Dey Pharma, LP v. Sunovion Pharmaceuticals, Inc.
Bayer Schering Pharma AG v. Lupin, Ltd.

In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litigation

After a bench trial, the U.S. District Court for the Dis-trict of Delaware found U.S. Patent Nos. 7,387,793 and 7,544,372 invalid as obvious. Case No. 2011-1409 is an appeal from that judgment. We reverse and vacate the district court’s judgment of invalidity because the district court erred when it declared the patents in suit invalid as obvious. Specifically, by failing to consider the lack of a known pharmacokinetic/pharmacodynamic relationship for the claimed drug formulation, the trial court erred when it assessed the importance of the teachings of the prior art to the obviousness analysis.

As an alternative ground in support of the district court’s judgment invalidating the ’793 and ’372 patents, the defendants argue that the district court erred when it found that the patents satisfy the best mode disclosure requirement. We affirm the district court’s best mode ruling. The evidence supports a finding that the patentsin suit enable one of ordinary skill in the art to practice the inventor’s preferred dew points. After invalidating the ’793 and ’372 patents as obvi-ous, the district court enjoined the defendants—the parties who prevailed at trial—from launching their generic product pending appeal to this court. That order is challenged in Case No. 2011-1399. We dismiss that appeal as premature because several outstanding issues in the district court leave uncertain whether the defendants could recover on their appeal bond.

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