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
9/6/2024
/ Administrative Review ,
America Invents Act ,
Claim Construction ,
Interim Guidance ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Prior Art ,
USPTO
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use...more
9/3/2024
/ Biologics ,
Coronavirus/COVID-19 ,
Emergency Use Authorization (EUA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Moderna Inc. ,
Pfizer ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Vaccinations
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor;...more
5/23/2024
/ Administrative Review ,
Appeals ,
Double Patent ,
Final Written Decisions ,
Indefiniteness ,
Jepson Claims ,
Life Sciences ,
Means-Plus-Function ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
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
4/5/2024
/ Amgen v Sanofi ,
Comment Period ,
Confidential Information ,
Daubert Ruling ,
Enablement Inquiries ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
NPRM ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Prior Art ,
USPTO
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
Genentech, Roche, and Biogen filed a Complaint on November 17 against Dr. Reddy’s Laboratories (“DRL”) and Fresenius in the U.S. District Court for the District of New Jersey, alleging infringement of 15 patents under...more
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
Last week, Regeneron filed a motion to terminate IPR2023-00620, an IPR filed by Celltrion on February 28, 2023, seeking cancellation of claims 1-4 of Regeneron’s U.S. Patent No. 10,406,226 which is generally directed to...more
Derivation Showing Overcome by Evidence of Respondent’s Prior Conception in Rare Derivation Proceeding -
The Board issued a decision in a rare derivation proceeding filed by Global Health Solutions LLC (“Petitioner”)...more
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
3/31/2023
/ Administrative Patent Judges ,
Conflicts of Interest ,
Denial of Rehearing ,
Due Process ,
Filing Deadlines ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Precedential Opinion ,
USPTO ,
Xerox
As we previously reported, Magistrate Judge Hall issued a Report and Recommendation (“R&R”) on February 10, 2023 denying Amgen’s motion to dismiss Regeneron’s antitrust claims in Regeneron Pharmaceuticals, Inc. v. Amgen Inc.,...more
As we previously reported, on March 1, 2023, Janssen filed a motion for preliminary injunction in Janssen Biotech, Inc. v. Amgen Inc., C.A. No. 22-1549-MN, seeking to enjoin Amgen from the commercial manufacturing, sale, and...more
Mylan Pharmaceuticals Inc. recently filed an IPR petition, PTAB-IPR2023-00099, seeking cancellation of claims 1-3 of U.S. Patent No. 10,857,205, assigned to Regeneron Pharmaceuticals, Inc. According to the petition,...more
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
Newly appointed USPTO Director Kathi Vidal issued a set of interim procedures clarifying how the Patent Trial and Appeal Board (PTAB or Board) should apply its Fintiv decision going forward. Vidal’s guidance, which will...more
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
6/15/2022
/ Estoppel ,
Expert Testimony ,
Inter Partes Review (IPR) Proceeding ,
Patent Examinations ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Prior Art ,
PTAB Precedential Opinion Panel (POP)
Results of the PROPER study, an interim analysis assessing the safety and efficacy of switching from Abbvie’s Humira to Samsung Bioepsis’s biosimilar adalimumab product, SB5, were presented last week at the European Crohn’s...more
Lannett Company, Inc. (“Lannett”) announced Friday that the FDA has completed its safety review of Lannett’s Investigational New Drug application for Lannett’s insulin glargine biosimilar, a product Lannett is co-developing...more
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
12/17/2021
/ Administrative Procedure Act ,
Admissible Evidence ,
Evidence ,
Ex Partes Reexamination ,
Federal Rules of Evidence ,
Final Written Decisions ,
Forum Selection ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Motion to Amend ,
Motion to Exclude ,
Non-Disclosure Agreement ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
USPTO
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
Bio-Thera Solutions and Intract Pharma announced at the end of last month that they had entered into a global collaboration and licensing agreement that gives Bio-Thera access to two oral delivery technologies for monoclonal...more
At an event held by the U.S. Manufacturers Association for Development and Enterprise and the Alliance for Automotive Innovation on Wednesday September 22, 2021, Senator Leahy (D- Vt.) announced the introduction of the...more
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
8/20/2021
/ Administrative Patent Judges ,
Appointments Clause ,
Covered Business Method Patents ,
Denial of Institution ,
Director of the USPTO ,
Discovery ,
Evidence ,
Executive Branch ,
Executive Powers ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Parallel Proceedings ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Prior Art ,
SCOTUS ,
Service by Mail ,
United States v Arthrex Inc ,
USPTO
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
12/31/2020
/ Administrative Procedure Act ,
Attorney's Fees ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Inter Partes Review (IPR) Proceeding ,
Parallel Proceedings ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Precedential Opinion ,
Real Party in Interest
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
11/2/2020
/ Clerical Errors ,
Estoppel ,
Exclusive Licenses ,
Motion to Amend ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Portal ,
Precedential Opinion ,
Prior Art ,
Real Party in Interest