12.18.2024

FTO Generic, check both Orange Book and FDA information at once

 

 What is the exact meaning of 'generic medicine', which was previously referred to as 'copy drugs'?

It refers to a medicine that is made using the disclosed technology of an original medicine whose patent has expired, and has the same main ingredient, content, formulation, efficacy, and dosage as the original medicine. It is a product that has been recognized by the pharmaceutical management agency of each country, such as the Ministry of Food and Drug Safety, as a product equivalent to the original medicine through a pharmaceutical equivalence test.

 A new medicine that a pharmaceutical company first makes is called an original. This medicine is protected by a patent. Generally, a patent is protected for 20 years from the date of application, but considering the period of product development, the actual effective patent period is about 15-18 years. Unlike other products whose sales volume drops sharply as the patent expiration date approaches, pharmaceutical sales tend to increase rapidly, so the patent protection period is often extended for several years. For this reason, the United States has been implementing the Patent Term Extension (PTE) system since 1984.

 Patent term extension is a system that extends the term of a patent for a certain period of time in cases where the patent cannot be actually enforced due to a long period of time required to obtain regulatory approval (Regulatory Review Period; RRP) during the patent term. After this system was introduced in the United States, other countries have introduced similar systems one after another. Korea also introduced the substance patent system in 1987, and the patent term extension system has been implemented since 1999. Multinational pharmaceutical companies devise protection strategies to effectively utilize the patent term extension system, and generic pharmaceutical companies devise various methods to avoid their patent extension strategies.

 With blockbuster diabetes treatment drugs set to expire one after another in the next three years, generic pharmaceutical companies are seeking various patent strategies to quickly enter the market and take the lead.

 The FDA is publishing the Orange Book to provide information on the evaluation of therapeutic equivalence of various prescription drugs to pharmacists in the United States. The Orange Book contains patent information on approved new drugs, and is used as important data for resolving pharmaceutical patent disputes. WIPS Global provides an FTO Generic search service by implementing a convergence service that links the Orange Book and US patents. Let’s take a look.

wipsglobal.com> FTO Generic

This is the Orange Book search field. You can search from three perspectives: product information, exclusive information, and related patent information (US registered patents).

wipsglobal.com> FTO Generic

 This is the search results screen. Based on the FDA application unit field, the corresponding product field is grouped (product number, type, pharmaceutical product name, patent number, dosage form; administration route, content, therapeutic equivalence code, reference drug) and displayed as a list.

wipsglobal.com> FTO Generic

 Click on the FDA application number to check the detailed information of the corresponding application information. This is a page that provides all the information held by the Orange Book. You can see product information, exclusive information, and related patent information (US registered patents) of the FDA application.

wipsglobal.com> FTO Generic

 Click on the patent number of the related patent (US registered patents) to go to the View Details and check detailed information such as bibliography, claims, description, trial/litigation, and chemical compounds.

wipsglobal.com> FTO Generic

 The related patent list is connected to ‘My Folder’ and ‘Easy Viewer’, so you can save it in My Folder or quickly review multiple patents.

wipsglobal.com> FTO Generic

 We provide a list of pharmaceutical patents that can be freely implemented. You can review the list of expired pharmaceuticals by selecting the year of expiration and the year of upcoming expiration.


 So far, we have looked at the FTO Generic search features provided by WIPS Global. 

Please make use of FTO Generic to view detailed information on new drugs and related patents from the Orange Book.




 

[International IP Briefing] JP, US

JP 

Patent Result Co.,Ltd in Japan announces ‘Pharmaceutical Industry Patent Asset Size Ranking 2024’

On October 30, 2024, Japanese Patent Result announced the ‘Pharmaceutical Industry Patent Asset Size Ranking 2024 (特許資産規模ランキング2024)’, which comprehensively evaluated the quality and quantity of patent assets held by each pharmaceutical company based on the Patent Result company’s own classification.

The Patent Result company assumed the patents held by companies (patent registrations approved by the Japan Patent Office, and not expired or abandoned) as ‘patent assets’ and calculated the patent score as an index for comprehensively judging the size of patent assets.

∙ The TOP 3 were ranked by evaluating patent scores for patents registered for one year from April 1, 2023 to the end of March 2024. F. HOFFMANN LA ROCHE ranked 1st, Merck ranked 2nd, and Pfizer ranked 3rd.

∙ Among La Roche’s most notable patents are ‘Novel heterocyclic compounds for the treatment of autoimmune diseases’ and ‘Thermal treatment device for in vitro diagnostic test samples’, and both technologies have been applied for in Japan, as well as with the EPO, the US, China, and other countries.

∙ Merck, ranked in 2nd, include ‘physical object tracking system for preventing product counterfeiting using automatic identification and authentication technology’ and ‘purification process for biopharmaceuticals and plasma derivatives using cellulose-containing filter materials’.

∙ Pfizer’s notable patents, ranked third, include technologies related to ‘antibodies that specifically bind to proteins (CD3) and their use to regulate immune responses and inhibit tumor growth’ and ‘cancer treatment inhibitors with desirable properties such as high crystallinity, purity, and stability.’

 

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US

The U.S. Artificial Intelligence Safety Institute (USAISI) announces the launch of the Testing Risks of AI for National Security (TRAINS)

On November 20, 2024, the U.S. Artificial Intelligence Safety Institute (USAISI) announced the formation of the Testing Risks of AI for National Security (TRAINS) Task Force (hereinafter referred to as the TRAINS Task Force).

USAISI, an agency within the National Institute of Standards and Technology (NIST) of the U.S. Department of Commerce (DOC), launched the TRAINS Task Force for National Security by bringing together partners from across the U.S. government to identify, measure, and manage emerging national security and public safety implications of rapidly evolving AI technology.

The TRAINS Task Force is chaired by USAISI and is comprised of four federal agencies (①-④). Each agency will provide expertise and resources to the TRAINS Task Force and collaborate on the development of new AI evaluation methods and benchmarks, as well as conduct joint training for national security risk assessment.

①The Department of Defense (DOD), including the Chief Digital and Artificial Intelligence Office (CDAO) and the National Security Agency

②The Department of Energy (DOE) and ten of its National Laboratories

The Department of Homeland Security (DHS), including the Cybersecurity and Infrastructure Security Agency (CISA)

The National Institutes of Health (NIH) at the Department of Health and Human Services (HHS)

Purpose and Role

∙ The TRAINS Taskforce, comprised of experts from U.S. federal agencies, aims to solve national security issues and strengthen America’s AI leadership.

 It will enable collaborative research and testing of advanced AI models in critical national security and public safety areas, including radiological and nuclear security, chemical and biological security, cybersecurity, critical infrastructure, and military capabilities.

 It will also maintain America’s leadership in AI development and prevent countries from misusing American innovation to undermine our national security.

- (Related)

Enabling safe, secure, and trustworthy AI innovation is not just an economic priority – it's a public safety and national security imperative,” said U.S. Secretary of Commerce Gina Raimondo. “Every corner of the country is impacted by the rapid progress in AI, which is why establishing the TRAINS Taskforce is such an important step to unite our federal resources and ensure we’re pulling every lever to address the challenges of this generation-defining technology. The U.S. AI Safety Institute will continue to lead by centralizing the top-notch national security and AI expertise that exists across government in order to harness the benefits of AI for the betterment of the American people and American business.”

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