The following arguments will be available to the public live, both in-person and through online audio streaming. Access information will be available by 9 AM ET each day of argument at: https://cafc.uscourts.gov/home/oral-argument/listen-to-oral-arguments/.

Tuesday, June 6, 2023

Axonics, Inc. v. Medtronic, Inc., No. 22-1532, Courtroom 402
 In IPR proceedings, Axonics challenged the patentability of certain claims in two patents owned by Medtronic. The claim limitations at issue relate to the automatic variation of an external power source's power output based on receiving certain inputs associated with current passing through an internal power source. The claims contain two separate "wherein" clauses that limit the "external power source" to using "a value" and "a measured current" as inputs. In the petition, Axonics treated the two "wherein" clauses as requiring a single input and relied on prior art containing only a single input. In its patent owner response, Medtronic asserted that the two "wherein" clauses should be construed as two distinct inputs. Axonics then presented new evidence under the two-input construction in the reply. In the final written decision, the Board adopted the two-input construction and refused to consider Axonics' arguments and evidence under that construction, finding them raised improperly for the first time in reply. The Board thus concluded that none of the challenged claims were unpatentable.

On appeal, Axonics relies on the Federal Circuit's Apple v. Andrea to argue that the Board's refusal to consider its reply arguments was "legal error" and an abuse of discretion because these arguments address "the same claims and limitations" based on "the same embodiments for each of the same references" from the petition. Axonics further asserts that its arguments were "directly responsive to Medtronic's response," which raised the claim-construction issue for the first time. Axonics also contends that the Board's approach precluded Axonics from having "an opportunity to respond to the new claim construction offered by Medtronic," one that Axonics argues it could not have addressed in the petition "before it was raised."

Medtronic responds that the Board did not abuse its discretion by refusing to consider Axonics' "new unpatentability theories." Medtronic argues that, unlike in Apple, Axonics' reply arguments "go far beyond elaborating on its positions in the petition" and instead present "entirely new mappings based on previously unidentified portions of the prior art." Medtronic also points out that Axonics had contemplated a claim construction in its petition based on the prosecution history and the specification, but did not account for an alternative theory that "simply flows from the plain language of the claims." Finally, Medtronic maintains that the Board did not deprive Axonics from having an opportunity to respond, as Axonics "recognized in its petition the potential for interpreting the claim such that it required two inputs" but "chose not to fully address that construction in its petition."

Wednesday, June 7, 2023

Actelion Pharms. Ltd. v. Mylan Pharms. Inc., No. 22-1889, Courtroom 402
In an ANDA litigation, Actelion sued Mylan for infringement of two patents related to Mylan's generic epoprostenol product. The parties proposed different constructions for the term "a pH of 13 or higher." Actelion contended that the phrase "a pH of 13" should be given its plain and ordinary meaning, with rounding based on significant figures that encompass a pH 12.5 to 13.4. Mylan insisted that the phrase "a pH of 13" should mean a pH of exactly 13. The district court sided with Actelion, finding that nothing in the specification or prosecution history "require[d] it to read an increased degree of precision into the claim language." The district court distinguished the Federal Circuit's AstraZeneca v. Mylan case, observing that the specification of the patents here did not "indicate that slight variations in pH would undermine the product." Following the district court's claim-construction ruling, Mylan stipulated to infringement and the district court entered a final judgment in favor of Actelion.

On appeal, Mylan argues that the specification's reference to adjusting the bulk solution's pH to "13.0" in several examples would lead a skilled artisan to understand that "a pH of 13" means "a pH of exactly 13." Mylan also contends that amendments and other statements made during prosecution, including amending "a pH of greater than 12" to "a pH of 13 or higher" and purportedly equating "a pH of 13 or higher" with "a pH of at least 13 or higher," support the conclusion that "[e]xactly 13, not 12.5, was the intended floor of the claimed range." Mylan further asserts that the district court improperly applied rounding rules "in the abstract" to its "acontextual construction" by overlooking the evidence in the specification and the prosecution history. Mylan finally insists that AstraZeneca is not meaningfully distinguishable because the facts are "highly similar."

Actelion responds that the district court properly construed "a pH of 13" to have its ordinary and customary meaning (which includes rounding) and that nothing in the intrinsic record suggests a higher level of precision. Actelion argues that the inventor employed whole numbers to describe the scope of the invention and that the specification "never refers to pH values of 'exactly 13.'" Actelion also contends that the prosecution history evinces no intent to narrow the pH value to an exact value, as the applicant and the examiner "consistently expressed the pH value of the inventive bulk solution with whole numbers." Finally, Actelion maintains that the district court's claim construction fully comports with AstraZeneca because, unlike in AstraZeneca, where the specification expressly distinguished an embodiment within the rounding range as "much more unstable," the patents here "report very high stability for all embodiments within the rounding range."

Friday, June 9, 2023

In re Cellect, LLC, No. 22-1293, Courtroom 402
Cellect obtained several related patents that all claimed priority to the same parent application. Due to delays during prosecution, some of these patents received varying periods of patent term adjustment ("PTA"). But for the PTA, these patents would have expired on the same day. In four ex parte reexamination proceedings, the examiner rejected the challenged claims in these patents as unpatentable for obviousness-type double patenting ("ODP") over similar claims in related, earlier-expiring patents that had received shorter or no PTA. Cellect appealed to the Board, which affirmed the examiner's ODP rejections.

On appeal to the Federal Circuit, Cellect argues that the Board committed legal error by treating PTA under 35 U.S.C. § 154 and patent term extension ("PTE") under 35 U.S.C. § 156 differently when applying ODP. Citing Federal Circuit caselaw addressing PTE, including a case holding that ODP cannot "cut off" a statutorily-authorized time extension, Cellect contends that the Board's "inconsistent application" of ODP cannot be reconciled with either the legislative intent or Federal Circuit precedent. Cellect also maintains that the equitable concerns underpinning the ODP doctrine do not exist in this case, where all the patents at issue are interrelated and no signs of gamesmanship or split ownership are present. Cellect further asserts that there is no substantial new question of patentability because the examiner "was well-aware of" the related patents and "considered any double patenting issue" during prosecution.

In response, the PTO argues that the Board acted properly because "expiration dates drive the ODP analysis" and that "ODP should be considered after any PTA is applied in calculating a patent's expiration date." The PTO contends that the distinction in statutory language between sections 154 and 156 evinces a clear legislative intent "for terminal disclaimers to bar patents from receiving the benefit of PTAs . . . but not prevent patents from receiving PTEs." The PTO also insists that, even applied to the pre-PTA expiration dates, the ODP rejections would still be proper in this case because, in the absence of terminal disclaimers ensuring common ownership, there remain risks for multiple assignees to seek past damages asserting essentially the same patented invention. Finally, the PTO points to the Board's finding that there was insufficient evidence that ODP was considered during the original prosecution to rebut Cellect's argument that the PTO had already considered any ODP issues.

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