The Patent Trial and Appeal Board (“PTAB”) regularly tracks statistics regarding administrative trials conducted under the processes created by the America Invents Act (“AIA”), which provide insight into recent trends...more
8/25/2021
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Biologics ,
BPCIA ,
Food and Drug Administration (FDA) ,
Orange Book ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Post-Grant Review ,
Purple Book ,
USPTO
In earlier blogs, we discussed when to amend and when not to amend claims in an inter partes review (“IPR”) pursuant to 35 U.S.C. § 316(d)(1). Below are guidelines on the procedural aspects of filing a motion to amend...more
In inter partes review (IPR) proceedings, the PTAB will often uphold the validity of dependent claims despite finding the independent claim invalid. Dependent claims recite additional limitations that must be separately...more
Discovery procedures in inter partes review (“IPR”) proceedings, governed by 37 CFR § 42.51, are more limited in scope and timing compared to cases in district court. There are three types of discovery at the Patent Trial...more
5/28/2021
/ Additional Discovery ,
America Invents Act ,
Discovery ,
Garmin Factors ,
Inter Partes Review (IPR) Proceeding ,
Litigation Strategies ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Trial Practice Guidance ,
USPTO
The expert declaration provides a unique opportunity for Patent Owners to bolster their case during the discovery period of an inter partes review (“IPR”) proceeding. We previously detailed how to effectively use an expert...more
The U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) recently grappled with the admission into evidence of expert deposition testimony that was presumably harmful to the petitioner in an inter partes...more
On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district courts over what constitutes...more
11/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
FRCP 12(b)(3) ,
Generic Drugs ,
Hatch-Waxman ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Principal Place of Business ,
Venue
On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals...more
5/15/2020
/ Dedication-Disclosure Defense ,
Doctrine of Equivalents ,
Expert Testimony ,
Extrinsic Evidence ,
Judgment on the Pleadings ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Question of Law
On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more
On December 5, 2019, Judge David C. Godbey of the Northern District of Texas denied the defendant Diebold Nixdorf, Inc.’s (“Diebold”) motion to dismiss under Rule 12(b)(6), in Nautilus Hyosung Inc. v. Diebold, Inc. et al.,...more
12/19/2019
/ Administrative Law Judge (ALJ) ,
Amended Complaints ,
Appeals ,
Cease and Desist Orders ,
Claim Construction ,
Exclusion Orders ,
Federal Rule 12(b)(6) ,
International Trade Commission (ITC) ,
Means-Plus-Function ,
Motion to Dismiss ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Section 337
On December 10, 2019, an agreement was reached between the United States, Mexico, and Canada on amendments to the U.S.-Mexico-Canada Agreement (“USMCA”). The USMCA, if ratified by each respective country, would replace the...more
12/18/2019
/ Biologics ,
Biotechnology ,
BPCIA ,
Copyright ,
Exclusivity ,
Exclusivity Rule ,
Foreign Entities ,
Intellectual Property Protection ,
NAFTA ,
Patent Term Extensions ,
Pharmaceutical Industry ,
Safe Harbors ,
Trade Associations ,
Trade Relations ,
United States-Mexico-Canada Agreement (USMCA)
In a recent decision clarifying the legal standards of the International Trade Commission’s domestic industry requirement, the Commission has upheld, with modified reasoning, Chief Administrative Law Judge Bullock’s initial...more
11/11/2019
/ Administrative Law Judge (ALJ) ,
Domestic Industry Requirement ,
Initial Determination (ID) ,
Intellectual Property Protection ,
International Trade Commission (ITC) ,
Multinationals ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Section 337 ,
Threshold Requirements
Recently, in Sanofi-Aventis v. Mylan, 2:17-cv-09105-SRC-CLW, Judge Stanley Chesler of the United States District Court, District of New Jersey, denied a motion by defendant Mylan for summary judgment of invalidity of asserted...more
10/11/2019
/ Appeals ,
B&B Hardware v Hargis Industries ,
Collateral Estoppel ,
Inter Partes Review (IPR) Proceeding ,
Issue Preclusion ,
Motion for Summary Judgment ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Preponderance of the Evidence
Recently, Chief Administrative Law Judge (“CALJ”) Bullock of the U.S. International Trade Commission (“ITC”), in Certain Carburetors and Products Containing Such Carburetors, Inv. No. 337-TA-1123, Order No. 77, suggested that...more
The August 13, 2019 decision from the United States District Court for the District of New Jersey in WAG Acquisition, LLC v. Multi Media LLC, Civil Action No. 2-14-cv-02340, deals a blow to a common attack on litigation...more
On August 9, 2019, the United States Court of Appeals for the Federal Circuit, in Eli Lilly & Co. v. Hospira, Inc., Nos. 2018-2126, 2127, 2128, reversed in-part and affirmed in-part a district court’s determination of...more