Posts Tagged: "pharmaceutical patents"

An April 2025 report from the Initiative for Medicines, Access & Knowledge (I-MAK) titled, “The Heavy Price of GLP-1 Drugs,” presents grossly misleading information regarding the patent protection for semaglutide products (marketed by Novo Nordisk under the trademarks Ozempic, Rybelsus, and Wegovy) and tirzepatide products (marketed by Eli Lilly under the trademarks Mounjaro and Zepbound). The report accuses Novo Nordisk and Eli Lilly of engaging in patent abuse to extend protection for their products. This accusation is predicated on I-MAK’s assertion that these companies own large numbers of patents covering their respective products. But, as the United States Patent and Trademark Office (USPTO) noted in its recent Drug Patent and Exclusivity Study, “simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product because not every patent or exclusivity has the same scope.”

The Council for Innovation Promotion (C4IP) submitted its comments on the recent Listening Sessions hosted by the Federal Trade Commission (FTC) and Department of Justice (DOJ) on lowering drug prices in an August 15 letter addressed to Meredyth Andrus, an attorney in the Health Care Division, Bureau of Competition, at the FTC.

The Council for Innovation Promotion (C4IP) today issued a statement taking Congress to task for supporting a bill introduced in July that would limit the ability of patent owners to assert more than one patent from the same “Patent Group” in a patent infringement action, with the goal of addressing so-called patent thickets.

The U.S. Senate Committee on the Judiciary on Thursday convened an executive business meeting during which the full committee voted on a series of six drug patent-related bills towards a vote on the full floor of the Senate. While many of these bills were hailed by committee members as strong steps toward reining in consumer drug prices, the perceived problems addressed by these bills have been fomented by controversial data reports, leading to questions as to whether these bills will achieve their intended cost reductions without negatively impacting the next generation of pharmaceutical innovation.

On Thursday morning, the full U.S. Senate Judiciary Committee will convene an executive business meeting to consider several pieces of proposed legislation aimed largely at regulating patent-related activities in the pharmaceutical sector. Although one proposed bill would call for a study into the role of intermediaries in the pharmaceutical supply chain, the remaining drafts are meant to address perceived issues related to drug patents, many of which have been made more menacing by data reports that have been refuted by U.S. government sources.

IPWatchdog LIVE opened today with a sneak preview of the latest episode of the IPWatchdog Unleashed podcast, which will be published Monday, and where IPWatchdog Founder and CEO Gene Quinn will examine the current state of the U.S. Patent and Trademark Office (USPTO) in light of developments having to do with both the Trump Administration and the U.S. Court of Appeals for the Federal Circuit (CAFC). The combination of a patent application backlog that some now estimate to be 1.2 million, the administration’s potential firing of a large number of examiners, and CAFC cases that have held prosecution laches is presumed if it takes more than six years to obtain a patent, thus making a patent unenforceable, has led to a patent system Quinn said “feels to me an awful lot like the Titanic right now, and like we’re fast approaching an iceberg, with disaster imminent.”

My conversation this week with John White was much like any number of conversations we have had over the years over dinner or drinks. What prompted me to ask John to speak with us this week was an article he recently wrote, which we published on IPWatchdog. It was styled as an open letter to Elon Musk and Vivek Ramaswamy, the incoming co-leaders of the soon-to-be Department of Government Efficiency. In that article John explains that “the patent system is currently foundered”, but that it can be fixed with “focus and ongoing commitment to see the fixes through to results.” So, that is where we start our conversation, like so many we have had over the last 26 years—what is wrong with the patent system and how should it be fixed.

During IPWatchdog’s Life Sciences Masters program, which is taking place this week from Monday to Wednesday, panelists on the one hand breathed a sigh of relief that certain rule proposals considered most destructive to the industry seem unlikely to move forward, but on the other, lamented the overall negative tenor of the public debate around pharmaceutical patents today.

Within just over two months (between April 8 and June 13), data gathered by our firm revealed that 37 new Paragraph IV infringement lawsuits (citing 21 U.S.C. §355(j)(2)(A)(vii)(IV)) were filed against Abbreviated New Drug Applications (ANDAs). These numbers underscore that litigation remains a viable option even during the early stages of regulatory approval in the United States and other countries with “patent linkage” systems. As we know, the outcomes of these cases directly impact market dynamics within the pharmaceutical industry. Consequently, both innovators and generic manufacturers should carefully weigh the implications of such litigation.

On Monday, September 30, U.S. Senator Bill Cassidy (R-LA), Ranking Member of the Senate Committee on Health, Education, Labor, and Pensions, sent a letter  to Robert Califf, Commissioner of the Food & Drug Administration (FDA), urging the agency to issue guidelines clarifying requirements for listing patents covering FDA-approved drugs in the agency’s Orange Book. Cassidy’s letter criticizes the FDA’s inaction in response to industry pleas for clarity, calling for quick action to address confusion created by the Federal Trade Commission’s (FTC) recent enforcement campaign against allegedly improper Orange Book patent listings.

The U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday told the U.S. District Court for the District of Delaware that it “misapprehended its role in adjudicating the issue of patentability” when it sua sponte determined claims of Astellas Pharma’s patent invalid under 35 U.S.C. § 101 as directed to an ineligible natural law. The opinion was authored by Judge Lourie.

Although Professors Sean Tu and Aaron Kesselheim have advocated for legislation to respond to the Federal Circuit’s 2021 opinion in GSK v. Teva, that case did not—as they assert—“threaten[] to nullify every skinny label carveout.” Rather, the Federal Circuit applied the unremarkable principle that generic drug manufacturers are obligated to ensure that their labeling and other representations do not induce infringement of an innovator’s method-of-use patents. Consistent with this longstanding principle, generic drug manufacturers continue to pursue skinny labeling strategies. In fact, several recent court decisions have distinguished GSK and found lack of inducement by a generic applicant’s proposed labeling, showing that skinny labeling strategies have not been “nullified.” 

The U.S. Chamber of Commerce today responded to a recent U.S. Patent and Trademark Office (USPTO) report that the Chamber says proves much of the data that is often cited as proof of life sciences companies abusing the patent system is “more fiction than truth.” According to the USPTO, the report, published on June 12, shows that “simply quantifying raw numbers of patents and exclusivities is an imprecise way to measure the intellectual property landscape of a drug product because not every patent or exclusivity has the same scope.”

In May 2024, the Brazilian Senate Committee on Science, Technology, Innovation, and Informatics hosted two public hearings to discuss implementing Regulatory Data Protection (RDP) for pharmaceutical products of human use. The call for hearings (REQ 27/2023) was presented by Senator Izalci Lucas (Liberal Party). While recognizing that regulatory changes would have significant implications for the local industry, the healthcare system, and consumers, Sen. Lucas expressed concern that a lack of measures could discourage investment in R&D.