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FDA Approves First Cancer-Treatment Biosimilar -- Amgen's Mvasi

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

9/15/2017  /  aBLA , Amgen , Biosimilars , FDA , Life Sciences

Amgen Inc. v. Hospira, Inc. (Fed. Cir. 2017)

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

FDA Report: Agency Announces Expedited Review of Certain ANDAs

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

SCOTUS: Supreme Court Lifts Biosimilars by Allowing Early Commercial Marketing Notice

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

BIO International Convention 2017 Preview

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 International Convention 2017 Preview

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

Sandoz Inc. v. Amgen Inc. (2017)

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

Biosimilars Update -- Pfizer's Proposed Epogen®/Procrit® Biosimilar Recommended for Approval

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

TC Heartland LLC v. Kraft Foods Group Brands LLC (2017)

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

Supreme Court Hears Oral Argument in Sandoz v. Amgen -- Patent Dancing and Missing Puzzle Pieces

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

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc.

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

Novartis AG v. Torrent Pharmaceuticals Ltd. (Fed. Cir. 2017)

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

PTAB Update -- Shire Has Rare Motion to Amend Granted

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

Novartis AG v. Noven Pharmaceuticals Inc. (Fed. Cir. 2017)

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

TC Heartland LLC v. Kraft Foods Group Brands LLC -- 98 Professors Chime In

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

Supreme Court Preview -- TC Heartland LLC v. Kraft Foods Group Brands LLC

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

MBHB Snippets: A review of developments in Intellectual Property Law - Volume 15, Issue 1

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

Post-Grant Review Estoppel – Looking Forward by Looking Back at Estoppel in Inter-Partes and Covered-Business-Method Review

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

Supreme Court to Review BPCIA -- Amgen v. Sandoz Petitions for Writs of Certiorari Granted

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

Phigenix, Inc. v. ImmunoGen, Inc. (Fed. Cir. 2016)

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

Patent Trolls Beware! -- Supreme Court to Review Patent Venue Statute

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

Supreme Court Preview -- Life Technologies Corp. v. Promega Corp.

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

IPR Update -- Is Reviewability of Time-Bar Institution Decisions Headed En Banc?

"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

Biotechnology Innovation Organization's Amicus Brief for In re Aqua Products, Inc.

On Friday, December 9, 2016, the Federal Circuit will hear oral arguments en banc in the In re Aqua Products, Inc. case to consider two questions related to the PTAB's treatment of Motions to Amend in IPR proceedings. ...more

In re NuVasive, Inc. (Fed. Cir. 2016)

The Federal Circuit remanded a final written decision of the Patent Trial and Appeal Board ("PTAB" or "Board") because the Board invalidated certain claims in a patent without providing adequate notice or opportunity to the...more

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