En Banc Activity / Petitions

Here is an update on recent en banc activity at the Federal Circuit in patent cases. Highlights include four new petitions, responses to petitions in two cases (including three responses in Arthrex, Inc. v. Smith & Nephew, Inc.), and the denial of a petition along with a dissenting opinion in the same case. Here are the details.

New Petitions

Four new petitions were filed.

In Columbia Sportswear North America, Inc. v. Seirus Innovative Accessories, Inc., Columbia Sportswear asked the en banc court to review the following two questions:

  1. “When conducting a design-patent infringement analysis under Gorham v. White, may a fact-finder consider the addition of brand names or other labeling on an otherwise infringing design?”
  2. “When conducting a design-patent infringement analysis under Gorham v. White, should the fact-finder compare the overall appearance of the claimed design (i) to the overall appearance of the accused design, or (ii) to the overall appearance of the entire accused product, which may include aspects extraneous to the claimed design (e.g., logos, tradenames, color, size, etc.)?”

In Amgen Inc. v. Hospira, Inc., Hospira asked the en banc court to review the following question:

  • “Whether 35 U.S.C. § 271(e)(1) provides a safe harbor against infringement of patents claiming a method of manufacture, when the product manufactured is used to generate information for submission to the Food and Drug Administration (‘FDA’) in order to seek approval of a biosimilar drug.”

In Idenix Pharmaceuticals LLC v. Gilead Sciences Inc., Idenix Pharmaceuticals asked the en banc court to review the following two questions:

  1. “Does the decision conflict with Section 112 and undermine genus claiming?”
  2. “Does the decision conflict with the Seventh Amendment?”

In FOX Factory, Inc. v. SRAM, LLC, SRAM asked the en banc court to review the following two questions:

  1. “Whether the Panel erred by creating a new legal standard that a nexus between a patent claim and objective evidence of nonobviousness can only be presumed where the patentee has first proven that the underlying commercial product is ‘essentially the claimed invention’?”
  2. “Whether the Panel erred by effectively ruling that there can never be a presumption of nexus between a patent claim and objective evidence of nonobviousness if the commercial product is covered by multiple patent claims, unless the claims are first proven to be ‘essentially the same invention’?”

New Responses and Requests for Responses

Responses to petitions were filed in two cases.

In Duke University v. Biomarin Pharmaceutical Inc., Biomarin Pharmaceutical argues that rehearing en banc is unwarranted on the two categories of issues raised by Duke in its petition. First, on the issue of obviousness, Biomarin Pharmaceutical contends that “[t]he Board found that even considering a presumption of nexus, there was insufficient evidence of nonobviousness to outweigh the evidence of obviousness.” Second, on the issues relating to the decision in Arthrex, Biomarin Pharmaceuticals argues that, “[s]ince Duke did not present Appointments Clause challenges in its opening brief, Duke forfeited these arguments.”

Responses to each of the three pending petitions were filed in Arthrex, Inc. v. Smith & Nephew, Inc., each requesting the Court to grant en banc review. In its response, the United States argues that the panel decision “announces an important Appointments Clause ruling that is flawed in critical respects; compounds that ruling by ordering an unnecessarily burdensome remand remedy; and in so doing, threatens substantial disruption to the mission of the U.S. Patent and Trademark Office (USPTO) and the activities of private parties.” As such, the United States urges the Court to grant rehearing en banc “to fully address the important constitutional, remedial, and procedural questions raised by the panel’s decision.”

Smith & Nephew also argues that “[e]n banc rehearing is warranted to sort through these important issues, which—as the amici attest—will have wide-ranging consequences for the entire system of administrative patent adjudication under the AIA.” Furthermore, Smith & Nephew takes the position that “the panel’s rigid three-part test for principal officer status [] contravenes Supreme Court precedent,” and that “[t]he government correctly explains that the Director’s supervision and control over APJs makes them inferior officers under Edmond.”

And, lastly, Arthrex also urges the Court to grant rehearing en banc. According to Arthrex, although the “panel correctly found APJs to be principal officers under the Appointments Clause,” it “adopted a remedy that is both contrary to congressional intent and insufficient to cure the problem.”

In addition to these briefs on pending petitions, the Federal Circuit invited responses to the petitions filed in the following two cases:


The Federal Circuit denied the petition in Biodelivery Sciences Int’l v. Aquestive Therapeutics, Inc. Notably, Judge Newman dissented from the denial and expressed “concern [] with the PTAB’s position that it need not follow the court’s Remand Order, for reasons of efficiency and expense.” Judge Newman further argued that “[s]uch agency authority cannot be discerned in the America Invents Act, and contravenes decades of constitutional jurisprudence,” and consequently, “[t]he PTAB’s refusal to comply with our Remand Order to implement the Supreme Court’s ruling warrants en banc attention.”