Federal Circuit: Written description and enablement depend on what a patent ‘claims,’ not what the claims cover
[co-author: Shivani Prakash]
The Federal Circuit reversed a recent district court decision which found that a patent that failed to describe after-arising technologies did not satisfy the written description requirements. The Federal Circuit explained in this way that written description and ability are evaluated on the basis of the subject matter claimed, not products that practice these claims. As a result, the patentee was not required to describe unclaimed, later-discovered features of the accused products despite the broad language in the claims that undisputedly covered the products.
Several companies filed ANDAs seeking approval to market a generic version of Novartis’s drug Entresto(r), which consists of the compounds valsartan and sacubitril complexed together through weak noncovalent bonds. In response, Novartis brought suit in the District of Delaware alleging infringement of one of its patents directed to pharmaceutical compositions of valsartan and sacubitril “administered in combination.”
At the district court, Defendant MSN argued that the patent was invalid for lack of written description and enablement because it did not include any description of combinations of valsartan and sacubitril where the drugs were complexed. MSN argued, more specifically, that the patent was invalid for lack of written description and enablement because it did not disclose valsartan/sacubitril combinations. Novartis responded by stating that since its Entresto (r)product was developed and patented after the patent application was filed, it is an after-arising technology. Therefore, the specification did not have to describe or enable complexed Valsartan-sacubitril in order to satisfy Section 112. It only needs to support combinations of sacubitril and valsartan that were known at the time. After a three-day bench-trial, the district judge ruled that the patent met the enablement requirement. He explained that enablement was based on the state-of-the-art at the time of filing and did not need to enable later-developed complex combinations. The district court, however, took a different approach when it came to the written description. It argued that the same facts were fatal because Novartis couldn’t possibly describe something that it hadn’t yet conceived.
On the Federal Circuit’s appeal, they reversed the district courts written description determination, while affirming their holding on enablement. The Federal Circuit ruled that the district court had “erroneously confused the distinct issues of infringement and patentability” in its evaluation of written description. The question isn’t whether the patent adequately describes complexed forms valsartan sacubitril. The question is not whether the patent adequately described what was claimed but rather, if the patent adequately described what was claimed i.e. A combination of sacubitril and valsartan. As for the claimed features, however, the specification provided ample disclosures demonstrating the inventors were in possession of a pharmaceutical composition of valsartan and sacubitril administered
in combination
.10MSN recently petitioned for rehearing focused on the argument that when the broadly construed claims include technology that was not available at the time of invention (and therefore, could not have been described), the written description requirement is not met. As to the claimed features, however, the specification provided ample disclosures demonstrating the inventors were in possession of a pharmaceutical composition of valsartan and sacubitril administered
in combination
.01001010MSN recently petitioned for rehearing focused on the argument that when the broadly construed claims include technology that did not exist at the time of invention (and thus, could not have been described), the written description requirement is not met.01001010Practice Tip01001010: While it is true that a patent must describe and enable the full scope of the claims, it is important to remember that the scope of what is claimed may differ from the scope of what the claims cover. When determining what is included in the full scope of a claim, and therefore relevant to a written analysis or enablement, parties should take into consideration whether there are any features that were developed later. Those features may very well fall outside of the scope of the claims for the purposes of written description and enablement, while the product may nevertheless practice the claims as they are written.01001010In Re: Entresto (Sacubitril/Valsartan), 2023-2218 (Fed. Cir. Jan. 10, 2025).01001010
