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

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

Struggling to get tough biotech patents allowed? A reactive, traditional "strategy" often fails. Try these 4 proactive, effective patenting tips to get valuable patents to issue.   FILE A ROBUST PATENT APPLICATION It starts at the top; Give yourself your best chance at success with a robust patent application filing with numerous fallbacks supported by working examples with surprising results. FILE A DECLARATION DURING PROSECUTION WITH SUPPORTIVE AND SURPRISING DATA Strengthe

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

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

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

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

A day to celebrate biotech! 🥳 Congrats to Vertex and CRISPR Therapeutics on FDA approval of CASGEVY • 1st product that uses gene editing (See Exa-cel below for more info) And Bluebird for FDA approval yesterday of Lyfgenia • another autologous stem cell-based gene therapy to treat Sickle cell disease Interesting that both were approved on a single-arm (no control arm) trial, as the FDA is more willing to accept this data for a rare genetic disease with a high unmet need, and