During the week of October 8, 2018, the Patent Trial and Appeal Board (“the Board”) issued five decisions in Tech Center 1600.  One decision denied institution of post-grant review (“PGR”), and the other four—which were related inter partes review (“IPR”) petitions—instituted the IPR petitions and granted the requests for joinder.  The decisions are summarized below.

Alnylam Pharm., Inc. v. Silence Therapeutics GmbH, No. PGR2018-00059 (Decision Denying Institution Entered October 10, 2018)Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed a PGR petition to cancel Silence Therapeutics GmbH’s (“Silence’s”) U.S. Patent No. 9,695,423 (“the ’423 patent”) on small interfering RNA molecules.  Alnylam filed four related PGR petitions (PGR2018-00067, -00075, -00088, and -00089), all of which are pending.

The ’423 patent is directed to RNA molecules, particularly small interfering RNA molecules for inhibiting gene expression.  PGR2018-00059, Paper 9 at 3-4.  While the ’423 patent claimed a priority date before the PGR eligibility date of March 16, 2013, Alnylam challenged this priority date by claiming that none of the ’423 patent’s priority applications provided support under 35 U.S.C. § 112 for the ’423 patent’s claims.  Id. at 11-14.  Alnylam challenged written description and enablement using largely equivalent arguments—namely, that certain claim elements were not adequately described and explained in the specification.  Id. at 23-24.  The Board reasoned, however, that each of the following challenged claim elements was adequately described and enabled before March 16, 2013:

  • “the modification at the 2’-position of the flanking nucleotide being different from the modification at the 2’-position of the modified nucleotide”: Because Alnylam acknowledged that the priority applications provided a generic embodiment that met this limitation, the Board found that this limitation satisfied § 112. Id. at 17-18.
  • “has a double-stranded region of 17-21 nucleotides in length”: The Board found that the priority applications adequately disclosed a range encompassing 17-21 nucleotides. Id. at 18.
  • “capable of RNA interference”: Alnylam argued that the priority applications characterized longer (i.e., 17-nucleotide long) RNA molecules as non-functional, but the Board found the described non-functionality limited to a narrow context, and the broader disclosure described RNA molecules of this length that were capable of RNA interference. Id. at 18-20.
  • “has increased stability”: The Board found that this limitation also satisfied § 112, because the priority applications described that these small interfering RNA molecules were stable. Id. at 20-21.
  • “inhibits the expression of a target nucleic acid”: The Board pointed out that the priority applications disclosed methods for inhibiting gene expression by introducing the claimed RNA molecules, and therefore this limitation also met § 112. Id. at 21.

Because each of the challenged limitations was adequately described, the Board found that Alnylam did not meet its burden of demonstrating that the claims failed either written description or enablement as of the critical date, and therefore did not meet its burden of demonstrating that the ’423 patent was eligible for PGR review.  Id. at 25.

Mylan Pharm. Inc. v. Anacor Pharm., Inc., Nos. IPR2018-01358; IPR2018-01359; IPR2018-01360; and IPR2018-01361 (Decisions Granting Institution and Joinder Entered October 11, 2018).  FlatWing Pharmaceuticals filed four IPR petitions (IPR2018-00168, IPR2018-00169, IPR2018-00170, and IPR2018-00171) to cancel four of Anacor Pharmaceuticals’s patents (U.S. Patent Nos. 9,549,938; 9,566,289; 9,566,290; and 9,572,823; respectively) covering boron-containing compounds for topical onychomycosis and cutaneous fungal infection treatment.  See, e.g., IPR2018-00168, Paper 9 at 3.  After the Patent Owner did not file preliminary responses, the Board instituted these petitions in June 2018.  See IPR2018-00168, Paper 9; IPR2018-00169, Paper 9; IPR2018-00170, Paper 9; and IPR2018-00171, Paper 9.

Subsequently, Mylan filed four IPR petitions challenging the same four Anacor patents and sought to join the four FlatWing petitions.  On October 11, 2018, the Board instituted all four Mylan petitions on all grounds, for the same reasons stated in the Board’s institution decisions in the FlatWing IPRs.  See IPR2018-01358, Paper 11 at 3; IPR2018-01359, Paper 11 at 3; IPR2018-01360, Paper 9 at 3; and IPR2018-01361, Paper 9 at 3.  Further, the Board granted Mylan’s motions for joinder, reasoning that Mylan’s petitions were not substantively different from, and relied on the same expert declarations as, FlatWing’s petitions, and Mylan agreed to assume a “silent understudy” role as long as FlatWing remained a party.  See IPR2018-01358, Paper 11 at 4; IPR2018-01359, Paper 11 at 4; IPR2018-01360, Paper 9 at 4; and IPR2018-01361, Paper 9 at 4.