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Issue 45: PTAB Trial Tracker

In Pfizer Inc., v. Sanofi Pasteur Inc., SK Chems Co. Ltd., v. Vidal, 2019-1871 (March 5, 2024), the Federal Circuit affirmed the Board’s conclusions that claims 1–45 of U.S. Patent No. 9,492,559 were unpatentable due to...more

Issue 44: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Fresenius Kabi and Formycon Reach Settlement Agreement for Ustekinumab Biosimilar Candidate in Europe and Canada

On March 18, 2024, Fresenius Kabi (“Fresenius”) and Formycon announced a settlement agreement with Johnson & Johnson regarding FYB202, a proposed ustekinumab biosimilar to STELARA in Europe and Canada. The terms of the...more

Issue 43: PTAB Trial Tracker

Petitioner Allowed to Proceed in “Understudy Role” - In American Honda Motor Co., Inc. v. Neo Wireless, LLC, IPR2023-0791 (P.T.A.B. March 30, 2023), American Honda Motor Co., Inc. (“Honda”) filed a “copycat” Petition...more

Issue 42: PTAB Trial Tracker

The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Year in Review: Top Legal Developments of 2022

As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more

Request for Comments on USPTO Initiatives To Promote Generic Drug and Biosimilar Competition

The U.S. Patent and Trademark Office (USPTO) recently published a request for comments addressing a variety of topics related to generic drug and biosimilar competition. In July 2021, President Biden issued an Executive Order...more

Issue 38: PTAB Trial Tracker

Fate of Fintiv - As discussed in our Client Alert, “Fintiv 2.0: USPTO Director Issues Guidance Softening Risk of Discretionary Denial,” USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the PTAB...more

Genentech and Samsung Bioepis Settle Bevacizumab Biosimilar Patent Dispute

​​​​​​​As we previously reported, on June 28, 2020, Genentech, Inc. (“Genentech”) filed a complaint against Samsung Bioepis Co., Ltd. (“Samsung”) in the District of Delaware, alleging infringement of fourteen patents under...more

Mylan Files New IPR Petitions on Aflibercept Patents

Mylan recently filed two IPR petitions seeking cancellation of various claims of patents assigned to Regeneron relating to dosing regimens for EYLEA® (aflibercept): IPR2022-01225 challenging claims 1, 3-11, 13-14, 16-24, and...more

Issue 37: PTAB Trial Tracker

Expert Testimony Alone Insufficient to Show Examiner's Material Error in Considering Prior Art - In Nespresso USA, Inc. v. K-fee System GmbH, IPR2021-01222, Paper 9, at 25 (PTAB Jan. 18, 2022), the Board denied...more

Issue 36: PTAB Trial Tracker

FORUM SELECTION CLAUSES MAY OR MAY NOT PRECLUDE PTAB REVIEW - In Kannuu Pty Ltd. v. Samsung Electronics Co., Ltd. & Samsung Electronics America, Inc., No. 21-1638 (Fed. Cir. Oct. 7, 2021), the Federal Circuit considered...more

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