Supreme Court Denies Eli Lilly’s Prozac Patent Appeal
The Supreme Court yesterday refused to consider Eli Lilly's appeal of a ruling invalidating the patent on its anti-depressant Prozac, ending a six-year legal battle over the rights to the medication, the AP/Nando Times reports. Without comment, the court let stand an appeals court decision that Lilly had improperly "double-patented" Prozac to extend its exclusive control over the drug (Gearan, AP/Nando Times, 1/14). In August 2000, the U.S. Circuit Court of Appeals for the Federal Circuit shortened the length of Lilly's patent from December 2003 to 2001 after concluding that the drug maker had first obtained a patent for Prozac's active ingredient and then another patent after discovering a "new use" for the drug (Vicini, Reuters/Philadelphia Inquirer, 1/15). The case originated in 1996, when Lilly sued Barr Laboratories and other generic drug makers after they applied for FDA approval to make a generic version of Prozac (AP/Nando Times, 1/14). On Aug. 2, 2001, six days after the federal judge rejected Prozac's patent extension, Barr began shipping its version of the popular medication, leading Prozac sales in the third quarter of 2001 to decline by one-third (Murphy, Washington Times, 1/15). In its brief to the Supreme Court, Lilly said that the appeals court ruling had "incorrectly cut short its market exclusivity for the drug by nearly three years, costing the company some $4 billion in sales" (Greene/Greenberger, Wall Street Journal, 1/15). Barr Chair and CEO Bruce Downey said, "Today's decision represents a final victory for Barr and for the generic industry" (AP/New York Times, 1/15). Barr's version of Prozac earned $175 million in sales in its first two months (Washington Times, 1/15).
In another win for generic drug makers, a U.S. District Court in Los Angeles granted a summary judgment on Friday in favor of generic drug maker Ivax Corp. in its patent dispute with American BioScience Inc. over the generic version of the cancer drug Taxol (Wall Street Journal, 1/15). Ivax, which has "accused the drug's original marketer, Bristol-Myers Squibb Co., of using ABI to help delay generic competition on Taxol," had asked the judge to invalidate ABI's patent "because it didn't cover anything new," Bloomberg/Los Angeles Times reports. Ivax began selling its version of the drug in October 2000 after a court ordered the removal of ABI's patent from the FDA patent registry. On Nov. 6, the U.S. Court of Appeals ruled that the FDA had "erred" in approving the generic version of Taxol, "jeopardizing Ivax's right to sell the drug" (Bloomberg/Los Angeles Times, 1/15). However, that ruling did not consider the validity of the patent, which was the subject of yesterday's decision (Wall Street Journal, 1/15).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.