Antitrust Law Daily Wrap Up, ANTITRUST NEWS: Boehringer, Teva, Barr delay generic Aggrenox, Bluecross Blueshield claims, (Jun 25, 2015)

By Greg Hammond, J.D.

Louisiana Health Service Indemnity Co., doing business as Bluecross/Blueshield of Louisiana (BCBSLA), has filed an antitrust suit against various pharmaceutical companies for allegedly entering into an unlawful reverse payment agreement. The agreement allegedly has delayed the launch of generic Aggrenox—a combination antiplatelet agent used to reduce the risk of stroke in patients who have already suffered a mini-stroke or completed ischemic stroke (Louisiana Health Service Indemnity Co. v. Boehringer Ingelheim Pharma Gmbh & Co. KG, June 23, 2015).

Boehringer Ingelheim Pharma Gmbh & Co. KG received approval to manufacture, market, and sell Aggrenox in the United States from the U.S. Food and Drug Administration in 1999. After Barr Pharmaceuticals Inc. sought regulatory approval to manufacture, market, and sell a generic version of Aggrenox, Boehringer sued for patent infringement. The parties later allegedly entered into an exclusion payment agreement in which Boehringer agreed to pay Barr in exchange for Barr’s commitment to delay marketing generic Aggrenox. Specifically, Boehringer agreed to pay cash payments provided under the guise of a co-promotion agreement—an estimated $120 million in one-time and yearly royalty payments, and an agreement not to compete against Barr’s generic Aggrenox product with Boehringer’s own generic product once generic entry belatedly occurs.

BCBSLA claims that the exclusion payment agreement was designed to and did: (1) delay the entry of less expensive generic versions of Aggrenox; (2) fix, raise, maintain or stabilize the price of 25 mg aspirin/200 mg extended-release dipyridamole capsules; and (3) allocate 100 percent of the market for 25 mg aspirin/200 mg extended-release dipyridamole capsules to Boehringer for up to seven years. Further, once generic entry occurs, BCBSLA asserts that the agreement was designed to and will allocate 100 percent of the generic segment to Barr during the 180-day exclusivity period, reducing inter-generic competition.

But for the agreement, BCBSLA argues that less expensive, generic versions of Aggrenox would have been available as early as August 2008. Consequently, BCBSLA has paid substantially higher prices for Aggrenox than it otherwise would, absent the agreement, the complaint alleges.

BCBSLA sets forth nine counts in its complaint: (1) declaratory and injunctive relief under Section 16 of the Clayton Act for violations of Section 1 of the Sherman Act; (2) conspiracy and combination in restraint of trade under state law; (3) conspiracy and monopolization under state law; (4) violation of the Florida Deceptive and Unfair Trade Practices Act; (5) violation of the Illinois Consumer Fraud and Deceptive Business Practices Act; (6) violation of the Louisiana Unfair Trade Practices Act; (7) violation of the Massachusetts Consumer Protection Act; (8) consumer protection and unfair and deceptive trade practices under state law; and (9) restitution for unjust enrichment.

In its demand for judgment, BCBSLA seeks a judgment that declares the defendants’ conduct violates Sections 1 and 2 of the Sherman Act; enjoins the defendants from continuing their illegal activities; grants BCBSLA equitable relief in the form of disgorgement, restitution, and the creation of a constructive trust to remedy the defendants’ unjust enrichment; awards BCBSLA damages, along with treble, multiple, punitive, and other damages; and awards BCBSLA costs of suit and attorney fees.

The case number is 15-964.

Attorneys: David L. Belt (Hurwitz Sagarin Slossberg & Knuff LLC), Robert L. Salim (Salim-Beasley LLC), Thomas T. Townsend (T. Taylor Townsend, LLC), and John Alden Meade (Young Cotter & Meade LLC) for Louisiana Health Service Indemnity Co.

Companies: Louisiana Health Service Indemnity Co.; Boehringer Ingelheim Pharma Gmbh & Co. KG; Boehringer Ingelheim International Gmbh; Boehringer Ingelheim Pharmaceuticals, Inc.; Teva Pharmaceuticals USA, Inc.; Teva Pharmaceuticals Industries Ltd.; Barr Pharmaceuticals Inc.; Barr Laboratories, Inc.; Duramed Pharmaceuticals, Inc.; Duramed Pharmaceuticals Sales Corp.

News: Antitrust