Posts Tagged: "Food and Drug Administration"

A Look at the Comments on USPTO-FDA Collaboration Initiatives: How Bad Data Could Chill Critical Drug Innovation

In the days leading up to the recent all-day listening session on initiatives pursued by the U.S. Patent and Trademark Office (USPTO) and the U.S. 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. Some comments cited data pointing to supposed issues with artificially extended market exclusivity for branded drugs, while at least one pharmaceutical firm called out a well-known data source as improperly inflating that company’s patent data. Suggestions for intra-agency collaboration included more access to drug dossier information during patent prosecution, although concerns were also raised regarding the prospect that such increased engagement could tax agency resources to the detriment of all patent applicants.

Deadline to Register as a Speaker at the Public Listening Session on USPTO-FDA Collaboration Efforts Almost Here

he United States Patent and Trademark Office (USPTO) sent out a reminder today to those interested in speaking at an upcoming Public Listening Session on collaboration efforts between the USPTO and Food and Drug Administration (FDA) that they must sign up to participate by January 5, 2023. The listening session will be held on January 19, 2023. Speakers must attend in person. Those who just wish to listen, virtually or in person, must register for the event by January 17, 2023. The Federal Register Notice announcing the listening session and request for comments on the subject was published on November 7, 2022 and relates to a joint July 2022 announcement of the USPTO and FDA that the Office plans to execute a number of initiatives aimed at lowering drug prices, as directed in July 2021 by President Joe Biden’s “Executive Order on Promoting Competition in the American Economy.”

‘What’s in a Name?’ When it Comes to Approval for a Drug Name, a Lot

The process of bringing a new pharmaceutical drug to market is time-consuming and expensive. The process of naming the new drug, while not as scientifically complex, is often no less work. Drugs have several names, including their chemical (or scientific), generic (or non-proprietary) and brand (or proprietary) names. The chemical name specifies the molecular structure of the drug. The generic name specifies the underlying compound of the drug and includes a “stem” that informs health care professionals about how the drug will work in the body. In the United States, generic names must be approved by the United States Adopted Names (USAN) Council and the World Health Organization (WHO) INN Programme. While the chemical and generic names may be available for use by others in the industry, the brand name—under which the new drug is typically marketed—is unique and exclusive to the brand owner and is the focus of this article.

Vidal Takes Next Step on Senators’ Call to Curb Inconsistencies in USPTO/FDA Statements

Late last week, United States Patent and Trademark Office (USPTO) Director Kathi Vidal announced in a blog post that the agency had issued a notice in the Federal Register, which was published on Friday, to clarify the duties of disclosure and reasonable inquiry for pharmaceutical patent applicants, as well as parties to Patent Trial and Appeal Board (PTAB) proceedings. 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.

Use of Research Tools May Expose Companies to Patent Infringement Claims

The safe harbor provision set forth in 35 U.S.C. § 271(e)(1) immunizes many types of activities in pursuit of a Food and Drug Administration (FDA) submission from patent infringement claims. Research tools are frequently used in pursuit of an FDA submission, such as drug development, testing and screening. But research tools themselves generally are not subject to FDA or other regulatory approval. Depending on the circumstances, using research tools to submit data to the FDA may not be protected by the safe harbor provision and thus may expose companies to patent infringement claims.