News & Analysis as of

United States Patent and Trademark Office › Inter Partes Review (IPR) Proceeding › Food and Drug Administration (FDA)

The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.... more +
The U.S. Patent and Trademark Office is an agency of the United States Department of Commerce that serves a fundamental role in the U.S. intellectual property system by issuing patents and registering trademarks.    less -
American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Evaluates Impact of the Final Written Decision (FWD) in a Parallel Inter-Partes Review (IPR) on District Court’s...

Sheppard Mullin Richter & Hampton LLP on

In United Therapeutics Corp. v Liquidia Tech Inc., the Federal Circuit reviewed the district court’s decision on invalidity and infringement of two pharmaceutical patents and the impact of the Final Written Decision (FWD) in...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

American Conference Institute (ACI)

[Event] 18th Annual Paragraph IV Disputes - April 19th - 20th, New York, NY

American Conference Institute (ACI) on

Hosted by ACI, 18th Annual Paragraph IV Disputes Conference returns to New York City for another exciting year with curated programming that not only addresses the hot topics, but also puts them within the context of pre-suit...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

WilmerHale

PTAB/USPTO Update - November 2022

WilmerHale on

USPTO News - ..On October 19, 2022 the USPTO issued a report titled “Where are U.S. women patentees? Assessing three decades of growth” examining trends in women’s patenting in the U.S. from 1990-2019. ..Director...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Foodtech Pioneer Impossible Foods Sues Competitor Motif for Patent Infringement

Rothwell, Figg, Ernst & Manbeck, P.C. on

The food tech industry has been rapidly growing in recent years with the rise in popularity of alternative (“alt-“) animal products. Such alt-animal products typically consist of non-animal (e.g., plant-based) proteins or...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

Proskauer - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

Proskauer - Life Sciences on

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

American Conference Institute (ACI) on

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

Kramer Levin Naftalis & Frankel LLP

Biosimilar Litigation Trends and Lessons Learned in 2019

Kramer Levin Naftalis & Frankel LLP on

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

Troutman Pepper

Bass Continues Fishing; Pharma Seeks Sanctuary

Troutman Pepper on

It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs. Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and...more

Locke Lord LLP

A Stay of Litigation Pending IPR Does Not Provide a Basis For Extending 30-Stay of FDA ANDA Approval

Locke Lord LLP on

On December 11, 2015, the United States District Court for the Southern District of Indiana granted a motion to stay a Hatch-Waxman litigation pending the outcome of inter partes reviews (IPRs) on two of the patents-in-suit...more

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