Posts Tagged: "Food and Drug Administration"

In a recent brief to the Patent Trial and Appeal Board (PTAB), Pfizer and BioNTech (Pfizer) told PTAB judges that Moderna’s dismissal of prior art listed in Pfizer’s August 2023 petition for inter partes review (IPR) of Moderna’s patent on mRNA vaccine technology is inconsistent with its declarations to the Food and Drug Administration (FDA) during the drug approval process. According to the brief, when Moderna was seeking approval for its COVID-19 vaccines, the company “candidly represented to the FDA that prior studies for related vaccines…supported an expectation of safety and efficacy. But now, faced with invalidating vaccine prior art…Moderna wrongly casts the same vaccine prior art as irrelevant.” The brief referred to this as a “litigation-driven one-eighty.”

On October 7, the Federal Trade Commission (FTC) sent letters to 10 pharmaceutical companies notifying them of the agency’s intent to challenge allegedly improper patent listings in the U.S. Food and Drug Administration’s (FDA) Orange Book. While the FTC argues that improperly listed patents can delay consumer access to affordable generics, some have questioned whether the FTC’s regulatory action could slow the development of new treatments, which would in turn delay access to new generics.

The U.S. Supreme Court on Friday added another case to its docket that challenges the Chevron Doctrine, a decades-old principle instructing lower courts to defer to federal agencies’ interpretations of ambiguous laws. The Court said it will hear Relentless, Inc. v. Dept. of Commerce in tandem with an almost identical appeal brought by Rhode Island herring fishers. Mark your bingo card if you had “Rhode Island herring fishers.”

The U.S. Solicitor General on Wednesday filed an amicus brief with the United States Supreme Court advising it to grant Teva Pharmaceuticals’ petition for writ of certiorari relating to generic manufacturers’ liability for infringement through the use of “skinny labels” on generic drugs. The SG’s brief said that the U.S. Court of Appeals for the Federal Circuit (CAFC) got it wrong, and that the decision could upend the careful balance contemplated by the Hatch-Waxman Amendments between incentivizing new brand name drugs and allowing cheaper generics into the market.

On February 24, the U.S. 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). Previously closed on February 6, the comment period on USPTO-FDA collaboration initiatives is now extended until March 10. The reason stated in the Federal Register notice for reopening and extending this comment period is to “ensure that all stakeholders have a sufficient opportunity to submit comments on the questions presented” in the agency’s RFC on ways that the two agencies could cooperate to improve market entry of generic drugs and biosimilars, and to reduce the number of patent grants related to certain drugs. The reopening of the comment period comes a few weeks after the USPTO also reopened and extended the deadline for responding to the agency’s RFC on ensuring robust and reliable patent rights. As reported at that time, while it’s understandable that the agency is interested in hearing from as many stakeholders as possible, some have said the extensions are creating uncertainty as to which stakeholders are being given more time to prepare their full comments for submission.

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.

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.”

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.

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.

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.

From the “one hand doesn’t know what the other hand is doing” category, believe it or not, the Food and Drug Administration (FDA) is effectively refusing to release documents it possesses relating to the approval of the Pfizer-BioNTech COVID-19 vaccine. More precisely, Public Health and Medical Professionals for Transparency (PHMPT), a group of doctors and scientists, submitted a Freedom of Information Act (FOIA) request for documents relating to the approval of the Pfizer COVID-19 vaccine. After the FDA denied a request by the PHMPT to expedite release of the documents, a lawsuit was filed. In response to that lawsuit, the FDA proposed to release 500 pages per month, which would allow the agency time to redact material as necessary. Given that there are 329,000 pages responsive to the PHMPT request, at the proposed FDA rate of 500 pages per month it would take 55 years for the FDA to fully release the Pfizer COVID-19 vaccine documents.

On the final day of IPWatchdog LIVE last week, a panel titled “Jurassic Patents: Genetic Engineering and the Future of Life Science Innovation,” moderated by president and CEO of the PCT learning center and founding partner of Berenato & White, John White, examined the challenges of patenting discoveries in the life sciences in light of recent legal developments. The panel included patent litigator and partner at Akin Gump, Dr. Rachel Elsby, patent prosecutor and shareholder with Volpe Koenig, Dr. Douglas Bucklin, and food and drug lawyer and counsel at McGuire Woods, Kae Gruner.

On Thursday, September 9, Senators Thom Tillis (R-NC) and Patrick Leahy (D-VT) sent a letter addressed to Drew Hirshfeld, performing the functions and duties of the Director of the U.S. 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). The Senators are asking the USPTO to take swift action to ensure that applicants are disclosing all known prior art at both the USPTO and the FDA.

Believe it or not, a recent op-ed in the Washington Post written by Robin Feldman took the position that pharmaceutical companies should charge prices for their drugs that would surely guarantee that they go bankrupt. An absurd position even for a law professor who is ideologically predisposed to an irrational hatred of patents, but precisely the position Feldman articulated. How someone as smart as a law professor does not understand basic business reality raises important questions about her intellectual honesty—or at the very least raises questions about whether she is truly an expert on this topic.