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

It's that time of year again... Annual patent planning for your company/client(s) for next year. Here are some key dates to track as you set your annual patent budget and help your team schedule their priorities: Regular application 12-month filing due dates for your priority applications (e.g. provisionals) filed this year. ⇨ Not only PCTs and regular U.S. app filing due dates, but consider non-PCT countries too. ⇨ For China, consider whether to directly file a utility and u

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

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

DHL is excited to announce the launch of the new doublehelixlaw.com. The new site more clearly conveys info about our high-quality, innovative, non-traditional life sciences patent law firm. We take on less overhead to fit more time building our client's patent portfolios into their IP budget. Check out the new doublehelixlaw.com. About DHL Double Helix Law (DHL) has decades of experience building strong patent portfolios for life science companies. Learn more about DHL and m

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