Article III Standing in Patent Law May Be Before the Supreme Court Soon

By Rachel Sachs

Who has standing to challenge a patent’s validity? And under what circumstances can Congress define an injury for the purpose of creating Article III standing? Those questions underlie a new petition for certiorari filed by Consumer Watchdog, who is asking the Supreme Court to reverse a Federal Circuit opinion holding that Consumer Watchdog lacked Article III standing to challenge a patent on embryonic stem cells.

Consumer Watchdog, a non-profit consumer organization, requested an inter partes reexamination of a patent on embryonic stem cells held by the Wisconsin Alumni Research Foundation (WARF), alleging that the patent should be invalidated on several grounds. After a lengthy administrative process, the Patent Trial and Appeal Board (PTAB) upheld the patent as valid. Consumer Watchdog subsequently appealed, under sections of the Patent Act that expressly permit third-party requesters (like Consumer Watchdog) in inter partes reexamination proceedings to appeal to the Federal Circuit if they are “dissatisfied” with the PTAB’s decision or if any “final decision [is] favorable to the patentability” of the claims in question. The Federal Circuit held that Article III’s case or controversy requirement imposes a separate, irreducible constitutional minimum requirement on standing — and that Consumer Watchdog hadn’t met that requirement. 

Specifically, the Federal Circuit concluded that even though Congress had the ability to allow Consumer Watchdog to appear before the PTAB, it could not by statute entirely eliminate Consumer Watchdog’s need to have a particularized stake in the case once it reached federal court. The Federal Circuit did not award special salience to the involvement of the PTAB, rejecting the idea that a loss before an administrative agency might itself create an injury. The Federal Circuit went on to state that Consumer Watchdog had not identified any other “particularized, concrete interest,” because it was not “engaged in any activity involving human embryonic stem cells that could form the basis for an infringement claim” nor was it “an actual or prospective licensee.” Additionally, Consumer Watchdog’s concerns about “the potential preemptive reach” of the patent were not sufficient to establish standing.

This is not the first time the Federal Circuit has been asked to decide whether organizational plaintiffs of this type have standing. Its 2012 opinion in the Myriad gene patent case notably held that several organizational plaintiffs lacked standing in their declaratory judgment action, along similar lines. Legal scholars have taken notice, with recent works by Michael Burstein and Sapna Kumar criticizing the Federal Circuit’s narrow perspective of the concept of “injury” in these cases on both doctrinal and policy grounds.

The Supreme Court should note that this will not be the last time the Federal Circuit will be asked to decide this issue. Consumer Watchdog is not the only organizational plaintiff active in making reexamination requests, and appeals from reexamination proceedings instituted by organizations like RPX (for which the standing analysis may well be different) or EFF will likely come before the court soon. This would be a helpful time to provide authoritative guidance on the question.

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This entry was posted in Health Law Policy, Intellectual Property, Judicial Opinions, Rachel Sachs, Stem Cells by rachelsachs. Bookmark the permalink.

About rachelsachs

Rachel Sachs is an Associate Professor at the Washington University in St. Louis School of Law. Previously, she was an Academic Fellow at the Petrie-Flom Center. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. Rachel's primary research interests lie at the intersection of patent law and health law, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems.

One thought on “Article III Standing in Patent Law May Be Before the Supreme Court Soon

  1. Your above link to “petition for certiorari filed by Consumer Watchdog” now gives a not found (404) response. But what the Federal Court ruled on required “particularized, concrete interest” is easy to overcome (not that one knows it …) could easily be overcome by any organization I suspect. To be “engaged in any activity … that could form the basis for an infringement claim” – mightn’t it even suffice to hold shares in a company that is active in a field that a patent impinges on?

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