Which parties to an IPR proceeding have standing to either appeal or participate in an appeal from an adverse final written decision by the Board? The Federal Circuit had previously held that a petitioner that did not...more
Pharmaceutical patent owners have been one of the more vocal groups decrying the creation and existence of inter partes reviews and other PTAB post-issuance proceedings. And for good reason. Congress enacted the...more
On September 28, 2017, both parties to the AbbVie v. Amgen litigation announced a settlement that resolves all intellectual property-related litigation over Amgen's FDA-approved adalimumab biosimilar AMGEVITA™/AMJEVITA™. ...more
In the third installment of the "Amgen v." trilogy of BPCIA Federal Circuit cases, the Court in Amgen Inc. v. Hospira, Inc. answered a question that had been lingering since the very first case -- can a reference product...more
8/11/2017
/ aBLA ,
Amgen ,
Amgen v Hospira ,
Biosimilars ,
BPCIA ,
Hospira ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
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
On June 12, 2017, 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...more
6/13/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
On March 31, 2017, the Patent Trial and Appeals Board ("PTAB" or "Board") granted a motion to amend claims in Amerigen Pharmaceuticals Ltd. v. Shire LLC (IPR2015-02009). This is, of course, an uncommon event. Depending on...more
Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more
7/12/2016
/ aBLA ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz v Amgen
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar -
The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
6/7/2016
/ aBLA ,
Amended Regulation ,
America Invents Act ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Community Trademark ,
Declaratory Judgments ,
EU ,
Filing Fees ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Inventions ,
Notice Requirements ,
On-Sale Bar ,
Patent Dance ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Preliminary Injunctions ,
Prior Art ,
Public Use ,
Renewal Fees ,
Sandoz ,
Sandoz v Amgen ,
Trademark Registration ,
Uniform Commercial Code (UCC) ,
USPTO
In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more
6/3/2016
/ aBLA ,
Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen
BIO and Biosimilars -
The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more
As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. On Tuesday, April 12,...more
Earlier today, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. This marks only the second...more
According to the Federal Circuit website, the appeal from the Amgen Inc. v. Apotex Inc. case will be argued on April 4, 2016 in Courtroom 402. This case is an appeal from a decision by Judge Cohn of the Southern District of...more
3/3/2016
/ aBLA ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
Will The "No Supplier Exception" to the On-Sale Bar Fall?
On November 13, 2015, the Federal Circuit granted a petition for rehearing en banc filed in The Medicines Company v. Hospira, Inc. As we previously reported, the...more
Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more
9/14/2015
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Injunctive Relief ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz v Amgen
On July 21, 2015, the Federal Circuit decided the Amgen v. Sandoz appeal in a case of first impression regarding the interpretation of the disclosure and notice provisions of the Biologics Price Competition and Innovation Act...more
9/11/2015
/ Amgen ,
Amicus Briefs ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
En Banc Review ,
FDA Approval ,
First Impression ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more
7/24/2015
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Applications ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) -
On June 18, 2015, the Federal Circuit handed down...more
6/26/2015
/ Claim Construction ,
Nautilus Inc. v. Biosig Instruments ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sandoz ,
SCOTUS ,
Teva Pharmaceuticals ,
Teva v Sandoz
The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District...more
The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at...more
The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more
On March 19, 2015, U.S. District Judge Seeborg of the Northern District of California denied a motion for a preliminary injunction filed by Amgen to prevent the imminent launch by Sandoz of a biosimilar version of NEUPOGEN®...more
Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more
4/4/2015
/ Abbreviated New Drug Application (ANDA) ,
Apotex ,
Declaratory Judgments ,
Federal Jurisdiction ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Litigation ,
Jurisdiction ,
Medicare Modernization Act ,
Mylan Pharmaceuticals ,
Noninfringement ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Subject Matter Jurisdiction
When can a district court's factual findings related to the extrinsic evidence in a claim construction determination not be given deference by the Federal Circuit? At least one situation is when the findings do not...more