Inherency Patent Law 2/10/2004

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InherencyPatent Law 2/10/2004

• Schering v Geneva, 339 F.3d 1373 (Fed Cir 2003)

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Vilani 233 Patent The Billion Dollar Molecule
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(No Transcript)
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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.

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Schering-Ploughs 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

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Patent Franchise Extension Techniques Pharma
Industry

• Dosage forms
• Packaged drugs
• Intermediates/active ingredients
• Different formulations, production techniques,
  etc.

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Vilani 716 Patent The DCL Metabolite
(Intermediate) Patent
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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.

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233 Prior Art Patent
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COOEt
This compound metabolizes to . . .
This compound
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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

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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 . . .