“As we have long recognized, ‘[t]he invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” – CAFC opinion
The U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision reversing a district court’s determination that certain claims of a patent for Novartis’ heart failure drug Entresto were invalid for lack of written description, and affirming a finding that the claims were not shown to be invalid for obviousness, lack of enablement, or indefiniteness. Judge Lourie authored the opinion.
MSN Pharmaceuticals, Inc. and other generic companies submitted an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Entresto. 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 U.S. District Court for the District of Delaware agreed with Novartis that the single term of the ‘659 patent under dispute—i.e., “wherein said [valsartan and sacubitril] are administered in combination” —should be given its plain and ordinary meaning. While MSN attempted to argue that the plain and ordinary meaning “would render the claims invalid for lack of written description and enablement because the specification nowhere describes such complexes,” the district court found that there was “no basis to believe that the construction [the court] adopt[ed was] necessarily consigning the asserted claims to a judgment of invalidity.” MSN stipulated to infringement of the asserted claims based on the court’s claim construction and the case proceeded to a three-day bench trial.
At trial, the court was unpersuaded by MSN’s obviousness arguments and ultimately said the claims were not proven invalid by clear and convincing evidence. But on the subjects of written description and enablement, the district court agreed with MSN that the claims lacked written description and with Novartis that the claims were enabled. 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.”
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 [Novartis] 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, “‘[Novartis] scientists, by definition, could not have possession of, and disclose, the subject matter of [such complexes]’ in 2002, and therefore, ‘axiomatically, [Novartis] cannot satisfy the written description requirement’ for such complexes,” wrote the court.
On review, the CAFC said that “[b]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, ‘[t]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 court ultimately rejected MSN’s proposed construction because the ’659 patent ‘is silent on whether sacubitril and valsartan must be separate (and not complexed).’… The term was therefore given its plain and ordinary meaning: ‘wherein said [valsartan and sacubitril] are administered in combination.’ Id. That invention is plainly described throughout the specification.”
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 appellate court thus found that the district court clearly erred in its analysis of written description and reversed.
The CAFC found no error with respect to the district court’s enablement or obviousness analyses and affirmed those.
