News & Analysis as of

Post-Grant Review Inter Partes Review (IPR) Proceeding Pharmaceutical Industry

Venable LLP

Venable’s BiologicsHQ Monthly Injection - July 2024

Venable LLP on

Please see full Newsletter below for more information....more

Venable LLP

Venable’s BiologicsHQ Monthly Injection - June 2024

Venable LLP on

Venable’s BiologicsHQ Monthly Injection – June 2024...more

Knobbe Martens

PREVAIL Act Proposes Significant Changes PTAB Proceedings

Knobbe Martens on

IP rights can be vital to the success of medical device companies.  Significant legislative changes governing some of these rights may be on the horizon.  Senators Coons (Delaware), Durbin (Illinois), Hirono (Hawaii), and...more

American Conference Institute (ACI)

[Event] 21st Advanced Summit on Life Sciences Patents - May 18th - 19th, New York, NY

ACI’s 21st Advanced Summit on Life Sciences Patents returns to New York City, this May, to provide practical insights on how to maximize your patent term and develop strategies to enhance global protections for your patent...more

Venable LLP

The State of Biosimilars in 2023

Venable LLP on

It has been 13 years since the Biologics Price Competition and Innovation Act (BPCIA) was enacted and biosimilars had a pathway to enter the U.S. market. While there have been challenges over this time, the U.S. biosimilar...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

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 - Life Sciences

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

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

Morgan Lewis

Blockbuster Biologics Review | Quarterly Update – April 2021

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. This past quarter as COVID spread across the globe, challenges to patents...more

Fish & Richardson

2020 Post-Grant Report

Fish & Richardson on

In a year of extraordinary change, the Patent Trial and Appeal Board (PTAB) rose to the challenge - Given the challenges of 2020 – a global pandemic, a deep economic recession, and a turbulent presidential election, among...more

Morgan Lewis

Blockbuster Biologics Review | Quarterly Update – February 2021

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. This past quarter as COVID spread across the globe, challenges to patents...more

Morgan Lewis

Blockbuster Biologics Review | Quarterly Update – September 2020

Morgan Lewis on

Welcome to our quarterly update relating to biologics and biosimilars, including post-grant and patent litigation challenges to blockbuster biologics. The BPCIA celebrated its 10-year anniversary on March 23, 2020. During...more

McDonnell Boehnen Hulbert & Berghoff LLP

Momenta Pharmaceuticals, Inc. v, Bristol-Myers Squibb Co. (Fed. Cir. 2019)

The Federal Circuit has on several occasions taken the opportunity to address (and in doing so, flesh out) the requirements for Article III standing to appeal an adverse determination in a post-grant review proceeding...more

Jones Day

Sen. Hatch Introduces Hatch-Waxman Integrity Act

Jones Day on

Sen. Orrin Hatch has introduced a bill that would augment the Hatch-Waxman Act, limiting challengers ability to proceed with patent challenges both in court and at the PTAB. Following is the introduction of the “Hatch-Waxman...more

Goodwin

Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants (Updated)

Goodwin on

On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes...more

Hogan Lovells

U.S. + Germany Patent Update - September 2018

Hogan Lovells on

The U.S. and Germany are two of the most important fora in the world for patent litigation. The U.S. has long been one of the largest markets for patent litigation, and Germany has constantly attracted more than 50% of all...more

Jones Day

Hatch Bill: Restore Hatch-Waxman Balance; Limit Generics’ Access to PTAB

Jones Day on

Senator Orrin Hatch (R-Utah), the namesake and coauthor of the Hatch-Waxman Act, proposed (but has not yet introduced) an amendment titled the “Hatch-Waxman Integrity Act of 2018” during the Senate Judiciary Committee held on...more

Goodwin

Proposed Amendment to Hatch-Waxman and BPCIA Could Curb IPRs by Generic and Biosimilar Applicants

Goodwin on

On June 13, Senator Orrin Hatch (R-UT), co-author of the Drug Price Competition and Patent Term Restoration Act (aka the “Hatch-Waxman Act”), proposed an amendment in the Senate Judiciary Committee to modify the inter partes...more

Foley & Lardner LLP

The Hobson's Choice Of The Hatch-Waxman Integrity Act

Foley & Lardner LLP on

As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more

Hogan Lovells

PTAB: Tribal Sovereign Immunity Does Not Provide a Basis to Terminate IPRs

Hogan Lovells on

On February 23, 2018, in a much-anticipated decision, the PTAB ruled that tribal sovereign immunity could not be used to shield certain Allergan Inc. (“Allergan”) patents from review in a number of IPRs. Allergan had assigned...more

Troutman Pepper

Allergan’s Mohawk Gambit Fails At The PTAB

Troutman Pepper on

The Patent Trial and Appeal Board (PTAB) has not taken kindly to a move by the Irish drug company Allergan to shield its key patents on its dry-eye drug Restasis from challenge at the U.S. Patent Office by assigning these...more

Fenwick & West Life Sciences Group

USPTO and EPO Examiners Discuss Key Considerations for Filing Effective Precision Medicine and Bioinformatics Applications in the...

At a symposium and webinar presented by Fenwick & West and Mewburn Ellis, we asked U.S. Patent and Trademark Office and European Patent Office examiners to provide perspective on the preparation and prosecution of patent...more

Troutman Pepper

PTAB Can Rely on New Evidence Introduced by Petitioner in its Reply

Troutman Pepper on

In a decision last month, the Court of Appeals for the Federal Circuit gave petitioners in AIA proceedings yet another weapon to invalidate patents – by affirming a Patent Trial and Appeal Board (PTAB) decision that relied,...more

36 Results
 / 
View per page
Page: of 2

"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:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide