Inherency Patent Law 2/10/2004 Schering v Geneva, 339 F.3d 1373 (Fed Cir 2003)

Vilani ‘233 Patent: “The Billion Dollar Molecule”

Claritin Sales History 1995, $790 million 1996, $1.2 billion 1997, $1.7 billion 1998, $2.3 billion 1999, $2.7 billion 2000, $3 billion 2001, $3.16 billion 2002, $1.8 billion.

Schering-Plough’s Patent Expiration Dilemma ‘233 Patent: Filed, 6/19/1980; Expiration – December, 2002 Here come the generics! –Typically, pioneer firm loses half market share in first 6 months of generic availability

Patent Franchise Extension Techniques – Pharma Industry “Dosage forms” “Packaged drugs” Intermediates/active ingredients Different formulations, production techniques, etc.

Vilani ‘716 Patent: The “DCL” Metabolite (Intermediate) Patent

‘716 Patent 716 Patent Prosecution History –“The present application is a continuation-in- part of U.S. application Ser. No. 580,304, filed Feb. 15, 1984, now abandoned, the benefit of which is claimed pursuant to the provisions of 35 U.S.C. 120.”

‘233 Prior Art Patent

COOEt This compound “metabolizes” to... This compound

Inherency requirements Reference must predictably and regularly disclose/produce the claimed invention –Spurious results –Theoretically possible but practically unknowable results (In re Seaborg) Is “recognition in the art” required? –No: p. 1377/50

Contrary Indications? Continental Can/Eibel Process/Tilghman v Proctor? –“accidental anticipation” versus “lack of recognition or appreciation” Resolving the issue: which rule makes more sense? –Bright line anticipation rules, versus –Incentives to explore and expand prior art...