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5 Key Takeaways | AI and Your Patent Management, Strategy & Portfolio
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Hilary Preston, Vice Chair at Vinson & Elkins, Discusses Energy Innovation: Protecting Your Intellectual Property Portfolio
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(Podcast) The Briefing: 2025 IP Resolutions Start With a Review of IP Assets
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Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
(Podcast) The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
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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
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In 1910, German scientist Paul Ehrlich introduced a groundbreaking concept to the world: chemical compounds could be engineered to interact with unique receptors on disease-causing cells while avoiding interaction with...more
Early last year, Aurobindo, one of the Defendants* in ANDA litigation against Merck, advanced the proposition that in cases where a patent had been reissued patent term extension ("PTE") under 35 U.S.C. § 156 should be...more
Hosted by American Conference Institute, the Summit on Biosimilars & Innovator Biologics returns to New York City, on June 20 - 21, 2024. Now in its 15th year, the 2024 conference will dive deep into the latest legal,...more
The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more
Gain a comprehensive understanding of Hatch-Waxman and BPCIA essentials, a critical competency for legal and business professionals in the biopharmaceutical arena. Attend ACI’s Hatch-Waxman and BPCIA Proficiency Series...more
Arguments to the Patent Office That Contradict Information Submitted to the FDA Support an Inference of Deceptive Intent In Belcher Pharmaceuticals v. Hospira, Inc., Appeal No. 20-1799, the Federal Circuit held that a...more
Join us for a one-day virtual event for Counsel for Hatch-Waxman Litigators. While COVID-19 prevented us from meeting in person this April in NYC, we are pleased to announce a special one-day virtual event Paragraph IV on...more
After offering to expedite review of trademark applications for COVID-19 products and services, the USPTO has now launched a prioritized examination pilot program for certain patent applications “that claim products or...more
The USPTO has authorized an initiative to prioritize examination of patent applications having COVID-19 uses that would require FDA approval. A pilot program only for small and micro entities has been implemented effective...more
On May 14, 2020, the United States Patent and Trademark Office (USPTO) began accepting requests for prioritized examination of up to 500 patent applications without requiring payment of certain fees associated with...more
Earlier this month, the U.S. Patent and Trademark Office announced that it would be implementing a COVID-19 Prioritized Examination Pilot Program, in which applicants that qualify for small or micro entity status will be...more
The coronavirus global pandemic has ushered in extraordinary roadblocks for the pharmaceutical industry. To help you carve out a path forward, in-house senior executives and industry leaders will convene virtually at ACI’s...more
The United States Patent and Trademark Office (USPTO) has recently launched two new initiatives to support COVID-19 innovations: 1) a COVID-19 Prioritized Examination Pilot Program, and 2) Patents 4 Partnerships that provides...more
In an effort to help independent inventors and small businesses bring “important and possibly life-saving treatments” to market more quickly, the United States Patent and Trademark Office (USPTO) is implementing the COVID-19...more
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
3D printing specialist Materialise recently received FDA 510(k) clearance for its Mimics inPrint software. Mimics inPrint is said to use to create 3D anatomical models from medical image data and output those models to a 3D...more
This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more
The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more
In response to President Obama’s National Cancer Moonshot initiative to eliminate cancer, the USPTO has launched the “Cancer Immunotherapy Pilot Program.” The Pilot Program provides an accelerated review for applications...more
Knobbe Martens client Pinnacle Spine Group, LLC, a developer of innovative spinal fusion systems, today announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 9,216,096 titled Intervertebral Implants and...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
Laboratory developed test (LDT) providers, previously exempt from U.S. Food and Drug Administration (FDA) oversight, under a new FDA proposal, must now consider if their LDTs constitute moderate-risk (Class II) or high-risk...more
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
Diagnostic medicine is experiencing new challenges at the USPTO and the U.S. Food and Drug Administration (FDA). Under a new FDA proposal, laboratory developed test providers, previously exempt from FDA oversight, must now...more