In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more
The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more
6/27/2017
/ Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
SCOTUS
The Supreme Court handed down its opinion in Impression Products v. Lexmark, reversing the Court of Appeals for the Federal Circuit regarding the scope of the patent exhaustion doctrine. The Court held that patent rights are...more
The U.S. Supreme Court handed down its decision today in Impression Products, Inc. v. Lexmark International, Inc., unsurprisingly reversing the Federal Circuit regarding the metes and bounds of the patent exhaustion doctrine....more
On Wednesday, April 26, the Supreme Court will hear oral arguments in Sandoz Inc. v. Amgen Inc, involving interpretation for the first time of the Biologics Price Competition and Innovation Act ("BPCIA"), which was enacted...more
4/26/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Oral Argument ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
Despite the Supreme Court's admonition, in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., that attorney's fees and other measures of enhanced damages be granted, in a...more
From the nadir of the Supreme Court's allegations that the Federal Circuit "fundamentally misunderstood" the law of inducing infringement in Limelight Networks, Inc. v. Akamai Technologies, Inc., the nation's specialized...more
In its first pronouncement regarding the post-grant reviewing proceedings established by the America Invents Act ("AIA"), the Supreme Court ruled that the Patent and Trademark Office's positions on two of the law's provisions...more
6/21/2016
/ Administrative Proceedings ,
America Invents Act ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Chevron Deference ,
Claim Construction ,
Cuozzo Speed Technologies v Lee ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Patent Trial and Appeal Board ,
Patents ,
SCOTUS ,
Standard of Review ,
USPTO
On June 13, 2016, the Supreme Court ruled unanimously, in an opinion by Chief Justice Roberts, that an award of enhanced damages pursuant to 35 U.S.C. § 284 should be within the sound discretion of a district court, albeit...more
6/14/2016
/ 35 U.S.C. § 284 ,
Abuse of Discretion ,
Appeals ,
Enhanced Damages ,
Halo v Pulse ,
Highmark ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patents ,
SCOTUS ,
Standard of Proof ,
Standard of Review ,
Stryker v Zimmer ,
Totality of Circumstances Test ,
Willful Infringement
The aphorism that "[t]he race is not always to the swift nor the battle to the strong, but that's the way to bet," variously attributed to Damon Runyon, Franklin P. Adams, and Hugh Keough, could readily be updated to include...more
6/14/2016
/ 35 U.S.C. § 284 ,
Abuse of Discretion ,
Enhanced Damages ,
Halo v Pulse ,
Highmark ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patents ,
SCOTUS ,
Standard of Proof ,
Standard of Review ,
Stryker v Zimmer ,
Totality of Circumstances Test ,
Willful Infringement
In a recent book entitled Imbeciles: The Supreme Court, American Eugenics, and the Sterilization of Carrie Buck, author Adam Cohen examines the case of Buck v. Bell, where Justice Oliver Wendell Holmes wrote that "[t]hree...more
As reported on February 17, 2016 in IP Law360, Sandoz has petitioned the U.S. Supreme Court for certiorari to review the Federal Circuit's decision that reversed the District Court in Amgen v. Sandoz. In its decision, two...more
The Federal Circuit affirmed a decision of obviousness, and that a patentee not be able to amend claims in an inter partes review proceeding, in an opinion handed down January 29th in Illumina Cambridge Ltd. v. Intelligent...more
The Supreme Court on Friday granted certiorari to review the Federal Circuit's decision that the U.S. Patent and Trademark's Patent Trial and Appeal Board was entitled to perform claim construction in inter partes review...more
1/19/2016
/ Administrative Appeals ,
Appeals ,
Broadest Reasonable Interpretation Standard ,
Certiorari ,
Claim Construction ,
Cuozzo Speed Technologies ,
Inter Partes Review (IPR) Proceeding ,
Judicial Review ,
Patent Trial and Appeal Board ,
Patents ,
SCOTUS ,
Statutory Authority
The Federal Circuit declined to rehear en banc the panel decision in Ariosa v. Sequenom. This decision was not surprising but what may be surprising was that only three judges wrote opinions, one in dissent (Judge Newman)...more
The Federal Circuit today denied the petitions for rehearing by the panel and rehearing by the en banc Court filed by both parties in Amgen v. Sandoz. Amgen had petitioned for rehearing on the panel's decision that the...more
10/19/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
En Banc Review ,
FDA Approval ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
The diplomats negotiating the Trans Pacific Partnership (TPP) agreement have done the seemingly impossible: they have kept the details of the draft agreement secret from the press and interested parties in the United States,...more
10/16/2015
/ AMP v Myriad ,
Biologics ,
BPCIA ,
CLS Bank v Alice Corp ,
Copyright ,
Fast Track Process ,
GATT ,
Innovation ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Obama Administration ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
SCOTUS ,
Trademarks ,
Trans-Pacific Partnership ,
TRIPS Agreement ,
WTO
More than three years after the June 15, 2012 deadline for providing it, the U.S. Patent and Trademark Office has issued its report on so-called "second opinion" genetic diagnostic testing, mandated by Section 27 of the...more
10/7/2015
/ America Invents Act ,
AMP v Myriad ,
Centers for Medicare & Medicaid Services (CMS) ,
Congressional Reports ,
Diagnostic Tests ,
DNA ,
Exclusive Licenses ,
Genetic Testing ,
Health Insurance ,
Healthcare ,
Innovation ,
Mayo v. Prometheus ,
Patents ,
Public Disclosure ,
SCOTUS ,
USPTO
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
9/30/2015
/ Amicus Briefs ,
AMP v Myriad ,
En Banc Review ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
SCOTUS ,
Sequenom
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
9/24/2015
/ Amicus Briefs ,
AMP v Myriad ,
CLS Bank v Alice Corp ,
En Banc Review ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Novartis ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Pharmaceutical Patents ,
Prior Art ,
SCOTUS ,
Sequenom
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
9/23/2015
/ Amicus Briefs ,
AMP v Myriad ,
CLS Bank v Alice Corp ,
En Banc Review ,
Mayo v. Prometheus ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Prior Art ,
SCOTUS ,
Sequenom ,
TRIPS Agreement ,
USPTO
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
9/21/2015
/ America Invents Act ,
Amicus Briefs ,
AMP v Myriad ,
CLS Bank v Alice Corp ,
En Banc Review ,
EPO ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
SCOTUS ,
Sequenom
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
9/18/2015
/ Amicus Briefs ,
AMP v Myriad ,
CLS Bank v Alice Corp ,
En Banc Review ,
Mayo v. Prometheus ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
Prior Art ,
SCOTUS ,
Sequenom
Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more
9/17/2015
/ Amicus Briefs ,
AMP v Myriad ,
Biotechnology ,
CLS Bank v Alice Corp ,
En Banc Review ,
Mayo v. Prometheus ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Petition For Rehearing ,
PHRMA ,
SCOTUS ,
Sequenom ,
USPTO
A bedrock principle of U.S. patent law is that the patent grant comprises a quid pro quo. In exchange for a limited term of exclusivity (presently, twenty years from the earliest filing date), the patented invention is placed...more
9/16/2015
/ Brulotte ,
Kimble v Marvel Enterprises ,
License Agreements ,
Patent Expiration ,
Patent Infringement ,
Patent Litigation ,
Patent Royalties ,
Patents ,
Quid Pro Quo ,
SCOTUS ,
Stare Decisis