On July 27th, the PTAB issued institution decisions in five IPRs brought by Hospira challenging four Genentech patents related to Herceptin® (trastuzumab). The patents are directed to various methods of treating cancer patients with combination therapies incorporating anti-ErbB2 antibodies. Three challenges were instituted (IPR2017-00737, -00804, and -00805), and two were denied (IPR2017-00731 and -00739). These decisions mark a new point in the challenge to Herceptin® patents, which have been challenged in IPRs more than any other biologic drug—seventeen times in 2017 alone.
Pfizer has shown its muscle in the biosimilars field, purchasing Hospira in 2015 and launching the second biosimilar on the U.S. market, Inflectra® (infliximab), a biosimilar of Johnson & Johnson’s Remicade®. Pfizer is now eying Genentech’s Herceptin (trastuzumab), which was first FDA approved for metastatic breast cancer in 1998. Pfizer filed two IPRs on June 30th challenging a Herceptin® patent, U.S. Patent No. 8,591,897. The ’897 patent is directed to methods of treating patients with non-metastatic HER2-positive breast cancer by administering anthracycline/cyclophosphamide (AC) based chemotherapy, followed by sequential administration of a taxoid and trastuzumab. The earliest priority date on the face of the ’897 patent is May 2005.
On June 7, 2017, Kyle Bass received his last final written decision in a long list of PTAB decisions rendered over the past two years as Kyle Bass sought to invalidate pharma patents. U.S. Patent No. 8,476,010 (the “’010 patent”) is owned by Fresenius Kabi USA, and is the only Orange Book patent covering Fresenius’ anesthetic drug Diprivan®. The Board found all challenged claims unpatentable as obvious.
Tasha Francis, Will Orlady and Dorothy Whelan Author NYIPLA Article, “Recent Developments in Biopharma PTAB Practice”
Tasha Francis, Ph.D., Will Orlady, and Dorothy Whelan authored “Recent Developments in Biopharma PTAB Practice,” in the February/March 2017 issue of The Report – NYIPLA.
On June 9, 2017, the Patent Trial and Appeal Board ruled in favor of Coherus’ petitions for inter partes review (IPR) of AbbVie’s U.S. Patent 9,073,987 (‘987 Patent) and U.S. Patent 9,017,680 (‘680 Patent). The PTAB’s decision invalidates all claims of the patents that were directed to a method of treating rheumatoid arthritis. Back on May 16, Coherus prevailed at the PTAB in a similar IPR proceeding involving AbbVie’s U.S. Patent 8,889,135 (‘135 Patent).