WARF Could Avoid Federal Circuit Review

01 December 2013 Personalized Medicine Bulletin Blog

On November 25, 2013, Consumer Watchdog (“CW”) and Wisconsin Alumni Research Foundation (“WARF”) responded to the Federal Circuit’s Order directing each party to brief whether CW, as a third party requester, has standing to appeal the U.S. Patent and Trademark Office’s (“USPTO’s”) decision in the inter partes reexamination of WARF’s U.S. Patent No.  7,029,913 (the ’913 Patent, entitled “Primate Embryonic Stem Cells). CW previously filed an appeal to the Court to raise, among other issues, the patent-eligibility of in vitro cultured human embryonic stem cells (hESCs) claimed in the ’913 Patent. For a review of the issues on appeal, see my prior posts of September 15th and July 8th, 2013.

Consumer Watchdog Alleges a Procedural Right to Appeal

Article III of the U.S. Constitution limits the jurisdiction of federal courts to actual cases or controversies. Standing is an element of Article III’s case or controversy requirement. To satisfy Article III standing, the Appellant must establish: 1) an injury-in-fact, 2) a causal connection between the complained-of conduct and 3) the likelihood that the injury will be redressed by a favorable decision.

CW alleges standing based on a statutory right or entitlement created by Congress that confers standing even in the absence of a judicially cognizable injury. CW points to the Freedom of Information Act which confers jurisdiction upon courts to hear cases brought by parties who request documents from governmental agencies and are dissatisfied by the agency’s response. A second example of a statutory right is that of voters who appealed an agency determination under the Federal Election Campaign Act of 1971, to determine the identity of certain campaign donors.

In the case at hand, CW notes two pre-America Invents Act (“AIA”) statutes for its procedural standing. The first is 35 U.S.C. § 141, which states in part that a third-party requester in an inter partes reexamination proceeding, who is dissatisfied with the USPTO’s decision, may appeal the decision to the Federal Circuit. The second is 35 U.S.C. § 315(b)(1). CW alleges that this statute similarly provided prior to the AIA that a third-party requester may appeal with respect to any final decision favorable to the patentability of any patent claim. Thus, CW concludes, Congress purposefully and knowingly created inter partes reexamination as a mechanism by which third parties could challenge the validity of patent claims at the USPTO and appeal any unfavorable decision. CW argues that in addition, 28 U.S.C. § 1295(a)(4)(A), provides that the Federal Circuit has exclusive jurisdiction of an appeal from the USPTO, with respect to a patent reexamination, at the instance of a party who participated in the proceeding at the USPTO.

CW also urges the Court that if it is not convinced that it has standing to appeal the USPTO’s decision, to consider inviting the United States to opine on the issue, as a decision that CW does not have standing in this case could raise a Constitutional question. CW also notes that due to the potential far reaching effects of a decision limiting standing of third parties to appeal USPTO determinations, amici may wish to submit briefs to the Court on the issue and should perhaps be provided an opportunity to do so.

WARF Urges No Standing Absent an Injury-in-Fact

WARF urges that CW lacks standing as it cannot establish an injury-in-fact. WARF states that while Congress has the power to define injuries and chains of causation, Congress cannot eliminate the requirement that the party seeking review has suffered a concrete and particularized injury. Indeed, WARF notes, CW has not pointed to any statute that alters or eliminates this constitutional requirement. The procedural rights relied upon by CW, WARF argues, may relax the redressability and immediacy requirements of standing, but not the injury-in-fact requirement. WARF argues that CW has not alleged any concrete and personalized injury, either to itself or any organization member traceable to WARF. For example, CW has not alleged that WARF has undertaken any affirmative act to enforce the ’913 Patent against CW or any member. WARF also notes that CW has not alleged that it or any of its members is conducting research on human embryonic stem cells or is willing and able to conduct such research but is precluded to do so because of WARF. WARF notes that rather, it has broadly licensed the technology claimed in the ’913 Patent.

Finally, WARF notes that CW’s only interest in challenging the ’913 Patent is an unsupported “burden on taxpayer-funded research in the State of California where [CW] is located.” WARF brief at page 8 (attached below), citing Appellant’s Brief at page 2. For these reasons, WARF urges, the appeal should be dismissed.

Third Key Issue

In addition to addressing whether the claimed cultured human embryonic stem cells qualify as patent-eligible subject matter under 35 U.S.C. § 101 and whether this issue can be raised in a reexamination proceeding, the standing issue briefed by the parties is the third important issue this appeal raised from what would otherwise be a rather routine appeal of an inter partes reexamination decision. Should CW lose on the standing issue, similarly situated groups that do not practice the claimed invention would have no redress in the courts to challenge adverse USPTO reexamination determinations.

Oral argument is scheduled for December 2, 2013.

CW’s brief is attached here.

WARF’s brief is attached here.

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