Today, the district court entered a scheduling order in the Amgen v. Adello BPCIA litigation concerning Adello’s aBLA for a biosimilar of Neupogen® (filgrastim). The scheduling order is generally consistent with the joint proposed discovery plan that the parties submitted last week and sets deadlines through the end of expert…
Today, Genentech filed a complaint in the District of Delaware against Amgen concerning its aBLA for ABP 980, a proposed biosimilar of Herceptin® (trastuzumab). Genentech alleges infringement of 37 patents directed to a variety of different subject matters. According to the complaint, the parties engaged in the patent dance, during…
As we previously reported, on May 22, 2018 in Genentech v. Amgen, which concerns Amgen’s Mvasi® (bevacizumab-awwb) biosimilar, Genentech filed a motion to dismiss and to strike Amgen’s counterclaims and certain affirmative defenses. On June 19, 2018, after Amgen filed under seal an amended answer and counterclaim, Genentech filed updated…
As we previously reported, in September 2017 FDA issued draft guidance entitled Statistical Approaches to Evaluate Analytical Similarity that “describes the type[s] of information a sponsor of a proposed biosimilar product should obtain” to support a showing of analytical similarity to a licensed reference product biologic. Today, FDA withdrew this draft guidance….
Last month we reported that Vermont, Connecticut, New Hampshire, and Alaska were in the process of considering biosimilar substitution bills. Vermont and Connecticut recently enacted their respective bills. On May 30, Vermont Governor Phil Scott signed bill S.92 into law as Act No. 193. The Act directs pharmacists to dispense…
On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes review (IPR) process for pharmaceuticals. The amendment, titled the Hatch-Waxman Integrity Act of 2018, would require aBLA…
On June 25-June 27th, at the Intercontinental New York Times Square, industry leaders from both innovator and biosimilar companies will convene at ACI’s 9th Annual Summit on Biosimilars to discuss the future of biosimilars and formulate solutions to the complex regulatory and patent challenges ahead. Goodwin is a proud sponsor…
We have recently reported on multiple discovery rulings in the ongoing AbbVie v. Boehringer Ingelheim litigation concerning Boehringer Ingelheims’s (“BI’s”) aBLA for Cyltezo™ (adalimumab-adbm), a biosimilar version of AbbVie’s Humira® (adalimumab) product. On June 14, 2018, Magistrate Judge Lloret issued two additional opinions regarding discovery in the case. In the first opinion, the Court granted-in-part…
As we reported last month, YL Biologics (a joint venture between Lupin’s subsidiary Kyowa and Yoshindo) recently submitted a New Drug Application (NDA) for Marketing Authorization of Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for YLB113, a proposed biosimilar of Enbrel® (etanercept). Yesterday, Lupin and Nichi-Iko Pharmaceutical announced that they…
Below are a few recent updates in IPR proceedings concerning biologic-related patents: Today, the Board denied Samsung Bioepis’ petition for IPR of Genentech’s U.S. Patent No. 7,846,441 (IPR2017-00192), directed to cancer treatment methods using trastuzumab. In its decision, the Board explained that it was exercising its discretion to deny the petition in…