How IP Can Fuel Your Startup's Growth
Navigating PTAB’s New Approach to IPR and PGR Discretionary Denial - Patents: Post-Grant Podcast
5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
What Were the Cooler Wars? (Part 2) — No Infringement Intended Podcast
A Guide to SEP: Standard Essential Patents for Tech Startups
Hilary Preston, Vice Chair at Vinson & Elkins, Discusses Energy Innovation: Protecting Your Intellectual Property Portfolio
What Were the Cooler Wars? (Part 1) — No Infringement Intended Podcast
5 Key Takeaways | Building a Winning Evidentiary Record at the PTAB (and Surviving Appeal)
(Podcast) The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
(Podcast) The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
A Conversation with Phil Hamzik
5 Key Takeaways | Alice at 10: A Section 101 Update
PODCAST: Williams Mullen's Trending Now: An IP Podcast - IP and M&A Transactions
4 Tips for Protecting Your AI Products
Innovating with AI: Ensuring You Own Your Inventions
Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
AGG Talks: Cross-Border Business Podcast - Episode 20: Mastering ITC Section 337 Investigations
Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more
The U.S. stands at a crossroads in light of rising drug prices and it is unclear what the future will hold in answer to the rising drug costs. Biologic medicines have rapidly expanded available treatment options and accounted...more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
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...more
The US Court of Appeals for the Federal Circuit affirmed the grant of a preliminary injunction (PI) in the biopharmaceutical space, concluding that the plaintiff satisfied the requirements for injunctive relief, including...more
As an essential component of the drug development process, human clinical trials assist in determining whether a given drug will serve its intended purpose, but patent applicants should consider disclosure of such trials in...more
There have been only a few precedential decisions from the Federal Circuit related to obviousness since spring sprung. While these decisions have produced mixed results for the lower courts, clinical study protocols have held...more
In a final written decision of an inter partes review proceeding, the Patent Trial and Appeal Board found all 12 claims of a challenged patent unpatentable as either anticipated or obvious. Each ground of unpatentability...more
With the ever-growing adaptation of software in all realms of health care, the market for software for medical devices (SaMD) is forecasted to grow 16.7% per year over the next decade and surpass $5 billion by 2032....more
Gene therapies have been the subject of tremendous scientific research and investment. With hundreds of clinical trials in progress and many target applications, the biotechnology, agricultural, and pharmaceutical fields are...more
Hosted by American Conference Institute (ACI), the National Forum on IP, Funding and Tech Strategies for Novel Therapeutic Modalities and Gene Therapies will highlight leveraging technology, safeguarding IP, and securing...more
The Cancer Moonshot Expedited Examination Pilot Program (the new Pilot) will accord special status (earlier examination) to patent applications directed to technologies to prevent cancer and cancer mortality. The new Pilot...more
IP for Psychedelics: Lessons From Biopharma - Following hot on the heels of the cannabis industry is the readily emerging psychedelic industry. Indeed, earlier this month, the Psychedelic Bar Association held its first...more
Thank you for reading the September 2022 issue of Sterne Kessler's MarkIt to Market® newsletter. This month, we discuss the how the growing psychedelic industry can learn from the cannabis and biopharma industries regarding...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
Case Name: Novartis Pharms. Corp. v. Accord Healthcare, Inc., No. 2021-1070, 2022 WL 16759 (Fed. Cir. Jan. 3, 2022) (Circuit Judges Moore, Linn, and O’Malley presiding; Opinion by O’Malley, J.; Dissenting Opinion by Moore,...more
Biogen International GMBH, Biogen MA, Inc., v. Mylan Pharmaceuticals Inc. marks the Federal Circuit’s most recent interpretation of the 35 U.S.C. § 112 written description requirement in the Hatch-Waxman context. No....more
Last month the United States Government Accountability Office (GAO) was asked to review federal contributions to the R&D of the drug remdesivir and determine government agencies' patent rights to the drug. The GAO determined...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
You’ve finished drafting the patent application for a critical, clinical stage invention. The scientific team wrote up the examples and they even included comparative data. You’ve finalized the claims and specification....more
On August 4, 2020, a bipartisan coalition of over 30 attorneys general led by California Attorney General Xavier Becerra and Louisiana Attorney General Jeff Landry sent a letter request to United States Health and Human...more
Congratulations! Your team has made a critical discovery based on its analysis of your company’s clinical data. You want to file a patent application so that your company can secure patent rights for that discovery. Simple,...more
Pharmaceutical companies only need patents for compositions of matter and general methods of use, right? Wrong. Discoveries can happen well into Phase III and IV and pharmaceutical companies should seek patent protection for...more
For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
Alexion Pharmaceuticals’ SOLIRIS (eculizumab) is approved in the U.S. for the treatment of paroxysmal nocturnal hemoglobinuria (PHN), atypical hemolytic uremic syndrome (aHUS), myasthenia gravis (gMG), and neuromyelitis...more