December 1, 2021
Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen’s U.S. patent 8,399,514 (the ’514 patent) were invalid under 35 U.S.C. §112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court’s previous invalidity determination.
The ’514 claims are directed to treating multiple sclerosis (MS) using Tecfidera® (dimethyl fumarate -- DMF) in an amount of about 480 mg/day. The ’514 patent claims priority from a provisional application filed in 2007.
The Federal Circuit noted that the ’514 patent contains only one paragraph related to treating diseases which mentions “about 480 mg/day.” Significantly, the Federal Circuit pointed out that this paragraph (1) is not linked to amounts for treating specific diseases, let alone linked to specific amounts for treating MS; and (2) only identifies about 480 mg/day “at the bottom end of the spectrum of a DMF 480–720 mg/day range.” Indeed, this paragraph cautions that “[e]ffective doses will also vary, as recognized by those skilled in the art, dependent on route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments including use of other therapeutic agents.”
So could this paragraph really indicate that the inventor(s) had in mind, at the time the ’514 application was filed, a specific amount of DMF to treat MS? At minimum, it is understandable why the Federal Circuit agreed with the district court’s analysis (or at least did not have sufficient reason to overturn the district court’s decision) that the ’514 patent did not indicate the specific concentration of “about 480 mg/day” for treating MS.
It is interesting that the Federal Circuit noted that the Biogen inventor initially named on the application in 2007 was Dr. Lukashev (a Biogen scientist who focused on more basic research related to pathways) – Dr. O’Neill was not listed as a co-inventor at that time as he did not work on pathways. Rather, O’Neill was added as an inventor in 2011 when the application was focused on methods of treating MS.
The Federal Circuit noted: “[w]hen asked during trial, Lukashev testified that he did not know why O’Neill was added as an inventor. Lukashev also corroborated the original application’s emphasis on drug discovery by noting that his work had encompassed ‘a more exploratory nature. It[ was] to explore potential for follow-on compound discovery . . . .’ (alteration in original). And, more importantly, he ‘denied that his research could be extrapolated to a clinical dose of DMF; it ‘was never the focus of [his] work to inform the clinical dosing of [DMF].’’”
Here’s the point regarding the inventorship discussion: was Biogen trying to fit a square peg into a round hole by adding MS treatment claims in 2011 to an application directed to pathway research filed in 2007? Is this why it was easier for the district court to find (and the Federal Circuit to agree) that the description in the ’514 patent did not correspond to the claims directed to treating MS? Would Biogen have been better off filing a new application directed to treating MS once it had determined to use 480 mg/day in phase III trials instead of trying to use the pending application as a vehicle for such claims?
If the Federal Circuit’s Biogen decision highlights one action point going forward for any company, not just pharma companies, it is this: make sure your patent applications keep up with your current R&D efforts. You cannot always assume that previously-filed applications will be sufficient to protect current R&D work. Sometimes it makes more sense to file new applications rather than trying to repurpose older, more general applications.