Enveric Biosciences Announces Withdrawal of Petition Against Its Patent
MWN-AI** Summary
Enveric Biosciences (NASDAQ: ENVB), a biotechnology company focused on developing small-molecule therapeutics for psychiatric and neurological disorders, has announced the withdrawal of a Post-Grant Review (PGR) petition initially filed against its U.S. Patent No. 12,138,276 by Gilgamesh Pharmaceuticals. This decision comes in light of Enveric's request for discretionary denial of the petition, which relates to the company’s promising compound, bretisilocin (GM-2505), currently in clinical trials.
The PGR petition was filed with the U.S. Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) on August 12, 2025, and was subsequently connected to AbbVie Inc.’s acquisition of bretisilocin from Gilgamesh for up to $1.2 billion. Following Gilgamesh’s transition to being a wholly-owned subsidiary of AbbVie, discussions led to the formal withdrawal of the petition on November 20.
Enveric's CEO, Dr. Joseph Tucker, expressed satisfaction with this development, emphasizing the company’s commitment to defending its intellectual property. The withdrawn petition underscores the strength of Enveric’s patent portfolio, which supports its innovative approach to developing non-hallucinogenic therapeutics targeting mental health conditions.
With this action, Enveric has successfully removed any existing challenges to its patent, reinforcing its legal standing as it progresses in clinical trials and continues its research and development endeavors. The company aims to leverage its unique drug discovery platform to advance novel compounds that promote neuroplasticity and address significant unmet needs in mental health treatment. For further updates and more information, investors and interested parties are encouraged to visit Enveric’s website.
MWN-AI** Analysis
The recent announcement by Enveric Biosciences (NASDAQ: ENVB) regarding the withdrawal of the Post-Grant Review (PGR) petition against its U.S. Patent No. 12,138,276 showcases the company's proactive approach in safeguarding its intellectual property. This strategic move comes amidst a highly competitive landscape in the psychiatric and neurological therapeutics sector, where patent protection is critical for maintaining a competitive edge.
With no remaining challenges to its patent, investors may take this as a positive indicator of stability and confidence in Enveric's product pipeline, particularly the bretisilocin (GM-2505) molecule, which is currently undergoing clinical trials. The withdrawal of the petition signals a potential strengthening of Enveric's market position, especially as the biotechnology space continues to draw significant attention and investment.
The backing of prominent firms like AbbVie Inc. following the acquisition of Gilgamesh Pharmaceuticals adds a layer of validation to Enveric's innovations. Analysts should closely monitor the developments surrounding bretisilocin, particularly its clinical trial outcomes, as they could significantly influence market perception and stock performance.
Given that Enveric acknowledges its patent portfolio as a key asset, investors may consider this a time to closely evaluate the stock for potential entry points, particularly if it experiences increased volatility following this news. The company is also strategically positioned to benefit from the broader trend towards non-hallucinogenic therapeutics for mental health, which is an area garnering elevated interest from both the medical community and investors.
In conclusion, Enveric's successful defense of its intellectual property may bolster investor confidence. However, vigilance is advised as clinical results and regulatory developments can heavily sway market sentiment. A cautiously optimistic outlook, coupled with close monitoring of Enveric's pipeline, is prudent for current and prospective investors.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
As a result of this action, there are no remaining challenges currently pending against Enveric’s patent
Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced that the previously announced Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals (Gilgamesh) against Enveric’s issued U.S. Patent No. 12,138,276 (the ’276 patent) has been withdrawn. This action follows Enveric’s filing of a Request for Discretionary Denial of the petition. As a result of this action, there are no remaining challenges currently pending against Enveric’s patent.
Enveric’s ‘276 patent, entitled, “Halogenated psilocybin derivatives and methods of using," includes claims that appear relevant to the bretisilocin (GM-2505) molecule currently in clinical trials.
On August 12, 2025, Gilgamesh filed a PGR petition in the United States Patent and Trademark Office, Patent Trial and Appeal Board (PTAB) against Enveric’s ’276 patent. On August 25, 2025, AbbVie Inc. agreed to acquire bretisilocin from Gilgamesh in a definitive transaction valued at up to $1.2 billion ( AbbVie to Acquire Gilgamesh Pharmaceuticals’ Bretisilocin, a Novel, Investigational Therapy for Major Depressive Disorder, Expanding Psychiatry Pipeline ). On November 7, Gilgamesh notified the PTAB that on October 17, 2025, the petitioner, Gilgamesh Pharmaceuticals, Inc., became a wholly owned subsidiary of Warka Intermediate LLC, which is in turn a wholly owned subsidiary of AbbVie Inc. In that filing, Gilgamesh identified Warka Intermediate LLC and AbbVie Inc. as real parties-in-interest in the proceeding.
On October 15, 2025, Enveric announced that it had hired intellectual property powerhouse Fish and Richardson P.C. to contest the PGR petition filed by Gilgamesh against Enveric’s ’276 patent. On October 24, 2025, Fish and Richardson filed a Request for Discretionary Denial of the PGR petition on behalf of Enveric.
On November 20, counsel for AbbVie filed a request to the USPTO asking to withdraw the petition Gilgamesh had filed. Enveric is pleased to announce that the PTAB granted the request, and the petition is now withdrawn.
“Enveric is gratified by this turn of events, which we believe demonstrates our willingness to fully defend the intellectual property that protects our valuable discoveries,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “The fact that the PGR petition was filed in the first place underscored the breadth of our intellectual property footprint in the field, embodied by the numerous discoveries pertaining to next-generation, small-molecule psychedelics and potential non-hallucinatory neuroplastogenic therapeutics targeting psychiatric and neurological disorders. We believe that our patent portfolio will continue to generate value for our shareholders and support our efforts towards developing novel therapeutics to benefit patients with mental health conditions.”
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric’s lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT? A and 5-HT? B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience.
For more information, please visit www.enveric.com .
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans," "expects" or "does not expect," "proposes," "budgets," "explores," "schedules," "seeks," “sees,” "estimates," "forecasts," "intends," "anticipates" or "does not anticipate," or "believes," or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: finalize and submit its IND filing to the U.S. Food and Drug Administration; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively.
A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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Investor Relations
Tiberend Strategic Advisors, Inc.
David Irish
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dirish@tiberend.com
Media Relations
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Casey McDonald
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FAQ**
How does the withdrawal of Gilgamesh Pharmaceuticals' PGR petition impact the intellectual property strategy of Enveric Biosciences Inc Com ENVB moving forward in the competitive biotech landscape?
What implications does the partnership between Gilgamesh and AbbVie Inc have for the clinical development of Enveric's bretisilocin-related therapeutics, considering Enveric Biosciences Inc Com ENVB’s patent now remains uncontested?
Given that Enveric Biosciences Inc Com ENVB focuses on novel neuroplastogenic therapeutics, how might the current legal situation surrounding their patents influence potential collaborations with larger pharmaceutical companies?
With the ongoing development of EB-003 aimed at addressing mental health conditions, what steps will Enveric Biosciences Inc Com ENVB take to ensure regulatory success and safeguard its patent portfolio against future challenges?
**MWN-AI FAQ is based on asking OpenAI questions about Enveric Biosciences Inc Com (NASDAQ: ENVB).
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