En Banc Activity / Petitions

Here is an update on recent en banc activity at the Federal Circuit in patent cases. Highlights include two new petitions raising questions related to waiver of the prevailing arguments made in Arthrex, Inc. v. Smith & Nephew, Inc., non-obviousness, and argument-type prosecution history estoppel, two letters filed by the government in response to arguments related to Arthrex, Inc. v. Smith & Nephew, Inc., two amicus briefs in Arthrex, Inc. v. Smith & Nephew, Inc. itself, and the denial of four petitions. We have the details.

New Petitions

Two new petitions were filed.

In Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc., Sanofi-Aventis presented two questions:

  1. “[W]hether a litigant can waive a constitutional defense based on an intervening change of law that implicates important issues of public concern;” and
  2. “[W]hether, consistent with KSR, patent claims can be obvious when there is no prior art evidence of the problem identified and solved by the claimed invention and, consistent with Panduit, the patent specification can constitute prior art.”

In LoggerHead Tools, LLC v. Sears Holdings Corp., LoggerHead Tools presented one long question:

  • “Does a patentee clearly and unmistakably surrender claim scope by argument-based prosecution history disclaimer under longstanding precedent of this Court where: (a) the purportedly disclaiming statement responded to, but did not adopt, the Examiner’s mapping of claims to a prior art patent, but instead distinguished that reference, without characterizing the scope or meaning of that claim element, by logical inference based on how the Examiner mapped the reference to the claim elements, (b) during prosecution the patentee separately and successfully distinguished the same reference based on a different claim element than the one purportedly narrowed by argument, (c) a district judge in the same case had considered and rejected the same alleged disclaimer argument and found, citing this Court’s precedent, that patentee’s arguments were not a clear and unmistakable disclaimer because they were amenable to multiple reasonable interpretations, one of which is consistent with the full scope of patentee’s express definition of the claim element, and (d) the disclaimer-based claim construction (i) excludes a preferred embodiment, (ii) ignores claim differentiation, and (iii) the construction was based on and motivated by the accused device.”

New Responses, Letters, and a Request for a Response

Responses to petitions were filed in three cases.

In 23andMe, Inc. v. Ancestry.com DNA, LLC, Ancestry.com DNA characterized the petition as arguing that rehearing is appropriate “because the district court failed to properly consider whether two dependent claims (claims 7 and 12) survive § 101 review.” According to Ancestry.com DNA, however, “[t]his kind of case-specific concern does not conflict with this Court’s case law; nor is it the kind of question of ‘exceptional importance’ that merits en banc intervention.”

In HZNP Finance Limited v. Actavis Laboratories UT, Inc., Actavis argued that, “[i]n essence, Horizon’s petition asks whether the definiteness requirement of § 112 applies to claims that use the transitional phrase ‘consisting essentially of,’ just as it applies to every other kind of claim.” Actavis contends that “[t]he en banc court does not need to answer that question [because] it answers itself.”

And in DiStefano Patent Trust III v. LinkedIn Corporation, LinkedIn contended that “DiStefano’s plea that this Court vacate the district court’s Judgment should be rejected” for two reasons. “First,” explained LinkedIn, “the Judgment DiStefano now attacks as erroneous was submitted to the district court by DiStefano jointly with LinkedIn.” “Second,” LinkedIn continued, “DiStefano mentioned this issue in passing for the first time in its Reply brief on appeal, and only in a footnote, without ever requesting the relief it now demands” and, as a result, “[t]he argument is waived.”

The government filed similar letters with the court in two cases where parties have raised late arguments adopted by the Court in Arthrex, Inc. v. Smith & Nephew, Inc.

In BioDelivery Sciences Int’l, Inc. v. Aquestive Therapeutics, Inc., the government’s letter explains that, “[u]nlike its practice in cases in which parties raised constitutional challenges earlier in the appellate proceeding, the Court did not issue an order giving the United States a period to intervene in this case.” Furthermore, among other arguments included in the letter, the government maintains that “because BioDelivery did not present this argument in its earlier appeal, much less its opening brief here, it is forfeited.”

In Duke University v. Biomarin Pharmaceutical Inc., the government’s letter similarly explains that “[u]nlike its practice in cases in which parties raised constitutional challenges at an earlier point in appellate proceeding, the Court did not issue an order giving the United States a period to intervene in this case.” And, again similarly, the government maintains that “[b]ecause appellant did not present this argument in its opening brief, it is forfeited.”

The court also invited a response to the petition in Duke University v. Biomarin Pharmaceutical Inc. from Biomarin Pharmaceutical. While the petition presents two questions related to Arthrex, Inc. v. Smith & Nephew, Inc., it also presents one question on the issue of non-obviousness.

New Amicus Briefs

Two amicus briefs were filed in Arthrex, Inc. v. Smith & Nephew, Inc., a case in which Arthrex, Smith & Nephew, and the government all filed petitions for rehearing.

The New York Intellectual Property Law Association filed an amicus brief supporting the government’s petition for en banc rehearing. According to the NYIPLA, “[t]he issues raised by the United States in its Petition are the subject of substantial debate and should be addressed by the full Court.” It goes on to explain that “”[t]he damage caused by continuing uncertainty cannot be overstated” and, as a result, “[t]he full Court needs to act quickly and decisively.” Notably, the NYIPLA did not take a position on any of the questions presented by the government, but merely agreed that the petition should be granted: “The NYIPLA takes no position on which party should ultimately prevail on the merits of the underlying dispute.”

The Association for Accessible Medicines likewise filed an amicus brief supporting rehearing, but, unlike the NYIPLA, it expressed support for the government, Smith & Nephew, and ultimately overturning the panel’s decision. According to the Association, “[t]he government and Smith & Nephew have ably set out the reasons why the panel’s determination that Administrative Patent Judges . . . are ‘principal officers’ is incorrect.” Rather than repeat those arguments, the Association instead filed its brief to “emphasize the urgent need for this Court’s review in light of the widespread confusion that reigns in the wake of the panel’s decision and the particular harms that decision creates for the manufacturers and distributors of generic and biosimilar drugs, and ultimately for the patients who depend upon them.”


The Federal Circuit denied petitions in four cases: