Posts Tagged: "FDA"

Pfizer Alleges Inconsistencies in Moderna’s Statements to FDA and PTAB

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.”

FTC’s 100-Patent Orange Book Challenge Creates Uncertainty for Pharma Patent Listings

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.

Is the Food and Drug Administration Killing Chevron Deference?

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.”

CAFC Affirms Mixed Ruling on Pulmonary Hypertension Drug Patent, Noting ‘Safety and Efficacy’ is for FDA

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Monday issued a precedential decision affirming a district court’s mixed ruling in a patent infringement case involving two patents owned by United Therapeutics on the pulmonary hypertension drug, Tyvaso.
U.S. Patent 10,716,793 and U.S. Patent 9,593,066 cover methods of treating pulmonary hypertension and pharmaceutical compositions comprising treprostinil—Tyvaso is an inhaled solution formulation of treprostinil. United Therapeutics also owns a new drug application (NDA) for Tyvaso, No. 022387.

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.