Healthy Skepticism Library item: 1517

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Publication type: news

Court Declines Patent Case Over 'Off-Label' Drug Uses
Wall Street Journal 2003 Dec 1

Full text:

The Supreme Court dealt a blow to large drug manufacturers Monday, refusing to hear an appeal over patent rights for drugs that are prescribed for uses regulators haven’t officially approved.

The case involved the lucrative patents granted to a drug’s original developer and competition from rival generic-drug makers. Big companies that develop and sell drugs wanted the court to make it easier to protect patents for drugs that may be used “off-label.”

Once a drug is approved by the Food and Drug Administration, doctors can prescribe it for uses other than its intended purpose. The common practice is based on research or anecdotal evidence from other doctors, and is unrelated to whether the drug is the patented original or a generic knockoff.

In this case, drug maker Allergan Inc. claimed that generic-drug makers exploited the off-label potential of a patented glaucoma drug. A federal appeals court ruled against Allergan, and the company appealed to the Supreme Court.

Makers of generic drugs may seek permission to make copies of FDA-approved medications only for the uses the government has already approved. Allergan claims that Alcon Laboratories and other generic manufacturers asked permission to make the glaucoma drug brimonidine knowing that it would be used extensively in a way not foreseen when the drug was first brought to market.

Brimonidine was originally used to lower pressure in the eyes of glaucoma patients. Later, however, researchers at Allergan discovered that the drug can also be effective in preventing the death of optic nerve cells in glaucoma patients, and doctors now prescribe it for that purpose.

Prescriptions for off-label uses of drugs may account for more than 25% of the approximately 1.6 billion prescriptions written each year, lawyers for Allergan told the court. (Allergan Inc. v. Alcon Laboratories)