In a significant development in the ongoing debate over U.S. drug pricing, Richard Saynor, CEO of Sandoz, a leading generic pharmaceutical company, has called on former President Donald Trump to address the issue of “lazy patent expansion” in his efforts to reduce prescription drug costs. Saynor’s remarks come as Trump seeks to implement a “most favored nation” policy, aiming to align U.S. drug prices of other nations. While supporting this initiative, Saynor emphasized the need for reform in the generics market to ensure sustainable access to affordable medications.
The Problem: Patent Thickets and Evergreening
Saynor criticized the practice of “evergreening,” where brand-name drug manufacturers file numerous patents on slight modifications of existing drugs to extend their market exclusivity. This strategy, often referred to as creating “patent thickets,” has been used to delay the entry of generic competitors, thereby maintaining high drug prices. For instance, blockbuster drugs like AbbVie’s Humira have been subject to extensive patent filings, with over 140 patents filed per top-selling drug, causing prices to remain high and limiting competition.
Impact on Generic Drug Market
Generic drugs account for approximately 90% of prescriptions in the U.S. and are significantly more affordable than their branded counterparts. However, the proliferation of patent thickets has led to shortages and limited availability of generics. Saynor highlighted that the rebate system, which involves pharmacy benefit managers, further inflates drug costs, making it more challenging for generics to compete.
Proposed Solutions
To address these issues, Saynor advocated for reinstating a six-month exclusivity period for first-to-market generics, a policy that could incentivize the development and availability of affordable alternatives. Additionally, he cautioned against proposed pharmaceutical tariffs, which could disproportionately impact generics due to their low margins and reliance on overseas production.
Legislative Efforts and Challenges
Bipartisan efforts to reform the patent system have been introduced in Congress, targeting practices like patent thickets, product hopping, and pay-for-delay agreements. Despite strong support, these bills have faced obstacles in becoming law, often due to legislative gridlock and opposition from industry stakeholders.
Global Implications
Trump’s “most favored nation” policy, which seeks to align U.S. drug prices with those paid by other countries, has raised concerns internationally. In the UK, for example, where branded drugs cost significantly less than in the U.S., pharmaceutical firms may respond by raising prices elsewhere or withholding drugs from certain markets. This could strain healthcare systems globally and potentially discourage pharmaceutical innovation.
Conclusion
As the U.S. continues to grapple with high drug prices, addressing the issue of “lazy patent expansion” is crucial for fostering a competitive and affordable pharmaceutical market. While Trump’s policy initiatives aim to reduce costs, comprehensive reform of the patent system is necessary to ensure long-term access to essential medications for all Americans.
medical science
Nobel Prize Winners Convince Court to Revive CRISPR Patent Dispute
In a significant legal development with profound implications for the future of genetic engineering, a U.S. federal appeals court has agreed to revisit a high-stakes patent battle over CRISPR-Cas9 gene-editing technology. This decision follows a petition spearheaded by Nobel Prize-winning scientists Jennifer Doudna and Emmanuelle Charpentier, who are seeking to reclaim intellectual property rights over one of the most groundbreaking discoveries in modern biology.
The CRISPR Breakthrough
CRISPR-Cas9, a revolutionary tool that enables precise editing of DNA, has transformed the field of genetics since its development in the early 2010s. The technology allows scientists to alter genes with unprecedented ease and accuracy, offering promise in treating genetic diseases, improving crops, and even combating climate change. In 2020, Doudna and Charpentier were awarded the Nobel Prize in Chemistry for their pioneering work on CRISPR.
A Complex Legal Landscape
The CRISPR patent battle has pitted the University of California, Berkeley—where Doudna conducted much of her research—against the Broad Institute of MIT and Harvard. In 2022, the U.S. Patent and Trademark Office (USPTO) ruled in favor of the Broad Institute, recognizing its claim over the use of CRISPR in eukaryotic cells, including human cells.
UC Berkeley had earlier filed for the foundational CRISPR patent, but the Broad Institute’s expedited filing and specific focus on eukaryotic applications earned it a separate, and so far, legally upheld claim. The dispute centers on whether the Broad’s innovations were obvious extensions of the original CRISPR work or merited independent patent protection.
The Revival of the Case
In a rare move, the U.S. Court of Appeals for the Federal Circuit has agreed to review the previous ruling, citing newly presented arguments and scientific evidence by the UC Berkeley team and their legal representatives. Doudna and her colleagues argue that the Broad Institute’s patents should be invalidated on the grounds that the underlying concept of CRISPR in eukaryotic cells was an “obvious” step from their foundational research.
“The decision to revisit the case acknowledges the evolving understanding of CRISPR’s development and the need to fairly assign credit for its invention,” said a UC Berkeley spokesperson.
Legal analysts believe that the court’s decision could reshape the landscape of biotechnology patents. “This is not just about who owns CRISPR,” said Lisa Morgan, a biotech patent attorney in Washington. “It’s about how intellectual property is awarded in rapidly advancing scientific fields.”
Scientific and Commercial Stakes
The implications of the patent dispute are enormous. CRISPR-based therapies are currently in clinical trials for conditions such as sickle cell anemia, cancer, and blindness. With billions of dollars in potential revenue at stake, the ownership of key CRISPR patents determines who can license the technology and at what cost.
The legal battle has also sparked concern within the scientific community over how intellectual property law intersects with collaborative research and open science. Many researchers argue that patent disputes could stifle innovation and slow the development of life-saving treatments.
What’s Next?
The appeals court is expected to hear oral arguments later this year, with a decision anticipated in early 2026. Until then, the scientific community, biotech firms, and investors will be closely watching the proceedings.
As the legal saga unfolds, the core of the dispute remains a fundamental question about innovation in science: Who truly owns a discovery when multiple researchers contribute to a single transformative breakthrough?
Clearmind Medicine Secures European Patent Publication for Psychedelic-Based Cocaine Addiction Therapy
Clearmind Medicine Inc. (Nasdaq: CMND, FSE: CWY0), a clinical-stage biotechnology firm focused on the development of next-generation psychedelic-based treatments, has officially announced the publication of a European patent application for its novel cocaine addiction therapy. The patent, filed with the European Patent Office (EPO) under number EP 4531826, represents a critical milestone in the company’s mission to address substance use disorders with innovative, non-addictive therapeutic solutions.
A Groundbreaking Therapeutic Combination
The newly published patent centers around a proprietary formulation that combines MEAI (5-methoxy-2-aminoindane) with N-Acylethanolamines (NAEs), including Palmitoylethanolamide (PEA). This unique combination aims to reduce cocaine cravings and prevent relapse by targeting the neurological pathways associated with drug addiction, without negatively impacting the natural reward systems in the brain.
These studies showed that animals treated with MEAI experienced a significant reduction in drug-seeking behavior. Notably, the research also found that the treatment did not impair the animals’ motivation for natural rewards such as sucrose, indicating the therapy’s ability to specifically address compulsive drug use without affecting healthy reward mechanisms.
Enhancing Global IP Protection
The European patent publication marks a key development in Clearmind’s broader strategy to strengthen its global intellectual property portfolio. The company has filed similar patent applications in multiple jurisdictions, and this European recognition further validates its proprietary approach to addiction therapy.
“This milestone reinforces our commitment to protecting the science behind our innovative treatments,” said Adi Zuloff-Shani, Ph.D., CEO of Clearmind Medicine. “Securing intellectual property rights in major global markets is essential for supporting the future commercialization of our psychedelic-based therapeutics and ensuring continued leadership in this evolving field.”
Strategic Collaboration and Expansion
The patent is also part of an ongoing collaborative effort with SciSparc Ltd. (Nasdaq: SPRC). The partnership is exploring the combined potential of Clearmind’s MEAI compound with SciSparc’s PEA-based technologies to develop advanced treatments for a range of central nervous system (CNS) disorders. This alliance is expected to further accelerate the development of therapies targeting addiction, anxiety, depression, and other mental health conditions.
About Clearmind Medicine Inc.
Clearmind Medicine is a clinical-stage psychedelic pharmaceutical company dedicated to creating transformative solutions for pressing and under-treated health conditions. Its research and development efforts focus primarily on psychedelic-derived compounds, with the goal of advancing them through the regulatory pipeline for use as pharmaceutical treatments, functional supplements, or food-grade therapies.
The company currently manages an expansive IP portfolio comprising 19 patent families and 31 granted patents, and continues to pursue additional filings to protect its proprietary formulations and discoveries.
The publication of this European patent application represents a significant leap forward in Clearmind’s pursuit of effective therapies for cocaine addiction. By combining rigorous scientific research with strategic global partnerships and IP protection, the company continues to establish itself as a leader in the emerging field of psychedelic-based mental health treatments.