Benjamin Dach, Ph.D., Esq.

An access plan in a license agreement provides a mechanism for wider distribution of the licensed product or service. For licensors who have human good as their stated purpose, access serves that purpose. It also can generate incremental revenue. Translating commitment into access (and revenue) takes an implementation strategy, such as going it alone, finding partners, working through Medicines Patent Pool, or a combination of these. GHIAA can help both licensor and licensee organizations create an access strategy along with providing model agreement terms through MAPGuide®. #MAPGuide #EquitableAccess #GHIAA

11

1 Comment

The Beta Agonists decision signals an important shift in Section 337 trade secret enforcement. Viking Therapeutics established that a domestic industry can rest on R&D alone, without a commercial product, broadening how complainants may satisfy Section 337(a)(1)(A). The Commission also reinforced the cost of discovery misconduct, imposing sanctions and drawing adverse inferences that influenced the injury analysis. And the seven-year exclusion order reflects a tailored remedy, accounting for overlapping development timelines rather than simply counting each misappropriated trade secret. For practitioners, the case underscores two points: the ITC’s willingness to adapt Section 337 to protect early-stage innovation, and its insistence on procedural rigor throughout the process. #Section337 #TradeSecrets #ITC #IPLaw #InnovationProtection

6

Key Update in Trade Secret Litigation: Ninth Circuit Clarifies DTSA Procedures In Quintara Biosciences v. Ruifeng Biztech (9th Cir. Aug. 12, 2025), the court clarified that plaintiffs under the Defend Trade Secrets Act (DTSA) are not required to identify trade secrets with “reasonable particularity” before discovery begins rejecting California’s stricter pre-discovery rule. ⚖️ Key Takeaways: No Pre-Discovery Particularity Requirement: DTSA does not adopt California’s § 2019.210 rule; trade secrets can be refined during discovery. Iterative Identification Endorsed: Courts should allow evolving disclosures as parties exchange information. Particularity as a Jury Question?: The Ninth Circuit controversially framed trade secret specificity as a factual issue for trial raising concerns about adding extra-statutory burdens. Procedural vs. Substantive Confusion: Identification should be a case management tool, not a merits question. Best Practices: Follow guidance from the Sedona Conference and Federal Judicial Center to refine trade secret definitions during discovery, fix them by expert disclosures, and litigate the merits thereafter. https://lnkd.in/gZZ2CcjU #TradeSecrets #DTSA #IPLaw #LitigationStrategy #SedonaConference #LegalUpdate #CaseManagement #LinkedInLegal

2

$20M judgment erased because the plaintiff did not own the patent ⚖️ 1️⃣ In October 2025, the U.S. Court of Appeals for the Federal Circuit vacated a $20 million damages award in Rasmussen Instruments, LLC v. DePuy Synthes Products, Inc. The reason was not about infringement or validity. The court held that Rasmussen lacked standing because it did not actually own the asserted patent rights when it filed suit. 2️⃣ The problem went back to a 2006 assignment agreement. The original patent rights had been transferred to a different entity. That entity was later dissolved. But the rights were never properly reassigned to Rasmussen before the lawsuit was filed. The Federal Circuit concluded that Rasmussen therefore lacked exclusionary rights at the time of filing — and without exclusionary rights, there is no standing. 3️⃣ The commercial implication is severe. A full jury trial. A $20M award. Years of litigation. Vacated because the ownership chain was broken. 4️⃣ This is what IP assignments really mean in practice: 📌 Who held legal title on the exact filing date? 📌 Were corporate restructurings documented? 📌 Were assignments recorded and traceable? 📌 Did any entity in the chain cease to exist? 🗺️ In litigation, ownership is jurisdictional. In transactions, it is valuation-critical. A broken chain of title can eliminate enforcement power entirely. Clean assignment architecture is not clerical hygiene. It is commercial risk control. 📢 Have you ever seen standing issues surface late in litigation or due diligence❓ What controls do you use to audit assignment chains before enforcement or exit❓ 🚀 Hi, are you an IP expert? We're looking for IP subject matter experts for the entire innovation chain of companies. Want to work with firms in Europe to protect their innovation results and strengthen their innovative capacity? I'll give you the Link to the Call 2026 in the comments 👇 - and just send me a direct message here on LinkedIn.

137

54 Comments

“Subject to the terms of this Agreement”—it's more consequential than it sounds. 1. Licensor grants Licensee an irrevocable license. 2. Subject to the terms of this Agreement, Licensor grants Licensee an irrevocable license. The difference is easy to miss when you’re scanning a draft, but it’d be a big miss. In the first, the license is unconditional—it’s really irrevocable. In the second, if the Licensee somehow breaches the agreement, the license can be terminated. Two very different outcomes: One gives certainty; the other makes the parties play nice. Before signing, both parties need to ask themselves, which version reflects what we really want?

21

1 Comment

Sharing IP is caring...BUT you need clear guardrails in place to make sure is a win-win Although the number of patent applications has more than tripled (from 1 million to 3.55 million), an estimated 90–95% of those filings will never be commercialized by the companies that created them. When corporations began using patents primarily as swords to kill competitors, they started hoarding ideas rather than using them as tools to spread innovation. Patents are not necessarily the best way to move quickly in the innovation race. Instead, building systems that treat innovation as something meant to be shared (while also creating safeguards to prevent theft and misuse) is key. For startups, this approach not only fosters collaboration but also enables them to monetize their assets while keeping their ideas open and accessible.

5

1 Comment

The CRISPR patent war between the Berkeley team (Doudna/Charpentier) and the Broad-MIT–Harvard team (Zhang) has dragged on since 2016—nine years after both sides first performed CRISPR-Cas9 experiments in 2012. The central question in the US is who can claim the patents covering CRISPR in animal and human cells. Earlier this month the U.S. Court of Appeals for the Federal Circuit considered that it is not just about who filed first that matters, but who can prove they were the first to come up with a working description. The Court upheld Board’s view that Berkeley’s original application never sufficiently described how to make CRISPR-Cas9 work inside a cell with a nucleus. Because that early filing is off the table, Berkeley must now rely on later evidence, while Broad’s already-issued patents stay intact. Side note: obtaining a solid patent is not just about strong science; it is also about how clearly the use case is described in the patent application text. For companies planning CRISPR therapies or tools, the decision may tilt control over CRISPR towards Broad. Even if you create a better CRISPR variant, a licence may be needed for Broad’s patent claims. Europe tells a similar story: the European Patent Office recently granted Broad a key CRISPR patent, but freedom-to-operate worldwide remains fragmented because multiple companies have overlapping patent rights. EP&C Patent Attorneys #lifesciences #crispr #patent

13

A crisp set of key takeaways for IP professionals from the July 2, 2025 Delaware court decision in HQ Specialty Pharma Corp. et al. v. Fresenius Kabi USA, LLC: Strategic Lessons from the Calcium Gluconate Patent Case - Inventorship Accuracy Is Critical Claims 2 and 3 were invalidated due to improper inventorship, reinforcing that precise inventor attribution is essential for patent enforceability. - Formulation Patents Can Be Resilient The court upheld the patent against an obviousness challenge, showing that clinical advantages like shelf-stability can support strong formulation claims. - Inequitable Conduct Requires High Proof Allegations of misconduct during prosecution were dismissed, reminding litigants that clear and convincing evidence is the standard. - Corrective Measures Are Viable The plaintiffs plan to correct inventorship post-verdict, demonstrating that errors can be remedied, though they may delay enforcement. - FDA Approval Doesn’t Shield Against IP Risk Fresenius’s experience highlights that regulatory clearance doesn’t immunize generic products from patent litigation. This case is a powerful reminder that IP diligence isn’t just about drafting—it’s about foresight, documentation, and strategic defense.

76

2 Comments

With respect to patent eligibility under 35 U.S.C. §101 in the biotechnology area, the Federal Circuit just handed down a decision in Regenxbio Inc. v. Sarepta Therapeutics, Inc., No. 24-1408, slip op. (Fed. Cir. Feb. 20, 2026).  In this decision, the Federal Circuit confirms that genetically engineered products are patent eligible under 35 U.S.C. § 101 -- provided that the patent claims are directed to “markedly different characteristics from any found in nature” and have “the potential for significant utility.”  Interestingly, the Federal Circuit relied heavily on the older Chakrabarty case (bacteria transfected with 4 genetically engineered plasmids allowing them to degrade oil contamination, something no naturally occurring bacteria could do) and mentioned the newer Alice/Mayo cases almost as an afterthought, probably because the facts of Chakrabarty were so similar to the facts of this case.  Slip op. at 7-9 (citing Diamond v. Chakrabarty, 447 U.S. 303 (1980)).    Here, the host cells were transfected with a vector encoding certain adeno-associated virus capsid proteins (vp1, claim 1, and vp3, claim 5) spliced with a heterologous non-AAV sequence, yielding a result of human-made genetic engineering, not a product of nature.  Thus, the Federal Circuit, reversing the district court, held the claims to be directed to eligible subject matter.

18

1 Comment

The FDA’s September 2025 guidance places detailed glycosylation profiling at the center of biosimilar evaluation. It also underscores the need for scientifically sound, flexible analytical methods. For antibody developers, this shift heightens both the opportunity and the pressure to secure patents defined by glycosylation signatures. I outline the key implications in the article.

4

2 Comments

🆕 D. Mass. IP Litigation Blog post by Tom McNulty: MSTM, LLC et al. v. AB Sciex LLC d/b/a SCIEX (D. Mass. 23-cv-11121). MSTM and co-plaintiff M&M Mass Spec Consulting, LLC alleged that Sciex entered into confidentiality and non-disclosure agreements in connection with considering taking a license on the plaintiffs’ mass spectrometry ionization technology and patents, and subsequently breached those agreements and infringed one of the patents in making, importing and selling its own ionization equipment. Read the full case summary at 🔗 https://lnkd.in/eWVG6CrV #patents #nda #DMass #IPLitigation #IPLaw

5

USPTO, U.S. Department of Justice file 3rd joint pro-injunction brief since June in standards-RELATED but NOT undisputedly standard-ESSENTIAL patent case: next stop WILUS, Inc v. Askey? Radian Memory Systems argued that it was "iced out" from standards development. Netlist claims to own proprietary technologies, though Samsung Electronics has raised FRAND defenses. Collision Communications described its patents as non-essential and Samsung accepted, with only a temporary dispute over amended infringement evidence that was standards-related. The new aspect of Collision is that it's an NPE (unlike Radian and Netlist). Counsel for Collision: Caldwell Cassady & Curry PC’s Brad Caldwell, Chris Stewart, Justin Nemunaitis, Aisha Mahmood Haley, Austin Curry, Bailey Blaies, Hamad Hamad, James Perkins, James Smith, James Yang, Jason Cassady, John Summers, Robert Reich, and Alex G., as well as Andrea Fair, Charles Everingham, and Garrett Parish of Miller Fair Henry. Counsel for Samsung: Quinn Emanuel’s Kevin Hardy, Sean Pak, Victoria Maroulis, Brian Mack, John McKee, Austin Buscher, Brady Huynh, Brice Lynch, Joseph Reed, Nagendra (Nick) Setty, Olga Slobodyanyuk, and Patrick Stafford, as well as GILLAM & SMITH LLP’s Melissa Smith. https://lnkd.in/dsG4n7Ka

4

MoFo's Bindu Donovan recently spoke on a panel, “Charting the Evolving Boundaries of the Safe Harbor Defense to Patent Infringement: Activities 'Reasonably Related' to FDA Approval", at the 14th Annual Summit on Biosimilars & Innovator Biologics, hosted by the American Conference Institute in Boston. https://gag.gl/9zVa7Y

5

In a recent Federal Circuit decision, the court affirmed PTAB rulings invalidating Agilent's CRISPR-Cas9 patents. MBHB Partner Kevin E. Noonan analyzes how the court's application of the Dickinson v. Zurko "substantial evidence" standard continues to shape patent challenges in inter partes review proceedings. Read more in IP Litigator: http://bit.ly/4mnNzvv

5

Patent delays can be frustrating — especially when you don’t know what’s causing them. In this article, we break down the most common reasons behind patent prosecution delays, from USPTO backlogs to office action complexities and applicant-side issues. Understanding these factors can help you plan strategically and avoid unnecessary setbacks. 👉 Read the full article here: https://lnkd.in/eF5c38eX #Patents #IntellectualProperty #PatentLaw #USPTO #Innovation

7

1 Comment