News & Analysis as of

Biotechnology Inter Partes Review (IPR) Proceeding

Venable LLP

Celltrion Submits an aBLA for Actemra® (tocilizumab) Proposed Biosimilar CT-P47

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On January 28, 2024 Celltrion announced the submission to the FDA of an aBLA for CT-P47, a proposed biosimilar of Genentech’s Actemra® (tocilizumab). This is the third publicly announced aBLA filing for an...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

Morgan Lewis

Blockbuster Biologics Review | Issue 16

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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

Jones Day

Section 316(a)(11) Time Limits Do Not Apply Beyond First FWD

Jones Day on

In Laboratoire Francais du Fractionnement et des Biotechnologies S.A. v. Novo Nordisk Healthcare AG, the Patent Trial and Appeal Board (PTAB) denied the Petitioner’s motion to terminate the inter partes review (IPR) and to...more

Morgan Lewis

Blockbuster Biologics Review Issue 15

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

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

2021 PTAB Year in Review: Analysis & Trends: Case Studies and Trends at the PTAB Involving 35 U.S.C. § 112

Over the last 20-plus years, US Court of Appeals for the Federal Circuit cases concerning written description and enablement have become a hot-button issue in the chemical and life sciences practices. The year 2021 was no...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

Knobbe Martens

Ranges for Interdependent and Interactive Components Can Be Tricky to Derive

Knobbe Martens on

MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION - Before Lourie, O’Malley and Stoll.  Appeal from the Patent Trial and Appeal Board. Summary: A presumption of obviousness based on overlapping ranges requires showing...more

Proskauer - Life Sciences

When (Patent) Success Isn’t Obvious

In Univ. of Strathclyde v. Clear-Vu Lighting LLC, the Federal Circuit grappled with the issue of whether claims directed to methods and systems for inactivating bacteria using blue light were obvious in view of a prior art...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

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

The mRNA Patent and Competitive Landscape: Pioneers, Litigation Outlook and Big Pharma’s Next Moves (Part III)

In Part I of this series providing a summary of the mRNA IP and competitive landscape through one year of the COVID-19 pandemic, we focused on market players BioNTech, Moderna and CureVac; in Part II, we discussed Translate...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

McDonnell Boehnen Hulbert & Berghoff LLP

Top Stories of 2020: #5 to #8

After reflecting upon the events of the past twelve months, Patent Docs presents its 14th annual list of top patent stories.  For 2020, we identified eight stories that were covered on Patent Docs last year that we believe...more

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

Breaking Down Moderna’s COVID-19 Patent Pledge: Why Did They Do It?

Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine, made the following statement regarding enforcement of its patents: We feel a special obligation under the current...more

American Conference Institute (ACI)

[Event] Biosimilars Summit – Legal, Regulatory, and Commercial Strategies – June 24th-25th, New York City, NY

2019 marks the 9th anniversary of the Biologics Price Competition and Innovation Act (BPCIA). ACI has been with you from the introduction of the first House and Senate bills through to the actual signing of the law. As we...more

American Conference Institute (ACI)

[Event] Life Sciences Patents Summit – Perfect Your Patent Prosecution Strategies in the U.S. and Around the World - May 16-17,...

Come to network and benchmark with top life sciences industry patent and intellectual property counsel. ACI’s 17th Global Summit on Life Sciences Patents returns to New York in May to provide practical insights on how to...more

Troutman Pepper

Why Biotech and Pharma Patents Survive IPR

Troutman Pepper 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

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

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Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more

Wilson Sonsini Goodrich & Rosati

The PTAB Review - March 2018

Challenges to Immunology Patents Lead Increase in Biotechnology Cases at the PTAB in 2017 - Throughout the history of inter partes review (IPR) proceedings, petitions have been dominated by challenges to patents directed...more

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

Global Patent Prosecution Newsletter - June 2017

Revocation Proceedings Around the World - Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more

Morgan Lewis

Humira Patents Invalidated in Inter Partes Reviews

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AbbVie’s arguments raised in a prior IPR were key to the PTAB’s finding of no commercial success. The Patent Trial and Appeal Board (PTAB) found all of the claims of three AbbVie Biotechnology Ltd. (AbbVie) patents...more

McDonnell Boehnen Hulbert & Berghoff LLP

Lessons Learned from AIA Invalidity Proceedings in the Bio/Pharma Space

September 16, 2016, marked the fourth anniversary of the effective date for the invalidity proceedings before the Patent Trial and Appeal Board (PTAB or Board) created by the America Invents Act (AIA). These new AIA...more

McDonnell Boehnen Hulbert & Berghoff LLP

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

McDonnell Boehnen Hulbert & Berghoff LLP

BIO International Convention 2016 Preview

U.S. Patent Practice – the PTAB, Federal Courts, and Patent Eligibility - The 2016 BIO International Convention has already begun in San Francisco, but most of the sessions and forums get underway beginning on Tuesday,...more

Fish & Richardson

Legislative Developments in Post-Grant Proceedings

Fish & Richardson on

Amidst a spate of high-profile IPR filings in the life sciences space by hedge fund financiers, the biotechnology industry has mobilized behind two chief legislative strategies designed to limit or eliminate its exposure to...more

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