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. Amgen secured a U.S. The post Biocon Settles with Janssen, Securing U.S.

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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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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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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

MAY 19, 2023

billion by 2025, at a compound annual growth rate of 32%. Intellectual Property Rights : The commercial deal between the parties may dictate that certain intellectual property rights (commonly copyright) in the end-product created by the influencer relating to a campaign are owned by the brand.

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IP Tech Blog

MAY 19, 2023

billion by 2025, at a compound annual growth rate of 32%. Intellectual Property Rights : The commercial deal between the parties may dictate that certain intellectual property rights (commonly copyright) in the end-product created by the influencer relating to a campaign are owned by the brand.

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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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LexBlog IP

FEBRUARY 23, 2024

Alvotech is still awaiting FDA approval of AVT04 in the United States, but has already secured a licensing agreement with Johnson & Johnson for the U.S. subject to regulatory approval, no later than February 21, 2025. Per the settlement agreement, AVT04 can be marketed in the U.S.,

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LexBlog IP

APRIL 17, 2023

Xolair’s substance patent has already expired and the formulation patent is set to expire in March 2024 in Europe and November 2025 in the U.S. Celltrion said that it “plans to complete the remaining phase 3 studies of CT-P39 and file for product license in Korea and key other countries later this year.”

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LexBlog IP

SEPTEMBER 28, 2023

has announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceuticals Co., According to the press release, the first molecules subject to the agreement are expected to launch as early as 2025. Insulin Biosimilars: Meitheal Pharmaceuticals, Inc. Anti-Tumor Biosimilars: Chime Biologics Ltd.,

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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

NOVEMBER 5, 2023

Under the IRA, drugs selected for the Program remain “selected drugs” until HHS determines that there is at least one product that is both “approved or licensed” as a generic or biosimilar of the selected drug and “marketed pursuant to such approval or licensure.”

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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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Kluwer Copyright Blog

DECEMBER 13, 2023

A full economic integration and IP harmonization might be possible in the future, since the ASEAN is already heading in that direction through the establishment of the ASEAN Free Trade AREA (AFTA) and the ASEAN Economic Community Blue Print 2025.

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LexBlog IP

OCTOBER 3, 2023

passport, license, or ID card. Compliance Timeline: Companies established or registered before January 1, 2024, have until January 1, 2025, to file their initial report. This includes their full legal name, date of birth, residential address, and a unique identification number from a valid U.S.

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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

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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LexBlog IP

JULY 25, 2023

A Reporting Company must, in a report to FinCEN, provide each beneficial owner’s name, date of birth, residential or business address, and a unique identifying number from an acceptable identification document (such as a state driver’s license or passport). What are the Reporting Timelines & Deadlines for Companies?

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LexBlog IP

JULY 31, 2023

The remaining six divisions, serving more rural areas, have been deferred to the 2025 Texas Legislature for approval and funding. Each of the five urban divisions will have two judges, and the remaining six rural divisions—if created and funded by the 2025 Legislature—will have one.

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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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IP Close Up

JANUARY 30, 2024

Since China became worldwide leader in patent applications in 2011, overtaking Japan, the number of its applications have soared. The question today is not so Continue reading

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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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Fish & Richardson Trademark & Copyright Thoughts

FEBRUARY 4, 2021

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. Legislation Relating to Biologics and Biosimilars. BPCIA Litigation. Antitrust Litigation. Post-Grant Challenges at the PTAB. Conclusion.

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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. Coherus intends to launch the product at EYLEA biosimilar market formation, currently expected to be in 2025, if approved.

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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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SpicyIP

APRIL 30, 2023

Case: Microsoft Technology Licensing, Llc Vs The Assistant Controller Of Patents And Designs On 24 April, 2023 (Delhi High Court) Image from here. adds Belarus, Bulgaria to intellectual property watch list. The dispute is around the interpretation of Section 3(k) by the court. Glenmark to pay USD 87.5

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LexBlog IP

AUGUST 25, 2023

Biologic drugs are eligible for inclusion in the Program if, by the time the drug is selected for the negotiation program, at least 11 years will have elapsed since the date of its initial licensure, and there is no licensed and marketed biosimilar product that lists it as the reference product.

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IP Tech Blog

OCTOBER 12, 2023

Of course, partisan approaches to AI policymaking also exist. Some therefore believe comprehensive federal legislation is not on the horizon this year, and instead smaller ( i.e. , not comprehensive) bills could possibly advance during the remainder of the current Congress (118th).

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LexBlog IP

OCTOBER 12, 2023

Of course, partisan approaches to AI policymaking also exist. Some therefore believe comprehensive federal legislation is not on the horizon this year, and instead smaller ( i.e. , not comprehensive) bills could possibly advance during the remainder of the current Congress (118th).

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