By Jason Rantanen
Boston Scientific Corp. v. Johnson & Johnson (Fed. Cir. 2011) Download 10-1230
Judges: Bryson, Gajarsa (concurring-in-part), Moore (author)
The line between written description and enablement analyses is often unclear; Boston Scientific makes it even blurrier, at least in the eyes of one Federal Circuit judge.
The patents involved in this appeal relate to drug-eluting coronary stents using a particular chemical compound. One set of patents ("the 1997 patents") claims stents using either rapamycin or a macrocyclic lactone analog of rapamycin, while the other patent-in-suit, the '662 patent, claims stents using either rapamycin or a macrocyclic triene analog of rapamycin. In both cases, the the analog limitations were added well after the patents' priority date. For purposes of the appeal, both analogs were broadly defined to be any molecule with structural similarity to rapamycin.
The district court granted summary judgment of invalidity of the 1997 patents based on a lack of enablement and lack of adequate written description, and granted summary judgment of the '662 patent based on lack of adequate written description. The patent holders appealed.
Species-Genus Analysis
On appeal, the majority applied the "species-genus" framework to hold the patents invalid for lack of adequate written description. Under that approach, "a sufficient description of a genus requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." Slip Op. at 17, quoting Ariad, 598 F.3d at 1350. Here, the 1997 patents contained no examples of macrocyclic lactone analogs of rapamycin and gave no essentially guidance as to how to determine whether a compound falls into that category. Similarly, the '662 patent, although disclosing the broad genus of "analogs" of rapamycin, failed to disclose the sub-genus of "macrocyclic triene analogs" of rapamycin.
Lack of Examples is Telling
In reaching its conclusion, te majority paid particular heed to the lack of any examples of the claimed genera. "Although examples are not always required to satisfy the written description requirement, the lack of any disclosure of examples may be considered when determining whether the claimed invention is adequately described." Slip Op. at 18.
Use of POSITA Knowledge to Fill In the Blanks
Although acknowledging that in some cases it may be appropriate to look to the knowledge of one of skill in the art when performing a written description analysis, the majority imposed a substantial limit on this approach. "Because the specification is viewed from the perspective of one of skill, in some circumstances, a patentee may rely on information that is "well-known in the art" for purposes of meeting the written description requirement….However, when the four corners of the specification directly contradict information that the patentee alleges is "well-known" to a person of skill at the effective filing date, no reasonable jury could conclude that the patentee possessed the invention." Slip Op. at 22-23. In this instance, the majority concluded that "specification of the 1997 patents itself refutes any conclusion that the structural elements and its mechanism of action and biological activity was known….Thus, there is insufficient correlation between the function and structure of rapamycin and its analogs to provide adequate written description support for the entire genus of macrcyclic lactone analogs of rapamycin." Slip Op. at 23 (internal citation omitted).
Judge Gajarsa: Stop Using Written Description When Enablement Will Do
Concurring in the judgment of invalidity and with the majority's ruling on the '662 patent, Judge Gajarsa wrote separately to express the view that "[t]he enablement requirement of 35 U.S.C. § 112 ¶ 1 is the appropriate tool for invalidating claims that are broader than their disclosure." The result is a blurring of the line between enablement and written description:
The majority’s opinion further extends the written description requirement into the realm of enablement. Much of the confusion in this case is due to the difficulty of determining what constitutes a genus or a subgenus, the relationship between the structure and the function of compounds, and how the written description requirement applies to novel compounds as opposed to novel combinations of known elements. These are legal inquiries predicated on disputed issues of material fact. Applying the enablement requirement would help to clear the thicket of jurisprudence regarding § 112 ¶ 1. As discussed briefly below, in this case, the enablement analysis is simpler and more appropriate.