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Schering v. Geneva: Inherency Patent Law and the Billion Dollar Claritin Sales History

The case of Schering v. Geneva (339 F.3d 1373) underscores the complexities of patent law, particularly concerning inherency and its implications for pharmaceutical patents like the '233 patent for Claritin. This patent, filed in 1980, faced expiration in December 2002, leading to the entry of generics that typically capture significant market share. The notable sales figures reflect Claritin's success, generating up to $3.16 billion in 2002. The case raises critical questions about anticipation rules, prior art recognition, and the pharmaceutical industry's strategies to extend patent lifecycles.

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Schering v. Geneva: Inherency Patent Law and the Billion Dollar Claritin Sales History

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

  2. Vilani ‘233 Patent: “The Billion Dollar Molecule”

  3. 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.

  4. 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

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

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

  7. ‘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.”

  8. ‘233 Prior Art Patent

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

  10. 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

  11. 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 . . .

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