Latest Publications

Share:

More Aqua Products Fallout -- Taiwan Semiconductor Manufacturing Co. v. Godo Kaisha IP Bridge

In November, Chief Judge David P. Ruschke of the U.S. Patent and Trademark Office's Patent Trial and Appeal Board issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products" (see "PTAB Motions to...more

Wi-Fi One, LLC v. Broadcom Corp. (Fed. Cir. 2018) (en banc)

On Monday, January 8, 2018, the en banc Federal Circuit held in Wi-Fi One, LLC v. Broadcom Corp. that PTAB time-bar determinations under 35 U.S.C. § 315(b) are appealable because they do not fall within the scope of the...more

PTAB Motions to Amend Post-Aqua Products -- Chief Judge Ruschke Issues Guidance

On November 21, 2017, PTAB Chief Judge Ruschke issued a memorandum entitled "Guidance on Motions to Amend in view of Aqua Products." As we reported at the time, the Federal Circuit in Aqua Products determined that the PTAB...more

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

More Views on Venue -- Federal Circuit Addresses In re Micron Fallout

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

Remands at the PTAB -- Board Issues Standard Operating Procedure 9

Earlier this month, the Patent Trial and Appeal Board released it Standard Operating Procedure 9 entitled "Procedure for Decisions Remanded from the Federal Circuit for Further Proceedings." To date, the Federal Circuit has...more

Oil States Preview Take II -- Just What Did the Supreme Court Hold in McCormick Harveting Machine v. Aultman?

Last week, we provided a preview of the Supreme Court case Oil States Energy Services, LLC. v. Greene's Energy Group, LLC. that will be argued on November 27, 2017. The underlying case has received a lot of attention, so it...more

Supreme Court Preview -- Oil States Energy Services, LLC v. Greene's Energy Group, LLC

On November 27, 2017, the Supreme Court will hear arguments in two cases that were ultimately appealed from IPR Final Written Decisions issued by the PTAB. The first of these, Oil States Energy Services, LLC v. Greene's...more

CAFC Shifts the Burden for IPR Claim Amendments from the Patent Owner to the Petitioner

In Aqua Products Inc. v. Matal, a highly fractured en banc Federal Circuit determined that the PTAB, in ruling whether to allow claim amendments in an IPR proceeding, can no longer place the burden to establish the...more

Aqua Products, Inc. v. Matal (Fed. Cir. 2017)

More Than a Mere Academic Exercise - On October 4, 2017, in Aqua Products, Inc. v. Matal, a highly fractured en banc Federal Circuit determined that the PTAB can no longer place the burden of establishing the patentability...more

HUMIRA® Biosimilar Update -- Settlement in AbbVie v. Amgen Case Announced and AbbVie v. Boehringer Ingelheim Litigation Begins

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

Views on Venue -- Take Two: Did the District of Delaware Get It Right?

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

Views on Venue -- District of Delaware Provides Some Guidance on Venue in ANDA Cases Post-TC Heartland

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

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

200 Results
/
View per page
Page: of 8

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.