IIPRD

APRIL 2, 2024

xii] This clause gives the original researchers ownership of their clinical trial data for a predetermined amount of time, usually ranging for a period of six years. If implemented, data exclusivity would create hurdles for generic drug developers who traditionally rely on originator’s clinical trial data for regulatory approval.

Intellectual Property 105

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LexBlog IP

AUGUST 24, 2023

In continuation of Goodwin’s previous webinar series concerning biosimilars, Big Molecule Watch is launching the 2023-2024 webinar series , which will dive deep into some of the key topics pertaining to this burgeoning industry and corresponding area of law.

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The IPKat

JULY 31, 2023

Readers can also watch this video interview with Thomas Böhmer, Head of IP at Pieris Pharmaceuticals, for a glimpse into his work and the topics that will be covered in October. The IPKat has also negotiated a special discount for readers. To save 10% please use VIP code IPKAT at checkout.

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IP Editing Intellectual Property Patent 52

The IPKat

SEPTEMBER 4, 2023

For ethical reasons, clinical trials will also often be conducted in patients who continue to receive standard-of-care throughout the trial. The judge also found Yeda to be entirely consistent with the (latest) CJEU case law on the topic, specifically Santen ( C-673/18 ) (para.

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Patently-O

NOVEMBER 29, 2023

Article III standing remains a hot topic at all levels of federal litigation and across many different areas of law. With surgery as the only viable course of treatment, Cloudbreak Therapeutics created a topical application of multikinase inhibitors to provide a non-surgical treatment to prevent recurring tumors, which is recognized in U.S.

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LexBlog IP

APRIL 13, 2023

The letters themselves are called Notice of Penalty Offense (Notice) letters, and since it has been awhile since we discussed the topic, we will provide a brief recap of the legal authority that the agency is invoking. Representing that a product is clinically proven in the absence of adequate evidence.

Advertising 52

Advertising Advertising Litigation Marketing 52

SpicyIP

MARCH 4, 2024

Here is another round of SpicyIP flashbacks by Lokesh, where he looks into a variety of topics ranging from IP and Gaming to Biodiversity and Benefit Sharing! approval for their under trial AI models. Clinical trials to commence soon. Do let us know your thoughts on these mini-guides in the comments below!

Invention 59

Invention Trademark IP Patent 59

43(B)log

FEBRUARY 17, 2022

Plaintiff ChromaDex sought to exclude defendant Elysium’s survey expert and damages rebuttal expert, while Elysium moved to exclude ChromaDex’s survey, damages, FDA regulation, and clinical studies experts. Each motion was granted in part and denied in part. He also concluded that the statements were material.

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False Advertising Advertising Advertising Social Media 59

43(B)log

JULY 20, 2023

Her education and research were insufficient to qualify her t o testify as to the clinical benefits of zinc and the prevention and treatment of COVID-19. He conducted no studies or research , led/participated in no clinical trials , and published no academic papers in any peer-reviewed journal.

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Government Advertising Advertising Social Media 52

IP and Legal Filings

MARCH 6, 2023

Doping in competitive sports is a controversial topic since it undermines fair play and sportsmanship at its core. It is urgent to change the NADA’s Disciplinary Tribunals’ current operating procedures because they frequently do not afford the opportunity for a fair trial and are adversely affected by the delays they produce.

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Law Government IP 76

Intepat

OCTOBER 17, 2023

Health and Education – Indispensable Factors Health consistently holds a prominent position in G20 conferences, with global discussions on this vital topic being a common occurrence. These significant advancements are poised to elevate the status of patent statutes to a new level.

IP 52

IP Intellectual Property Blogging Privacy 52

Fish & Richardson Trademark & Copyright Thoughts

DECEMBER 21, 2020

For example, experts in the medical field believe that blockchain could facilitate drug development by making the results of clinical trials more widely accessible. [5] We may dive into this topic in a future blog post. [2] ERC20 tokens that run on the Ethereum blockchain such as Crypto.com Coin (CRO). [see [link]. [3]

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Technology Copying Invention Patent Prosecution 76

Fish & Richardson Trademark & Copyright Thoughts

DECEMBER 2, 2020

For more information about any topic herein, please see our October 20, 2020 webinar, “ IP and Cannabis: The Current Landscape ,” or contact your Fish attorney. Nevertheless, the current IP landscape surrounding cannabis, while very much in flux, does allow for some forms of IP protection and enforcement. FDA Regulation.

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IP Registration Trademark Branding 52

Velocity of Content

APRIL 16, 2024

Often, the answer does not exist in a single source and must be gleaned from reviewing regulatory comments, clinical trial data, or patent filings. Additionally, the internet and social media have blurred the traditional distinction between actively searching for information and passively discovering content serendipitously.

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Social Media Journalism Licensing Publishing 111

Patently-O

SEPTEMBER 26, 2022

Topics: Enablement / Written Description (All three are biotech / pharma): 3 Cases; Infringement (FDA Labeling): 1 Case; Anticipation (On Sale Bar): 1 Case; Double Patenting (Still the law?) The setup involves an unpatented drug with multiple clinical uses, only some of which are patented. Amazon.com, Inc. ,

Patent Law 126

Patent Law Law Patent Invention 126

LexBlog IP

OCTOBER 19, 2023

What are some challenges and solutions for individualized CGTs that need to be tested and released rapidly, either because the product has a very short shelf life or because the patient’s clinical status may be rapidly declining and treatment is urgently needed?

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Editing Designs Design Technology 52

The IPKat

DECEMBER 22, 2023

G2/21 and the mysteries of plausibility The topic that this Kat has spent the most electronic ink on this year is undoubtedly G 2/21. After a flurry of decisions at the start of the year , the Boards of Appeal have gone rather silent on the topic of ViCo oral proceedings. This is one to watch for 2024.

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SpicyIP

JANUARY 9, 2023

Upon a few trial runs, she remarks that the platform is pretty user friendly and all the relevant information related to a judgement is made available to the user such as date of the decision, status of the case and case number within the platform. Continuing with our annual tradition, we curated a list of the top IP developments in India.

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Velocity of Content

FEBRUARY 22, 2023

This is done using enabled vocabularies including MeSH, ChEMBL, and SciBite VOCabs. In the Imbue study , they highlight that “ the ability to extract knowledge from data remains a primary goal and a key competitive advantage for life science companies.

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Branding Brands Branding Licensing 98

SpicyIP

NOVEMBER 13, 2023

In this month’s edition, he looks into topics including copyright and education, transparency and clinical trial data, Google ad-word cases, and more! The court held that despite being aware about the proceedings, the plaintiff took no steps to pursue the proceedings and thus find no error in the Trial Court’s judgement.

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Trademark Copyright IP Registration 59

Trademark and Copyright Law Blog

APRIL 7, 2020

In order to move this application to the Supplemental Register, the applicant would have to demonstrate active use of the mark in commerce for COVID-19 vaccines (at least in clinical trials), which would be great for non-trademark-related reasons! My Favorites of the (Mostly) Doomed Applications.

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LexBlog IP

DECEMBER 31, 2022

In the intellectual property (IP) space, there has been explosive growth in this area, with AI-based patent filings addressing trending areas, including disease identification and diagnosis, drug discovery, personalized medicine, and clinical trials, among others. The Mayo Clinic has a database of more than 7 million ECG records.

Intellectual Property 52

Intellectual Property IP Technology Privacy 52

Fish & Richardson Trademark & Copyright Thoughts

JANUARY 11, 2022

The continued slow pace of approvals is potentially the result of the COVID-19 pandemic and related delays in clinical trials and facility inspections by FDA, as well as a re-prioritization and shifting of agency resources towards COVID-19 vaccines and treatments. New FDA Guidance and Information. the -2258 case and the -2899 case.

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