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Judge Judge Entresto includes the active ingredients valsartan and sacubitril “in a specific form known as a ‘complex,’ which combines the two drugs into a single unit-dose-form through weak, non- covalent bonds,” according to the CAFC opinion.
Novartis sued, alleging the ANDA directly infringed claims 1-4 of Novartis’ U.S. Patent 8,101,659. The M M MSN’s argument was that the patent must enable and describe the relevant complexes “since a patent must enable and describe the full scope of the claims,” while Novartis said that “a complex of valsartan and sacubitril was an after-arising invention that need not have been enabled or described.” Novartis specifically noted that its “later, nonobvious discovery of valsartan and sacubitril in the form of a complex should not invalidate the ‘659 patent claims to Novartis’s earlier invention: the novel combination of valsartan and sacubitril.”[t]While the district court agreed with Novartis that later-existing state of the art may not be properly considered as part of the enablement analysis because enablement is judged as of the priority date, it added that “the facts that helped
with respect to enablement proved fatal for written description.” In other words, since complexes were unknown to a person of ordinary skill in the art, “‘
scientists, by definition, could not have possession of, and disclose, the subject matter of
‘ in 2002, and therefore, ‘axiomatically, [valsartan and sacubitril] cannot satisfy the written description requirement’ for such complexes,” wrote the court.[the court]On review, the CAFC said that “[ed was]ecause the ‘659 patent does not claim valsartan-sacubitril complexes, those complexes need not have been described.” Citing Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1564 (Fed. Cir. 1991), the opinion explained that “as we have long recognized, ‘
he invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” The CAFC continued:
“Recall that, at claim construction, MSN sought–as accused infringers often do–a construction that would exclude from infringement the accused product: a valsartan-sacubitril complex. The That invention is plainly described throughout the specification.”[Novartis]The ‘659 patent’s lack of description for a complexed form of valsartan and sacubitril “does not affect the validity of the patent,” said the CAFC, because that complex, which wasn’t discovered until four years after the priority date of the ‘659 patent, is not what was claimed. The
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