On May 14, 2018, the Federal Circuit (Judge Linn, with Judges Reyna and Hughes) ruled on mandamus to address two important issues related to proper venue in a patent infringement case: 1) whether regional or Federal Circuit law governs the analysis of proper venue under 28 U.S.C. § 1400(b), and 2) which party bears the burden of persuasion on the issue when a defendant challenges proper venue.  The court held that Federal Circuit law applies, and the plaintiff bears the burden of persuasion.  In re: ZTE (USA) Inc., No. 2018-113 (Fed. Cir. May 14, 2018).

Continue Reading Federal Circuit to District Courts: On Venue, Apply Our Law, Not Theirs

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 13, 2018, the Federal Circuit issued a new decision in its recent line of cases analyzing whether generic drug labels may be evidence of induced infringement of method of treatment claims in Hatch-Waxman cases. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd., the Court, in upholding the District Court’s finding of induced infringement, held that proposed instructions to physicians can satisfy the specific-intent element of induced infringement. 887 F.3d 1117 (Fed. Cir. 2018) (Judges Lourie and Hughes, Chief Judge Prost dissenting on other issues). This decision follows and builds upon the Federal Circuit’s 2017 decisions in Eli Lilly and Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) and Sanofi v. Watson Laboratories Inc., 875 F.3d 636 (Fed. Cir. 2017).

Continue Reading Generic Drug Labels May Establish Specific Intent to Induce Infringement of Method of Use Claims

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

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

In a final written decision in April 2017, the PTAB found that Petitioner did not satisfy its burden of proving claims of U.S. Patent No. 8,618,135 (“the ’135 patent”) were unpatentable in part because the PTAB found a slide deck presented to business persons was not prior art.  In Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01f835, Paper No. 56 (PTAB March 6, 2017) Petitioner argued that the ’135 patent was unpatentable over a combination of prior art that included a slide deck prepared by Evan Stein, M.D., Ph.D., for PPD, Inc. (“Stein”).

Stein was presented during Analyst Day at PPD, Inc. live and via webcast, and a hyperlink was distributed.  Moreover, Stein was reported in Pink Sheet, a news webpage.  In asserting Stein was prior art, Petitioner alleged Stein was “targeted to financial analysts, investors, and skilled artisans interested in drug discovery and development.”  Petitioner also asserted that the presentation was publicized for weeks, and that skilled artisans would have taken great interest in it.  Continue Reading Presentation Directed Toward Business Persons, Rather Than Skilled Artisans, Did Not Qualify As Prior Art