Congress has taken an important step along the road to reforming patent eligibility law. As announced in this press release, Senators Tillis (R-NC) and Coons (D-DE) and Representatives Collins (R-GA-9), Johnson (D-GA-4) and...more
The USPTO has announced new procedures patent holders can follow to obtain additional Patent Term Adjustment (PTA) under the Federal Circuit’s January 2019 decision in Supernus Pharm., Inc. v. Iancu. According to the May 9,...more
Provisional applications tempt stakeholders with the possibility of securing a filing date on an expedited basis and limited budget, but the value of that filing date will depend on its ability to serve as a valid priority...more
In United Cannabis Corp. v. Pure Hemp Collective, Inc., Judge Martinez of the U.S. District Court for the District of Colorado determined that UCANN's CBD patent was not invalid under 35 USC § 101. The court reached its...more
In Natural Alternatives Internat'l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. I previously wrote about...more
In Natural Alternatives Internat’l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. The claims at issue...more
In Momenta Pharmaceuticals, Inc. v. Bristol-Meyers Squibb Co., the Federal Circuit issued another decision analyzing the contours of a petitioner’s Article III standing to appeal PTAB decisions upholding a patent. In contrast...more
2/26/2019
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Article III ,
Bristol-Myers Squibb ,
Inter Partes Review (IPR) Proceeding ,
Momenta ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Standing
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Supreme Court interpreted the “on sale bar” of the America Invents Act (AIA) version of 35 U.S.C. § 102 as unchanged from the pre-AIA version. In so doing, the...more
1/30/2019
/ America Invents Act ,
Appeals ,
Assignment of Inventions ,
Confidentiality Agreements ,
Helsinn Healthcare SA v Teva Pharmaceuticals USA Inc ,
Inventions ,
On-Sale Bar ,
Patent Applications ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Use ,
Reaffirmation ,
Reversal ,
SCOTUS ,
Section 102 ,
Third-Party Relationships
I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more
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