Below are recent updates in biosimilar-related IPR proceedings:
GENERAL BIOLOGICS PATENTS
On December 1, 2017, the Board granted institution of four IPRs on Celltrion’s petitions (IPR2017-01373 and IPR2017-01374) and Pfizer’s petitions (IPR2017-01488 and IPR2017-01489 [decisions under seal]) challenging Genentech’s Carter patent, U.S. Patent No. 6,407,213, directed to humanized antibodies. This same patent is also the subject of pending IPR petitions by Boehringer Ingelheim and Samsung Bioepis. The ’213 patent has also been asserted by Genentech in its BPCIA litigations against (1) Amgen, regarding its bevacizumab biosimilar, Mvasi®, and (2) Pfizer, regarding its proposed trastuzumab biosimilar.
On December 1, 2017, the Board granted institution of IPRs on Pfizer’s petitions (IPR2017-01373 and IPR2017-01358) challenging Chugai’s U.S. Patent Nos. 7,332,289 and 7,927,815, respectively, directed to methods of antibody or protein purification.
NEUPOGEN / NEULASTA
On December 4, 2017, the Board granted the parties’ request for an oral hearing in IPR2016-01542 concerning U.S. Patent No. 8,952,138, which is directed to a protein refolding process. The hearing is scheduled for December 13, 2017, beginning at 1:00 pm. This patent was also the sole patent-in-suit in the Sandoz v. Apotex litigation in which the district court ruled that Apotex’s proposed filgrastim and pegfilgrastim biosimilars were non-infringing. The Federal Circuit affirmed that ruling last month, though Amgen still has the ability to seek rehearing.
On December 1, 2017, Pfizer filed an IPR petition challenging Biogen’s U.S. Patent No. 9,296,821 (IPR2018-00186). The ’821 patent is directed to methods for treating low grade or follicular non-Hodgkin’s lymphoma using rituximab. This patent is also the subject of Celltrion’s IPR2017-01095, which the Board instituted in-part in October. (Celltrion has requested rehearing regarding the claim for which the Board denied institution.)
On December 1, 2017, Pfizer filed an IPR petition challenging Biogen’s U.S. Patent No. 9,504,744 (IPR2018-00231). The ’744 patent is directed to methods for treating diffuse large cell lymphoma using rituximab.
On November 30, 2017, Samsung Bioepis filed an IPR petition challenging Genentech’s U.S. Patent 7,846,441 (IPR2018-00192), which is directed to cancer treatment methods using trastuzumab. The Board has already instituted IPRs of this patent on petitions filed by Celltrion (IPR2017-01121) and Pfizer (IPR2017-00731). In addition, Pfizer has filed two other IPR petitions challenging this patent (IPR2017-02063 and IPR2018-00016).
On December 1, 2017, the Board granted institution of three IPRs on Samsung Bioepis’ petitions (IPR2017-01958, IPR2017-01959, IPR2017-01960) challenging Genentech’s U.S. Patent Nos. 6,627,196, 7,371,379, and 7,892,549, respectively, which are directed to cancer treatment methods using trastuzumab. The Board simultaneously granted Samsung Bioepis’ motions for joinder with Pfizer’s IPR2017-00804, IPR2017-00805 and IPR2017-00737, respectively, which were all instituted this past July. Although the Board had previously granted institution and joinder of IPR2017-01960, the Board subsequently expunged that decision because it was a draft that was improperly issued due to administrative error. The ’196, ’379 and ’549 patents are also the subject of Celltrion’s IPR2017-01139, IPR2017-01140 and IPR2017-01122, respectively, which the Board instituted in October.
These four patents are among the 40 that Genentech is asserting against Pfizer in the trastuzumab BPCIA litigation.