IP Watchdog

APRIL 5, 2022

On Friday, April 1, Senator Thom Tillis (R-NC) wrote to the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO) to once again voice his concerns about several sources advancing data on the effects of pharmaceutical patents on drug pricing.

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JD Supra Law

AUGUST 5, 2022

On July 29, 2022, the United States Patent and Trademark Office (USPTO) issued a Notice by Director Kathy Vidal that may be relevant to those seeking or holding patents on medical devices that require Food and Drug Administration (FDA) approval. By: Knobbe Martens

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JD Supra Law

AUGUST 5, 2021

Has the Food and Drug Administration (FDA) finally ushered in a new era for the U.S. Many in the industry are hopeful after the Agency approved its first interchangeable biosimilar, Mylan’s Semglee (insulin glargine) on July 28, 2021. biosimilar marketplace? By: Mintz - Health Care Viewpoints

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IP Watchdog

FEBRUARY 27, 2023

Patent and Trademark Office (USPTO) issued a notice in the Federal Register indicating that the nation’s patent agency was reopening the comment period related to its request for comments (RFC) on collaboration initiatives with the U.S. Food & Drug Administration (FDA). On February 24, the U.S.

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IP Watchdog

SEPTEMBER 12, 2021

Patent and Trademark Office (USPTO), discussing the issue of inconsistent statements made by patent applicants pursuant to their disclosure requirements at the USPTO and other federal agencies, especially the U.S. Food and Drug Administration (FDA).

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IP Law 360

NOVEMBER 7, 2022

Food and Drug Administration warned the Federal Circuit on Monday that the court risked upending the way the agency awards exclusivity to drugs and provides incentives to create new ones if it sides with Sandoz Inc.

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IP Watchdog

FEBRUARY 15, 2022

Food and Drug Administration (FDA), expressing concern about policymaking on drug patents and drug prices being driven by a narrative rooted more in policy goals than in actual data. Earlier this month, Senator Thom Tillis (R-NC) sent a letter to the U.S. Patent and Trademark Office (USPTO) and to the U.S.

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JD Supra Law

AUGUST 11, 2023

Food and Drug Administration (FDA) to approve “indications for use” of their products–for use selling them in the U.S. In both cases, the companies seek to persuade federal government agencies to approve their requests. Medical Device companies often need the U.S. Those same companies often seek U.S.

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JD Supra Law

OCTOBER 12, 2021

Food and Drug Administration (FDA), sent a letter to Andrew Hirshfeld, Director of the U.S. The Letter called upon the agencies’ cooperation to address FDA’s patent-related concerns, specifying three practices by which FDA asserts pharmaceutical patentees may abuse the.

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IP Watchdog

JANUARY 30, 2023

Food and Drug Administration (FDA) to address drug patent issues, 30 public comments were filed in response to the Federal Register notice issued last November seeking input on ways that both agencies could promote both innovation and patient access to generic pharmaceuticals.

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LexBlog IP

DECEMBER 26, 2023

Food and Drug Administration (FDA) and the Health Products Regulatory Authority (HPRA), on behalf of the European Medicines Agency (EMA). The news comes shortly after FDA approval of CASGEVY, which we recently reported here. An approval decision by the European Commission is expected in February 2024.

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IP Watchdog

AUGUST 1, 2022

The notice was specifically targeted to parties proceeding before both the USPTO and Food and Drug Administration (FDA) and was issued in response to urging by Senators to establish interagency communications aimed in part at eliminating so-called drug patent thickets.

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LexBlog IP

FEBRUARY 6, 2024

The case, which involves alleged unlawful disclosure of trade secrets by government officials to generic drug competitors, presents several issues of first impression. At the core of the case are two of Vanda’s brand-name drugs, Fanapt and Hetlioz. The legal battle between VANDA Pharmaceuticals, Inc.

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LexBlog IP

NOVEMBER 16, 2023

Earlier today, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) granted conditional marketing authorization to Vertex Pharmaceuticals and CRISPR Therapeutics for their CRISPR/Cas9 gene therapy, CASGEVY (exagamglogene autotemcel), marking the world’s first regulatory approval for a CRISPR-based gene-edited therapy.

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IP Law 360

MAY 17, 2023

Food and Drug Administration with questions Wednesday during oral arguments about the expedited approval the agency gave decades ago to a now widely used abortion medication, while also picking apart the arguments of anti-abortion physicians who claim they face imminent harm by the drug's approval.

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JD Supra Law

DECEMBER 14, 2022

The United States Patent and Trademark Office (USPTO) issued updated guidance on the duty of candor and duty to disclose in relation to submissions made to other government agencies, particularly the Food and Drug Administration (FDA).

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IP Law 360

APRIL 19, 2023

Food and Drug Administration in Maryland federal court Wednesday to prevent the agency from "upending nearly a quarter-century of public reliance on a safe and effective drug" by enforcing attempts to interfere with its approval process. The generic maker of the abortion medication mifepristone sued the U.S.

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IP Law 360

NOVEMBER 18, 2022

Food and Drug Administration to pull a patent that purportedly covers a narcolepsy drug from the agency's so-called Orange Book after a Delaware federal court found that it covers a distribution method and not the drug itself. Jazz Pharmaceuticals has two weeks to ask the U.S.

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IP Law 360

OCTOBER 12, 2022

Food and Drug Administration's decision to give exclusivity to a Sanofi multiple sclerosis drug, saying at the D.C. Circuit that the agency's decision was "legally unsupportable." Novartis unit Sandoz is continuing its fight against the U.S.

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IP Law 360

NOVEMBER 23, 2022

Food and Drug Administration to pull a patent that purportedly covers the distribution of a narcolepsy drug from the agency's so-called Orange Book while it appeals. Jazz Pharmaceuticals has asked a Delaware federal court to pause an order requiring it to ask the U.S.

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IP Law 360

JULY 6, 2022

Food and Drug Administration to work more closely on generic drug matters, leaders at both agencies said Wednesday that they were trying to strengthen the patent system to curb abuse. Amid congressional calls for the U.S. Patent and Trademark Office and the U.S.

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IP Watchdog

DECEMBER 2, 2022

Food and Drug Administration halts authorization for Eli Lilly’s COVID-19 treatment for lack of effectiveness against dominant Omicron subvariants; and more. Court of Appeals for the Federal Circuit to Reject Attempts to Curb Delaware Chief Judge’s Litigation Funding Rules; the U.S.

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LexBlog IP

JULY 21, 2023

Food and Drug Administration (FDA) accepted for review its Biologics License Application (BLA) for DRL_RI, a biosimilar referencing RITUXAN (rituximab). On July 12, Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s) announced that the U.S.

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IP Law 360

SEPTEMBER 14, 2022

Food and Drug Administration with a suit on Wednesday in D.C. federal court over what it says are the agency's "sharply uneven" standards for blood medications, arguing it was subjected to multimillion-dollar clinical trials while competitors were allowed to skip the "critical step."

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Above the Fold

AUGUST 29, 2021

Whether the United States Patent and Trademark Office (USPTO) possessed trademark registrations for its own trademarks was honestly not something I had ever thought about before. It appears the reason for doing so after so many years is based on the increase in misleading solicitations and trademark filing scams.

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LexBlog IP

AUGUST 29, 2021

Whether the United States Patent and Trademark Office (USPTO) possessed trademark registrations for its own trademarks was honestly not something I had ever thought about before. It appears the reason for doing so after so many years is based on the increase in misleading solicitations and trademark filing scams. military. .”

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U.S. Department of Commerce

AUGUST 9, 2021

Imagine you are a trademark applicant who receives a notice in the mail from an agency claiming to be the USPTO, with an almost identical logo, informing you that the USPTO will deny or cancel your registration unless you pay a required fee. Some of these scammers attempt to impersonate the USPTO or claim varying forms of endorsement.

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LexBlog IP

AUGUST 31, 2021

Food & Drug Administration (FDA). From the start, FDA’s regulatory position has been complicated by CBD’s previous approval as the active ingredient in the prescription drug Epidiolex. Subject to limited exceptions, the active ingredient in a drug cannot be added to food or dietary supplements.

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IPilogue

MARCH 9, 2023

Health Canada, in a joint effort with the US Food and Drug Administration and the U.K. ‘s Medicines and Healthcare Products Regulatory Agency, has identified ten guiding principles to inform the development of Good Machine Learning Practices (the dominant method used to train AI systems).

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JIPL Online

APRIL 22, 2021

By: Eddy Atallah Since the inception of the Hatch-Waxman Amendments, the Food and Drug Administration’s (FDA) determination for three-year clinical investigations exclusivity was generally unquestioned. FDA brought about significant interpretive challenges to the provision and questions about agency deference.

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LexBlog IP

JULY 20, 2021

Among the 72 initiatives set forth in the Order are instructions that charge various agencies with tasks to promote generic and biosimilar competition. The post President Biden Issues Executive Order Including Provisions To Promote Generic Drug and Biosimilar Competition in the American Economy appeared first on Big Molecule Watch.

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Velocity of Content

MAY 2, 2023

JR: The last few years have witnessed the ongoing expansion of real-world healthcare data (RWD) sources, which has been accompanied by a rise in the recognition and approval of these data by global regulatory agencies, including the U.S. Tell us an interesting fact about Linguamatics that people may not know. How are we responding?

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The IPKat

MAY 5, 2023

For example, the National Agency for Food and Drug Administration and Control (NAFDAC) permits the use of the acceptance notices to proceed with registration of food and drug products with the agency pending the receipt of trade mark registration certificate. Negotiation fails.

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JIPL Online

APRIL 22, 2021

i] This confusion has a direct impact on the willingness to invent, drug pricing, the recovery of research and development (R&D), and other basic purposes of the Act. [ii]. iii] Often, a new clinical purpose, or “clinical investigation,” includes the development of a new dosage form or route of administration. By: Eddy Atallah.

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LexBlog IP

SEPTEMBER 24, 2022

The objective of the Executive Order is to “coordinate a whole-of-government approach to advance biotechnology and biomanufacturing towards innovative solutions in health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.” ” Data Initiative.

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LexBlog IP

AUGUST 9, 2022

If you have been to any kind of spa, beauty supply store or health food store in the past four years, chances are you have seen, if not purchased, a product with cannabidiol (CBD). CBD products that are mislabeled as THC-free can create problems for individuals subject to workplace drug testing.

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Above the Fold

JULY 16, 2021

The Food and Drug Administration (“FDA”) and U.S. Because both of these agencies have primary jurisdiction over their own regulated products, they can choose whether or not they would like to change their requirements to conform to the requirements set out in the FTC’s new rule.

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