During the week of September 24, 2018, the Patent Trial and Appeal Board (“the Board”) issued two decisions in TC 1600, both denying institution of inter partes review.  A summary of the decisions follows:

Apotex Inc. and Apotex Corp. (“Apotex”) v. Celgene Corporation (“Celgene”), IPR2018-00685 (Decision Denying Institution entered September 27, 2018).

In its petition, Apotex challenged claims 1-4, 8, 9, 15, and 20 of U.S. Patent No. 8,741,929 (“the ’929 patent”) on anticipation and obviousness grounds.  The ’929 patent is directed to methods of treating mantle cell lymphoma (“MCL”) using the immunomodulatory compound lenalidomide, marketed by Celgene under the tradename Revlimid® (or Revimid®).

Apotex challenged the claims as anticipated and/or obvious based on references by Drach, Zeldis, Querfeld, and a Celgene press release.  In its preliminary response, Celgene argued that Apotex replaced art considered during prosecution with art containing the same disclosures and presented substantially the same arguments that had been overcome during prosecution.  The Board exercised its discretion under 35 U.S.C. § 325(d) to determine whether to institute inter partes review based on its determination of whether the same or substantially the same prior art or arguments had already been presented to and considered by the Office during prosecution.  In evaluating the prior art and arguments, the Board considered several non-exclusive factors, including:

  1. the similarities and material differences between the asserted art and the prior art involved during examination;
  2. the cumulative nature of the asserted art and the prior art evaluated during examination;
  3. the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection;
  4. the extent of the overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguished the prior art;
  5. whether Petitioner has pointed out sufficiently how the Examiner erred in its consideration of the asserted prior art; and
  6. the extent to which additional evidence and facts presented in the Petition warrant reconsideration of the asserted prior art or arguments.

On balance, the Board found the factors weighed in favor of Celgene.  The Board further held that Apotex failed to provide a compelling reason why the Board should adjudicate the issues based on the art and arguments presented in the Petition.  In addition, the Board relied on Celgene’s prior arguments of unexpected results, which had overcome the prima facie obviousness rejection during prosecution.  Regarding the Celgene press release, the Board determined that Apotex had failed to provide evidence that the reference was sufficiently accessible to the public prior to the critical date.

The Board concluded that for the references that qualified as printed publications, Apotex had merely cited the same or substantially the same prior art or arguments as were presented to the Office during prosecution.

As such, the Board exercised its discretion under § 325(d) and denied institution of inter partes review.

Oxford Nanopore Technologies, Inc. (“Oxford”) v. Pacific Biosciences of California, Inc. (“Pacific”), IPR2018-00789 (Decision Denying Institution entered September 25, 2018).

Oxford challenged claims 1-15 of U.S. Patent No. 9,546,400 (“the ’400 patent”) on anticipation and obviousness grounds.  The ’400 patent is directed to a method for sequencing of polymeric molecules, such as nucleic acids, including single-stranded DNA.

Oxford challenged the claims as obvious based on seven references, used alone or in various combinations.  In particular, element (d) of challenged claim 1 was disputed by the parties.  Element (d) recites “determining the sequence of the template nucleic acid using the measured property from step (c) by performing a process including comparing the measured property from step (c) to calibration information produced by measuring such property for 4 to the N sequence combinations.”  In its preliminary response, Pacific argued that certain cited references had been thoroughly considered by the Office during prosecution and that Oxford failed to show either a sufficient reason to combine or a reasonable expectation of success.  The Board agreed with Pacific and determined that Oxford had failed to provide a clear analytical path from statements regarding prior art difficulties to the calibration information recited in element (d).  As such, the Board held that Oxford had failed to show that there was a reasonable likelihood that it would prevail in establishing obviousness of claim 1.

Consequently, the Board denied institution of Oxford’s petition in IPR2018-00789 and no trial was instituted against the claims of the ’400 patent.