Posts Tagged: "FDA"

The U.S. Court of Appeals for the Federal Circuit (CAFC) today held in a precedential split decision authored by Judge Stoll that the safe harbor provision of 35 U.S.C.§ 271(e)(1) applied to Meril Life Sciences’ importation of two demonstration samples of its transcatheter heart valves to a medical conference. Judge Lourie dissented, explaining that both the district court and the Federal Circuit have erred in interpreting the statute, specifically by failing to adequately consider the word “solely,” under which interpretation it could be reasonably held that Meril “at least partially” imported the valves for commercial reasons.

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. 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.

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.

The U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration (FDA) today jointly held an all-day listening session featuring speakers from patient advocacy and industry groups, academia, and brand and generic pharmaceutical companies who weighed in on the relationship between patents and affordable access to medicines. The session was announced via a Federal Register Notice and request for comments on the subject, published on November 7, 2022, stemming from a joint July 2022 announcement that the two agencies plan 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.”

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.

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.

Innovator (or “reference”) biologic drug makers and small-molecule drug makers face differing legal obligations with respect to public patent disclosures. Under the Hatch-Waxman Act, reference small-molecule drug makers are required to provide to the U.S. Food and Drug Administration (FDA) a list of the patents covering the active ingredients, compositions, formulations, and methods of treatment for their approved reference drug products, which the FDA in turn is required to publish in its “Orange Book.”  21 U.S.C. § 355(b)(1), (c)(2). The publication of such patents in the FDA Orange Book thus gives all generic drug applicants advance notice of the patents to be asserted by a reference drug maker in future Hatch-Waxman litigation.

Last week, the U.S. Court of Appeals for the Federal Circuit addressed a question of first impression regarding whether an act of patent infringement occurs in a Hatch-Waxman case “only when and where an ANDA-filer submits its ANDA to the FDA [Food and Drug Administration] or occurs wherever future distribution of the generic is contemplated.” Valeant Pharmaceuticals v. Mylan Pharmaceuticals. The court ultimately determined the answer to be the former; however, in the case of a foreign defendant, venue is proper in any judicial district. The court ultimately determined the answer to be the former; however, in the case of a foreign defendant, venue is proper in any judicial district. It was the first time the court has had a chance to address the question of where infringement occurs in an ANDA case since TC Heartland v. Kraft Food Group Brands.

One thing you should never say in 2020 is: “Well, at least things can’t get any worse.” They can and often do. The latest exhibit—in the intellectual property space at least—is a letter to Health and Human Services (HHS) Secretary Azar, National Institutes of Health (NIH) Director Collins and Food and Drug Administration (FDA) Commissioner Hahn authored by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry. It’s also signed by 32 other state attorneys general, along with those representing the District of Columbia, Guam and American Samoa. They are demanding that the government use its authorities under the Bayh-Dole Act to march in against Gilead Sciences, the maker of the COVID-19-fighting drug remdesivir, so that it can be made more widely available at a lower cost.