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The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today in Otsuka America Pharmaceutical, Inc. v. Hetero Labs Limited, affirming a preliminary injunction that blocks Hetero Labs Limited from launching a generic version of the neurological drug Nuedexta. The court also vacated a district court order that had excused Otsuka from posting a bond pending appeal, remanding the issue for further proceedings. Circuit Judge Dyk dissented in part from the majority’s claim construction and would have reversed the injunction.
Most patent attorneys know the Jerome Lemelson story—the prolific inventor whose aggressive use of continuation and continuation-in-part applications resulted in some patents remaining pending for decades, earning the label of “submarine patents.” While Lemelson’s tactics sparked controversy and eventual legislative reforms aimed at curbing undue delays, one principle emerged clearly from his experiences: new matter in patent law must receive a new priority date…. To patent applicants, 35 U.S.C. § 132(a) means that the detailed description of their non-provisional patent applications must be perfect when filed, and that even if new information is discovered after filing, no changes can be made. In practice, this is an extremely harsh standard, and is disproportionately punitive to small business inventors who lack the deep pockets to absorb repeated filing costs and years of delay.
The U.S. Court of Appeals for the Federal Circuit (CAFC), in a Per Curiam opinion, today affirmed a Trademark Trial and Appeal Board (TTAB) ruling that the mark MON AMI is confusingly similar to the previously registered mark, AMÌ, and that MON AMI could therefore not be registered.
This week on IPWatchdog Unleashed, I spoke again with Fran Cruz, Senior Vice President of IP Solutions for Juristat. Our conversation was about a topic that should be top of mind for every patent prosecution firm, every in-house IP department, and every legal operations professional trying to make sense of the current market for patent related legal work. Where is patent prosecution work going, when does work move from firm to firm, when it does move, where is it moving, and what will firms have to do to win—or keep—the patent preparation and prosecution work?
This week on IPWatchdog Unleashed, my conversation with patent broker Louis Carbonneau centers on a fundamental breakdown in the economic engine that has historically driven innovation. While innovation itself has not disappeared, the incentive structure that once enabled a repeatable cycle—innovate, patent, monetize, reinvest—has eroded. Large market participants increasingly operate under a “use now, pay later (if ever)” model, which disproportionately disadvantages individual inventors and smaller entities. As a result, many innovators are unable to sustain continued development beyond an initial breakthrough, leading to a systemic drag on long-term innovation output. This shift is reinforced by a broader cultural normalization of “free” access to intellectual property, which has migrated from the copyright into the patent and innovation industry.
Patent monetization is often discussed as if the hard part begins when a patent owner makes the decision to license, sell, finance, or enforce its patent assets. That is a mistake and demonstrates a lack of understanding of the difficulties and complexities of patent monetization. By the time a patent owner is sitting across the table from a potential licensee, buyer, lender, litigation funder, or accused infringer, much of the outcome has already been fully determined. The real work begins years earlier in preparation for monetization.
Patent monetization is often discussed as if the hard part begins when a patent owner makes the decision to license, sell, finance, or enforce its patent assets. That is a mistake and demonstrates a lack of understanding of the difficulties and complexities of patent monetization. By the time a patent owner is sitting across the table from a potential licensee, buyer, lender, litigation funder, or accused infringer, much of the outcome has already been fully determined. The real work begins years earlier in preparation for monetization.
Following the U.S. Supreme Court’s closely watched decisions in Trump v. Slaughter and Trump v. Cook, which together clarified the scope of presidential authority to remove certain federal officials from office, the Court today denied the Trump Administration’s request to stay a lower court order temporarily restoring Register of Copyrights Shira Perlmutter to office while her challenge to her removal proceeds in court. The Court emphasized, however, that “[t]he denial of the application is not a ruling on the merits of the legal issues presented in the litigation,” leaving the substantive dispute for a later day.
The U.S. Supreme Court today granted certiorari in Apple Inc.’s appeal of a civil contempt finding stemming from its App Store dispute with Epic Games, Inc. The case centers on a 2021 injunction issued by the U.S. District Court for the Northern District of California and a subsequent contempt order tied to Apple’s commission structure on external purchases.
The United States patent system is not failing because Americans have stopped inventing. It is failing because the legal and institutional architecture built to protect invention no longer operates as a coherent innovation framework. Over time, the system has become a patchwork of overlapping tribunals, inconsistent legal standards, procedural inefficiencies, and doctrinal barriers that make it harder to obtain, defend, enforce, license, and rely upon even high-quality patent rights covering innovations of extraordinary consequence. Now in the coming months we will move forward with a candid, serious, historically grounded, and focused conversation on building—not merely patching—the next American patent system.
When I sat down with former USPTO Director Andrei Iancu for this week’s episode of IPWatchdog Unleashed, I expected a serious conversation about the condition of the U.S. patent system. Instead of rehashing everything that has gone wrong with the U.S. patent system from the perspective of an innovator over the last two decades, what took place was a deep and revealing conversation about whether the legal architecture that once made the United States the world’s innovation leader is still fit for purpose in an economy increasingly defined by software, artificial intelligence, data, biotechnology, and other intangible assets.
This week on IPWatchdog Unleashed, I spoke with Brent Bellows, a partner with Knowles Intellectual Property Strategies (KIPS). We discussed a variety of issues including Hatch-Waxman, Orange Book listings, paragraph IV certifications, skinny labels, generic entry, clinical trial costs, regulatory exclusivity, and the enormous financial risk associated with bringing new drugs to market. Gene and Brent explore the tension between public demand for lower drug prices and the need for durable incentives that make high-risk drug development economically viable, particularly for oncology, Alzheimer’s, Parkinson’s, antibiotic resistant bacteria, and other difficult-to-treat conditions. The episode closes with a broader innovation-policy message: patents are not a peripheral feature of drug development—they are a core operating asset that enables private-sector investment, supports breakthrough therapies, and ultimately drives the availability of future generic medicines.
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