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

“Bio/pharma funding deal data in H1 2025 reveals a troubling downward shift starting in February.” Investment in bio/pharma was down in H1 2025 according to data from the BiopharmIQ database¹. From the total first half data, this was most apparent in data related to public companies. However, more troubling were the downward trends in bio/pharma investment seen as 2025 progressed. Q2 2025 had the lowest private and post-IPO public funding activity of any quarter since Q1 2024

(Check out the short version of this post, if you don't want all the details in this patent professional version.) Introduction: It can often be difficult to get valuable patents covering biotech inventions to issue in the U.S. This is especially true if your patent team files quick and minimal patent applications and Office Action Responses, and uses a traditional reactive patent prosecution “strategy”. Alternatively, in this post, we provide 4 proactive and effective paten

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

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

The $AMRN/Vascepa story... A sad 🥲 but insightful🤔 story about the value of U.S. biopharma patents From ~$23/share to ~$1/share in ~5 yrs Vascepa - the "good" fatty acid in fish oil • Approved for 2 indications ⇨ Pts with very high blood trigs ⇨ Cardiovascular risk reduction • Existing U.S. patents cover Indication 2 and mfg method 📅 Fall 2018 • Vascepa Reduce-It Ph3 cardiovascular risk results • Landmark cardiovascular risk Study ⇨ https://lnkd.in/g4AJ4fhK $$$$AMRN ~$23/s

If you are interested in learning more about prior patent term extension filings, the USPTO and FDA provide some helpful links, which are provided in this post. Two ways that the term of a patent can be extended* are PTA and PTE: 1) Patent Term Adjustment (PTA) is based on delays during patent examination by the USPTO, and 2) Patent Term Extension (PTE) is based on the time it takes a drug from getting the OK from the FDA to start clinical trials to the date of approval as l

March 26, 2023 The U.S. Supreme Court will hear oral arguments tomorrow in Amgen v. Sanofi, an important biotech enablement case. The...