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 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
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
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
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
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
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
In Droplets, Inc. v. E*Trade Bank, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that Droplet’s patent was not entitled to the priority date of a provisional application because...more
In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the...more
5/29/2018
/ Claim Limitations ,
Evidence ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Printed Matter Doctrine ,
Prior Art ,
Section 101 ,
Section 102 ,
Section 103
Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more
We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance....more
It’s that time of year when we make resolutions to improve our health, our relationships, our careers, or other areas of our lives. I’m not starting a new diet today (although if I were, the invention described in this patent...more
1/2/2018
/ Claim Construction ,
Foreign Patent Applications ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Applications ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
USPTO
While Congress is trying to pass a tax reform bill that would cut corporate taxes, USPTO patent fees will increase effective January 16, 2018. The 72% jump in the Inter Partes Review request fee has gotten the most attention,...more
In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more
10/7/2017
/ Appeals ,
Innovation ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101 ,
USPTO
In recent decisions, the Federal Circuit has found error in the USPTO Patent Trial and Appeal Board’s approach to obviousness rejections, including its reliance on the doctrine of routine optimization without evidence of an...more
In a split decision with Judge Lourie dissenting, the Federal Circuit vacated an obviousness rejection that had been affirmed in an ex parte appeal to the USPTO Patent Trial and Appeal Board. The decision was rendered in In...more
9/11/2017
/ Appeals ,
Burden of Proof ,
Burden-Shifting ,
CAFC ,
Ex Parte ,
Obviousness ,
Patent Examinations ,
Patent Trial and Appeal Board ,
Patents ,
USPTO ,
Vacated
In Personal Audio LLC v. Electronic Frontier Foundation, the Federal Circuit ruled that an IPR petitioner does not need to satisfy Article III standing requirements in order to participate in a patent owner’s appeal from a...more
In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes...more
In separate non-precedential decisions issued by three different panels, the PTAB has permitted state university patent owners to invoke the Eleventh Amendment in Inter Partes Review proceedings. Each panel found that IPR...more
I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more
On May 22, 2017, the Supreme Court granted certiorari in SAS Institute, Inc. v. Lee, where it has been asked to decide whether the PTAB is statutorily required “to issue a final written decision as to every claim challenged...more
In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more
4/25/2017
/ FDA Approval ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Nexus ,
Novartis ,
Obviousness ,
Orange Book ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Substantial Evidence Standard