Biogen v. Mylan: When Does a Specification Fail to Describe a Newly-Presented Claim?
The disclosure requirements that will meet the written description requirement of s. 112(1) had a fairly mundane priority policing role prior to the expansion of the importance of the requirement in the biotech cases leading up to the en banc Ariad decision in 2010. However, in the recent district court’s ruling in Biogen v. Mylan, Civil Action 1:17C116 (N. D. West Virginia, June 18, 2020), Mylan and the other defendants in this Hatch-Waxman litigation returned to the roots of the WDR to convince the judge that the originally filed specification of U. S. Pat. No. 8,399,514 did not provide an adequate description of Biogen’s later-presented claims to a method of treating multiple sclerosis (MS) with dimethyl fumarate and/or monomethyl fumarate in a daily dose of 480 mg. This has been reported as a big deal, since DMF is Biogen’s biggest selling drug, under the trade name Techfidera.
I know that this is quite a run-on sentence, but it summarizes the outcome of this suit, and I will try to condense the judge’s 48 page opinion, or at least tell you why it rubbed me the wrong way. Almost all of WDR jurisprudence since about the time of the Fed. Cir. Decisions in U. of Rochester v. Searle and U.C.. v. Lilly have involved cases in which patentee had obtained a broad generic claim, e.g., to a non-steroidal compound that would inhibit the COX-1 enzyme or to an agent that would inhibit the NF-kB enzyme. I have blogged extensively on Ariad and I going to try to not review its history here. Please look at my Posts dates March 5, 2010 and March 23, 2010 – and there are many others. Since Ariad, it been nearly impossible for inventors who elucidate mechanism-of-action claims to any agent that, e.g., blocks pathway X, in the absence of a representative number of working examples describing such agents, and there are almost never enough descriptions, read formulae, of the agents to support such claims. See, J. Mueller, Patent Law (4th ed.) at 143-172.
But the claims in the ‘514 patent were not the least bit generic – they were straightforward method of medical treatment claims. There was only one art-recognized pathology to treat, only two structurally defined drugs, and a single number unit dosage form. Biogen had begun prosecution with claims directed to screening methods for agents that would activate the “Nrf2 pathway.” Following successful phase III clinical trials, Biogen amended the claims of the pending application to focus on methods of treatment claims, which eventually issued as thee ‘514 patent. When Biogen sued Mylan and “other generics”, as the judge called them, they defended by urging that the specification failed the WDR, since it did not demonstrate that the inventors had possession of the newly added claims.
There is a problem with this defense. The judge is bound to rely on the requirements for “possession” as set forth in the recent biotech decisions mentioned above. However they all involved broad generic claims that failed to disclose any specific active agents or didn’t disclose enough of them to support the claims. Whether or not you think that the standards promulgated by these Fed. Cir. Decisions make sense or not, going back to the roots of the WDR doesn’t provide much guidance to the case in suit here. These include hoary cases like In re Smith, 458 F .2d 1389 (CCPA 197) and In re Ruschig, 379 F .2d 990 (CCPA 1967).
While citing the recent WDR biotech decisions for “broad principles that hold true across all cases, the judge chose to rely heavily on Nuvo Pharm. v. Dr. Reddy’s Labs., 923 F .3d 1368 (Fed. Cir. 2019). In this opinion, Nuvo had claimed a unit dosage form comprising “esomeprazole, wherein at least a portion of said [drug] is not surrounded by an enteric coating;” and naproxen surrounded by a coating that would not release it from the dosage form unless the coated naproxen was in a medium with a pH. Of 3.5 or higher. Defendant argued that the claim covered esomeprazole that was completely uncoated and that that embodiment was not adequately disclosed in the specification. The court agreed with defendants and invalidated the patent for failure to meet the WDR. (It is not clear if the claim language I summarized was from original claims or not.)
A big problem with reliance on Novo is that the issue was the proper scope of a generic claim – “at least a portion of [the drug] is not surrounded by an enteric coating.” That key claim term encompasses both partially and completely uncoated drug, and I don’t think that the inventor even intended to claim uncoated esomeprazole. A slip of the drafter’s pen doomed this patent; the term could have been written “esomeprazole comprising an enteric coating wherein at least a portion of the [drug] is not surrounded by said coating.”
A bigger problem for a WDR attack on the Biogen claims is that they are both extremely narrow and that all of the claim elements are disclosed in haec verba in the specification. In Ariad, Judge Lourie wrote about the need for “blaze marks” to direct the POSA to the claimed invention, and I think there are more than enough of these. The patent is long, with a lot of pharma boilerplate, but the ability of DMF to treat MS is specifically spelled out. For example, MS is emphasized in the boilerplate list of conditions treatable by DMS. Also while the Examiner focuses on the potential dosages in one paragraph of the patent, that paragraph is part of a longer section of the patent that explains the utility of animal models of MS – which existed prior to the filing date of the application that yielded the patent in suit. See Col. 18, line 64 – Col. 17, line 66.
In brief, the judge agreed with Mylan that “when viewed as an integrated whole, the combination of selectively-plucked disclosures in the specification of the ‘514 patent fails to sufficiently describe the claimed invention.” But when viewed as an “integrated whole” – language that seems to contradict the “picking and choosing” involved in writing the treatment claims– there are plenty of “blaze marks” that lead to the claimed method. When this case reaches the Fed. Cir., I hope that the panel will adhere to the court’s own “broad principles”, including that a constructive reduction to practice that identifies the claimed invention “in a definite way” can satisfy the WDR.