Institution Decisions

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Drug product labels (also known as prescribing information) are often asserted as prior art by patent challengers, both in front of the PTAB and in district court ANDA litigation.  Before the PTAB, using such prior art requires showing that it qualifies as a “printed publication” under 35 U.S.C. §§ 102 and 311(b).  Recently, the PTAB appears to be applying greater scrutiny to the use of such prior art when cited in invalidity grounds.  The Board’s analysis in such situations “involves a case-by-case inquiry into the facts and circumstances surrounding the reference’s disclosure to members of the public.”  Sandoz Inc. v. AbbVie Biotechnology Ltd., IPR2018-00156, Paper 11 at *9 (June 5, 2018) (citing In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004)).  A pair of recent rulings identify some of the evidentiary issues catching the eyes of PTAB panels as they consider invalidity arguments that rely on product-label prior art.
Continue Reading Recent PTAB Rulings Reflect Greater Scrutiny Of Product-Label Prior Art

SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), established a clear rule requiring institution on all challenged claims in future IPR proceedings. But the Supreme Court’s April 24 decision created immediate uncertainty regarding the hundreds of IPRs in which the PTAB had already instituted review or issued a final written decision on fewer than all claims and all grounds presented in the petition. The Federal Circuit’s immediately apparent interest in SAS transitional issues has led to swift action—the court’s precedential decision in PGS Geophysical AS v. Iancu explains that (1) SAS requires institution on all claims and all grounds presented in a petition for IPR, (2) the Federal Circuit can exercise appellate jurisdiction in pre-SAS cases where the Board granted only partial institution, and (3) parties can waive requests for SAS-based relief on appeal.
Continue Reading Federal Circuit Rules that Pre-SAS Appeals from Partially Instituted IPRs Can Proceed

The Supreme Court’s recent decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), has bred considerable uncertainty about what to do with the multitude of pending inter partes review (IPR) cases that were instituted under pre-SAS standards. The adjudicators tasked with applying SAS in those cases—at the PTAB and the Federal Circuit—are now sorting through the fallout.

The PTAB reacted quickly by releasing guidance two days after SAS that outlined the agency’s initial response: (1) future institution decisions will be decided on an all-or-nothing basis as to all claims and all grounds in the petition, (2) panels presiding over pending trials that were instituted on fewer than all claims and grounds in the petition are issuing orders to supplement the institution decision and institute on all claims and grounds, and (3) panels may take further actions in individual pending cases, such as allowing supplemental briefing or extending trial deadlines, depending on factors such as the particulars of the case, the stage of proceedings, and input from the parties. The PTAB noted that it will continue to assess its response to SAS and may issue additional guidance in the future.

The Federal Circuit is likewise wrestling with SAS.
Continue Reading SAS Institute v. Iancu – What Now?

On April 24, 2018, the Supreme Court held that the Patent Trial and Appeal Board (“PTAB”) must address all challenged claims of an instituted Petition in a final written decision. SAS Inst. Inc. v. Iancu, Dir. U.S. Pat. & Trademark Off., No. 16-969, slip op. (U.S. Apr. 24, 2018).  By way of background, in its Petition for inter partes review (“IPR”), SAS sought review of all the claims of ComplementSoft’s software patent.  During the IPR proceedings, the PTAB instituted review on some of the claims, relying on a Patent Office regulation that allowed for “partial institution.”  The PTAB held seven of those claims unpatentable and confirmed the patentability of one claim.  SAS argued to the Federal Circuit on appeal that the patent statute required the PTAB to address all challenged claims in its final written decision.  The Federal Circuit rejected that argument and the Supreme Court granted certiorari.  The Supreme Court disagreed with the Federal Circuit and held that all challenged claims must be addressed in an instituted IPR’s final written decision.  Id.
Continue Reading Supreme Court holds that when PTAB institutes an inter partes review, it must decide patentability of all challenged claims

The PTAB recently designated as “informative” two decisions exploring how 35 U.S.C. § 325(d) applies to art or arguments previously presented to the Office at the institution stage:  Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper No. 8 (PTAB Dec. 15, 2017), and Kayak Software Corp. v. International Business Machines Corp., CBM2016-00075, Paper No. 16 (PTAB Dec. 15, 2016).  In those decisions, the Board identified several factors that guide its discretion in applying § 325(d).  The Board underscored the broad relevance of those factors by designating Becton Dickinson and Kayak Software as informative.

In both cases, the Board invoked § 325(d) to deny institution of asserted obviousness grounds based on references that had been considered during original prosecution of the challenged patents.  The examiner had not addressed the precise combinations of prior art references asserted in each of the petitions, but the Board concluded that incremental, non-substantive differences in asserted secondary references did not distinguish the patentability issues previously considered by the Office.  In so doing, the Board identified factors that may influence the § 325(d) analysis. 
Continue Reading PTAB Offers Further Guidance On Its Willingness To Hear Arguments Previously Presented

In a July 2017 decision designated as informative, the PTAB provided guidance as to when it may exercise its discretion under 35 U.S.C. § 325(d) to deny institution when “the same or substantially the same prior art or arguments previously were presented to the Office.”  In Hospira, Inc. v. Genentech, Inc., IPR2017-00739, Paper No. 16 (PTAB July 27, 2017), the Board denied institution because the arguments presented had already been made during prosecution.

In its petition Hospira challenged claims of U.S. Patent No. 7,892,549, which relates to therapy for breast cancer.  Hospira argued that certain claims were invalid as anticipated by one or more of three references.   The use of those references as anticipatory prior art was premised on Hospira’s position that the challenged claims were not entitled to claim priority to an earlier application.  In its priority date challenge, Hospira argued that the prior application did not enable or provide written description support for the challenged claims.
Continue Reading In An Opinion Designated Informative, The Board Denied Institution For Failing To Raise Grounds Not Already Considered By The Patent Office