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Novartis v. Accord Redux – Panel 2 Reverses Panel 1

To save me a lot of typing, please read my post of January 10, 2022, summarizing the first Panel’s holding in Novartis Pharmaceutical v Accord Healthcare, Inc., 21 F.4th 1362 (Fed. Cir., 2022). The panel in that decision was Judges Moore, O’Malley and Linn, with Moore dissenting. A brief summary of the holding was that the majority of the panel found that a negative limitation that was disclosed only by implication in the specification satisfied the written description requirement.  A slightly different Panel,  consisting of Judges Moore, Linn and Hughes granted rehearing.  The panel split, with Moore writing for the majority and Linn dissenting.

This panel reversed the holding of the district court and Panel 1 (Appeal No. 2021-1070 (June 21, 2022, Fed Cir.)). The negative limitation was that a drug treatment for MS was given daily, “absent an immediately preceding loading dose regimen.” The specification had rat data and a prophetic human trial, neither of which disclose the absence of a loading dose, or any advantages of not administering a loading does. On the other hand, neither of these examples employed a loading dose. The district court and Panel 1 agreed with expert testimony that opined that “'[i]f a loading dose were directed, the Patent would say that a loading dose should be administered ‘initially.’” Panel 1 disagreed with Novartis’ assertion that “’silence alone cannot serve as a basis for’ a negative limitation”, finding that a POSA would recognize “that the new language reflects what the specification shows had been invented.”

Writing for the majority of Panel 2, Judge Moore is in the driver’s seat. In the majority’s opinion, while a negative limitation can be supported by a specification describing the reason to exclude the relevant element or even a discussion of the disadvantages of using the element, “[t]he common denominator of these examples is disclosure of the element” [citing Ariad, 598 F.3d at 1351].  She reasons that if the mere absence of a positive recitation provides the basis for an exclusion, “then every later-added negative limitation would be supported so long as the patent makes no mention of it…[T]here must be something in the specification that conveys to [a POSA] that the inventor intended the exclusion, such as a discussion of disadvantages or alternatives.” She goes on to note that “implicit disclosure” urged by Novartis is a fictional standard that is distinct from the requirement for “express or inherent disclosure.” She discusses inherent disclosure:

“If, however, a patent owner could establish that a particular limitation would always be understood by skilled artisans as being necessarily excluded from a particular claimed method, the written description requirement would be satisfied despite the specification’s silence.”

The key word in the above quote is “necessarily”. The minority recognizes that is a high standard and while Judge Moore denigrates the expert testimony relied upon by Novartis, satisfaction of the WDR remains a question of fact. Would the outcome have been different if the expert testimony had concluded that the loading dose would be recognized by art workers in this field as necessarily absent from the claimed daily method-of-dosing? The majority does not deal with this argument, but reviews the prosecution history and  concludes:

“If reciting a ‘daily dosage’ without mentioning a loading dose necessarily excluded a loading dose, there would have been no reason for the applicants to add the no-loading dose limitation. Neither the applicants nor the examiner understood the words ‘daily dosage’ without the words ‘ no loading dose’ to convey the absence of a loading dose…importantly, there is intrinsic evidence that a skilled artisan would not understand reciting a daily dosage to exclude a loading dose.”

This sounds uncomfortably like exposing the applicant to Catch 22. In other words, if an element is absent and applicant needs to argue “inherent negative limitation”, applicant cannot add the negative limitation to the claim, without first convincing the examiner that it is inherent in the specification, in which case applicant should not be trying to amend the claim to add it.

The minority uses the term “implicit disclosure” throughout the dissent, noting that it is used in the MPEP. The minority’s summation makes its position clear:

“The majority asserts that ‘the question is not whether the patentee intended there to be a loading dose; the question is whether the patentee precluded the use of a loading dose’…I submit that the question posed by the majority is misstated. The question is not whether the patentee precluded the use of a loading dose but whether the claim language that precludes the administration of a loading dose is supported by the written description passages that disclose the effective administration of nothing more than a ‘daily dose.’ In context, that disclosure, according to the testimony of Novartis’s experts, implies the absence of a loading dose to the [POSA]. That is all that is required.”


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