by Dennis Crouch
Biogen Int’l v. Mylan Pharmaceuticals (Fed. Cir. 2022) (en banc denial)
Back in December 2021, the Federal Circuit invalidated Biogen’s U.S. patent 8,399,514–affirming the lower court’s ruling of invalidity for lack of written description. 35 U.S.C. §112(a).
- The claimed method has one step: administering “a therapeutically effective amount [of] about 480 mg” of DMF per day along with an excipient for treatment of multiple sclerosis.
- The specification’s only reference to that dosage is in a prophetic example reciting “an effective dose of DMF … can be from … about 480 mg to about 720 mg per day; or about 720 mg per day.”
The appellate majority noted that this was the “sole reference,” the “one and only reference”, a “single passing reference” to 480 mg/day and that it appeared “at the end of one range among a series of ranges.” The court also contrasted the 480 mg/day disclosure with the specification’s disclosure of 720 mg/day that was specifically identified and elsewhere in the patent shown to be effective. Although the patentee’s prophetic example recited effectiveness, at the time the patentee did not actually have evidence that the 480 mg/day dosage was effective. Thus, the Federal Circuit concluded that “a skilled artisan would not have recognized, based on the single passing reference to a DMF480 dose in the disclosure, that DMF480 would have been efficacious in the treatment of MS, particularly because the specification’s only reference to DMF480 was part of a wide DMF dosage range and not listed as an independent therapeutically efficacious dose.” We know now that 480 mg/day is effective — but that knowledge is based upon post-filing research that cannot be added back into the written description.
The original opinion was penned by Judge Reyna and joined by Judge Hughes. Judge O’Malley (now retired) wrote in dissent.
After losing, the patentee then petitioned for en banc rehearing with two written description questions (paraphrased below):
- Must a “written description” prove the invention’s efficacy?
- Is there a need to repeatedly emphasize elements of the invention in order to satisfy the written description requirement?
The Federal Circuit has now released its 6-3 decision denying the en banc petition. Since Judge O’Malley is retired, she did not participate in the rehearing petition. Judges Stoll and Cunningham also did not participate.
Judge Lourie wrote in dissent, joined by Chief Judge Moore and Judge Newman. The trio argued that this case is a true outlier.
[I]n all [the] history [of the written description requirement], this case, in which every claim limitation is expressly described in the disclosure of the patent specification, is at the farthest end of the spectrum of cases where written description has not been found. It is an outlier.
Judge Lourie dissenting from the en banc denial. The dissent particularly argues that the decision “blurs the boundaries between the written description requirement and the other statutory requirements for patentability. In doing so, the court has contributed to the muddying of the written description requirement.”
From my point of view, the majority was wrong to place so much emphasis on the fact that 480 mg/day was only mentioned once in the specification. A single reference is certainly sufficient to satisfy written description.
However, I am also drawn-in by claim language that expressly requires that the 480 mg/day dosage be “therapeutically effective.” The patentee expressly claimed the therapeutic effectiveness, but did not include enough in the specification to demonstrate that it actually was effective at the 480 mg/day dosage.
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Today, the Federal Circuit also denied an en banc petition in another written description case focusing on claimed ranges, Indivior UK v. Dr. Reddy’s Labs (Fed. Cir. 2022). In my post on the case, I wrote “Four points are not A range.” The basic holding: although the specification described several embodiments covered by the claims, it did not describe the full-scope of the claimed invention. No dissent in the Indivior denial. Judge Lourie dissented in Biogen in favor of the patentee, but wrote the majority opinion invaliding the claims in Indivior.