Here is an update on recent activity at the Supreme Court in cases decided by the Federal Circuit. With respect to granted cases, there is no new activity to report since our last update. With respect to petitions, most notably the Solicitor General filed an amicus brief expressing the view of the United States that the Court should grant review in two patent cases. No new petitions were filed, but the government waived its right to respond to two petitions and a party filed a supplemental brief in response to the Solicitor General’s amicus brief recommending the Court grant review in a patent case raising a question about so-called skinny labelling. Here are the details.
There is no new activity to report. We are waiting on the Court to decide Amgen Inc. v. Sanofi, Aventisub LLC, a patent case concerning the enablement requirement.
The Solicitor General filed an identical amicus brief in two patent cases: Tropp v. Travel Sentry, Inc. and Interactive Wearables, LLC v. Polar Electro Oy, both presenting questions patent eligibility. The Solicitor General expressed the view of the government that both petitions should be granted.
In Tropp, the petitioner presented the following question for review:
- “Whether the claims at issue in Tropp’s patents reciting physical rather than computer-processing steps are patent-eligible under 35 U.S.C. § 101, as interpreted in Alice Corporation Pty v. CLS Bank International, 573 U.S. 208 (2014).”
In Interactive, the petitioner presented the following questions for review:
- “What is the appropriate standard for determining whether a patent claim is ‘directed to’ a patent-ineligible concept under step one of the Court’s two-step framework for determining whether an invention is eligible for patenting under 35 U.S.C. § 101?”
- “Is patent eligibility (at each step of the Court’s two-step framework) a question of law for the court based on the scope of the claims or a question of fact for the jury based on the state of art at the time of the patent?”
- “Is it proper to apply 35 U.S.C. §112 considerations to determine whether a patent claims eligible subject matter under 35 U.S.C. § 101?”
The government argues that these cases “provide an opportunity for the Court to clarify the proper reach and application of the abstract idea exception to patent eligibility under Section 101.” It contends that, even when an invention is directed to an abstract idea, the court should ask “whether a claimed invention sufficiently transforms an abstract idea into the kind of innovation eligible for patent protection.” According to the government, the Interactive court did not undertake that inquiry, and instead “placed undue emphasis on considerations of novelty, obviousness, and enablement.” By contrast, it contends, “the Tropp court correctly held that nothing in the claimed method transforms it into a technological invention.” Moreover, although the decisions below were unanimous, the government points out, “the Federal Circuit has repeatedly divided in recent years over the content of the abstract-idea exception and the proper application of the two-step methodology under Section 101.”
Waivers of Right to Respond
The government waived its right to respond in Nike, Inc. v. Adidas AG, a patent case considering whether the Patent Trial and Appeal Board in an inter partes review holds the power to raise sua sponte a new ground of unpatentability to reject a patent claim.
GlaxoSmithKline (“GSK”) filed a supplemental brief in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline LLC, a case raising a question about so-called skinny labelling. In its brief, GSK addresses the Solicitor General’s view that the Court should grant review in this case. The petitioner asked the Court to review 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?”
In its amicus brief, the government argued that “[a] generic manufacturer’s labeling cannot provide the requisite evidence of specific intent to induce infringement in a case like this one.” If the generic manufacturer’s use of FDA-approved carved-out labeling could support a finding of intent to induce infringement, the government contended, then “generic manufacturers’ invocation of the section viii pathway [enabling manufacturers to market generic versions of a brand-name drug where the drug itself is not patented] would be substantially deterred.” Moreover, the government argued, “the inference of intent is inappropriate here.” It maintained that “[t]he carved-out labeling did not reflect petitioner’s unencumbered choice, but instead was driven by FDA regulatory requirements and GSK’s own identification of the indication that should be excised.” It also argued “[t]he decision below subverts the balance struck by Congress, creates significant uncertainty for FDA and generic manufacturers, and invites gamesmanship by brand-name manufacturers.”
Now, in response, GSK argues that, “[r]ather than address the actual facts of this case and the documented history of the section viii ‘carveout’ process, the government rewrites both to reach the result it wants.” GSK asserts “[c]ertiorari should not be granted based on such false premises, which will lead to messy merits proceedings dominated by factual disputes, making this case a poor vehicle for addressing the issues raised by the government.”
In particular, GSK contends “[t]he government focuses on one piece of that evidence—the label itself—to the exclusion of everything else” but “[t]he jury heard voluminous additional evidence of Teva’s intent.” Anyway, it argues, “[a]lthough no additional support was needed, the label itself was also evidence of Teva’s intent.” According to GSK, “[t]he government’s contrary assertions rest on a clear misunderstanding about how the carved-out label arose.”
GSK highlights that the form it used with the FDA allows patent holders “to identify the approved use covered by their patents by ‘indication or method of use information.’” GSK contends that it “used language describing its approved (and patented) ‘method of use’ in language from the approved label.” Regardless, GSK maintains, the form at issue was not submitted until six moths after Teva launched its product, long after it created its own label. Thus, it says, GSK’s “form had nothing to do with FDA’s or Teva’s conduct, so it cannot serve as the basis for overturning the jury’s willful infringement finding.”