Novartis Pharmaceuticals Corp. v. Torrent Pharma Inc., et al., Nos. 2023-2218, -2220, -2221 (Fed. Cir. (D. Del.) Jan. 10, 2025). Opinion by Lourie, joined by Prost and Reyna.
The FDA approved a New Drug Application from Novartis for a combination therapy of valsartan and sacubitril, which Novartis markets and sells under the brand name Entresto®. Entresto includes valsartan and sacubitril in a specific form known as a “complex,” which combines the two drugs in a particular way. Entresto is protected by several patents, including the one at issue in this appeal, although the “complex” form of Entresto was not discovered until four years after the patent’s priority date.
When several generic manufacturers (collectively “MSN”) submitted an Abbreviated New Drug Application seeking FDA approval to market and sell a generic version of Entresto, Novartis sued for infringement.
During the litigation, the parties disputed the meaning of a claim phrase requiring administering valsartan and sacubitril “in combination.” The district court rejected MSN’s argument that the language covers administering valsartan and sacubitril only “as two separate components” and not as a “complex.” The court instead agreed with Novartis that the term should have its plain and ordinary meaning encompassing both a combination and a complex. After claim construction, MSN stipulated to infringement.
The case proceeded to a three-day bench trial. After trial, the court found the claims invalid for lack of written description, but not invalid for obviousness, lack of enablement, or indefiniteness. As to the written description, Novartis argued that a “complex” of valsartan and sacubitril was an after-arising invention that need not have been described. According to Novartis, the patent needed to describe only the “combination” of valsartan and sacubitril. The district court disagreed, ruling that the specification needed to but did not sufficiently describe “complexes” of valsartan and sacubitril and thus lacked the required written description. Novartis appealed.
The Federal Circuit reversed the written description determination. The appeals court held that the Novartis patent “does not claim valsartan-sacubitril complexes,” so “those complexes need not have been described.” The complex was not discovered “until four years after the priority date” of the patent and “is not what is claimed” in the patent. The court explained that for purposes of the written description inquiry, “the invention is … whatever is now claimed.” Thus, the patent’s written description was sufficient.
The Federal Circuit next affirmed the district court’s enablement determination for similar reasons, explaining that “a specification must only enable the claimed invention.”
Lastly, the Federal Circuit saw “no clear error warranting reversal of the district court’s obviousness analysis.” The court ruled that MSN’s obviousness theories “impermissibly use valsartan and sacubitril as a starting point and retrace the path of the invention with hindsight.” Thus, the Federal Circuit upheld the determination that the claims would not have been obvious.