U.S. Supreme Court

Kagan Considers Meaning of 'Not An' in Ruling for Generic Drugmaker


A generic drug company that claims a brand-name competitor submitted an overbroad description of its patent to the Food and Drug Administration will get a chance to challenge the description in ongoing patent litigation.

In a unanimous opinion, the U.S. Supreme Court said generic companies may bring a counterclaim in a patent infringement suit in an effort to force correction of an overbroad FDA patent description for use of a drug. The FDA uses the information submitted by brand-name companies when it considers applications to market generic drugs.

Justice Elena Kagan wrote the opinion (PDF) siding with Caraco Pharmaceutical Laboratories Inc., which is seeking to market a generic version of the diabetes drug Prandin. Brand-name company Novo Nordisk has an existing patent that covers use of Prandin in combination with another diabetes drug. Caraco wants to market a generic version of the drug by itself and in a different drug combination than the patented Novo Nordisk use.

One issue in the case concerned the meaning of “not an” in the relevant statute. Kagan sided with Caraco’s reading, though she acknowledged ambiguity. “If your child admits that she ‘did not read a book all summer,’ you will surmise that she did not read any book (but went to the movies a lot),” Kagan wrote, listing several other examples. She went on to present the other interpretation. “Suppose your child explains her mediocre grade on a college exam by saying that she ‘did not read an assigned text.’ You would infer that she failed to read a specific book, not that she read nothing at all on the syllabus.”

Brand-name companies have said the type of counterclaims allowed in today’s opinion will lead to costly litigation, the Wall Street Journal (sub. req.) reports.

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