News & Analysis as of

Life Sciences Biosimilars Intellectual Property Protection

Jones Day

U.S. Senate Unanimously Passes Bill Limiting Number of Patents Asserted Against Biosimilar Applicants

Jones Day on

The Situation: Senate Bill 150 ("S.B. 150")—the Affordable Prescriptions for Patients Act of 2023—unanimously passed the Senate and would amend 35 U.S.C. § 272(e) to limit, under certain circumstances, the number of patents...more

Goodwin

Amgen and Sandoz Settle Denosumab BPCIA Litigation

Goodwin on

As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab...more

Morgan Lewis

Blockbuster Biologics Review - Issue 23

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

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] Pharma & Biotech Patent Litigation Conference in Europe - May 29th - 30th, Amsterdam, Netherlands

Hosted by C5 Group, the 17th Annual Forum on Pharma & Biotech Patent Litigation in Europe returns for another exciting year with curated programming that will provide up-to-the-minute information and strategic insights on...more

Mayer Brown

BioUtah Podcast with Vera Nackovic

Mayer Brown on

Join BioUtah president & CEO Kelvyn Cullimore and Mayer Brown’s Vera Nackovic in a discussion about current trends and issues in the life sciences industry....more

Morgan Lewis

Blockbuster Biologics Review - Issue 22

Morgan Lewis on

Welcome to the latest issue of Blockbuster Biologics Review, which covers the status and developments of post-grant challenges and patent litigations implicating blockbuster biologics and legislative proposals related to...more

Hogan Lovells

日本企業を取り巻くAPACライフサイエンス産業において、ゼネラルカウンセルが注目する重要課題についてパネリストが議論

Hogan Lovells on

2023年10月4日に東京事務所にて開催された「ライフサイエンス・サミット」では、ホーガン・ロヴェルズのライフサイエンス・ヘルスケア分野のアジア太平洋(APAC)リードであるフレデリック・チェン博士(東京事務所代表パートナー)、メリッサ・ビアンキ(ワシントンDC事務所パートナー)、ペニー・パウウェル(ロンドン事務所パートナー)、カレン・テイラー(ノーザンバージニア事務所パートナー)、へイン・ファン・デン・ボス(アムステルダム事務所パートナー)が、...more

Goodwin

Celltrion Expands Access to YUFLYMA (adalimumab-aaty)

Goodwin on

On October 5, Celltrion Healthcare Co. announced that it has signed a contract with Ventegra, a major U.S. Medical Benefits Manager (MBM) “who administers pharmacy benefits through its Pharmacy Services Administration (PSA)...more

American Conference Institute (ACI)

[Webinar] 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 10th - 26th, 1:00 pm EST

Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more

Morgan Lewis

Blockbuster Biologics Review - Issue 20

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

Smart & Biggar

Update on biosimilars in Canada – March 2023

Smart & Biggar on

In this article, we provide a further update on developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory, market access and competition) since our last update in June 2022....more

Smart & Biggar

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more

Morgan Lewis

Blockbuster Biologics Review | Issue 18

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...more

Morgan Lewis

Blockbuster Biologics Review | Issue 17

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

McDonnell Boehnen Hulbert & Berghoff LLP

President Biden's Biotechnology and Biomanufacturing Executive Order: Funding

President Biden announced his signing of an Executive Order launching a major effort to enhance U.S. capabilities in biotechnology and biomanufacturing last week (see "President Biden Signs Executive Order on Biotechnology...more

McDonnell Boehnen Hulbert & Berghoff LLP

Penguin Genetics Suggests Complex History

Penguins are unique among bird species, having lost the ability to fly more than 60 million years ago and adopting a "hyperspecialized marine body plan" consistent with their unique habitat in the higher latitudes of the...more

Morgan Lewis

Blockbuster Biologics Review | Issue 16

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

American Conference Institute (ACI)

[Event] 13th Summit on Biosimilars & Innovator Biologics - June 28th - 29th, Boston, MA

This June, join the “who’s who” of the biosimilars and innovator biologics industries as they gather in Boston for ACI’s 13th Annual Summit on Biosimilars & Innovator Biologics....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

[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

Proskauer - Life Sciences

Preparing for Europe’s Unified Patent Court

After years of contemplation and delays, Europe’s Unified Patent Court will be operational in about one year. U.S.-based Life Sciences patent applicants should start preparing now to ensure that their applications withstand...more

American Conference Institute (ACI)

[Complimentary Conference] Pharma & Biotech Patent Litigation - February 23rd - 24th, 9:00 am - 5:00 pm CET

15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more

Smart & Biggar

2021 Highlights in Canadian Life Sciences IP and Regulatory Law

Smart & Biggar on

In the fall of 2021, the Rx IP Update team celebrated its 20thyear of monthly updates on Canadian life sciences IP and regulatory law. Below are highlights from our team’s 2021 updates...more

Goodwin

FDA Approves First Interchangeable Biosimilar Insulin Product - Update

Goodwin on

July 28, 2021 - the U.S. Food and Drug Administration (FDA) approved Viatris Inc.’s (formerly Mylan Pharmaceuticals Inc.) SEMGLEE (insulin glargine-yfgn), a biosimilar to LANTUS (insulin glargine). According to the press...more

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