Brown Sues Abbott And Fournier for Blocking Generic Cholesterol Drug

LOS ANGELES--California Attorney General Edmund G. Brown Jr. today sued Abbott Laboratories and French drug company Fournier for devising “an elaborate scheme” to block less expensive generic versions of TriCor, a drug that controls cholesterol.

“Through an elaborate scheme—involving multiple drug patents, baseless lawsuits, and market manipulation—Abbott and Fournier thwarted competition,” Attorney General Brown said. “These companies made billions of dollars in annual profits, while Californians were burdened with artificially high drug prices,” Brown added.

After the Food and Drug Administration approved TriCor in 1998, Abbott and Fournier immediately devised a complicated strategy to prevent generic companies from entering the market and driving down Tricor prices. Key elements of the company’s scheme included the following:

• First, the company made trivial changes to the formulations of TriCor, for example switching from a capsule to a tablet, and then withdrew the original drug from the market.
• Then, Abbott and Fournier aggressively marketed their slightly altered versions of TriCor—although these drugs did not offer new medicinal benefits.
• Next, Abbott and Fournier deleted references to the original forms of the drug from national drug databases to confuse pharmacies or health plans, consequently making it impossible for a generic version of TriCor to obtain generic status.

At the same time, Fournier got the U.S. Patent Office to issue a series of patents covering the minor variations of TriCor, and then filed meritless patent infringement lawsuits against generic companies that tried to compete.

Abbott and Fournier knew that their patents were unenforceable but the litigation triggered mandatory thirty-month periods in which the Food and Drug Administration could not approve generic versions of TriCor. These delays from litigation gave Abbott and Fournier enough time to deplete the market of the older versions of TriCor so that no generic company could compete.

All of these baseless lawsuits were ultimately terminated or dismissed by Abbott and Fournier after their market-switching schemes were completed.

The attorney general alleges that these practices violate California’s antitrust law as well as the Sherman Act and have caused Californians to pay artificially high prices for TriCor. California and its citizens pay more than $150 million on TriCor per year. Studies show that when generic competition to a branded drug becomes available, the price for the drug decreases between 50 and 80 percent.

The civil complaint, filed today in federal court in Delaware along with twenty three other states, seeks triple the amount of damages incurred by the state’s public health agencies and individual consumers. The reason for seeking these exemplary damages is due to the willful, egregious and repeated nature of these violations.

Abbott Laboratories develops, manufactures, and sells pharmaceuticals and health care products and services throughout the United States. The company’s principal place of business is 100 Abbott Park Road in Illinois. Fournier Industrie et Sante is a French corporation headquartered at 42, Rue de Longvic, 21300 Chenove, France. Laboratoires Fournier, S.A., a subsidiary, collaborated with Abbott for regulatory approval, production and sale of TriCor in the United States.

TriCor is a brand-name prescription drug that uses the active ingredient, fenofibrate, to regulate triglyceride and cholesterol levels. TriCor and other fenfibrate drugs lower triglyceride levels, reduce low-density lipoprotein cholesterol, and increase high-density lipoprotein cholesterol. TriCor is generally prescribed as a maintenance drug for long-term cholesterol problems.

Eighteen states joined California today in filing this lawsuit including: Arizona, Arkansas, California, Connecticut, District of Columbia, Florida, Iowa, Kansas, Maine, Maryland, Minnesota, Missouri, New York, Nevada, Oregon, Pennsylvania, South Carolina, Washington and West Virginia.

The complaint is attached.