By Chris Holman
Novartis Pharms. Corp. v. Accord Healthcare, Inc., 2022 WL 2204163, — 4th — (Fed. Cir. June 21, 2022)
Here we have a case in which a petition for rehearing by the Federal Circuit leads to a flipped decision that appears to be the consequence of a change in panel composition.
In the original decision, authored by Judge O’Malley and decided January 3, a divided panel upheld a district court’s determination that the patent claims at issue were not invalid for failure to satisfy the written description requirement. The Federal Circuit agreed to rehear the case, but the composition of the panel rehearing the case was altered by the replacement of Judge O’Malley (who retired in March) with Judge Hughes. The reconfigured panel flipped the result of the earlier decision, this time reversing the district court. The second decision was authored by Judge Moore, the dissent in the original decision. Judge Linn, who sided with Judge O’Malley in the original decision, found himself writing in dissent the second time round.
The relevant issue before the court was whether a negative claim limitation was adequately supported by the priority patent application. The claims are directed towards methods of treating relapsing-remitting multiple sclerosis (RRMS) through the administration of fingolimod (an immune suppressant) “at a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.” The “no loading dose” limitation was added by amendment during prosecution in order to overcome an obviousness rejection. A loading dose is a “higher-than-daily dose,” usually given as the first dosage in a dosing regimen. It was undisputed that loading doses were well-known in the medical field generally, and that loading doses have been used with some medicaments used in the treatment of MS.
The priority application does not explicitly mention loading doses, let alone the absence of a loading dose, but the district court nonetheless found implicit support for the negative claim limitation in two examples provided in the specification (one a prophetic human clinical trial, the other an experiment conducted in rats) which disclosed dosage regimens that did not involve the use of an initial loading dose. There was expert testimony to the effect that a person of skill in the art (POSA) reading the examples would have understood them as being “complete,” and as such the fact that the examples do not mention a loading dose implicitly discloses a dosage regimen that is not preceded by a loading dose.
In the original decision upholding the district court’s decision as not erroneous, Judge O’Malley emphasized that the majority was not instituting a “new and heightened standard for negative claim limitations,” and acknowledged that the disclosure need not describe a limitation in haec verba. Writing in dissent, Judge Moore argued that the “no loading dose” limitation could not possibly find adequate support in a patent specification that fails to even mention loading doses.
Writing for the majority in the second opinion, Judge Moore reiterates her position that the district court clearly erred in finding written description support for the “no loading dose” limitation. While she acknowledges that a negative claim limitation does not necessarily require explicit written description support when the specification describes a reason to exclude the relevant element, e.g., when the specification identifies disadvantages of using that element, or “distinguishes among” the element and alternatives to it, she maintains that the element must at least be disclosed in some form, given that “the hallmark of written description is disclosure.” Judge Moore does not dispute that the written description requirement can be satisfied if a skilled artisan would have understood that the specification inherently discloses the negative limitation, but she found no evidence on the record in this case that a skilled artisan would understand silence regarding a loading dose to “necessarily exclude” a loading dose.
In his dissent, Judge Linn does not so much disagree with Judge Moore’s characterization of the law of written description, as with the way the majority applied that law to the facts of this case. In particular, he complains that majority improperly required the priority application to disclose that the negative limitation in question was “necessarily excluded”. He argues that it can be sufficient for the specification to merely provide a “reason to exclude” the negative claim limitation.