Petitions / Supreme Court Activity

Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With respect to granted cases, Arellano filed his reply brief in Arellano v. McDonough. With respect to petitions, one new petition was filed with the Court in a Rule 36 case, three amicus briefs were submitted in a patent case, and a brief in opposition was submitted in the same patent case. Here are the details.

Granted Cases

Arellano submitted his reply brief in Arellano v. McDonough, a case raising questions about equitable tolling of a one-year filing deadline for retroactive veterans benefits. In his opening merits brief, Arellano argued that the Court should “mak[e] clear that [38 U.S.C.] § 5110(b)(1)—like nearly all claim-processing rules in private litigation—may be equitably tolled in appropriate circumstances.” In its response brief, however, the government maintained that “[e]quitable tolling does not apply to the one-year grace period in [38 U.S.C. §] 5110(b)(1)” because the grace period is not a statute of limitations. The government also argued that, “[e]ven if the one-year grace period were viewed as a statute of limitations, the statutory text and context would rebut any presumption of equitable tolling.” The also government noted how “VA has long construed Section 5110 to preclude equitable tolling, and the Federal Circuit likewise has repeatedly adhered to that view.”

Now, in his reply brief, Arellano maintains that “equitable tolling can apply to unique statutory timing provisions, even if they lack a precise private analogue and do not look like ‘traditional’ or ‘typical’ statutes of limitations.” According to Arellano, anyway, the one-year filing deadline here operates as a statute of limitations because “[a] veteran wishing to claim retroactive service-connected disability benefits dating back to her date of discharge must do so within one year of discharge.” Arellano also notes that, “[j]ust as the copyright and patent statutes of limitations are presumptively amenable to equitable tolling . . . so too should the one-year filing deadline in § 5110(b)(1).”

Petition Cases

New Petition

In Manivannan v. Department of Energy, the petitioner asked the Court to consider the following questions:

  1. “Whether a court of appeals must provide an opinion explaining its reasoning in an appeal that involves a complex and unsettled area of the law and in which a written opinion would likely provide the appellant with a viable basis for seeking rehearing, rehearing en banc, or certiorari.”
  2. “Whether federal agency employees who disclose gross waste, mismanagement, or violations of laws, rules, or regulations are protected from agency retaliation only when they later can prove the disclosed misconduct in the Merit Systems Protection Board, where they have been denied any discovery and, ‘[a]s a practical matter, the agency has far greater access to and control over evidence.’ Whitmore v. Department of Labor, 680 F.3d 1353, 1375 (Fed. Cir. 2012).”

Amicus Briefs

Three amicus briefs were filed in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, a patent case raising a question about so-called skinny labelling. The Federal Circuit found that Teva could be held liable for inducement based on a “skinny label” that provided information only about unpatented uses. Teva’s petition presented the following question: “If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?”

Alvotec, a manufacturer of biopharmaceutical medicines, filed an amicus brief in support of the petitioner. According to Alvotec, the Federal Circuit’s decision to uphold an infringement verdict “provides incentives for branded companies to use litigation and threats of litigation in an attempt to delay the launch of unpatented drugs with unpatented indications.” Alvotec notes that the result will likely lead to “decreased competition in the biopharmaceuticals market, increased prices of already prohibitively expensive pharmaceuticals, and, ultimately, reduced patient access to life-saving medications.”

The Association for Accessible Medicines (“AAM”), an association representing manufacturers of generic medicines, also filed an amicus brief in support of the petitioner. The AAM maintains that the Federal Circuit’s decision “nullifies Congress’s skinny-label regime,” which allows manufacturers to come to market with a label that “excluded the uses that remained under patent.” It explains how “[n]o generic manufacturer would dare risk coming to market with a skinny label if it could face enormous liability . . . .” The AAM urges the Court to “correct this important mistake of law,” and “honor[] Congress’s scheme as written.”

Mylan Pharmaceuticals also filed an amicus brief in support of the petitioner. According to Mylan, the Federal Circuit “offered no guidance as to ‘what another generic in [Teva’s] shoes should do differently.’” Mylan explained that “Teva followed the same path that other generics follow” when releasing products. It explains that the FDA “spells out word-for-word precisely what each carve-out label must say.” Mylan urges that the Court “should intervene, or at least invite the views of the Solicitor General.”

Brief in Opposition

In the same case, Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, GlaxoSmithKline filed its brief in opposition to the petition. According to GlaxoSmithKline, “the law of induced patent infringement was correctly stated and applied below.” As a result, it argues, “no additional look by this Court is warranted.” Moreover, GlaxoSmithKline contends that the Federal Circuit’s decision, “like others before it addressing carve-out labels . . . has not had, and will not have, a chilling effect on the generic drug industry.” It notes that the case concerns “regulatory issues long since mooted.”