The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more
12/13/2016
/ Amgen ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sandoz ,
Sandoz v Amgen
The patent prosecutor's art requires exquisite foresight, if not prescience, in balancing the requirements for specificity needed to satisfy the disclosure requirements of § 112 while anticipating efforts to design around the...more
The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more
10/19/2016
/ Abbreviated New Drug Application (ANDA) ,
Allergan Inc ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Interest ,
Qui Tam ,
USPTO
In the late 1980's, Dennis Slamon discovered a new oncogene, Her2/neu,that was amplified in 25-33% of human beast cancers. Slamon et al., "Studies of the HER2/neu ProtoOncogene in Human Breast and Ovarian Cancer," Science...more
On May 4th the U.S. Patent and Trademark Office issued its latest Guidance on how Examiners are to apply recent U.S. Supreme Court and Federal Circuit precedent related to subject matter eligibility (see "USPTO Issues Update...more
7/19/2016
/ Ariosa ,
New Guidance ,
Paid Time Off (PTO) ,
Patent Examinations ,
Patent-Eligible Subject Matter ,
Patents ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Sequenom ,
USPTO
The past decade or so of U.S. patent law has been characterized by a consistent theme between Federal Circuit decisions and the Supreme Court's invalidation of them (and sometimes can be discerned even in those rare instances...more
As part of a session on the effects of inter partes review on biopharma patents presented today at the 2016 BIO International Convention, Bloomberg/BNA released a report on more than 300 biopharma patents that have been...more
On April 27th, Ambassador Michael B.G. Froman, U.S. Trade Representative (USTR), issued the 2016 Special 301 Report. According to the USTR website, "[i]ntellectual property is a critical source of economic growth and...more
5/20/2016
/ Copyright ,
Counterfeiting ,
Film Industry ,
Global Market ,
Innovation ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Life Sciences ,
Medical Research ,
Patents ,
Pharmaceutical Patents ,
Piracy ,
Software ,
Trade Secrets ,
Trademarks ,
USTR ,
WIPO
The Federal Circuit and the Supreme Court spent an inordinate amount of time wrestling with each of their conceptions of the scope and application of the doctrine of equivalents a dozen years ago, coming to an accommodation...more
Cold Spring Harbor Laboratory (CSHL) is a storied institution in molecular biology, being the site of annual meetings related to this view of life since Schrodinger proposed to use quantitative methods to examine biology in...more
The Biologic Price Control and Innovation Act (BPCIA), enacted as part of President Obama's Affordable Care Act (better known as "Obamacare," Public Law 111-148), provided for the first time in the U.S. a path for FDA...more
Last Thursday, the Federal Circuit handed down its non-precedential decision in Purdue Pharma v. Depomed, reviewing the decision of the Patent Trial and Appeal Board on three related inter partes reviews. While not quite a...more
Last Friday, Amgen filed a declaratory judgment action in the District Court for New Jersey against Sandoz, in the latest iteration of biosimilar litigation between the parties (see complaint). Amgen's and Sandoz's actions...more
The Obama Administration released the approved text of the Trans Pacific Partnership (TPP) agreement last week, and it is substantially (and perhaps entirely; there has not been sufficient time to compare) the same as the...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
Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more
10/15/2015
/ Abbreviated New Drug Application (ANDA) ,
De Novo Standard of Review ,
Doctrine of Equivalents ,
Estoppel ,
FDA Approval ,
Generic Drugs ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Sandoz
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
Sandoz is having a good year. The company succeeded in having their NEUPOGEN® (filgrastrim) biosimilar product, Zarxio™, approved by the FDA in March, a mere ten months after filing its biosimilar application last July. The...more
9/8/2015
/ Biosimilars ,
BPCIA ,
Injunctions ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Physicians ,
Sandoz ,
Sandoz v Amgen
Sandoz successfully (at least for now) has overcome conventional wisdom, the plain language of the Biologics Price Competition and Innovation Act (BPCIA) (or, at least those provisions regarding patent litigation) and Amgen...more
9/3/2015
/ Biologics ,
Biosimilars ,
BPCIA ,
Federal Trade Commission (FTC) ,
FTC v Actavis ,
Injunctions ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
One of the statistics gleaned from Director Michelle Lee's recent blog on the post-issuance review provisions of the America Invents Act is that only 42% of inter partes review petitions have been granted over the past three...more
8/25/2015
/ Abuse of Process ,
America Invents Act ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Owner Preliminary Response ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art
In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA or Act) in Amgen Inc. et al. v. Sandoz Inc. In doing so, the court limited the...more
7/22/2015
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Disclosure ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
In a seriously fractured decision, the Federal Circuit construed the provisions of the Biologics Price Control and Innovation Act (BPCIA) today in Amgen v. Sandoz. In doing so, the Court limited the information available to...more
7/21/2015
/ Amgen ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
There have been many voices raised in recent years against the patent system for a variety of political, policy, or personal reasons. Indeed, there is even a book entitled Don't File a Patent that sets out the authors'...more
7/15/2015
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
On-Sale Bar ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Reversal ,
USPTO
Over seven years ago, the Federal Circuit delivered a mixed ruling against Pfizer in litigation against Teva) relating to the pain medication Celebrex® (celocoxib) (where "celocoxib" is...more
6/25/2015
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Infringement ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pfizer ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Disaster survivors, and even people who just hear about a disaster, are often first overwhelmed by it; they can only rationally process its significance after some time. During that time they overcome the initial visceral...more
6/23/2015
/ DNA ,
Intellectual Property Litigation ,
Myriad-Mayo ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Sequenom