During the week of April 1, 2019, the Patent Trial and Appeal Board (“the Board”) issued the following decisions in TC 1600:

Dr. Reddy’s Laboratories, Inc. (“DRL”) v. Horizon Pharma USA, Inc. and Nuvo Pharmaceuticals (Ireland) Designated Activity Company (collectively referred to as “Horizon”), IPR2018-01341 (Decision Granting Petitioner’s Motion for Joinder and Instituting Inter Partes Review Entered April 1, 2019).

In its petition, DRL challenged claims 1-7 of U.S. Patent No. 9,393,208 (“the ’208 patent”), which is directed to methods for delivering a pharmaceutical composition in unit dose form of naproxen and esomeprazole.  With its petition, DRL timely filed a Motion for Joinder to IPR2018-00272, filed by Mylan Pharmaceuticals, which was instituted on June 14, 2018.  Horizon did not file an opposition to the joinder motion.

A motion for joinder should:

  1. set forth the reasons that joinder is appropriate;
  2. identify any new grounds of unpatentability asserted in the petition;
  3. explain what impact (if any) joinder would have on the trial schedule for the existing review; and
  4. address specifically how briefing and discovery may be simplified.

IPR2018-01341, Paper 21 at 6.  In its motion, DRL acknowledged it sought review of the same claims at issue in IPR2018-00272, on the same grounds, and agreed to rely on the declarations and testimony of Mylan’s experts.  Id. at 7.  DRL further agreed to not file any additional papers or pages, present any new, additional, or supplemental arguments, cross-examine Horizon’s experts or offer a rebuttal expert of its own, or present any arguments at oral hearing.  Id.

In view of the foregoing and the Board’s determination that DRL had demonstrated there was a reasonable likelihood it would prevail with respect to at least one of the challenged claims, DRL’s Motion for Joinder was granted.  Id. at 8.

 

Pfizer, Inc. (“Pfizer”) v Genentech, Inc. (“Genentech), IPR2017-01923 (Termination of the Proceeding Due to Settlement after Institution with Respect to Petitioner Only Entered April 2, 2019).

In its petition, Pfizer challenged claims 1-14 of U.S. Patent No. 7,976,838 (“the ’838 patent”), which is directed to antagonists (e.g., rituximab) that bind to B cell surface markers, such as CD20, and uses of such antagonists to treat autoimmune diseases.

Independent claim 1 is representative and recites:

A method of treating rheumatoid arthritis in a human patient who experiences an inadequate response to a TNFα-inhibitor, comprising administering to the patient an antibody that binds to CD20, wherein the antibody is administered as two intravenous doses of 1000 mg.

In March 2019, Pfizer and Genentech filed a Joint Motion to Terminate.  IPR2017-01923, Paper 109 at 2.  Under 35 U.S.C. § 317(a), upon a joint request of the petitioner and the patent owner, the Office shall terminate an inter partes review with respect to any petitioner.  However, the Board, which is not a party to the settlement, may independently determine a question of patentability should the determination be in the public’s interest.  Id. at 3 (citing 37 C.F.R. § 42.74(a)).

Here, the trial was instituted in April 2018, oral arguments occurred in January 2019, and the panel had already decided the merits of the proceeding.  Id. at 3.  In view of the foregoing, the Board determined that substantial resources had been invested in the matter and that it was reasonable at this stage to proceed to final written decision.  Id.  In addition, the Board felt it was warranted to proceed because of the public’s substantial interest in the ’838 patent—five other petitions against that patent have been filed.  Id.

As such, the Board granted-in-part, as to Pfizer, the Joint Motion to Terminate, but determined it would proceed to a final written decision as to Genentech.