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Articles by Ben Bourke
How Do You Characterize AI’s Contributions in Drug Discovery? Original
As AI use becomes more frequent in the invention of new drugs, it’s important to determine how it affects who’s credited with patentable inventions. • Using AI for drug discovery can require significant collaboration between AI and scientific experts. • Companies using AI tools in drug discovery programs should keep detailed records to demonstrate how the inventor contributed to the invention’s conception.
USPTO Replaces AI Inventorship Guidance | JD Supra
On November 28, 2025, the USPTO published new guidance on the Federal Register, replacing and rescinding its prior February 13, 2024 “Inventorship Guidance for AI-Assisted Inventions.” The new guidance makes clear that there will be no separate inventorship standard for inventions developed with AI assistance: the same legal standard that applies to traditional inventions applies to AI-assisted inventions.
Applying Modified Psychedelics to Therapeutic Means
In this era of industrialized capitalism, there are serious economic incentives to promote products in nascent industries. Intellectual property and the corresponding legal framework help achieve this promotion. Applying existing legal constructs to manufacturing products in burgeoning fields allows both the industry itself to grow and allows the players within those industries to profit from the growth that their innovation furthers within those industries.
2024 Hatch-Waxman Year In Review
In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation while ensuring access to affordable medications, remained a focal point for numerous legal battles and regulatory shifts.
2024 Hatch-Waxman Year in Review | JD Supra
In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation while ensuring access to affordable medications, remained a focal point for numerous legal battles and regulatory shifts.
Unexpected Results In Hatch Waxman Litigation: A Review Of Legal Decisions From 2023
Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art ("POSA") seem to make the obviousness decision a close call. This trend is just as common in Hatch Waxman litigation. Frequently, the active ingredient of a new branded drug exhibits superior, yet unanticipated, benefits over the available therapies at the time of the invention.
Unexpected Results in Hatch Waxman Litigation: A Review of Legal Decisions from 2023 | JD Supra
Patent owners generally look to secondary indicia to bolster their nonobvious defenses when prior art and/or knowledge of a person of ordinary skill in the art (“POSA”) seem to make the obviousness decision a close call. This trend is just as common in Hatch Waxman litigation. Frequently, the active ingredient of a new branded drug exhibits superior, yet unanticipated, benefits over the available therapies at the time of the invention.
Why High Court May Have Rejected IP Obviousness Appeal
By Zachary Murphy, Ben Bourke and Alex Wharton (May 6, 2024, 4:14 PM EDT) -- In February, Vanda Pharmaceuticals Inc. submitted a petition to the U.S. Supreme Court that challenged the U.S. Court of Appeals for the Federal Circuit's reasonable expectation of success, or RES, standard for determining obviousness.[1]... Law360 is on it, so you are, too. A Law360 subscription puts you at the center of fast-moving legal issues, trends and developments so you can act with speed and confidence.
Relaxing patent rights in a pandemic is a win for innovators and the public
08 Apr 2021 @IAM_Alerts Time is running out to help choose the IP Hall of Fame inductees for 2021.
Relaxing patent rights in a pandemic is a win for innovators and the public
07 Apr 2021 @IAM_Alerts This week's IAM Long Read - Relaxing patent rights in a pandemic is a win for innovators and the public.… https://t.co/hwy4uwG0Ns Read more 07 Apr 2021 @IAM_Alerts RT @IAM_Alerts: Thank-you Senator @ThomTillis ... "I’m a big fan of IAM ... My staff regularly read your work and there’s been a few times… Read more 07 Apr 2021 @IAM_Alerts Thank-you Senator @ThomTillis ... "I’m a big fan of IAM ...
Courts Answer Key Questions Over the Reach of the BPCIA
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has approved only two so far: Sandoz’s Zarxio® and Celltrion’s Inflectra™.
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