Although “any person” except the owner can challenge a patent in an Inter Partes Review (IPR) proceeding, only those who satisfy the constitutional requirements for standing can appeal a decision of the USPTO Patent Trial and...more
1/23/2019
/ Abbreviated New Drug Application (ANDA) ,
Article III ,
FDA Approval ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Applications ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Standing
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more
12/18/2018
/ Abbreviated New Drug Application (ANDA) ,
Novartis ,
Obviousness ,
Orange Book ,
OTDP ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pre-GATT ,
USPTO
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...more
Recently the USPTO Patent Trial and Appeal Board (PTAB) revised several of its Standard Operating Procedures (SOPs), including PTAB SOP 1 which relates to how Administrative Patent Judges (APJs) are assigned to cases. SOP 1...more
The USPTO Patent Trial and Appeal Board (PTAB) recently revised its Standard Operating Procedures, including PTAB SOP 2 which creates a new procedure for Precedential Opinion Panel review and outlines a process anyone can...more
In an opinion issued November 19, 2018, Judge Chesler of the U.S. District Court for the District of New Jersey found two Orange Book-listed patents for VIMOVO® invalid for indefiniteness in the way certain pharmacokinetic...more
In an October 25, 2018 Federal Register Notice, the USPTO announced staged implementation of the first phase of an initiative aimed at “leveraging electronic resources to retrieve information” of record in one patent...more
In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple...more
In Natural Alternatives Intl. Inc. v. Iancu, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that the patent at issue was not entitled to its earliest claimed priority date because...more
The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective...more
In Roche Molecular Systems, Inc. v. Cepheid, the Federal Circuit affirmed the summary judgment decision of the U.S. District Court for the Northern District of California that held nucleotide primer claims and detection...more
10/12/2018
/ CLS Bank v Alice Corp ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Section 101 ,
Summary Judgment ,
USPTO
In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of...more
In his keynote address at the Intellectual Property Owners Association Annual Meeting, USPTO Director Iancu revealed that the USPTO is working on revised patent eligibility guidelines he hopes will help keep patent...more
In E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit reversed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that had upheld Synvina’s chemical process patent against an obviousness challenge...more
One of the many concerns raised by the recent outage of the USPTO’s electronic filing system was the requirement to pay the surcharge due when a new U.S. application is not filed electronically. The surcharge is statutory...more
The USPTO has commenced a fee-setting process for fee adjustments it expects to implement in January 2021. While many fee changes are modest (~5%), the USPTO proposes significant increases to patent trial fees and two new...more
Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board...more
In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on...more
In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art...more
7/26/2018
/ CAFC ,
Inherency ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Public Use ,
Section 103
Practitioners with an international patent practice generally view the U.S. written description requirement as more liberal than similar requirements in other jurisdictions, especially the European Patent Office. That said,...more
In Impax Laboratories Inc. v. Lannett Holdings Inc., the Federal Circuit upheld the district court decision finding that defendants had failed to establish obviousness of AstraZeneca’s Zomig patents (directed to intranasal...more
Did you know there are patents on ice cream, ice pops, and other frozen confections? A search of the USPTO patent database identified 1452 granted patents with the term “ice cream” in at least one claim. What better way to...more
The Federal Circuit decision in In re Durance is a rare precedential decision in an ex parte appeal from a Patent Trial and Appeal Board (PTAB) decision rejecting a pending patent application. The Court took the USPTO to task...more
6/27/2018
/ Appeals ,
Corporate Counsel ,
Covered Business Method Proceedings ,
Ex Partes Reexamination ,
Inventions ,
Means-Plus-Function ,
Oral Argument ,
Patent Applications ,
Patent Examinations ,
Patent Trial and Appeal Board ,
Prior Art ,
Remand ,
USPTO
On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals....more
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more
6/19/2018
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review