The Novo Nordisk Case
The Federal Circuit Court of Appeals decided the case between Novo Nordisk (www.novonordisk-us.com) and Bio-Technology General in October 2005. The facts of the case are typical of a patent strategy, seeking to obtain patent protection on a novel form of a known protein, in this case, human growth hormone (hGH).
In the background section of the case the court noted that hGH is a known protein that is secreted from the pituitary gland and, until the mid-1980s, hGH for therapeutic purposes was obtained from the pituitary glands of human cadavers. Since hGH from cadaver pituitary glands carries a high risk of contamination and infection for patients, attempts were made to produce a biosynthetic hGH that would be free from contaminants and have the same in vivo activity as the pituitary-derived hGH.
Novo Nordisk obtained U.S. Patent 5,633,352 (the 352 patent) claiming a biosynthetic ripe hGH produced by recombinant DNA techniques free of contaminants from pituitary-derived hGH. This biosynthetic hGH was produced by transfecting a bacterium with the gene sequence for a fusion protein, comprising the gene sequences for a bacterial protein and human hGH. The pure hGH was produced by enzymatic cleavage of the expressed fusion protein using a proteolytic enzyme, DAP I.
The case at hand arose when Novo Nordisk sued Bio-Technology General (BTG) for infringing this patent. BTG counterclaimed that the 352 patent was invalid as being anticipated, or lacking novelty in light of the prior art, and was unenforceable due to inequitable conduct by the patentee during prosecution. The District Court agreed with BTG and found the 352 patent to be both invalid and unenforceable, and the Federal Circuit Court affirmed the District Courts findings.