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
In Novartis v. Noven Pharmaceuticals, Inc., the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board (PTAB) decisions invalidating certain claims of two Orange Book-listed Exelon patents. This decision has...more
While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more
3/4/2017
/ Administrative Appeals ,
Diagnostic Method ,
Ex Partes Reexamination ,
Mayo v. Prometheus ,
Method Claims ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
Section 101 ,
USPTO
On November 30, 2016, the USPTO Patent Trial and Appeal Board (PTAB) held oral hearings in two different inter partes proceedings involving the Biogen Tecfidera® patent with the latest expiation date. First, it heard...more
In Perfect Surgical Techniques, Inc. v. Olympus America, Inc., the Federal Circuit vacated and remanded a USPTO Patent Trial and Appeal Board decision in an Inter Partes Review proceeding, finding that the PTAB imposed too...more
11/23/2016
/ America Invents Act ,
Appeals ,
Due Diligence ,
Evidence ,
Inter Partes Review (IPR) Proceeding ,
Patent Trial and Appeal Board ,
Patents ,
Remand ,
Rule-of-Reason Analysis ,
Section 102 ,
USPTO ,
Vacated
The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted...more
The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more
In Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline...more
As we wait for the Supreme Court decision in Cuozzo Speed Technologies, LLC v. Lee, where the Court has been asked to decide whether the USPTO Patent Trial and Appeal Board (PTAB) should apply the “broadest reasonable...more
The USPTO Patent Trial and Appeal Board has instituted Post Grant Review (PGR) proceedings against a patent directed to a process for treating contaminated media. The petition for PGR challenged that patent on written...more
The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute...more
The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable...more
The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may...more
Although Sandoz’ application for FDA approval to market a biosimilar version of ENBREL® (etanercept) has yet to be approved, Amgen has brought suit under the Patent Act and Biologics Price Competition and Innovation Act...more
3/4/2016
/ Amgen ,
Biosimilars ,
BPCIA ,
Inter Partes Review (IPR) Proceeding ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
The Federal Circuit dismissed the appeal in Agilent Technologies, Inc. v. Waters Technologies Corp., because the appellant was not a “third-party requester” dissatisfied with the final decision in an inter partes...more
The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha...more
In Merck & Cie v. Gnosis S.p.A., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that held the challenged claims obvious in an Inter Partes Review (IPR) proceeding. Although the...more
In In re Urbanski, the Federal Circuit upheld the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding the claims of Urbanski’s patent application obvious. Urbanski had argued that the cited references taught...more
The USPTO has released proposed patent fee changes that include significant increases to PTAB trial fees. The proposed changes are summarized in the USPTO’s “Executive Summary” prepared for the Patent Public Advisory...more
In Ariosa Diagnostics v. Verinata Health, Inc., the Federal Circuit vacated and remanded two parallel final written decisions in favor of the Patent Owner, because it could not discern whether the Board had incorrectly...more
In Inguran, LLC v. Premium Genetics (UK) Ltd., the USPTO Patent Trial and Appeal Board (PTAB) instituted Post Grant Review (PGR) proceedings in a patent granted from an AIA transition application based on its finding that at...more
In In re: Commonwealth Scientific & Industrial Research Organisation, the Federal Circuit held that pre-AIA 35 USC §135(b)(1) does not embody a diligence requirement, such that interfering claims presented more than 5 years...more
In its 2013 decision in In re Morsa, the Federal Circuit vacated an anticipation rejection where “both the Board and the examiner failed to engage in a proper enablement analysis” to establish the enabling quality of the...more
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
10/13/2015
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Likelihood of Success ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Real Party in Interest ,
USPTO