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Patent Applications Clinical Trials Pharmaceutical Patents

Rothwell, Figg, Ernst & Manbeck, P.C.

One is the Loneliest Number: Can Single-Patient Case Studies Provide an Enabling Basis for Patent Claims?

The U.S. Court of Appeals for the Federal Circuit recently issued a non-precedential Rule 36 affirmance of the Patent Trial and Appeal Board (PTAB) in In re Adhami, No. 2024-1218, 2025 WL 1949797 (Fed. Cir. July 16, 2025)....more

MoFo Life Sciences

What Makes a Good Cell and Gene Therapy Application?

MoFo Life Sciences on

Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more

Akin Gump Strauss Hauer & Feld LLP

Patentee’s Own Clinical Trial Renders Unpatentable Patent Claims Directed to Antibody Treatment

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - September 2022: Watching the Pot™

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

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - September 2022

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

Haug Partners LLP

Next-Generation Antibodies: Antibody-Drug Conjugates

Haug Partners LLP on

Antibodies are part of the body’s adaptive immune response to defend itself against toxins and pathogens, such as bacteria and viruses. When the body identifies a foreign entity, it mounts a cascading response that culminates...more

BakerHostetler

Promoting the Progress of Science: Written Description and Enablement

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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

BakerHostetler

Promoting the Progress of Science: Avoiding Inherent Anticipation

BakerHostetler on

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

BakerHostetler

Promoting the Progress of Science: How Clinical Stage Patent Strategies Can Bring New Pharmaceuticals to Market

BakerHostetler on

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

Troutman Pepper Locke

FDA's 'Active Moiety' Interpretation of the Three-Year Clinical Investigation Exclusivity

Troutman Pepper Locke on

The court found that a different interpretation could result in marketing exclusivity for the original innovator drug in perpetuity. In Otsuka Pharmaceutical Co. v. Burwell, the U.S. District Court for the District of...more

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