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Section 101 Challenges are Out of Bounds in IPR Appeals

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, IPR, Section 101, Sections 102/103
Neptune Generics v. Eli Lilly & Company, Case No. 2018-1257, 2018-1258 (Fed. Cir. April, 2019), concerns an Eli Lilly & Co. patent protecting method of administering folic acid and a methylmalonic acid (MMA) lowering agent, e.g., vitamin B12. Specifically, the method concerns the administration of these products before administering pemetrexed disodium, an anti-folate chemotherapeutic, to … Continue Reading

Have You Included Specific Reference to Every Document in Your Priority Claim?

By Lynn L. Janulis, Ph.D. on Posted in Appeals, Inter Partes Review
Incorporation by reference is not sufficient to satisfy specific reference to each prior-filed patent application to be entitled to an earlier priority date (Droplets, Inc. v. E*Trade Bank (887 F.3d 1309 (2018)). This appeal to the Federal Circuit stems from a dispute between Droplets, Inc. and E*TRADE Bank, over a patent (U.S. Patent No. 8,402,115 … Continue Reading

Federal Circuit Affirms Tribal Sovereign Immunity Does Not Apply to IPR

By Lynn L. Janulis, Ph.D. on Posted in Appeals, Inter Partes Review, IPR, Real Party-in-Interest
The Federal Circuit recently affirmed the PTAB’s decision that tribal immunity cannot be asserted in an IPR (Saint Regis Mohawk Tribe v. Mylan Pharma Inc., Case No. 2018-1638 (Fed. Cir. July 20, 2018). On appeal, Allergan, Inc. (“Allergan”) argued that the Board improperly denied its motion to withdraw from IPR proceedings, and the Saint Regis … Continue Reading

Tribal Sovereign Immunity Alone Cannot Protect Patents from IPR

By Lynn L. Janulis, Ph.D. on Posted in Appeals, Inter Partes Review, Real Party-in-Interest
In late March, the Federal Circuit issued an order staying the PTAB proceedings concerning numerous related IPRs of patents issued to Allergan, Inc. (“Allergan”), but assigned to the Saint Regis Mohawk Tribe (“the Tribe”). These IPRs were headed toward a final hearing on the merits previously scheduled for April 3rd. In those IPRs, the PTAB denied the Tribe’s … Continue Reading

Precedential and Informative Board Decision on Serial IPR Petitions

By Lynn L. Janulis, Ph.D. on Posted in Institution / Denial, Inter Partes Review, IPR, Real Party-in-Interest, Sections 102/103
Serial IPR petitions directed to previously-challenged patents account for many of the petitions filed with the PTAB; however, 35 U.S.C. § 325(d) provides the Board with discretion to reject petitions where the same, or substantially the same, prior art or arguments have already been presented to the USPTO.  The Board recently designated as precedential part … Continue Reading

Late Payment of Petition Fee Thwarts IPR

By Lynn L. Janulis, Ph.D. on Posted in Institution / Denial, Inter Partes Review, IPR
If a Petitioner does not timely file the required petition fee, an IPR will not be instituted. In Cultec, Inc. v. Stormtech LLC  [Case No. IPR2017-00526, Paper 14 (July 17, 2017)], consistent with earlier decisions, the Board denied institution of an IPR because the Petitioner, Cultec, Inc., did not pay the required filing fee until … Continue Reading

IPR Challenge May Proceed Even in the Absence of Some Patent Owners

By Lynn L. Janulis, Ph.D. on Posted in Institution / Denial, Inter Partes Review, IPR, Joinder
When a patent is co-owned by a state university and another party, an IPR may proceed against the remaining party even after the state university co-owner has been determined to have sovereign immunity from the proceeding.  Reactive Surfaces Ltd., LLP v. Toyota Motor Corp., [Case No. IPR2017-00572, Paper 32 (July 13, 2017)]. This recent decision … Continue Reading

Presentation Not Qualified as a Printed Publication Because Audience Lacked Expertise

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Biotechnology, Inter Partes Review, IPR, Sections 102/103
In a recent final written decision (Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017)), the Board determined that the Coalition for Affordable Drugs (“Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (“the ’135 patent) were obvious. The claims … Continue Reading

PTAB Declines to Institute IPR on Immersion’s Indefinite Means Plus Function Claims

By Lynn L. Janulis, Ph.D. on Posted in Claim Construction, Institution / Denial, Inter Partes Review, IPR, Section 112, Sections 102/103
Petitioners are finding themselves caught in a Catch-22.  The PTAB declares claims too indefinite under Section 112 to construe, but then declines to address the patentabilty of the claims.  Section 112 deficiencies are not grounds to challenge a patent in an IPR, but the PTAB has authority to find such deficiencies. Recently, the PTAB decided … Continue Reading

PTAB Should Have Canceled All Challenged Claims in CBM Reviews

By Lynn L. Janulis, Ph.D. on Posted in Appeals, Claim Construction, Covered Business Method, Post Grant Review, Section 101
In Apple, Inc. v. Ameranth, Inc. (Fed. Cir. 2016), the Federal Circuit reviewed the final written decisions in CBM reviews of three related patents owned by Ameranth, Inc., directed to computerized systems for generating and displaying menus for use in the restaurant industry.  The court determined that the PTAB properly construed all disputed claim terms, … Continue Reading

PTAB Accords Little Weight to Evidence without Analysis or Explanation

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, Sections 102/103
The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430.  Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy … Continue Reading

An Overview of Amendments to the PTAB Rules

By Lynn L. Janulis, Ph.D. and Sharon M. Sintich, Ph.D. on Posted in Amendments, Claim Construction, Inter Partes Review
On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided an overview of the new PTAB rules during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The final rule on Amendments to the Rules of Practice for Trials Before the Patent Trial and Appeal Board, which we have previously discussed [April 21, 2016 and August 20, 2015] … Continue Reading

Federal Circuit Upholds Rule that New Petitioner Arguments Cannot Be Raised in IPR Reply Briefs

thumbnail image of DNA strandBy Lynn L. Janulis, Ph.D. on Posted in Appeals, Biotechnology, Inter Partes Review, Sections 102/103
The Federal Circuit recently affirmed the Board’s IPR decision that IBS failed to satisfy its burden of demonstrating obviousness of the challenged claims of Illumina’s U.S. Patent No. 7,566,537 (“the ‘537 patent), and determined that the Board did not abuse its discretion in refusing to consider IBS’s reply brief.  Intelligent Bio-Systems, Inc. v. Illumina Cambridge … Continue Reading
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