Wednesday, November 13, 2013

In re Metoprolol Succinate Patent Litigation case brief

In re Metoprolol Succinate Patent Litigation case brief summary
494 F.3d 1011 (2007)


CASE SYNOPSIS
Plaintiff patent holders filed actions under 35 U.S.C.S. § 271(e), alleging that defendants, pharmaceutical companies that filed Abbreviated New Drug Applications (ANDA), committed patent infringement. The U.S. District Court for the Eastern District of Missouri granted defendants' motions for summary judgment on their claims that U.S. Patent Nos. 5,001,161 and 5,081,154 were invalid and unenforceable. The patent holders appealed.

CASE FACTS

  • In 1988, U.S. Patent No. 4,780,318 ('318 patent) was issued to a company that held rights under Swedish law to a process for delayed release dosage forms of pharmaceutical compositions, including metoprolol succinate. 
  • In 1991 and 1992, U.S. Patent Nos. 5,001,161 ('161 patent) and 5,081,154 ('154 patent) were issued to another company (patent holder) that manufactured and sold metoprolol succinate. 
  • When several pharmaceutical companies filed an ANDA, seeking permission to sell a generic form of metoprolol succinate, the patent holder claimed patent infringement.

DISCUSSION

  • The court of appeals held that the '154 patent was invalid due to double patenting because it was not distinct from the '318 patent. 
  • However, it reversed the district court's order awarding the pharmaceutical companies summary judgment on their claim that the patents were unenforceable because the patent holder engaged in inequitable conduct. 
  • Although the patent holder did not inform the U.S. Patent and Trademark Office (PTO) that there was a dispute about who invented the process, the evidence did not show conclusively that the patent holder intended to deceive the PTO when it withheld that information.
CONCLUSION
The court of appeals affirmed the district court's judgment that the '154 patent was invalid based on double patenting, but vacated the district court's judgment that the '154 and '161 patents were unenforceable because the patent holder committed inequitable conduct, and remanded the case.

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