Novartis Pharmaceuticals Corporation v. Torrent Pharma Inc., No. 23-2218 (Fed. Cir. 2025) — On January 10, 2025, the Federal Circuit reversed the district court’s opinion that claims of a Novartis patent are invalid for lack of adequate written description, but affirmed the district court’s finding that the claims were not proven invalid for lacking enablement or being obvious over the asserted prior art. The Federal Circuit emphasized that the proper analysis for enablement and written description challenges is focused on the claims and after-arising technology need not be enabled or described in the specification—even when the after-arising technology is found to infringe the claims because the issues of patentability and infringement are distinct. “It is only after the claims have been construed without reference to the accused device that the claims, as so construed, are applied to the accused device to determine infringement.”

Background

Novartis Pharmaceuticals Corporation (“Novartis”) sued multiple defendants accusing them of infringing all claims (1-4) of U.S. Patent No. 8,101,659 (“the ’659 patent”) titled “Methods of treatment and pharmaceutical composition.” The ’659 patent relates to a pharmaceutical composition comprising a combination of valsartan and sacubitril, which Novartis markets and sells as a treatment for heart failure under the brand name Entresto®.

The U.S. District Court for the District of Delaware found that although the claims of the ’659 patent were not shown to be invalid as being obvious, indefinite, nor lacking enablement, the claims were shown to be invalid for lacking a written description. The district court “construed the asserted claims [of the ’659 patent] to cover valsartan and sacubitril as a physical combination and as a complex.” After claim construction, defendants MSN Pharmaceuticals, Inc., MSN Laboratories Private Ltd., and MSN Life Sciences Private Ltd. stipulated to infringement of the as-construed claims. However, the district court found that since complexes of valsartan and sacubitril (which included the accused product) were unknown to a person of ordinary skill in the art as of the priority date of the ’659 patent (i.e., the accused product was an after-arising technology), “Novartis scientists, by definition, could not have possession of, and disclose, the subject matter of such complexes . . . and therefore, axiomatically Novartis cannot satisfy the written description requirement for such complexes.”

Novartis appealed the district court’s determination of invalidity.

Issues

The primary issues on appeal were:

1. Whether the claims of the ’659 patent are invalid for lack of written description?
2. Whether the claims of the ’659 patent are invalid for lack of enablement?
3. Whether the claims of the ’659 patent are invalid as being obvious?

Holdings and Reasoning

1. The claims of the ’659 patent are not invalid for lack of written description.

The Federal Circuit found that the district court clearly erred in finding that the claims of the ’659 patent are invalid for lack of a written description. Specifically, the Federal Circuit found the district court erred when it “construed [the claims] to cover complexes of valsartan and sacubitril.” And the district court’s written description analysis under this construction to be incorrect with respect to complexes of valsartan and sacubitril.

The Federal Circuit noted that the issue is whether the ’659 patent describes what is claimed (i.e., a pharmaceutical composition comprising valsartan and sacubitril administered in combination). And that the issue is not whether the ’659 patent describes complexes of valsartan and sacubitril—because the ’659 patent does not claim complexes of valsartan and sacubitril. The Federal Circuit found that by stating the claims of the ’659 patent were “construed to cover complexes of valsartan and sacubitril,” the district court “erroneously conflated the distinct issues of patentability and infringement.” The Federal Circuit explained that “claims are not construed ‘to cover’ or ‘not to cover’ the accused product. . . . It is only after the claims have been construed without reference to the accused device that the claims, as so construed, are applied to the accused device to determine infringement.” The Federal Circuit found that “the ’659 patent could not have been construed as claiming [] complexes [of valsartan and sacubitril] as a matter of law” because it was undisputed that the accused product was unknown at the time of the invention.

The Federal Circuit found that since the district court gave the disputed claim term its plain and ordinary meaning during claim construction (i.e., “wherein said [valsartan and sacubitril] are administered in combination”), the ’659 patent need only to adequately describe combinations of valsartan and sacubitril to satisfy the written description requirement.

The Federal Circuit further found that the ’659 patent “plainly described [combinations of valsartan and sacubitril] throughout the specification” and that accordingly, the claims of the ’659 patent are not invalid as lacking a written description.

2. The claims of the ’659 patent are not invalid for lack of enablement.

The Federal Circuit affirmed the district court’s ruling that the claims of the ’659 patent are not invalid for lack of enablement “for reasons similar to those that led us to reverse its written description determination: a specification must only enable the claimed invention.” The Federal Circuit found that “because the ’659 patent does not expressly claim complexes, and because the parties do not otherwise dispute that the ’659 patent enables that which it does claim . . . [the defendants] failed to show that the claims are invalid for lack of enablement.”

In affirming the district court’s ruling that the claims of the ’659 patent are not invalid for lack of enablement, the Federal Circuit agreed with the district court’s finding that “valsartan sacubitril complexes . . . are part of a ‘later-existing state of the art’ that ‘may not be properly considered in the enablement analysis.’”

3. The claims of the ’659 patent are not invalid as being obvious.

The Federal Circuit found “no clear error warranting reversal of the district court’s obviousness analysis” and thus affirmed the district court’s ruling that the claims of the ’659 patent are not invalid as being obvious. The Federal Circuit agreed that the district court’s rejection of the defendants’ two theories of obviousness: (1) that a person of ordinary skill in the art would have been motivated to modify a prior art therapy with valsartan and sacubitril to arrive at the claimed invention; and (2) that a person of ordinary skill in the art would have been motivated to individually select and combine sacubitril and valsartan from two different prior-art references to arrive at the claimed invention.

The Federal Circuit distinguished the cases defendants relied upon: Nalproprion Pharmaceuticals, Inc. v. Actavis Laboratories FL, Inc., 934 F.3d 1344 (Fed. Cir. 2019) and BTG International Ltd. v. Amneal Pharmaceuticals LLC, 923 F.3d 1063 (Fed. Cir. 2019). The Federal Circuit reasoned that in Nalproprion and Actavis, the prior art showed that the claimed drugs “were both together and individually considered promising . . . treatments at the time of the invention.” In contrast, the district court found that “there was no motivation in the relied-upon prior art to combine valsartan and sacubitril, let alone with any reasonable expectation of success.”

The Federal Circuit agreed “with the district court that [the defendants’] obviousness theories impermissibly use valsartan and sacubitril as a starting point and ‘retrace[] the path of the inventor with hindsight.’”

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