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
Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to...more
10/9/2015
/ AMP v Myriad ,
Australia ,
Biotechnology ,
Chilling Effect ,
Genetic Materials ,
Innovation ,
Mayo v. Prometheus ,
Monopolization ,
Myriad ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Scope of the Claim ,
SCOTUS ,
USPTO
Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more
10/1/2015
/ Abbreviated New Drug Application (ANDA) ,
Direct Infringement ,
Divided Infringement ,
Eli Lilly ,
En Banc Review ,
Generic Drugs ,
Induced Infringement ,
Limelight v Akamai ,
Method Claims ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels
Many pharmaceutical companies have complained about the IPR petitions filed by Kyle Bass and the Coalition for Affordable Drugs against Orange Book-listed patents covering approved pharmaceutical products, but Celgene Corp....more
9/28/2015
/ Abuse of Process ,
America Invents Act ,
Hedge Funds ,
Innovation Act ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Sanctions
In Astornet Technologies, Inc. v. BAE Systems, Inc., the Federal Circuit affirmed the district court’s dismissed of actions for induced infringement where the alleged direct infringer was the U.S. government. In particular,...more
In a divided en banc decision in SCA Hygiene Products v. First Quality Baby Products, the Federal Circuit preserved the defense of laches for patent cases even though the Supreme Court eliminated that defense in copyright...more
9/23/2015
/ Copyright ,
Copyright Infringement ,
Corporate Counsel ,
En Banc Review ,
Equitable Estoppel ,
Equitable Relief ,
Ex Partes Reexamination ,
Injunctive Relief ,
Laches ,
Motion for Summary Judgment ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Royalties ,
Patents ,
Petition For Rehearing ,
Petrella v. MGM ,
SCOTUS ,
Statute of Limitations ,
The Copyright Act
In a September 15, 2015 Federal Register Notice, the USPTO announced a pilot program that will permit certain Small or Micro Entities to expedite a pending ex parte appeal. According to the Notice, the USPTO aims to decide...more
9/18/2015
/ Appeals ,
Corporate Counsel ,
Ex Parte ,
Federal Pilot Programs ,
Federal Register ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
USPTO ,
Young Lawyers
The USPTO has launched two new programs aimed at improving patent quality by joining forces with the Japanese Patent Office (JPO) or the Korean Intellectual Property Office (KIPO) at the initial stages of the patent...more
9/16/2015
/ Collaboration ,
Federal Pilot Programs ,
Federal Register ,
Foreign Patent Applications ,
Intellectual Property Protection ,
Japan ,
JPO ,
Patent Applications ,
Patent Examinations ,
Patentability Search ,
Patents ,
Popular ,
South Korea ,
USPTO
On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the...more
9/8/2015
/ Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
USPTO
In Dow Chemical Co. v. Nova Chemicals Corp., the Federal Circuit held claims reciting a limitation that could be calculated in several ways indefinite where the patent claims, specification, and prosecution history failed to...more
9/3/2015
/ Ambiguous ,
Dow Chemical ,
Indefiniteness ,
Nautilus Inc. v. Biosig Instruments ,
Patent Infringement ,
Patent Litigation ,
Patent Prosecution ,
Patents ,
Reasonable Certainty Standard ,
SCOTUS ,
Teva v Sandoz
The USPTO has launched a Petitions Timeline that provides information on the types of petitions that can be filed at each stage of prosecution, the average time to decision and grant rate, and the deciding office. While some...more
Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have...more
8/31/2015
/ Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen
The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision...more
8/26/2015
/ Abuse of Process ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Real Party in Interest ,
USPTO
In an en banc, per curiam decision in Akamai Technologies, Inc. v. Limelight Networks, Inc., on remand from the Supreme Court, the Federal Circuit broadened the circumstances under which a party can be liable for direct...more
8/21/2015
/ Akamai Technologies ,
Biotechnology ,
Direct Infringement ,
Divided Infringement ,
En Banc Review ,
Limelight v Akamai ,
Method Claims ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Remand ,
SCOTUS
Sequenom, Inc. has filed a petition for rehearing en banc of the Federal Circuit decision that held its diagnostic method claims invalid under 35 USC § 101. (You can read my synopsis of that decision here). Stakeholders in...more
8/18/2015
/ En Banc Review ,
Mayo v. Prometheus ,
Myriad ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
SCOTUS ,
Section 101 ,
Sequenom
In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops against obviousness, written...more
8/13/2015
/ Allergan Inc ,
Allergan v Sandoz ,
Enablement Inquiries ,
Inherency ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Prior Art ,
Written Descriptions
In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more
8/13/2015
/ Allergan Inc ,
Allergan v Sandoz ,
Enablement Inquiries ,
Inherency ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Ownership ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Written Descriptions
I don’t usually write about district court decisions, but the patent indefiniteness ruling in Andrulis Pharmaceuticals Corp. v. Celgene Corp. (D. Del., July 26, 2015), caught my attention. The court held the asserted claim...more
On July 27, 2015, Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. filed a petition for Inter Partes Review (IPR) of the “Cabilly II” patent, U.S. Patent No. 6,331,415. The Cabilly II patent granted shortly after I...more
Since the implementation of the America Invents Act on September 16, 2012, and the Technical Corrections Act on January 14, 2013, Applicants have been able to delay submission of an executed inventors’ oath/declaration in a...more
In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more
7/23/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Generic Drugs ,
Marketing Exclusivity Periods ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
In Versata Development Group, Inc. v. SAP America, Inc., the Federal Circuit outlined the permitted extent of judicial review of Covered Business Method (CBM) patent review proceedings conducted by the USPTO Patent Trial and...more
7/23/2015
/ America Invents Act ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
Covered Business Method Patents ,
Covered Business Method Proceedings ,
Judicial Review ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
USPTO
A divided Federal Circuit denied the petition for rehearing en banc that would have required the court to revisit its decision in In re Cuozzo Speed Technologies, LLC (Fed Cir 2015), that upheld the USPTO’s use of the...more
7/23/2015
/ America Invents Act ,
Broadest Reasonable Interpretation Standard ,
Claim Construction ,
En Banc Review ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pending Legislation ,
Petition For Rehearing ,
Popular ,
Post-Grant Review ,
USPTO
In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more
7/22/2015
/ Biosimilars ,
BPCIA ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Sandoz v Amgen ,
Sponsors
I do not usually write about non-precedential Federal Circuit decisions, but I could not let the discussion of “simultaneous invention” in Columbia University v. Illumina, Inc., go without comment. As if protecting patents...more