Lead Opinion
The Federal Trade Commission and Minnesota (collectively the FTC) sued Lundbeck, Inc., alleging its acquisition of the drug NeoProfen violated the Federal Trade Commission Act, the Sherman Act, the Clayton Act, the Minnesota Antitrust Law of 1971, and unjustly enriched Lundbeck. After a bench trial, the district court
Patent duсtus arteriosus (PDA) is a life-threatening heart condition that primarily affects low-birth-weight, usually premature, babies. There are two primary treatments: pharmacological and surgical. Pharmacological treatment (a drug) is the first-line treatment; surgical ligation is considered after other treatments are ineffective. Approximately 30,000 casеs of PDA are treated with drugs in the U.S. yearly.
When this case was brought, there were two FDA-approved drugs for PDA: Indocin IV and NeoProfen. (In 2010, two generic alternatives to Indocin IV were introduced by Bedford Laboratories and APP Pharmaceuticals, LLC.) Indocin IV — an off-patent, injectable drug with the active ingredient indomethacin — has been FDA-approved for PDA since 1985. NeoProfen — a patented injectable drug with the active ingredient ibuprofen lysine — has been FDA-approved Tor PDA since 2006. Because their active ingredients differ, Indocin IV and NeoProfen are not bioequivalents and have different side effects.
Lundbeck purchased the rights to Indocin IV from Merck & Co. in 2005, and the rights to NeoProfen from Abbott Laboratories in 2006 (before it was put on the market). Until gеnerics appeared in 2010, Lundbeck owned all the drugs for PDA.
When Lundbeck purchased Indocin IV, Merck charged $77.77 per treatment. Lundbeck immediately raised the price of Indocin IV. Two days after acquiring the rights to NeoProfen, Lundbeck raised the price thirteen-fold. By 2008, the price of Indocin IV settled at $1614.44. When Lundbeck introduced NeoProfen in 2006, it chargеd $1450 per NeoProfen treatment, and its price eventually settled at $1522.50.
Both Indocin IV and NeoProfen are hospital-based drugs dispensed and used in inpatient care. Most hospitals assemble a formulary — a list of recommended drugs— to streamline purchasing. The formularylisted drugs are chosen by pharmacy and therapeutics committees who оften seek input from specialist physicians. Some hospitals use closed formularies (special approval is required to prescribe non-listed drugs). Others apply open formularies (physicians can prescribe non-listed drugs at their discretion). Hospitals use inclusion in the formulary to extract better prices from sellers of clinieally-substitutable drugs.
“The determination of the relevant market is an issue for the trier of fact.” Ryko Mfg. Co. v. Eden Servs.,
The FTC argues that this court should review the district court’s judgment de novo because the court “applied an incorrect legal standard” by failing to “ex-amin[e] all the pertinent factors” determining a relevant market. United States v. Empire Gas Corp.,
To prevail, the FTC bears the burden of identifying a relevant market. See HDC Med., Inc. v. Minntech Corp.,
The outer boundaries of a product market can be identified by the reasonable interchangeability, or cross-elasticity of demand, between the product and possible substitutes for it. Brown Shoe Co. v. United States,
In its fact-findings, the district court credited the testimony of five clinical pharmacists, representing approximately 43 hospitals throughout the country. The pharmacists uniformly stated that while they make drug recommendations, the neonatologists decide which drug a patient receives. The court also credited the testimony of seven neonatologists who said that treatment decisions are based solely on perceived clinical advantages/disadvantages of Indocin TV versus NeoProfen. The neоnatologists’ preferences differed (some prescribe Indocin IV, others Neo-Profen), but each echoed the same concept: The relative price of the drugs does not factor into the choice of drug treatment. The court was not persuaded by the testimony of one neonatologist (cited often by the FTC and its expеrts), who believed the drugs to be equally safe, implying he was comfortable using either one for PDA.
Based on this evidence, the court determined that the neonatologists “ultimately determine the demand for Indocin IV and Neoprofen,” and that these treatment decisions are made “without regard to price.” Thus, an increase in the price of Indoсin IV would not drive a hospital to purchase NeoProfen, and vice versa. Considering these facts, as well as testimony by Lundbeck’s expert whom the court found “persuasive,” the court ruled that there is low cross-elasticity of demand between Indocin IV and NeoProfen, and thus the drugs are not in the same product market. See H.J., Inc. v. International Tel. & Tel. Corp.,
The FTC contends that the district court relied too much on the testimony of the neonatologists, and ignored evidence demonstrating that Indocin IV and Neo-
Accоrding to the FTC, the district court (and the neonatologists) ignored the fact that Indocin IV and NeoProfen are practicable alternatives, relying instead on stated consumer preference. In fact, the practicable alternatives here are clear, were the subject of testimony by the neonatologists, and were considerеd by the district court. When the case was tried, Indocin TV and NeoProfen were the two drug treatments available for PDA. Aware of the drug options — the “practicable alternatives” — the neonatologists preferred one treatment or the other (without regard for cost), which the court credited as persuasive evidence of low cross-еlasticity.
In a variation of the “practicable alternatives” argument, the FTC asserts that functionally similar products must be in the same product market. To the contrary, functionally similar products may be in separate product markets, depending on the facts of the case. Compare Henry v. Chloride, Inc.,
Further attacking the district court’s reliance on consumer preference, the FTC argues that the court ignored the ability of marginal customers to constrain
Finally, the FTC contends that the district court ignored its own findings about Lundbeek’s internal documents, claiming they indicate Indocin IV and Neo-Profen are in the same market. True, industry recognition is a factor in a product market definition. See Brown Shoe Co.,
In the end, the FTC disagrees with the district court’s weighing of the facts applicable to the relevant market determination. The district court reached its deci
The judgment is affirmed.
Notes
. The Honorable Joan N. Ericksen, United States District Judge for the District of Minnesota.
. The FTC asserts that the district court failed to examine a hypothetical market where Indocin IV and NeoProfen were owned separately. In determining the relevant market, the district court need not consider a hypothetical market, especially here whеre the FTC offered no evidence about such a hypothetical market. See Yamaha Motor Co., Ltd. v. FTC, 657 F.2d 971, 977 (8th Cir.1981) (examining a hypothetical market, absent the challenged conduct, in order to determine whether a violation occurred, not to determine the relevant market); United States v. Microsoft,
Concurrence Opinion
concurring.
When defining the product market, and considering the issue of cross-elasticity of demand, the district court relied heavily upon the testimony of doctors that they would use Indocin or NeoProfen without regard to price. Admittedly, those doctors had no responsibility to pay for the drugs or otherwise concern themselves with cost. Thus, the doctors had scant incentive to conserve the scarce resources that would be devoted to paying for the medication. Why the able and experienced trial judge relied upon the doctors’ testimony so heavily is perplexing. In an antitrust case, it seems odd to define a product market based upon the actions of actors who eschew rational economic considerations. See, e.g., F.T.C. v. Tenet Health Care Corp.,
The foregoing having been said, the standard of review carries the day in this case as it does in so many others. As a result, I fully concur in Judge Benton’s excellent opinion.
