Ranbaxy recently settled an inter partes review (IPR) proceeding, using a USPTO patent trial to avoid potentially costly Hatch-Waxman litigation. Ranbaxy Laboratories, Ltd v. Vertex Pharms., Inc., IPR2013-0024. Ranbaxy, an Indian-based company which develops and markets generic drugs, challenged the validity of Vertex’s U.S. Patent No. 6,436,989 for Lexiva®, an HIV protease inhibitor.
On November 20, 2013, the House Judiciary Committee passed an anti-patent troll bill (Innovation Act of 2013, H.R. 3309). As discussed in our previous post, most of the provisions are directed towards discouraging patent trolls from filing federal district court infringement actions. However, there are a few provisions that would affect inter partes review (IPR) and post grant review (PGR).
The Board’s requirements for amending a claim in inter partes review impose significant limitations for a Patent Owner as compared to conventional patent prosecution, reissue proceedings, or ex parte reexamination. The Board’s recent decisions have discussed many of the requirements set forth in 37 C.F.R. 42.121, making clear that there are substantial limitations on the Patent Owner’s ability to amend its claims during inter partes review.
Rebuking the USPTO’s standard practice in inter partes reexaminations of evaluating evidence of secondary considerations only after the USPTO has already found that a prima facie case of obviousness has been established, the Federal Circuit reinforced that “consideration of…objective indicia is part of the whole obviousness analysis, not just an afterthought.” Leo Pharmaceutical Products, Ltd. v. Rea, 726 F.3d 1346, 1357 (Fed. Cir. 2013) (emphasis in original).
Although most of the provisions of the House of Representatives’ recent anti-patent troll bill (Innovation Act of 2013, October 23, 2013) are directed to discouraging patent trolls from filing Federal district court infringement actions, there are a few provisions that potentially affect inter partes review (IPR) and post grant review (PGR).
Practitioners understand that an inter partes review cannot be instituted more one year after service of a complaint. There have, however, been several questions regarding how the one year period is calculated.