In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more
5/30/2017
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
CAFC ,
Claim Construction ,
Induced Infringement ,
Noninfringement ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Product Labels ,
Reversal ,
Summary Judgment
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
The USPTO appears to have dropped its plans to overhaul the Information Disclosure Statement (IDS) process, but that’s no excuse for its failure to process IDSs in accordance with its current rules. Most egregiously, the...more
In Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit found that a publicly-announced “Supply and Purchase” agreement triggered the on-sale bar under pre-AIA 35 USC § 102(b) and under AIA 35 USC §...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 The Medicines Co. v. Mylan, Inc., the Federal Circuit construed composition claims of two Angiomax patents as requiring the recited “batches” to be made by a specific “efficient mixing” process illustrated in one of the...more
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
Judge Sleet of the U.S. District Court for the District of Delaware has dismissed Genentech’s complaint against Amgen for allegedly failing to comply with the the Biologics Price Competition and Innovation Act (BPCIA), but...more
3/10/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Dismissals ,
Genentech ,
Information Sharing ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Subject Matter Jurisdiction
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
The Federal Circuit focused on the “consisting of” language in the claims at issue when it reversed the district court’s finding that Watson’s ANDA product would infringe the only Orange Book-listed Shire Lialda patent. In so...more
The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more
The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more
1/19/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Certiorari ,
Commercial Marketing ,
Declaratory Judgments ,
License Applications ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Remedies ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
Solicitor General
On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December...more
12/28/2016
/ Administrative Procedure Act ,
Appeals ,
Dismissals ,
Electronic Filing ,
Filing Deadlines ,
Holidays ,
Inter Partes Review (IPR) Proceeding ,
Motion to Dismiss ,
Patent Litigation ,
Patents ,
Power Outages ,
Reviewability Determinations ,
USPTO
The Solicitor General of the United States has filed an amicus brief in Sandoz Inc. v. Amgen Inc., asking the Supreme Court to grant certiorari and reverse the Federal Circuit’s interpretation of one of the “patent dance”...more
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
As part of its ongoing efforts to improve patent quality, the USPTO is reevaluating its examination time goals and seeking public feedback on how much time examiners should have to examine a patent application. Examination...more
Some patent term adjustment (PTA) cases have broad impact–like Wyeth v. Kappos and Novartis v. Lee–but Acetelion Pharmaceuticals, Inc. v. Lee addresses a more esoteric issue: when does the 14-month clock start to run in a...more
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 has published a proposed fee schedule for patent fees likely to take effect October 1, 2017–the start of the USPTO’s next fiscal year. The proposed fee schedule makes “slight” changes to many fees, and more...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
The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors”...more
In Yeda Research and Development Co. v. Abbott GmbH and Co., the Federal Circuit invoked the doctrine of inherent disclosure to uphold a priority claim to a German priority application that only partly described the claimed...more
In LifeNet Health v. LifeCell Corporation, one of the many issues the Federal Circuit decided was that functional claim language did not create a divided infringement situation, even though an independent actor could impact...more
In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent...more