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PFIZER INC. v. TEVA PHARMACEUTICALS USA, INC.

Summarized by: 

Date Filed: 02-06-2014
Case #: Nos. 2012-1576, 2012-1601, 2012-1602, 2012-1603, 2012-1604, 2012-1605, 2012-1607
U.S. Court of Appeals, Federal Circuit
Full Text Opinion: http://www.cafc.uscourts.gov/images/stories/opinions-orders/12-1576.Opinion.2-3-2014.1.PDF
LexisNxis Link: 2014 U.S. App. LEXIS 2242
Westlaw Link: 2014 WL 463757

Patents: Claim Construction: Claims are construed under the term’s plain and ordinary meaning as understood by a person or ordinary skill in the art unless: 1) patentee defines and acts as own lexicographer, or 2) patentee disavows the full scope of a claim in specification or prosecution.

Opinion (Prost): Pfizer Inc. and others (collectively, “Appellees”) sued Teva Pharmaceuticals USA and others (collectively “Appellants”) because Appellants’ Abbreviated New Drug Applications (“ANDAs”) covering generic Lyrica® infringed on four of Appellees’ patents. Appellants first argued the district court erred in its claim construction, but the Court found that the plain language of the #819 patent covered 3-isobutylGABA generally rather than a narrowing limitation to only a racemic mixture of S- and R- enantiomers or 3-isobutylGABA. In fact, Appellants’ own expert admitted that claim 2 covers “3-isobutylGABA in any isometric form.” Because Appellants stipulated to infringement under the general construction, the Court affirmed infringement. Appellants also argued that the #819 patent was not sufficiently enabled by a prior patent application (the #692) because the #692 did not disclose how to prepare all isomers. However, the Court found that claims covering chemical compounds do not need to disclose how to prepare every particular isomer or mixture and therefore, the #692 patent was sufficiently enabling. Appellants similarly alleged the #819’s written description was inadequate because it did not reasonably convey the Appellants' possession of every isomer. The Court found that the Appellants confused the issue, and that a written description does not require inventors to be in “possession of every species of a genus claim” (here, every isomer of a chemical compound). Finally, the Court refused Appellants' appeal to invalidity due to obviousness because the record never explained how 3-isopropylGABA would have been chosen as a lead compound for its anticonvulsive properties. The district court’s judgments of infringement and no invalidity were AFFIRMED.