Supreme Court ruling causing heartburn
A favorable June 5 ruling for private-labeler Perrigo to launch its own version of the acid reducer Pepcid Complete reflects the influence of the recent U.S. Supreme Court decision that expanded the situations under which an invention can be considered obvious (1"The Pink Sheet" May 7, 2007, p. 7). Johnson & Johnson/Merck sued Perrigo for patent infringement after the private-labeler submitted an ANDA with a Paragraph IV certification to FDA to manufacture and market an equivalent of the famotidine/antacid combination, but the formulation patent concerning the use of the H2 blocker famotidine was invalidated on the grounds that it was obvious. In the precedent-shifting KSR v. Teleflex case, the Supreme Court said courts should now look at factors such as market demands and predictable solutions to a problem in assessing obviousness...
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The pharmaceutical industry could have a tougher time protecting certain drug patents - particularly those in ANDA litigation - following a U.S. Supreme Court decision that expands the situations under which an invention can be considered obvious
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