October 25, 2018
In a non-precedential decision issued by the U.S. Court of Appeals for the Federal Circuit (FWP IP APS v. Biogen MA, Inc., October 24, 2018, http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/17-2109.Opinion.10-24-2018.pdf), the Court was tasked with reviewing a PTAB decision of an interference between the named parties.
At issue were claims that Forward Pharma (a.k.a. FWP IP APS) “copied” to provoke an interference with Biogen relating to the treatment of multiple sclerosis (MS) with dimethyl fumarate (DMF) at a specific dosage (480 mg). While it is often the case in an interference the parties lobbed several bombs at each other, the PTAB focused on Biogen’s motion that Forward Pharma’s claims lack sufficient description and in ruling in Biogen’s favor on this motion, no other issues needed to be decided.
Forward Pharma appealed and the CAFC affirmed the PTAB’s decision. There appeared to be no question that each of the core limitations in the claims had support somewhere in the specification but that was not enough for the PTAB:
Forward’s specification lists over twenty diseases and conditions, and MS is not identified as of any particular interest. . .
while 480 mg/day dosage is expressly mentioned three times in the specification, the Board found that there “is no discussion that would guide one skilled in the art to treat MS with a therapeutically effective dose of 480 mg/day, or any other therapeutically effective dose within the ranges disclosed.”
Forward’s case requires selection and combination of claim elements from more than a single limited list: selection of MS from a list of diseases and selection of 480 mg/day from a large range of possible dosages. . . . “[S]uch necessary picking and choosing to arrive at the claimed invention . . . does not indicate it was described.”
. . .the Board found that our case law requires the specification itself to provide the blaze marks necessary to guide a skilled artisan to the claimed invention . . .
In short, the Court agreed with the PTAB and summarily affirmed each of the rationales in the PTAB’s decision:
. . . For the same reasons set forth by the Board, we agree that the ’871 application does not disclose the now-claimed MS treatment as a unified whole. . .
. . . As the Board correctly observed, a skilled artisan would need to pick and choose from Forward’s claims without any guidance from the written description. Forward provides no explanation as to why a skilled artisan would be able to cobble together selected elements from several different claims and thus recognize the now-claimed 480 mg/day of DMF and/or MMF for the treatment of MS from these 45 claims covering a broad scope of subject matter. . .
One of Forward Pharma’s arguments in the Appeal was that the PTAB used an improper standard but the Court was not persuaded and explained:
Forward argued that the Board misapplied written description law by applying a “heightened” blaze marks analysis. This is not so. First, the blaze marks analysis is part of the written description inquiry; it is not a heightened inquiry. The blaze marks analysis is a useful guide for evaluating laundry-list disclosures, like the one in Forward’s ’871 application. See Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996) (“In the absence of such blazemarks, simply describing a large genus of compounds is not sufficient to satisfy the written description requirement as to particular species or subgenuses.”). Recently in Nike, Inc. v. Adidas AG, we explained that the written description requirement “serves the same function as ‘blaze marks on the trees’ to help ‘find one’s way through the woods.’” 812 F.3d 1326, 1347 (Fed. Cir. 2016) (quoting In re Ruschig, 379 F.2d 990, 995 (CCPA 1967)). Second, Forward’s argument against the application of a blaze marks analysis is premised on the interference count being disclosed as a unified whole in the ’871 application, which the Board found was not the case. We observe no unified disclosure of all three limitations of the interference count in the ’871 application and thus see no reason to disturb the Board’s finding.
Another interesting nugget in this decision was the Court’s dislike for the manner in which the original claims had been presented in improper multiply dependent form. This was germane to the decision because Forward Pharma had argued, as an alternative basis, that the original claims provided sufficient support for the claims in the interference:
The task of locating the now-claimed subject matter within the original claims is made uncommonly more difficult by the original claims themselves, which are written in a cascading, multiple dependencies manner such that many of them generically refer back to any one of the preceding claims. . .
. . .Title 35 forbids this type of claim drafting because it can—as here—lead to bizarrely complex chains of cross-referencing claims in which one multiple dependent claim impermissibly serves as a basis for other multiple dependent claims, and so on.See 35 U.S.C. § 112 ¶ 5 . . .
. . . A review of the claims and their intermixing dependencies presents an overall picture of a set of claims designed to preempt a conspicuously large number of different dosage regimens for a large variety of conditions using a long list of formulations, which is disconnected from a written description that is far more limited in its disclosure. As the Board correctly observed, a skilled artisan would need to pick and choose from Forward’s claims without any guidance from the written description.
That form of multiply dependent claims is common outside the U.S. system, e.g., patent applications originating from Europe so it may be advisable to consider cleaning up the claims prior to or concurrently with the application filing in the U.S.