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
Earlier on September 14, 2017, the U.S. Food and Drug Administration approved Amgen's application to market Mvasi (bevacizumab-awwb), a biosimilar to Genentech's Avastin therapeutic antibody for the treatment of multiple...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
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Hospira ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents
On June 27, 2017, the U.S. Food and Drug Administration issued a press release stating how it would begin implementing its plan to increase competition for prescription drugs. This comes on the heels of FDA Commissioner...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
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Declaratory Judgments ,
Notice Requirements ,
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Patent Infringement ,
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Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz v Amgen ,
SCOTUS
BIO, Biologics, and Biosimilars -
The 2017 BIO International Convention began earlier this week, but there are still many sessions and forums still to come. Patent Docs has been highlighting a few sessions or other...more
BIO and the Microbiome -
The 2017 BIO International Convention begins this week in San Diego. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more
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
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Biosimilars ,
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Commercial Marketing ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz ,
Sandoz v Amgen
On May 25, 2017, the FDA's Oncologic Drug Advisory Committee recommended approval of biologics license application ("BLA") 125545 submitted by Hospira Inc., a Pfizer company, for Retacrit, a proposed biosimilar to Amgen...more
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
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Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
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Sandoz v Amgen
On Wednesday, April 26, the Supreme Court will hear oral arguments in the Sandoz Inc. v. Amgen Inc. case. This case involves the interpretation of the Biologics Price Competition and Innovation Act ("BPCIA"), which will be...more
4/25/2017
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Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Patent Dance ,
Patent Litigation ,
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Pharmaceutical Industry ,
Sandoz ,
Sandoz v Amgen
Can a prior art reference that does not contain a teaching sufficient enough to allow it to be used in an obviousness combination nevertheless be used as a background reference for evidence of motivation to combine? ...more
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
In inter partes review proceedings, is the U.S. Patent and Trademark Office's Patent Trial and Appeal Board required to take into account a final district court determination of non-obviousness of the same claims based on the...more
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 2011, the Leahy-Smith America Invents Act (“AIA”) established new post-issuance procedures for challenging the validity of a granted patent before the Patent Trials and Appeal Board (“PTAB” or “Board”). Inter partes...more
3/22/2017
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Covered Business Method Patents ,
Covered Business Method Proceedings ,
Estoppel ,
Inter Partes Review (IPR) Proceeding ,
Jurisdiction ,
Patent Agent Privilege ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Post-Grant Review ,
Trademark Registration ,
Trademarks ,
USPTO
In 2011, the Leahy-Smith America Invents Act (“AIA”) established new post-issuance procedures for challenging the validity of a granted patent before the Patent Trials and Appeal Board (“PTAB” or “Board”). Inter partes...more
3/16/2017
/ America Invents Act ,
Covered Business Method Patents ,
Covered Business Method Proceedings ,
Estoppel ,
Inter Partes Review (IPR) Proceeding ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent Validity ,
Patents ,
Post-Grant Review ,
Prior Art
On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court on February 16, 2016...more
Can any petitioner appeal a Board's final written decision from an inter partes review or post grant review proceeding? Contrary to the language of 35 U.S.C. § 141(c) which permits any party "who is dissatisfied with" the...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
"It appears to me that en banc consideration is warranted." -- Judge Taranto (concurring in Click-To-Call Technologies, LP v. Oracle Corp.).
"I write separately, however, to note that I believe the Supreme Court's...more