News & Analysis as of

Inter Partes Review (IPR) Proceeding Biosimilars United States Patent and Trademark Office

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Knobbe Martens

Settlements Don’t Close the Door: Antitrust Claims Follow IPR Challenges in Life Sciences

Knobbe Martens on

In the ongoing case of Carefirst of Maryland Inc. v. Johnson & Johnson, the plaintiffs successfully overcame a motion to dismiss. At the heart of the case is J&J’s legal strategy against biosimilar competitors, including...more

American Conference Institute (ACI)

[Event] 15th Summit on Biosimilars & Innovator Biologics - June 20th - 21st, New York, NY

Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more

American Conference Institute (ACI)

[Event] 14th Summit on Biosimilars & Innovator Biologics - June 27th - 28th, Boston, MA

Biologics have become the fastest-growing class of therapeutic compounds. They have provided innovative treatment alternatives for people who suffer from some of the most serious medical conditions known to man. The...more

Goodwin

An Interview with Rachel Goode, Ph.D, about Biological Patent Thickets

Goodwin on

Kevin DeJong (Senior Editor) and Shweta Kumar (Editor) from the Big Molecule Watch recently interviewed Rachel Goode, Ph.D. to discuss an article she recently co-authored, “Biological patent thickets and delayed access to...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Goodwin

Year in Review: Top U.S. Biosimilars-Related Regulatory Developments of 2021

Goodwin on

As 2021 comes to a close, Big Molecule Watch reviews the top five biosimilar regulatory developments of the year... President Biden Signs Orange Book Transparency Act - In January, we reported that President Biden...more

Morgan Lewis

Blockbuster Biologics Review Issue 14

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the Biologics Price Competition and Innovation Act...more

Proskauer - The Patent Playbook

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

American Conference Institute (ACI)

[Event] Paragraph IV Disputes Conference - November 9th - 10th, New York, NY

Join the conference that the “who’s who” of Hatch-Waxman litigators have designated as the forum which sets the standards for Paragraph IV practice. ACI’s Paragraph IV Litigation Conference is returning LIVE & IN-PERSON to...more

Morgan Lewis

Blockbuster Biologics Review | Quarterly Update – August 2021

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. Since the enactment of the BPCIA, 29 biosimilars have been approved, 16...more

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Goodwin

Biosimilar IPR Appeal Updates

Goodwin on

Following the Celltrion and Pfizer settlements of the trastuzumab litigation, the Federal Circuit granted the request of the Director of the PTO to intervene under 35 U.S.C. § 143 (i.e., defend a PTAB decision when a...more

Troutman Pepper Locke

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper Locke on

When the America Invents Act of 2011 ushered in a number of new administrative procedures for challenging issued patents, the biotechnology and pharmaceutical industries at first seemed largely unconcerned. Originally...more

Troutman Pepper Locke

Sometimes the Patent Office Has the Last and Only Word

Troutman Pepper Locke on

The Federal Circuit just issued a decision that confirms its stance on Article III standing for appeals from inter partes reviews (IPRs), making it tougher for unsuccessful IPR petitioners to obtain judicial review of U.S....more

WilmerHale

Federal Circuit Patent Updates - July 2016 #2

WilmerHale on

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

Troutman Pepper

Post-Grant Challenges in Life Sciences: A Midyear Assessment

Troutman Pepper on

The America Invents Act established inter partes review and post-grant reviews mechanisms to challenge the validity of issued United States patents. These procedures were created to improve patent quality, and were introduced...more

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