. Generic drug manufacturer Barr Laboratories (Barr) sought to market a generic equivalent and Boehringer filed suit for patent infringement. The two reached a settlement under the terms of which Barr agreed to delay bringing a generic version of Aggrenox to market and also promised to promote Aggrenox in return for which Boehringer would drop its patent infringement suit and pay Barr a sum of money in part based on net sales of Aggrenox. The agreement led Humana to file suit alleging that Barr and Boehringer illegally agreed to delay the generic drug in exchange for large and unjustified payments.

In 2009, the FTC began investigating whether the settlement was an unfair method of competition.

Discovery. Boehringer refused to turn over certain documents to the FTC claiming they were attorney opinion work product and the FTC sought to compel their production. The district court reviewed a representative sample of the documents in camera and permitted Boehringer to withhold the documents. On appeal, the D.C. Circuit ruled that the district court had applied an overly broad definition of opinion work product, vacated the ruling and remanded for a determination of which documents still withheld should be produced.

The district court then held that the majority of the documents were fact work product and ordered them produced. Boehringer was unsuccessful in obtaining a stay pending appeal and eventually produced 52 documents to the FTC.

After Boehringer’s motion to stay was denied, plaintiffs in the present case requested the same documents be produced. Boehringer refused, claiming privilege and arguing that disclosure to a government agency required a lesser showing of substantial need to obtain work product. Plaintiffs filed a motion to compel and the present court reviewed the documents in camera.

Estoppel. Boehringer was collaterally estopped from arguing that the documents were protected by the work product doctrine, according to the court. The D.C. district court held that the documents in question were work product and that ruling was affirmed by the D.C. Circuit. Boehringer insisted that the documents were opinion work product, afforded greater protection, and alternatively that plaintiffs had not met the burden of demonstrating substantial need or undue hardship required to discover fact work product under Rule 26(b)(3). The matter had already been heavily litigated with Boehringer afforded a full and fair opportunity to press its case. The decision of the district court following remand constituted final judgment that the documents were fact work product and subject to disclosure.

Work product. An independent review of the matter would also indicate the documents are in fact work product as the documents may have helped Boehringer’s general counsel to reach legal conclusions, but the general counsel in no way relied upon her legal opinions in requesting the particular data the documents contain.

Substantial need and hardship. Plaintiffs have made an adequate showing of substantial need for the documents as the financial analyses and forecasts within the documents are the only direct evidence of Boehringer’s contemporaneous valuation of the co-promotion agreement with Barr. The present antitrust case will rely on whether the payment to Barr was made in order to avoid the risk of patent invalidation. Nor could plaintiffs obtain the same information from oral questions after almost a decade had past. The documents are the only viable contemporaneous indication of how Boehringer understood the financial impact of the anticompetitive agreement. Plaintiffs request to compel production of the documents was granted by the court.

The case is No. 3:14-md-02516 (SRU).

Attorneys: Mathew P. Jasinski (Motley Rice LLC) for A.F. of L. - A.G.C. Buildings Trade Welfare Plan and Painters District Council No. 30 Health & Welfare Fund. Brigid M. Carpenter (Baker, Donelson, Berman, Caldwell & Berkowitz, PC) for Barr Pharmaceuticals Inc. n/k/a Barr Pharmaceuticals, LLC, Boehringer Ingelheim International GmbH and Boehringer Ingelheim Pharmaceuticals, Inc.

Companies: arr Pharmaceuticals Inc. n/k/a Barr Pharmaceuticals, LLC; Boehringer Ingelheim International GmbH; Boehringer Ingelheim Pharmaceuticals Inc.; Humana, Inc.; Louisiana Health Service Indemnity Co.

MainStory: TopStory Antitrust ConnecticutNews FederalTradeCommissionNews

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