After more than 25 years working with biotech innovators, I’ve learned that the real value of a patent family lies in the inventive scope where your science, legal strategy, and innovation truly meet . That intersection is what I call the patent sweet spot . So, what exactly is the sweet spot? It’s the range of claim scope that matches the working examples in your application — broad enough to protect what matters commercially, but grounded enough in data to avoid overreach

Innovation, collaboration, and thoughtful IP strategy, that’s what built Invitrogen’s success. And it’s still what drives the best biotech companies today. In 2004, I joined Invitrogen , one of the most dynamic biotech companies of its time. Recently, I came across my old Invitrogen catalog from that year, a snapshot of the start of the company’s golden era, and it brought back a flood of memories. The catalog reads like a roll call of transformative tools: Lipofectamine, Su

The Lip Service Problem In 25+ years of working with biotech leadership teams, I’ve heard countless executives assure investors, employees, and boards: “We are committed to strong patents.” But too often, those words are just lip service. Even well-meaning leadership teams that believe they are prioritizing IP often aren’t. The difference between talk and true commitment comes down to one rarely asked question: “What percentage of your R&D budget is dedicated to experiments r

Why Your Biotech Patent Keeps Getting Rejected, and What to Do About It. If your biotech patent application keeps getting rejected, it’s tempting to blame the patent examiner. But in most cases, the real issue is a weak patenting strategy or poor execution  — both of which can be fixed. Here’s how to diagnose what’s going wrong and turn things around. Point 1 – Are You Relying on Only One Examiner and One Claiming Strategy? If you have only one application, one examiner, and

SUMMARY   In this post we present a prioritization matrix tool that enables your IP team to dedicate an appropriate amount of resources to its highest value tasks and remain within its monthly, quarterly and annual budgets. For patent prosecution tasks, the matrix tool relies on prioritization not only at the patent family level, but at the individual patent application/country level as well. Such prioritization requires open and frequent communication with business, R&D, and

Biotech products and processes evolve over time. This can cause a misalignment between your issued/pending patent claims, and your improved processes and products. Thus, your patent team needs to stay closely connected to your R&D and product teams. Are your patent, product and R&D teams well connected? To find out, pose this question to your in-house IP coordinator/Chief patent counsel: Has an experienced patent attorney confirmed that the claims of our issued patents/pendin

Biotech innovation is regularly faced with a thicket of prior art that applicants must navigate during patent prosecution. Examiners at the U.S. Patent and Trademark Office (USPTO) often combine various pieces of prior art to reject the claims as obvious. As we discuss in our recent article , arguments that can be made to overcome obviousness rejections, focus on the following with respect to the cited prior art: all the elements of the claims are not disclosed; a lack of a

SUMMARY: Biologic candidates evolve during clinical trials - so should your patents. Updated filings before public trial disclosures (e.g., clinicaltrials.gov, conferences) can capture new, patentable refinements and avoid prior art issues. During clinical development of a biologic changes are often made in dosing, formulations, patient populations, and clinical endpoints. These refinements are frequently patentably distinct from initial filings. Beware: Clinical trial update

Too many biotech companies treat IP like a checkbox. Smart ones prune ruthlessly—and build value, not just volume: Prune entire families that no longer support the pipeline. Cut spend in countries with low ROI. Re-align IP quarterly with product + clinical shifts. Read below to learn more. Patent spend can get out of control, unless you prune your company's low value patent families. This is especially true for biotech companies that are at least 3 years old. Pruning can be c

INTRODUCTION Executives usually ask these quantitative but high-level questions: How much money did we spend on patent work this year? Was that within our IP budget? How many patent applications did we file this year? How many patents issued to our company this year? While those questions touch upon important metrics, this post provides much deeper and more insightful questions to ask, to much more effectively assess your IP team’s performance at building your company’s paten

As a biotech company, much of your value is in (pre-revenue) and/or protected by (post-revenue) your intellectual property. As you attempt to approach investors for your next round of financing, or as you consider reaching out re: potentially being acquired, it is important that your intellectual property documents are in order, and you understand your IP strengths and weaknesses and strategy. Here's a diligence checklist annotated with some pro tips that you can use to assu

Working examples are an important part of a biotech patent application, especially because this is considered an unpredictable art in U.S. patent law. Thus, although not mandatory, working examples, which are often set out in a separate Examples section, usually help assure that claimed subject matter is enabled, described, and definite (i.e., meets the requirements of 35 USC 112 (a) and (b)). Furthermore, working examples can provide important data to help differentiate the

SUMMARY Costs for prosecuting patents at the USPTO are set to increase on 1/19/25 Across-the-board 7.5% increase in fees Some targeted fees increase more Some new fees added After-Final 2.0 program terminated as part of fee increase changes Still possible that someone will file a lawsuit to delay Implementation of the fee increases so the future Trump-appointed USPTO Director can reconsider them What new fees/increases are most relevant to biotech companies? Noteworthy is the

Like many technology areas, the vast majority of, if not all, biotech/biopharma inventions build on prior art teachings. Thus, a major challenge can be to determine whether these inventions are patentable over the prior art. To be patentable over the prior art, a claimed invention must not only be novel in view of the prior art (i.e., no single prior art reference discloses all the elements/features of the claim), it must be non-obvious as well [FN1]. Obviousness typically re

The USPTO has provided 49 examples* to help understand the application of Section 101 (35 U.S.C. 101), subject matter eligibility, in particular situations. These examples were issued at different times between 2014 and 2024 (most recent group of examples published in July 2024) and are split between different documents. Thus, it can be hard to identify all of these examples quickly. We have compiled the examples that involve life sciences subject matter to help in this regar

Common misconceptions about patent rights: In my decades of counseling life sciences companies, I have found that many inventors and professionals are not aware of these counterintuitive fundamental principles of patent law: Patents grant a negative right: The right to exclude (or block) others from practicing an invention. [FN1] (See FIG.) Patents do NOT grant inventors the right to practice their invention. [FN2] Why is it important for you to understand these counteri

When should we assure we have FTO for our private biotech company? Summary: FTO for a private biotech company is typically a multi-stage process that should be started early and updated periodically to gain the right level of confidence during different product development and company funding stages. This leads up to a signoff deadline before product designs are locked, and continues post-launch to avoid difficult surprises and to assure proper action is taken with respect t

101 rejections at the USPTO plummeted in computational biology in 2023!      We analyzed office actions since 2008 related to bioinformatics/computer [1]  technologies. 3 Interesting Takeaways re: Patent Eligibility [2]  (See Graph): After 2014 (Alice S. Ct. decision), percent of 101 rejections increased substantially in these computer-related art units. From ~10-40% in 2013 to 70-80% by 2019. The increase occurred at different times/rates for different art units. Since 2019

INTRODUCTORY COMMENTS RE: BIOTECH/PHARMA EXTENDED PATENT FAMILIES In complex art areas like biotech/biopharma, patent strategy is about building extended patent families in key jurisdictions throughout the world, and especially in the U.S. This buildout should include numerous issued patents of different claim types and scope, from numerous related patent filings. These related filings typically share a lot of common disclosure, with numerous subsequent filings, typically pro

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