5 Key Takeaways | Building a Winning Evidentiary Record at the PTAB (and Surviving Appeal)
Wolf Greenfield Attorneys Review 2024 and Look Ahead to 2025
Recognizing and Avoiding Trademark Scams and Hoaxes
The Briefing: A Very Patented Christmas – The Quirkiest Inventions for the Holiday Season
5 Key Takeaways | Alice at 10: A Section 101 Update
Director Review Under the USPTO's Final Rule – Patents: Post-Grant Podcast
(Podcast) The Briefing: Thirsty for Clarity – Brand Confusion In The Beverage Category
The Briefing: Thirsty for Clarity – Brand Confusion In The Beverage Category
SCOTUS and federal court rulings on TTAB decisions on granting trademarks and trademark renewals; Netflix settling an anticipated defamation case with a disclaimer and donation
Legal Alert: USPTO Proposes Major Change to Terminal Disclaimer Practice
PODCAST: Williams Mullen's Trending Now: An IP Podcast - Artificial Intelligence Patents & Emerging Regulatory Laws
John Harmon on the Evolving Impact of Artificial Intelligence on Intellectual Property
Was the classic song “Over The Rainbow” plagiarized? How about a claim of copyright infringement against the script for “The Holdovers?” AI Legal strategies switch to claims of CMI removal
The Briefing: The Patent Puzzle: USPTO's Guidelines for AI Inventions
The Briefing: The Patent Puzzle: USPTO's Guidelines for AI Inventions (Podcast)
4 Key Takeaways | Updates in Standard Essential Patent Licensing and Litigation
Wolf Greenfield Attorneys Preview What’s Ahead in 2024
8 Key Takeaways | The Presumption of Irreparable Harm After the Trademark Modernization Act of 2020
(Podcast) The Briefing: SCOTUS to Determine if USPTO Refusal to Register TRUMP TOO SMALL is Unconstitutional
The Briefing: SCOTUS to Determine if USPTO Refusal to Register TRUMP TOO SMALL is Unconstitutional
ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...more
This week, we take a closer look at two precedential cases concerning pharmaceutical patent protections as applied to drugs in development. In Incyte Corp. v. Sun Pharm., Judge Hughes entered a dissent pushing back on the...more
The U.S. Court of Appeals for the Federal Circuit (CAFC) recently considered a novel question regarding calculation of the regulatory review period for patent term extension (PTE) under 35 USC § 156 for reissued patents....more
In the mid-2000s, the U.S. Patent Office (USPTO) determined that reexaminations would be more consistent and legally correct if performed by a centralized set of experienced and specially trained Examiners. As a result, the...more
Addressing the calculation of patent term extensions (PTEs) under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit affirmed a district court decision that under the act the issue date of the original...more
The Patent Term Extension (PTE) provisions of 35 U.S.C. § 156 compensate pharmaceutical patent owners for time they are not able to enjoy commercial market exclusivity because their products are not yet approved by the U.S....more
In a precedential opinion issued on March 6, the Federal Circuit affirmed the US District Court for the Eastern District of Virginia that the claims in ImmunoGen’s US patent application 14/509,809 (“the ’809 application,”...more
Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that that changing a definition has consequences, an apex...more
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...more
Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...more
For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...more
Vascular Solutions LLC, et al. v. Medtronic, Inc., et al., No. 2024-1398 (Fed. Cir. (D. Minn.) Sept. 16, 2024). Opinion by Mazzant (sitting by designation), joined by Moore and Prost....more
The Hatch-Waxman Act regulates the relationship between branded and generic drugmakers and attempts to strike a balance between two competing policy interests — encouraging pioneering drug development and facilitating market...more
The U.S. Patent and Trademark Office (USPTO), in conjunction with the Food and Drug Administration (FDA) and in response to January 2022 and April 2022 letters from Senator Thom Tillis (R-NC), has published a report examining...more
Antitrust authorities are cracking down on life sciences companies using patenting strategies to delay, block or impede access by competitors to the market. Firms with market power need to be mindful of antitrust when...more
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, forms the current framework for the United States’ regulation of drug approvals. The law amended the Food, Drug, and...more
Last November, the U.S. Patent and Trademark Office issued Guidance to the Examiner Corps that was disclosed to the public at the March 19, 2024 Biotechnology, Chemical, and Pharmaceutical Partnership Meeting, on resources to...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
In this review, we discuss the most important recent developments in the biosimilars space, including new biosimilar approvals and launches, litigation under the Biologics Price Competition and Innovation Act (BPCIA),...more
In response to Biden Administration goals regarding increasing pharmaceutical competition and lowering drug prices, the USPTO recently released training provided to the USPTO examining corps on utilizing publicly available...more
Hosted by American Conference Institute, the 20th Annual Paragraph IV Disputes & the 40th Anniversary of the Hatch-Waxman Act returns for another exciting year with curated programming that will take a retrospective look at...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
At its heart, a patent grants the right to stop another person from doing whatever falls within the scope of the patent’s claims. A patent is not a right to practice what is included in the patent, or a government stamp of...more