BSC v. J & J – Written Description Requirement Spreads its Wings
On June 7th, in a Fed. Cir. panel decision written by Judge Moore, the panel affirmed the invalidation of four J&J patents (a copy of these patents is available at the end of this post) for failure to meet the written description requirement of s.112(1). The patents claimed drug eluting stents, used to keep angioplastied arteries from re-closing, or undergoing restenosis. Boston Scientific Corp. v. Johnson & Johnson, App. No. 2010- 1230-1234 (Fed. Cir. June 7, 2011). The stents disclosed in the specifications all released rapamycin, a macrocyclic lactone, but the claims were broader, and used terms like “rapamycin or a macrocyclic lactone analog of rapamycin” or a” macrocyclic triene analog of rapamycin.” However, no such rapamycin analogs were disclosed in the specification.
The “problem” with the summary judgment below, at least as J&J saw it, was that a number of workable rapamycin analogs were known to the art as of the effective filing date of the applications. In fact, BSC was using one of them in its stents. J&J felt it could rely on the court’s holding in Capon v Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) which affirmed that claims to chimeric DNA molecules were adequately supported by the specification in combination with evidence that many examples of useful subunits were known.
The court started out by quoting from UC v. Lilly – always a bad sign for patentee – and then reaffirmed that the Lilly standards for meeting the WDR applied both to novel compounds and to “inventions claiming combinations of prior art compounds with other elements,” citing Carnegie Mellon Univ. v. Hoffmann-La Roche, 541 F.3d 1115 (Fed. Cir 2008). “The test for WDR is the same whether the claim is to a novel compound or a novel combination of known elements. The test is the same whether the claim element is essential or auxiliary to the invention [Ed.: remarkably now citing Aro Mfg. Co. v. Convertible Top Replacement Co.!].”
However, at this point, Judges Moore and Bryson get a bit lost. Instead of explaining why the specification read in combination with the knowledge of the art about rapamycin analogs fails to meet the Lilly standards, the majority jumped back to the deficiencies in the specification:
“With no guidance at all in the specification as to how to properly identify or choose the claimed analogs, and in light of the unpredictability and nascent state of using drug-eluting stents to treat restenosis, we agree with the [grant of SJ below].” Slip op. at 21.
The panel put a great deal of emphasis on disclosures in the two specifications that “directly contradict information that the patentee alleges is ‘well-known’ to a person of skill at the effective filing date.” In this case, the specifications of one group of patents stated that “the precise mechanism of action of rapamycin in still under active investigation…The shared specification indicates that the alleged correlation between structure and function was not well known by the effective filing date.” Slip. Op.. at 22. In other words, the panel used statements in the specification to effectively cut off the ability of the patentee to argue that knowledge available to the art could be used to meet the WDR:
“Given the absence of information regarding structural characteristics of [rapamycin analogs] in the specification, the unpredictability of the art and the nascent state of using drug eluting stents…we affirm the [grant of SJ]. The patent laws do not reward an inventors invitation to other researchers to discover which of the thousands of macrocyclic lactone analogs of rapamycin could conceivably work in a drug eluting stent.” Slip. Op. at 23.
This is starting to sound a lot like a holding based on “broader than the enabling disclosure,” and this was specifically noted by Judge Gajarsa, concurring-in-part, when he wrote: “The majority’s opinion further extends the [WDR] into the realm of enablement. Much of the confusion in this case is due to the difficulty of determining…how the [WDR] applies to novel compounds as opposed to novel combinations of known elements…the enablement analysis is simpler and more appropriate.” He would have affirmed the invalidation of the patent claims for non-enablement as well. If this opinion has anything to teach the court, it may be that the “easy button” of using the WDR to eliminate patents with claims a panel feels are just too broad, is not as easy as Lilly, Rochester and Ariad made it look.