In recent years, certain court decisions have suggested that copying is not a significant secondary consideration of non-obviousness in pharmaceutical patent infringement cases brought under the Hatch-Waxman Act. The notion of "no copying in ANDA cases'" appears to come from Eli Lilly & Co. v. Zenith Goldline Pharm., Inc., No. IP 99-38-CHK, 172 F. Supp. 2d 1060 (S.D. Ind. Oct. 29, 2001). In that case, at issue was a patent covering a drug molecule, and the court noted that the ANDA procedures established by the Hatch-Waxman Act require generic drug manufacturers to copy the approved drug to help ensure that a generic drug will be as safe and effective as the approved version. The court also stated:
The fact that copying is likely to be present in many Hatch-Waxman Act cases does not allow the court to ignore the copying as evidence of non-obviousness, even though it may be entitled to relatively little weight. In this case, in this field of new drug design, the very need for copying results from and emphasizes the unpredictability of medicinal chemistry. . . . To gain FDA approval, therefore, a company in Zenith's position must copy the patented invention as closely as possible. Small changes in chemical structure may have dramatic and unpredictable biological effects. To that extent, the evidence of copying adds a little weight against a finding of obviousness, though it is not essential to this court's ultimate conclusion.
Thus the idea that copying has very little weight in ANDA cases appears to be premised on the idea that an ANDA filer cannot simply design around a drug molecule patent and because, in effect, copying of the drug molecule(s) is mandated by the statute governing ANDAs.
But what about copying where the generic company had other, non-infringing alternatives but nevertheless opted to copy the patented invention? Many Orange Book-listed patents cover other aspects of an approved drug product, such as a particular API polymorph, salt, or drug product formulation, where the patent is directed to, e.g., the kind, number, and amounts of inactive ingredients (excipients) that make up the drug product along with the active drug molecule(s). The FDA permits some variations in physical form, salt form, and formulation of the approved API, so should copying of those patents be given increased weight? In this article, Finnegan attorneys Barbara R. Rudolph and Robert C. Stanley discuss copying as objective evidence of non-obviousness in ANDA litigation.
Previously published in BNA Pharmaceutical Law and Industry Report
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