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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

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

BYOOVIZ® (Ranibizumab-Nuna) Granted Interchangeable Status

Recently, Biogen and Samsung Bioepis’s ranibizumab biosimilar (BYOOVIZ) was granted interchangeable status by the U.S. Food and Drug Administration. BYOOVIZ was deemed interchangeable to Genentech’s LUCENTIS for the treatment...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

Issue 40: PTAB Trial Tracker

Precedential Opinion Addresses Conclusory Expert Declarations - In a precedential opinion in Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 (P.T.A.B. Aug. 24, 2022), the Board denied institution of an inter partes...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

Infliximab Clinical Trial Updates

The Big Molecule Watch is monitoring clinical trial activities involving infliximab. Here we report on recent studies with Celltrion’s INFLECTRA (infliximab-dyyb). ...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

FDA Testimony Before the U.S. Senate Regarding User Fee Agreements

This week Patrizia Cavazzoni (Director, CDER), Peter Marks (Director, CBER), and Jeffrey Shuren (Director, CDRH) of the FDA testified before the committee on Health Education, Labor and Pensions of the U.S. Senate regarding...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

Coherus and Junshi Biosciences Announce FDA Acceptance of Toripalimab BLA

Last week, Coherus and Junshi Biosciences announced that the FDA accepted their BLA for toripalimab in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic...more

Issue 35: PTAB Trial Tracker

TIMING OF REQUEST KEY FOR BOARD DECISIONS ON MOTIONS TO TERMINATE - In Ocado Group PLC v. AutoStore Technology AS, PGR2021-00038 (July 30, 2021), Petitioner moved to withdraw its petition, arguing that efficiency favored...more

FDA Schedules Public Meeting and Request for Comments on Biosimilar User Fee Act

Last week, FDA issued a notice of public meeting and request for comment relating to proposed recommendations for the reauthorization of the Biosimilar User Fee Act (“BsUFA”) for fiscal years 2023 to 2027. We have previously...more

Issue 34: 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Quebec Government Announces Shift to Biosimilar Drugs

On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs. The announcement stated that similar to other...more

Issue 32: PTAB Trial Tracker

APPLICATION OF NHK/FINTIV ANALYSIS CONTINUES TO EVOLVE - The Board’s application of its precedential NHK and Fintiv decisions to deny petitions based on parallel litigation continues to develop. The Board recently...more

PTAB Introduces Precedential Opinion Recommendation Portal

As a result of feedback it received, the PTAB introduced a new web portal that allows any member of the public to nominate a decision for precedential or informative designation. The request must provide information about the...more

The 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue Twenty-Nine: 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue Twenty-Eight: 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue Twenty-Seven: 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

Issue Twenty-Six: 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

U.S. Supreme Court Holds Willfulness Not Needed for Recovery of Trademark Profits

Yesterday, the United States Supreme Court held in Romag Fasteners, Inc. v. Fossil Group, Inc. et al. that a trademark owner is not required to show that a defendant willfully infringed a trademark before seeking to recover...more

Issue Twenty-Five: 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 monthly digest is designed to keep you up-to-date by highlighting interesting PTAB,...more

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