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January 20, 2017

This Week at the Board - January 20, 2017

Federal Circuit Dismisses Appeal Due to Lack of Standing

In a recent decision (Phigenix, Inc. v. ImmunoGen, Inc., 2016-1544), the Federal Circuit dismissed an appeal by Phigenix, Inc. as lacking standing to bring suit in federal court because it could not adequately establish that it had suffered an injury in fact. The case is the result of Phigenix’s appeal of a Patent Trial and Appeal Board Final Written decision pertaining to the inter partes review of ImmunoGen’s U.S. Patent No. 8,337,856 (“the ‘856 Patent”), which is used to produce the cancer-treatment drug Kadcyla ®™. Phigenix is a biotechnology, pharmaceutical, and biomedical research company, specifically focusing on cancer treatments, that does not manufacture any products.  In its appeal to the Federal Circuit, Phigenix argued that it had suffered an economic injury because the ‘856 Patent increases competition between itself and ImmunoGen, and that at least a portion of licensing revenue generated by Immunogen would be directed to Phigenix if the patent was invalidated. Further, Phigenix contended that an injury in fact was suffered because of a statutory basis for appeal and the estoppel effect of the PTAB decision. In rejecting these arguments, the Court noted that Phigenix had never contended or shown that it faced risk of infringement, that it was an actual or prospective licensee, or that it otherwise planned to take any action implicating the ‘856 Patent. Instead, the Court found that Phigenix had only relied upon a hypothetical licensing injury that could not be properly interpreted as an injury in fact. The Federal Circuit noted that Phigenix’s other arguments were also insufficient to raise standing, based on previous court decisions. 

The Federal Circuit also noted that there was not an established legal standard for determining standing on an appeal from a final agency action. In setting forth a standard, the Court noted “the standard must identify the burden of production, the evidence an appellant must produce to meet that burden, and when an appellant must produce that evidence.” As such, the Court determined that summary judgement burden of production is applicable for review of an agency decision when standing is in question, that the appellant must identify record evidence or provide additional evidence to support standing, and that the appellant must produce such evidence of standing at the earliest possible opportunity if there is no record evidence supporting standing.    

A link to the Federal Circuit’s decision is provided here.

PTAB Institutes IPR Based on Previously Presented Prior Art and Similar Arguments

In a recent institution decision related to IPR2016-01268, the Board decided to institute inter partes review of all challenged claims of U.S. Patent No. 8,365,742 (“the ‘742 Patent”) despite the fact that the same prior art and similar arguments had been presented in a separate proceeding (IPR2015-00859) in which institution was denied. While 35 U.S.C. § 325(d) does provide the Director the discretion reject petitions based on substantially the same prior art or arguments that were presented previously, the Board noted that institution is not prohibited. In addition, the Board noted that the Patent Owner had failed to demonstrate that the Petition constituted harassment or was part of a serial filing of petitions against the ‘742 Patent. Ultimately, the Board was persuaded by the Petitioner’s arguments related to previously cited prior art in finding that the Petition demonstrated a reasonable likelihood of prevailing on its challenge of the ‘742 Patent.  

A link to the PTAB’s decision is provided here.

Federal Circuit Orders En Banc Rehearing of Time-Bar Review Case

In a recent order from the Federal Circuit, the Court decided to grant Wi-Fi One, LLC’s petition for en banc rehearing of their appeal related to IPR2013-00601, IPR2016-00602, and IPR2013-00636. The case broadly relates to the whether or not a Patent Owner may challenge the timeliness of the filing of a Petition for inter partes review. This controversy relates to two AIA provisions: 35 U.S.C. §§ 315(b) and 314(d).  35 U.S.C. § 315(b) states, in relevant part, that “[a]n inter partes review may not be instituted if the petition requesting the proceeding is filed more than 1 year after the date on which the petitioner, real party in interest, or privy of the petitioner is served with a complaint alleging infringement of the patent.” 35 U.S.C. § 314(d) provides that “[t]he determination by the Director whether to institute an inter partes review under this section shall be final and nonappealable.” Accordingly, when the Board decides to institute a case, even if the petition may be time-barred, the Court had held that the judicial review was not available. Wi-Fi One was able to convince the Federal Circuit to reconsider based on the Supreme Court’s Cuozzo decision that noted there may be some portions of the institution decision that may be appealed. The Federal Circuit will now determine whether judicial review is available for a Patent Owner to challenge the Board’s determination that the Petitioner had submitted a timely petition under 35 U.S.C. § 315(b). The briefing period has commenced and a date for oral arguments will be scheduled at a later date.       

A link to the Federal Circuit’s order is provided here.

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