When the PTAB Attacks! -
In the past few years, the public's perception of the patent system in the United States has been at a low point. One of the causes of this lack of confidence in the system has been the increase...more
Fair Use and Social Media Sites like BuzzFeed -
Fair use, an evolving doctrine and a very popular fallback for those on the Internet, has continued to be “the most troublesome in the whole law of copyright.” Its goal has...more
We recently reported that Chief Judge Stark of the District of Delaware interpreted the second prong of the patent venue statute, 28 U.S.C. § 1400(b), in Bristol-Myers Squibb Company v. Mylan because the first prong was no...more
Last Spring, the Supreme Court in TC Heartland LLC v. Kraft Foods Group Brands LLC held that the word "resides" in the patent venue statute, 28 U.S.C. § 1400(b), "refers only to the State of incorporation" of the alleged...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 May 22, 2017, in TC Heartland LLC v. Kraft Foods Group Brands LLC, the Supreme Court reversed the Federal Circuit and held that the word "resides" in the patent venue statute, 28 U.S.C. § 1400(b), "refers only to the State...more
On April 26, 2017, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. Sandoz was represented by Deanne E. Maynard, and Amgen was represented by Seth P. Waxman. In addition, Anthony A. Yang presented the...more
4/28/2017
/ aBLA ,
Amgen ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Sandoz ,
Sandoz v Amgen
As we reported last week, the Supreme Court will hear oral arguments in the TC Heartland LLC v. Kraft Foods Group Brands LLC case on Monday March 27. In that previous report, we covered the background of the case, and...more
Next week, on Monday March 27, the Supreme Court will hear oral arguments in the TC Heartland LLC v. Kraft Foods Group Brands LLC case. This case involves the interpretation of the current patent venue statute. And while...more
In the past few years, the Supreme Court has been single-handedly tackling the so-called Patent Troll problem. Sure, in that time, the President and Congress have made Patent Trolls a focus of their agendas, and have...more
On Tuesday, December 6, the Supreme Court will hear oral arguments regarding the interpretation of 35 U.S.C. § 271(f)(1), with the pertinent section highlighted...more
On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more
10/20/2016
/ Biosimilars ,
Biotechnology ,
Celltrion ,
Food and Drug Administration (FDA) ,
Obviousness ,
Patent Expiration ,
Patent Infringement ,
Patent Invalidity ,
Patents ,
Pfizer ,
Pharmaceutical Industry
To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more
8/10/2016
/ AbbVie ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Inter Partes Review (IPR) Proceeding ,
Patent Dance ,
Patent Infringement ,
Patent Portfolios ,
Patents ,
Popular ,
Sandoz v Amgen
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
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
U.S. Patent Practice – the PTAB, Federal Courts, and Patent Eligibility -
The 2016 BIO International Convention has already begun in San Francisco, but most of the sessions and forums get underway beginning on Tuesday,...more
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
Have you ever mixed up the obviousness determinations of "motivation to combine" and "reasonable expectation of success"? If so, you are apparently not alone -- the Federal Circuit recently faulted the Patent Trial and...more
"You Can Arrange the Menu, the Venue, the Seating"
The above slightly-modified quote is from a lyric sung by Thomas Jefferson in the Tony-award nominated musical "Hamilton" (with apologies to Lin Manual Miranda) -- the...more
Are communications between a patent agent and a client privileged? Up until last week, the Federal Circuit had not addressed the subject, although there had been a split with the district courts that had considered the...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
Earlier today, the Supreme Court heard oral arguments in two related cases: Halo Electronics, Inc. v. Pulse Electronics, Inc. (Supreme Court docket number 14-1513) and Stryker Corp. v. Zimmer, Inc. (Supreme Court docket...more
2/24/2016
/ Attorney's Fees ,
Damages ,
Enhanced Damages ,
Halo v Pulse ,
Highmark v. Allcare ,
Octane Fitness v. ICON ,
Patent Infringement ,
Patents ,
SCOTUS ,
Stryker v Zimmer ,
Willful Infringement