During the week of July 15, 2019, the Patent Trial and Appeal Board (“Board”) issued four decisions in TC 1600, two of which involved the same parties and related patents. Three decisions instituted IPR petitions, and one decision denied institution.
Apotex Inc. v. UCB Biopharma SPRL, IPR2019-00400 (Decision Instituting IPR, Paper 17, Entered July 15, 2019): Petitioner Apotex challenged 11 out of 12 claims of UCB Biopharma’s U.S. Patent No. 8,633,194 (“the ’194 patent”). The ’194 patent is directed to pharmaceutical substituted benzhydryl piperazine compositions—such as levocetirizine, marketed under the brand name XYZAL®—with reduced preservatives (parabens) that nevertheless maintain stability from microbial contamination. Paper 17 at 4–6. The Board instituted IPR on all grounds and challenged claims.
At the outset, the Board did not feel the need to expressly construe any claim terms but noted that under the Phillips standard it understood the term “substantially free of bacteria” to mean having a low but clinically acceptable level of bacteria. The Board invited the parties to address any disagreement in future papers. Id. at 11–12.
In its Preliminary Response, UCB focused on arguing that Apotex’s petition should be denied under 35 U.S.C. §§ 325(d) and 314(a), rather than substantively rebutting the petition’s asserted grounds of unpatentability. Id. at 12–13. After authorizing additional briefing, the Board ultimately rejected these arguments. Id. at 23–35. The Board reasoned that the references cited in the petition and previously considered during prosecution had merely been cited in an IDS, the art and arguments in the petition were not cumulative of those considered during prosecution, and the co-pending but stayed district court litigation did not warrant discretionary denial. Id.
On the merits, the Board found that Apotex demonstrated a reasonable likelihood that the challenged claims would be held unpatentable under all asserted grounds, with the caveat that UCB has only previewed its substantive arguments. Id. at 3, 12–23. Under the first obviousness ground, the Board accepted Apotex’s argument that a POSA would have modified the formulation disclosed in WO ’094 with preservative information disclosed in the Handbook of Pharmaceutical Excipients (“Handbook”), which disclosed formulations that use low paraben levels. Id. at 15–19. Petitioner argued the POSA would have been motivated to reduce paraben levels due to their propensity for irritation. Id. at 16–17. On the current record, the Board rejected UCB’s argument that the limitation “substantially free of bacteria” meaningfully distinguished the patent’s independent claim from the prior art, and instead reasoned that UCB may have just recognized an additional antimicrobial benefit of the drug levocetirizine. Id. at 17–18.
For the second obviousness ground, the Board accepted Apotex’s argument that a POSA would have replaced the cetirizine disclosed in EP ’203 and the ’558 patent with levocetirizine, because the references noted that levocetirizine was the only active isomer. Id. at 21–22. The rest of Apotex’s reasoning was similar to its reasoning under the first ground, and the Board similarly found that Apotex had demonstrated a reasonable likelihood that the ’194 claims are unpatentable. Id. at 22–23.
Ocular Therapeutix v. Mati Therapeutics, Inc., IPR2019-00442 (Decision Denying Institution, Paper 9, Entered July 15, 2019): Also on July 15, the Board denied institution of Ocular Therapeutix’s (“Ocular”) petition to institute IPR on a subset of claims of U.S. Patent No. 9,463,114 (“the ’114 patent”). The ’114 patent claims methods of administering a drug by implanting a plug into the eye, which prevents drainage and can deliver a drug to the eye. Paper 9 at 2–5.
Importantly, all claims of the ’114 patent require the plug to be shaped as a cylinder of constant diameter. Id. at 5. While the petition asserted four grounds of unpatentability, the Board found that Ocular failed to establish a reasonable likelihood that any challenged claim was unpatentable because no reference disclosed a plug having the claimed cylindrical shape. Id. at 6–15. Specifically, Ocular relied on a reference common to all four grounds as disclosing the cylindrical plug shape, but the Board concluded that the reference disclosed a plug injected into the eye in liquid form that therefore would not necessarily take the required shape. Id. at 8–15. Since all claims of the ’114 patent—including the independent claims—included this shape limitation, the Board denied Ocular’s petition. Id. at 16.
Qiagen North Am. Holdings, Inc. v. HandyLab, Inc., IPR2019-00488, -00490 (Decisions Instituting IPR, Paper 8 (in both), Entered July 16, 2019): Qiagen filed two IPR petitions to invalidate the claims of two related HandyLab patents, both issued from the same patent application. U.S. Patents 7,998,708 (“the ’708 patent”) and 8,323,900 (“the ’900 patent”) relate to an apparatus, system, or methods for amplifying genetic material by conducting polymerase chain reaction (“PCR”) on multiple samples—either at the same time or separately—so that the samples can be analyzed with diagnostic testing. See 488 IPR Paper 8 at 2–7; 490 IPR Paper 8 at 2–6. The ’900 patent additionally claimed maintaining a substantially uniform temperature throughout the PCR reaction zone during each cycle. 490 IPR Paper 8 at 6, 13.
Qiagen relied for all grounds on the same primary reference. Qiagen asserted that reference disclosed most of the limitations in the ’708 and ’900 claims and that a POSA would have been motivated to incorporate other references disclosing additional standard features of the claimed integrated machines with a reasonable expectation of success. 488 IPR Paper 8 at 9–17; 490 IPR Paper 8 at 9–21. The Board agreed, rejecting HandyLab’s arguments as generally attacking references in isolation instead of in in the asserted combination. 488 IPR Paper 8 at 14–17; 490 IPR Paper 8 at 14–21. HandyLab also argued that a POSA would not have had a reasonable expectation of success in achieving the claimed invention by combining the references as asserted in the petition, but the Board invited the parties to further explore that issue in future briefing. 488 IPR Paper 8 at 17; 490 IPR Paper 8 at 21; see also 490 IPR Paper 8 at 19 (noting that HandyLab raised issues that will benefit from further development).
Apart from the analysis of the first ground in each IPR, the Board did not substantively address Qiagen’s other arguments, relying on SAS to institute IPR based on its determination that Qiagen had established a reasonable likelihood of showing certain claims of the ’708 and ’900 patents to be unpatentable. 488 IPR Paper 8 at 18–19; 490 IPR Paper 8 at 21–22.