LexBlog IP

MARCH 6, 2024

On February 29, Biocon Biologics Ltd announced that it signed a settlement and license agreement with Janssen Biotech Inc. The agreement allows Biocon to launch in the United States in February 2025, pending FDA approval. Market Entry Date for Ustekinumab Biosimilar appeared first on Big Molecule Watch. Amgen secured a U.S.

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LexBlog IP

DECEMBER 13, 2023

The post Janssen and Samsung Bioepis Settle STELARA (Ustekinumab) Litigation appeared first on Big Molecule Watch.

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SpicyIP

OCTOBER 31, 2023

Image from here Recently, the Print reported that Novartis and Eli Lilly have voiced their opposition to the idea of compulsory licensing (“ CL ”) for breast cancer medications, Ribociclib and Abemaciclib. It also says that no licenses were given out. crore in revenue from 8,000 units sold, its first year on the market.

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LexBlog IP

AUGUST 16, 2023

On August 7, 2023, Formycon AG and Fresenius Kabi announced that they have reached a settlement with Johnson & Johnson (“J&J”) in the United States relating to FYB202, a proposed ustekinumab biosimilar to STELARA®, marketed by J&J. Economic terms of the settlement were not disclosed in the press release.

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LexBlog IP

JUNE 13, 2023

announced that they reached a settlement and license agreement with Johnson & Johnson regarding AVT04, Alvotech’s proposed biosimilar to STELARA (ustekinumab) in the United States. Alvotech and Teva Pharmaceuticals, Inc.

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The IPKat

AUGUST 13, 2024

Upcoming events Assimilate IP Autumn Courses and Webinars : Protecting Confidential Information, Trade Secrets and Know How : 11 September 2024 Freedom to Operate for Life Sciences and Pharma : 25 & 26 September 2024 Patent and Know How Licensing : 9 & 10 October 2024 IP Essentials – Patent or Trade Secret? Call for abstracts.

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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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Herbert Smith Freehills

OCTOBER 14, 2021

"Abbisko is dedicated to the discovery and development of innovative and differentiated small molecule oncology therapies and has strategically designed and developed a diversified pipeline of 12 programs with global R&D and commercialisation rights and selectively in-licensed two programs.". from 2025 to 2030. HK?????????06609.HK????????06669.HK??.

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Velocity of Content

MAY 25, 2023

The agreement enables MARC to include CCC’s comprehensive rights catalog in the licenses it offers to educational and academic institutions in Malaysia. MARC is an independent, not-for-profit organization acting as a collective licensing organization on behalf of publishers, authors, and visual creators in Malaysia.

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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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The IPKat

DECEMBER 17, 2024

The consultation is likely to elicit strong views from both sides of the debate; some rightsholders will be dismayed at the potential weakening of their rights in a very important market for creators, whereas AI developers will want to know how any proposals will apply in practice. The consultation runs until 25 February 2025.

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IAM Magazine

SEPTEMBER 23, 2021

A new high-level policy calls for growth by a metric that includes not just royalty receipts but also payments to foreign IP owners.

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The IPKat

NOVEMBER 14, 2022

a wise cat that care about environment kindly provided in CC0 Public Domain license by Pixhere.com) Having to make a selection among the many topics covered, this GuestKat finds it interesting to note that during the conference the EPO case G2/21 on 'plausibility', was repeatedly discussed from different angles.

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SpicyIP

JULY 8, 2024

CGPDTM Announces Dates for 2025 Trademark and Patent Agent Exams Dates for Trademark and Patent Agent Exams 2025 have been announced by the CGPDTM. The Trademark Agent Exam is likely to be held on January 04, 2025 and the Patent Agent Exam is likely to be held on January 5, 2025. Microsoft Technology Licensing LLC v.

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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.

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SpicyIP

OCTOBER 27, 2024

Call for Papers: NLU Jodhpur’s Journal of Intellectual Property Studies Volume IX, Issue I [Submit by January 10, 2025] National Law University, Jodhpur’s Journal of Intellectual Property Studies is inviting original, unpublished manuscripts for its upcoming issue (Volume IX, Issue I). The last date for submissions is January 10, 2025.

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SpicyIP

MARCH 15, 2024

This post does not, in any manner, get into the arena of willingness or unwillingness of defendants to enter into a licensing agreement. If the trial spills over to 2025, the defendants will have to bear the cost for that as well. I pose questions (rather than offer comments) with regard to the Court’s approach on bank guarantees.

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IAM Magazine

SEPTEMBER 23, 2021

A new high-level policy calls for growth by a metric that includes not just royalty receipts but also payments to foreign IP owners.

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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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The IPKat

DECEMBER 20, 2024

Against this backdrop, larger issues emerge as regards the power wielded by AI companies in the medium to long term especially in a consolidated market, over social, economic and political aspects of our lives. The EU equivalents are contained in Articles 3 and 4 of Directive 2019/790 on Copyright in the Digital Single Market.

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Kluwer Copyright Blog

DECEMBER 17, 2024

There is a shared interest in ensuring that AI companies have legal routes to license content in the quantity required by this revolutionary technology. They would hopefully shape an open-minded and balanced approach in licensing, legislating, policy-making, publishing and researching.

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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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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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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.

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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.

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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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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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Herbert Smith Freehills

SEPTEMBER 10, 2021

In early 2020, a group of legislators submitted to the House of Representatives to prohibit the installation and operation of coal-fired power plants nationwide by 2025. Bill 3729/2004 was also approved by Congress, which creates more flexible and simpler processes for environmental licensing within Brazil. . Developing Initiatives.

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Herbert Smith Freehills

SEPTEMBER 10, 2021

In early 2020, a group of legislators submitted to the House of Representatives to prohibit the installation and operation of coal-fired power plants nationwide by 2025. Bill 3729/2004 was also approved by Congress, which creates more flexible and simpler processes for environmental licensing within Brazil. . Developing Initiatives.

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Intepat

OCTOBER 6, 2024

As a result, businesses are leveraging patents to secure their innovations in green technology, ensuring they stay competitive in a market that values sustainability. Globalization and Harmonization of Patent Systems The globalization of markets and the interconnectedness of economies are driving the need for a more harmonized patent system.

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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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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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Fish & Richardson Trademark & Copyright Thoughts

DECEMBER 2, 2020

billion by 2025. [ii] The 2018 Farm Bill led to widespread availability of products containing CBD, which are commonly marketed as dietary supplements, drugs, food, and cosmetics. Contracts, such as cannabis patent licenses, could also be unenforceable under federal law. billion, with an expected increase to $29.7

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Kluwer Copyright Blog

NOVEMBER 14, 2024

101(1)(a) AI Act) and other enforcement measures, such as withdrawal of the model from the European market. The reproduction by LAION was found to have been made for the purpose of obtaining information on “correlations” within the meaning of TDM of Sect.

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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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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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LexBlog IP

APRIL 25, 2023

“[The] Government [is] committed to delivering a Data Marketplace by 2025, to provide a single front door for Government users to discover public sector data. and] will explore how this could be expanded. ” ICO should update its guidance for processing activities relating to AI as a service (AIaaS).

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