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 Southwire Co. v. Cerro Wire LLC, the Federal Circuit upheld the USPTO decision rendered in an inter partes reexamination proceeding that found Southwire’s patent invalid as obvious. Although the court found that the USPTO...more
9/16/2017
/ Administrative Appeals ,
Appeals ,
CAFC ,
Harmless Error ,
Inherency ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patents ,
Prior Art ,
USPTO
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 Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira....more
8/31/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Collateral Order Doctrine ,
FDA Approval ,
Federal Rules of Civil Procedure ,
FRCP 11 ,
Hospira ,
Judicial Review ,
Motion to Compel ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Writ of Mandamus
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
On July 24, 2017, the USPTO issued a 48-page report on Patent Eligible Subject Matter. The report summarizes key court decisions interpreting and applying 35 USC § 101, international views on eligible subject matter, and...more
In a 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more
8/4/2017
/ Adverse Inference Instructions ,
Appeals ,
But For Causation ,
Discovery ,
Due Process ,
Fourteenth Amendment ,
Inequitable Conduct ,
Intent ,
Materiality ,
Patent Invalidity ,
Patent Prosecution ,
Patents ,
Pharmaceutical Patents ,
Sanctions ,
USPTO
In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...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
The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more
7/12/2017
/ Biotechnology ,
CLS Bank v Alice Corp ,
Dietary Supplements ,
Motion to Dismiss ,
Myriad-Mayo ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101
In Sandoz Inc. v. Amgen Inc. (which you can read more about here), the Supreme Court held that 42 USC § 262(l)(9)(C) sets forth the exclusive federal remedy for failing to provide a copy of the biosimilar application to the...more
6/29/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Disclosure Requirements ,
Exclusive Remedy ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Remand ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Supremacy Clause ,
Unfair Competition
The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized...more
The U.S. Supreme Court rendered its first interpretations of the biosimilar patent dispute resolution procedures of the Biologics Price Competition and Innovation Act (BPCIA), ruling largely in favor of Sandoz on both issues...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Content Marketing ,
Dispute Resolution ,
FDA Approval ,
Food and Drug Administration (FDA) ,
IP License ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more
6/12/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Inter Partes Review (IPR) Proceeding ,
License Applications ,
Life Sciences ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
In Impression Products, Inc. v. Lexmark International, Inc., the Supreme Court reversed the en banc decision of the Federal Circuit, and held U.S. patents rights exhausted by the patent owner’s sale of a patented article...more
6/8/2017
/ Exports ,
First Sale Doctrine ,
Foreign Sales ,
Imports ,
Impression Products v Lexmark International ,
IP License ,
Patent Exhaustion ,
Patent Infringement ,
Patents ,
Resales Agreements ,
Restraint on Alienation ,
SCOTUS ,
Single-Use/No Resale Restriction ,
Stream of Commerce
In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit reviewed a preliminary injunction based in part on a finding of likelihood of success in establishing infringement under the doctrine of equivalents....more
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
On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more
5/3/2017
/ Amgen v Sandoz ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Pharmaceutical Industry ,
Preemption ,
Product Exclusivity ,
SCOTUS ,
State Law Claims ,
USPTO
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