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

Venable LLP

Spotlight On: Biosimilar Litigations - January 2025

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Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

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Adalimumab 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

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

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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

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

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

Holland & Knight LLP

Top Section 101 Patent Eligibility Stories of 2020

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Light a fire, pour yourself some glogg (21+) and find a comfy corner to read about the biggest Section 101 stories of 2020 because we're gonna have the hap-hap-happiest time since Bing Crosby tap-danced with . . . Well, you...more

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

COVID-19 Vaccine Leader Moderna “Not Aware of Any Significant Intellectual Property Impediments” in Development of its Vaccine...

Moderna, one of the global leaders in developing a safe and effective vaccine to combat COVID-19, appears poised to get through clinical trials with a vaccine that is based on mRNA technology. As was recently announced,...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

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

Silicon Valley Challenges the PTAB’s NHK-Fintiv Rule: Can IPRs Be Denied Based on Non-Statutory Factors?

Last week, four major technology companies – Apple, Cisco, Google, and Intel – brought suit against the United States Patent and Trademark Office (“USPTO”), challenging its authority to reject petitions for inter...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

Troutman Pepper Locke

Updated Guidance on Section 101 Subject Matter Eligibility

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On October 17, 2019, the U.S. Patent and Trademark Office issued a 22-page updated guidance document on subject matter eligibility under 35 USC §101.  Subject matter eligibility is becoming increasingly important in the...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

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

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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