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

On June 1, 2018, the Patent Trial and Appeal Board (“PTAB”) designated as informative its April 25, 2018 order regarding Motions to Amend.  Western Digital Corp. v. Spex Techs. Inc., IPR2018-0082, IPR2018-00084 (PTAB April 25, 2018) (Paper 13).  The PTAB’s order provides guidance to practitioners on (1) contingent motions to amend, (2) the burden of persuasion with respect to substitute claims, (3) number of substitute claims, (4) requirement that amendments respond to unpatentability grounds, (5) scope of substitute claims, (6) claim listings, (7) page limits on briefs, and (8) duty of candor.  This new order replaces MasterImage 3D, Inc. v. RealD Inc., IPR2015-00040 (PTAB July 15, 2015) (Paper 42) and Idle Free Sys. Inc. v. Bergstrom, Inc., IPR2012-00027 (June 11, 2013) (Paper 26), which the also PTAB de-designated as informative.
Continue Reading PTAB Sets Forth Updated Standards for Motions to Amend

At the end of a week shortened by the Memorial Day holiday, the PTAB (“Board”) issued just two decisions in Technology Center (TC) 1600 during the week of May 28.  The Pfizer decision hammers home that hindsight is not always 20/20, and there is no place for such bias in an obviousness analysis, while the shorter Roquette Freres decision serves to remind us of the old adage ‘mean what you say and say what you mean.’
Continue Reading Hindsight Is Not 20/20: PTAB Technology Center 1600 Decision Round-Up: Week of May 28 – June 1, 2018

Aside from a quick termination of IPR proceedings pending settlement in Argentum Pharmaceuticals LLC v. Cipla Ltd., No. IPR2017-00807 (Decision Entered May 21, 2018), the Board entered four decisions in TC 1600 during the week of May 21, all denying institution of IPR petitions filed by Initiative for Medicines, Access & Knowledge (I-MAK), Inc. (“I-MAK”) against Gilead Pharmasset LLC. (“Gilead”).  Those decisions are as follows:  
Continue Reading PTAB Technology Center (TC) 1600 Decision Round-Up: Week of May 21-25, 2018

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 May 8, 2018, the United States Patent and Trademark Office (USPTO) announced a proposed rulemaking to change the current claim construction standard used in inter partes review (IPR), post-grant review (PGR), and covered business method (CBM) proceedings before the Patent Trial and Appeal Board (PTAB).  If approved, this change would align the standard applied in claim construction proceedings in the PTAB with the standard applied in District Courts and the International Trade Commission (ITC).  Currently, the PTAB interprets patent claims according to their broadest reasonable interpretation, while District Courts and the ITC apply the ordinary and customary meaning standard set forth in Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (en banc).  This proposed rule would change the claim construction standard applied in all pending IPR, PGR, and CBM proceedings, and not just newly-filed petitions.
Continue Reading PTAB Proposes to Adopt the Phillips Standard for Claim Construction in Post-Grant Proceedings

On April 24, 2018, the Supreme Court held that the inter partes review (IPR) process, used by the Patent Trial and Appeal Board (PTAB) to reconsider the patentability of claims in an already-issued patent, does not violate Article III or the Seventh Amendment to the Constitution.  Oil States Energy Servs., LLC v. Greene’s Energy Grp., No. 16-712, slip op. (U.S. Apr. 24, 2018) (Supreme Court link).

Following an IPR, the PTAB ruled claims of an Oil States patent were unpatentable.  In its appeal of the PTAB ruling, Oil States argued that IPR proceedings are unconstitutional because actions to revoke a patent must be tried in an Article III court before a jury.  After the Federal Circuit summarily affirmed the PTAB’s decision, Oil States appealed to the Supreme Court, and the Supreme Court affirmed the Federal Circuit.

Continue Reading Supreme Court Affirms Constitutionality of Inter Partes Review in Oil States Energy Servs., LLC v. Greene’s Energy Grp.

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

Under 35 U.S.C. § 316(a)(11), the PTAB should issue its final written decision in an inter partes review “not later than 1 year after the date on which the Director notices the institution of a review under this chapter,” except that the one-year period may be extended “by not more than 6 months” for good cause shown, or “adjust[ed]… in the case of joinder under section 315(c).”  See also 37 C.F.R. § 42.100(c) (“An inter partes review proceeding shall be administered such that pendency before the Board after institution is normally no more than one year.  The time can be extended by up to six months for good cause by the Chief Administrative Patent Judge, or adjusted by the Board in the case of joinder.”).

In IPR2016-00286 (Amerigen Pharms. Ltd. v. Janssen Oncology, Inc.), Amerigen challenged the patentability of U.S. Patent No. 8,822,438, directed to methods of treating prostate cancer.  The PTAB issued its notice of institution on 5/31/2016, and joined Argentum to the IPR on 9/19/2016.  The PTAB held oral argument on 2/16/2017, and its final written decision issued on 1/17/2018.  Thus, the final written decision issued 19 months and 17 days after the notice of institution, and 15 months and 29 days after joinder.
Continue Reading PTAB May Wait Longer Than 12 Months To Issue Final Written Decisions In Cases of Joinder