Chicago, IL - Legal arguments are being prepared for a showdown in state and federal courts that will determine just how far pharmaceutical companies can go to protect their drugs from generic competition, the Wall Street Journal reports [1].

In a story published online June 2, 2008, the Journal discusses the controversy surrounding TriCor, a fenofibrate made by Abbott Laboratories. At the heart of a state and federal investigation is whether Abbott violated antitrust laws in its attempt to keep Teva Pharmaceuticals Industries from selling a generic version of the cholesterol medication.

TriCor is a massive moneymaker for Abbott, breaking the $1-billion mark in sales in 2007. The outcome of the case, reports the Journal, could help provide future direction for drug makers, many of whom have struggled to find replacements for off-patent medications and are looking to squeeze every last dollar out of their existing drugs.

Abbott is accused of filing dubious patent improvements on TriCor, something critics say is a blatant attempt to extend its monopoly and deny cheaper generics from entering the market. In addition to these questionable improvements to the 33-year-old drug, the lawsuit, which was filed in federal court in Delaware, 25 states, and the District of Columbia, alleges that Abbott engaged in "product switching." The Federal Trade Commission is also investigating the product-switching charge.

According to Journal reporter Shirley Wang, product switching involves retiring an existing drug and replacing it with a "new and improved version." In doing so, pharmacists are unable to substitute the patented medication with a generic when prescriptions are filled. Although product switching is not against the law, the lawsuit alleges that Abbott abused the practice simply as a means to preserve its monopoly on TriCor. Abbott denies the claim, telling the Journal, "Any suggestion that new formulations did not offer patients benefit is false."

Abbott licensed TriCor from Fournier Laboratories of France and won approval from the Food and Drug Administration to sell the fenofibrate in the mid-1990s. Although the drug's underlying patent had expired—the drug was discovered in the 1960s—Abbott had patented a new way to make the drug.

As the Journal reports, one year after TriCor began selling in the US, Novopharm, which was later acquired by Teva Pharmaceuticals, applied to the FDA to make a generic version. Abbott sued for patent infringement, which bought it a 30-month waiting period. A generic drug, according to US law, can't be launched while patent challenges are worked out in court. During the 30-month period, however, Abbott altered TriCor by lowering the dose and changing the drug from a capsule to a tablet. It then filed for a new patent on this modified version of TriCor and bought back all the remaining supplies of older drugs from pharmacies.

"By the time 30 months had elapsed and Teva was ready to launch its generic version of the drug, there was no longer a market for it," writes Wang. "The reason: FDA rules say a pharmacist can substitute a cheaper generic for a branded drug only if they are strictly bioequivalent. Not only does that mean the generic version must contain the same active ingredient, it also must also be in the same form and dosage."

The whole saga was repeated again in 2002 when Teva sought to sell a generic version of this new TriCor. Again, Abbott sued, winning another 30-month reprieve, and then changed the formulation and dose a second time. After the courts ruled against Abbott in the patent lawsuits, it dropped the patent litigation in 2005.

Since 2005, Teva has filed a countersuit alleging Abbott violated antitrust laws. With a trial scheduled for November, Abbott is arguing it has a right to protect its improvements to the drug and denies altering the product simply to shut down Teva's attempts to bring a generic to market. It argues that the reformulations led to increases in HDL-cholesterol levels and eliminated to need to take the drug with food.

Still, though, the data the company uses to boast about its product and its lipid-altering capabilities are based on trials using the original TriCor. Not surprisingly, Teva says the active ingredient in TriCor was unaltered and all improvements are simply "smoke screens," writes Wang.

"Pharmaceutical companies should not be able to get away with protecting their patents purely on the basis of altering their products on dosage or small changes in order to keep their profits up," Florida attorney general Bill McCollum, who is leading the multistate suit, told the Journal. "The public interest is for patents to eventually expire."