A Patent Must Describe What Is Claimed, Not What Infringes

Written by: Raymond S. Lu and Douglas B. Wentzel

NOVARTIS PHARMACEUTICALS CORPORATION v. TORRENT PHARMA INC.

Before Lourie, Prost, and Reyna.  Appeal from the U.S. District Court for the District of Delaware.

Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment adopted by the defendant.

Patentee Novartis sued defendants including MSN, alleging infringement of a patent claiming a pharmaceutical composition.  During claim construction, the parties disputed the term: “wherein said [valsartan and sacubitril] are administered in combination.”  MSN argued that term limited the claim to administering valsartan and sacubitril as separate components rather than a complex.  The district court rejected MSN’s position and gave the term its plain meaning: “wherein said valsartan and sacubitril are administered in combination.”  Under that construction, MSN stipulated to infringement and the case proceeded to a bench trial on invalidity.  Because it was undisputed that valsartan and sacubitril complexes were unknown to a skilled artisan at the time of the patent, the district court found the patent was invalid for lacking written description of those complexes.  Novartis appealed.

The Federal Circuit reversed the district court’s finding of inadequate written description.  The Federal Circuit noted that the written description inquiry asks whether the patent adequately describes what is claimed.  The court emphasized that while MSN stipulated that its complex of valsartan and sacubitril infringes, that complex of drugs “is not what is claimed” because the claims more broadly recite valsartan and sacubitril “in combination.”  The court found that valsartan and sacubitril in combination is undisputedly described throughout the patent’s specification, and thus held the claims were adequately supported by the patent’s written description.

Editor: Sean Murray