Expert article by Joseph E. Cwik on April 29, 2014. Originally published on Healthcare Law Insights, reposted with the permission of Joseph E. Cwik.
When inter partes review actions first became available in 2012, no generic pharma companies availed themselves to this litigation tool. Not until 2013 did a generic pharma company first seek inter partes review (“IPR”) of a brand drug patent in Apotex Inc. v. Alcon Pharmaceuticals, Ltd., IPR2013-00012 and -00015. In response to Apotex’s petition for inter partes review, the Patent Trial and Appeal Board (“PTAB”) ruled there was a reasonable likelihood that the two challenged patents were invalid for obviousness. Interestingly, a U.S. District Court previously determined that one of the patents was not invalid based upon the same prior art references. Id. at Paper 43; March 19, 2013.
Soon after the Apotex challenge, another generic pharma company sought inter partes review in Ranbaxy Laboratories, Ltd. v. Vertex Pharmaceuticals, Inc., IPR2013-00024. Again, the PTAB ruled there was a reasonable likelihood that the generic pharma company would prevail in proving each of the challenged claims invalid. Id. at Paper 16; March 5, 2013. As a result of the initial PTAB findings, both Apotex and Ranbaxy were able to extract settlements from the brand drug patent owner. The Ranbaxy settlement resolved not only the IPR action but also “any potential Hatch-Waxman litigation on this patent between these parties.” Id. at Paper 69; Oct. 31, 2013.
Also in 2013, Apotex filed three more inter partes review challenges in Apotex Corp. v. Alcon Research, Ltd., IPR2013-00428, -00429 and -00430. On Jan. 2, 2014, the PTAB ruled again there was a reasonable likelihood that Apotex would prevail in proving each of the three challenged patents invalid. Id. at Papers 9, 8, 9, respectively; Jan. 2, 2014. Final oral argument is set for Sept. 17, 2014.
Prior to those Apotex challenges, generic pharma company Amneal Pharmaceuticals also sought inter partes review on three separate patents in Amneal Pharmaceuticals, LLC v. Supernus Pharmaceutical, Inc., IPR2013-00368, -371, -372. Once again, the PTAB ruled there was a reasonable likelihood that the generic pharma company would prevail in proving each of the three challenged patents invalid. Id. at Paper 8; Dec. 17, 2013. Final oral argument is set for Aug. 12, 2014.
Two additional drug-type patents were challenged in Baxter Healthcare Corp. et al. v. Millenium Biologix, LLC, IPR2013-00582, -00583, -00590, -00591, and the PTAB recently agreed that there is a reasonable likelihood that Baxter will prevail in proving the two patents invalid. IPR2013-00582 at Paper 8; IPR2013-00590 at Paper 9. Final oral argument is set for Nov. 14, 2014.
Finally, on the heels of a successful 2013, Apotex filed yet another inter partes review challenge in Apotex, Inc. v. Wyeth LLC, IPR2014-00115. There the PTAB has recently ruled there is reasonable likelihood that all claims of the challenged patent will be found invalid. Id. at Paper 10; April 21, 2014. Final oral argument is set for Jan. 15, 2015.
Most recently, in Endo Pharmaceuticals, Inc. v. Depomed, Inc., IPR2014-00651, -00652, -00653, -00654, -00655, -00656, a generic pharmaceutical company challenged three patents in six separate petitions.
Because many patent practitioners find the relatively new inter partes review challenge to be a faster, more economical and potentially more successful way to invalidate patents in comparison to U.S. District Court litigation, we may soon see many more generic pharmaceutical companies utilizing this new litigation tool.
Joseph E. Cwik will speak at ACI’s Paragraph IV Disputes Master Symposium:
ACI’s Hatch-Waxman Series
September 29th – October 1st
InterContinental Chicago, Chicago IL