LexBlog IP

AUGUST 30, 2023

market on March 7, 2025, if approved by FDA. J&J also recently filed a confidential settlement and license agreement to terminate a Samsung Bioepis challenge to all claims of U.S.

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Settlement Confidentiality Marketing Marketing 52

LexBlog IP

FEBRUARY 23, 2024

The settlements cover Canada, the European Economic Area, and Japan, clearing the way for Alvotech to launch AVT04 in those markets, where AVT04 has already received regulatory approval. Alvotech has commercial partners for AVT04 in each of the aforementioned markets. Per the settlement agreement, AVT04 can be marketed in the U.S.,

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Settlement Marketing Marketing Licensing 52

LexBlog IP

JANUARY 12, 2023

Coherus plans to file an abbreviated Biologics License Application (aBLA) with the FDA later this year and intends to launch the product at EYLEA biosimilar market formation, currently expected to be in 2025. The parties expect to complete the transaction in Q1 2023.

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Marketing Marketing Licensing Intellectual Property 52

LexBlog IP

JANUARY 16, 2023

The European Commission expressed its hope that the provisions of the regulation will enter into force across all EU member states in 2025. If approved, the EHDS proposal would introduce a new regime for the compulsory licensing of health data to third parties.

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Intellectual Property Confidentiality Business Advertising 52

LexBlog IP

SEPTEMBER 28, 2023

has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., to commercialize several of Abbott’s oncology, women’s health, and respiratory disease biosimilars for emerging markets in Latin America, Southeast Asia, the Middle East, and Africa. Insulin Biosimilars: Meitheal Pharmaceuticals, Inc.

Marketing 52

Marketing Marketing Contracts Registration 52

LexBlog IP

NOVEMBER 5, 2023

The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program. According to a reported statement from Amgen, its settlement agreement with Janssen allows Amgen to sell WEZLANA “no later than January 1, 2025.”

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Marketing Marketing Government Litigation 40

LexBlog IP

FEBRUARY 1, 2024

In October 2023, Accord settled with Janssen Biotech under confidential terms that would allow Accord to launch its proposed ustekinumab biosimilar no later than May 15, 2025, pending FDA approval.

Confidentiality 52

Confidentiality Reporting Licensing Marketing 52

LexBlog IP

JANUARY 25, 2024

FDA Approvals In 2023, there were 23 FDA approvals of Biologic License Applications , including for Vertex’s CASGEVY and Bluebird’s LYFGENIA, the first cell-based gene therapies for the treatment of sickle cell disease. As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023.

Marketing 52

Marketing Marketing Licensing Litigation 52

LexBlog IP

JANUARY 17, 2024

Any reporting company that is created or registered before January 1, 2024, must file a BOI report no later than January 1, 2025. The CTA takes effect on January 1, 2024.

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Reporting Business Editing Ownership 52

LexBlog IP

AUGUST 29, 2023

Any reporting company that is created or registered before January 1, 2024, must file a report no later than January 1, 2025. Reports will not be accepted prior to January 1, 2024. FinCEN is currently in the process of creating the specific reporting system and additional regulations surrounding the CTA.

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Reporting Ownership Business Editing 52

Kluwer Copyright Blog

DECEMBER 13, 2023

In this post, the focus is on the unlicensed use of copyright-protected works in the context of training GenAI models, where such use could jeopardise the market for those particular expressions (see Sobel ). It appears that a one-size-fits-all approach to training data licensing may not be optimal for the ASEAN.

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Copyright IP Music Licensing 52

LexBlog IP

AUGUST 14, 2023

Reporting Companies created before January 1, 2024, have one year (until January 1, 2025) to file the required information. Reporting Companies created on or registered prior to January 1, 2024, are not required to report their Company Applicant. When do I Need to Report By? The rule goes into effect January 1, 2024.

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Business Ownership Reporting Registration 52

Fish & Richardson Trademark & Copyright Thoughts

DECEMBER 2, 2020

billion by 2025. [ii] As with any growing industry, cannabis stakeholders are eager to protect their valuable intellectual property (IP) rights, but their ability to obtain comprehensive IP protection and enforce their IP rights is sometimes in conflict with federal drug law. billion, with an expected increase to $29.7

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IP Registration Trademark Branding 52

Fish & Richardson Trademark & Copyright Thoughts

FEBRUARY 4, 2021

At the same time, market uptake of biosimilars in the United States continued to increase, suggesting that there is room for expansion of biosimilars in the U.S. For the first time since FDA licensed the first biosimilar, Sandoz’s Zarxio ® (filgrastim-sndz), in 2015, the United States saw a decrease in annual biosimilar approvals in 2020.

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Litigation Settlement Marketing Marketing 52

LexBlog IP

DECEMBER 28, 2023

Reddy’s”) to license Dr. Reddy’s proposed biosimilar abatacept for the development and commercialization of COYA 302 for the treatment of neurodegenerative conditions. Ltd. (“THDB”) to market three biosimilars of the top selling branded insulins in the United States – asprat, lispro and glargine.

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Licensing Reporting Marketing Marketing 52

LexBlog IP

APRIL 25, 2023

” Government should announce a clear policy position on the relationship between intellectual property law and generative AI to provide confidence to innovators and investors. labelling) on generated output to support right holders of copyrighted work. . and] will explore how this could be expanded.

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Technology Government Reporting Intellectual Property 52

LexBlog IP

AUGUST 25, 2023

In effect, the Maximum Fair Price (MFP) must be set at no more than 40-75% (depending on how long the product has been on the market without generic or biosimilar competition) of what the drug’s average manufacturer price was in the year 2021. Beginning in 2025, CMS will publish its selected drugs on February 1.)

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