U.S. Government and USPTO Urges Federal Circuit to Dismiss Stem Cell Appeal

03 February 2014 Personalized Medicine Bulletin Blog

On January 17, 2014, the United States government and the United States Patent and Trademark Office (collectively “the government”) responded to the Federal Circuit’s December 4, 2013 order inviting them to address whether Consumer Watchdog (“CW”) has Article III standing to pursue its appeal of the USPTOs affirmation of the patentability of Wisconsin Alumni Research Foundation’s (“WARF”) human embryonic stem cell patent (U.S. Patent No. 7,029,913, the “’913 Patent”). The government argues that because CW fails to identify any concrete or particularized interest in the patentability of the ’913 Patent, it lacks standing to appeal to the federal court. The government notes that CW neither suggests that it is an actual or prospective competitor or licensee of WARF, nor does it assert any concrete interest in the invention of the ’913 Patent. The government also asks the court to provide guidance on whether appeals from the USPTO’s post-grant proceedings are governed by the same Article III inquiry that governs the availability of declaratory judgment relief in the federal district courts.

A Brief Review of the Dispute

CW appealed an USPTO inter partes reexamination (No 95/000,154) of the ’913 Patent assigned to WARF. The ’913 Patent, entitled Primate Embryonic Stem Cells, names Dr. James A. Thomson as the sole inventor. CW requested a reexamination of the ’913 Patent on the grounds the claims were neither novel (failing 35 U.S.C. Section 102) nor non-obvious (35 U.S.C. Section 103) over prior research describing embryonic mouse stem cells. The USPTO disagreed, and the patent claims were upheld. On appeal, CW again challenges the patentability of the claims, and adds a challenge that the claims fail to satisfy statutory patent-eligibility under 35 U.S.C. Section 101, raising many of the same arguments it raised in their prior challenge of Myriad’s BRCA1/2 patents claiming isolated human genes and gene fragments. (See Assn. for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __ (2013)).

During a hearing in early December, the Federal Circuit on its own initiative asked the government and the USPTO to brief the issue whether CW, as a third party requester, has standing to seek review of the USPTO’s affirmation of the ’913 Patent claims. The U.S. government and the USPTO in a joint brief, state that in their view, CW lacks standing and urges the court to dismiss the appeal. A detailed review of the history of this dispute is found in my prior posts of July 8, 2013; September 15, 2013; December 1, 2013 and December 8, 2013.

Wisconsin Alumni Research Foundation Lacks Standing

In their joint brief, the government and USPTO urge the Federal Circuit to dismiss the appeal because the Federal Circuit’s jurisdiction extends only to cases and controversies under Article III when:

“the irreducible minima of Article III jurisdiction are present. In particular, the requirement of an injury-in-fact is the hard floor of Article III jurisdiction. Summers v. Earth Island Institute, 555 U.S. 488,497 (2009). Except at the behest of a party with a concrete and particularized interest in the question present, neither this Court nor any other Article III tribunal has the power to render judgment. The fact that Congress has created a procedural right to appeal an adverse PTO decision does not by itself confer Article III standing. The appeal should therefor be dismissed for lack of jurisdiction.”

The government notes, however, that the Federal Circuit should avoid suggesting that the same standards that limit the availability of declaratory judgment relief in federal district court necessarily governs the ability of petitioners in USPTO post-grant proceeding to appeal adverse decisions to the Federal Circuit. The actions are distinct, the government notes, because actions for declaratory relief involve considerations of prudential ripeness, immediacy, and redressability that may not apply or may apply, with diminished force when the right to appeal is procedural. In addition, a petitioner with a more particularized interest in the patentability of a particular invention (for example a competitor deciding whether to proceed with commercializing a potentially infringing product) may satisfy the specific injury requirement due to the estoppel provisions of the American Invents Act (AIA) that would preclude future challenges. The government urges that the question is important because competitors and other likely users of the AIA inter partes review and post-grant review procedures may be loath to commence such proceedings if appellate review of such proceedings was limited to circumstances in which a conventional declaratory judgment action for patent invalidity would otherwise lie.

WARF filed a one paragraph statement in support of the government’s and USPTO’s arguments.

Consumer Watchdog’s Reply

CW again asserts that it has standing even in the absence of a specific injury independent of the adverse agency decision. CW also addresses the government’s statement that standing would apply for other third party requesters of an inter partes reexam whose disputes are unripe for declaratory judgment jurisdiction. CW argues that its harm is the same as an alleged competitor’s economic injury – that of having spent substantial resources on a proceeding that did not change its inability to practice the claimed invention and would also be estopped from challenging the validity of the upheld claims in the future.

A copy of the government’s brief: US Amicus Brief (Consumer Watchdog v WARF).

WARF’S Letter in Support: Letter from WARF re US amicus brief.

CW’s Reply:Consumer Watchdog Response Brief to US

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