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By Richard Gearhart
Founding Partner

Patent eligibility has emerged as a pivotal issue as artificial intelligence (AI) and biotechnology continue to expand and evolve. Recent legal developments have significantly impacted how innovations in these fields are patented. With AI challenging traditional notions of inventiveness and biotechnology pushing the boundaries of what can be patented, both areas face unique legal hurdles. 

Understanding Patent Eligibility

Patent eligibility involves the determination of whether an invention can be protected under law. To qualify for a patent, an innovation must be novel, useful, and non-obvious. In the contexts of AI and biotechnology, these criteria take on nuanced meanings. For instance, AI-related patents often grapple with issues of “inventorship” since the “inventor” may be an algorithm rather than a human. Similarly, biotechnological advancements must clearly demonstrate their inventive step beyond naturally occurring substances. By addressing these specific challenges, developers and researchers can better understand the landscape of what can—and cannot—be secured through patents in these advanced fields.

Recent Case Law Highlights

In recent years, several pivotal cases have significantly influenced the landscape of patent eligibility for AI and biotechnology. One landmark case is Thaler v. Hirshfeld, which tested the boundaries of AI as an inventor. The court concluded that under current U.S. patent law, only natural persons can be listed as inventors, thus not recognizing AI-generated inventions. This decision has sparked widespread discussion about potential reforms in patent laws to accommodate technological advancements.

In the realm of biotechnology, the Association for Molecular Pathology v. Myriad Genetics, Inc. case has had a profound impact. The Supreme Court ruled that naturally occurring DNA sequences cannot be patented, emphasizing the necessity for biotechnological inventions to demonstrate significant modifications or applications beyond natural biological products. Then, in Illumina, Inc. v. Ariosa Diagnostics, Inc., the U.S. Supreme Court addressed issues concerning the patentability of methods for preparing fetal DNA from maternal blood samples. The Court upheld the patents, ruling that the methods were patent-eligible because they were not purely based on natural phenomena but involved an innovative preparation method. 

Emerging Trends in AI and Biotechnology Patenting

Emerging trends in patenting within AI and biotechnology reflect the rapid advancements and increasing complexity of these fields. In AI, one notable trend is the consideration of whether artificial intelligence systems can be recognized as inventors. This issue arises from the increasing capacity of AI systems to generate inventive solutions independently. Although current legislation typically requires a human inventor, ongoing debates and legislative proposals suggest potential changes to accommodate AI’s role in innovation.

The expansion of CRISPR technology and its applications is a significant trend in biotechnology. As these technologies evolve, so does the landscape of patent eligibility, with an increasing emphasis on specific applications of gene editing techniques rather than the broader method itself. This shift aims to ensure that patents are granted for truly novel and non-obvious applications, avoiding overly broad claims that could stifle further research and development.

Practical Advice for Innovators and Developers

For innovators and developers working in AI and biotechnology, securing patent protection begins with a thorough understanding of your innovation’s novelty and utility. Documenting the development process carefully is crucial, highlighting how your invention differs from existing technologies and meets all patent criteria. Engaging with a patent attorney early can help clarify these distinctions and strategize the best approach for your patent application. Additionally, keeping abreast of the latest changes in patent law related to your field is essential. This proactive approach ensures that your inventions are not only protected effectively but also positioned advantageously within the evolving legal landscape.

Contact an Experienced AI and Biotechnology Patent Attorney

At Gearhart Law, we guide you through the complexities of patenting innovations in AI and biotechnology. Our experienced attorneys are ready to assist with every step of the patent application process. Contact us today to secure your invention’s future and leverage our knowledge for success.

About the Author
Richard Gearhart, Esq. is the founder of Gearhart Law and the host of a weekly radio show for entrepreneurs called “Passage to Profit”. He has built a firm with an international presence that helps entrepreneurs from around the world with their patent, trademark and copyright needs. Richard commands a breadth of experience that comes from nearly 30 years of practice in the writing and prosecution of hundreds of patents, and in all aspects of Intellectual Property law. In 2022, Richard was recognized by ROI New Jersey as a 2022 ROI Influencer in the Law List category for being one of the best of the best in New Jersey for intellectual property law. Gearhart Law emerged from Richard’s passion for entrepreneurship and startups and his belief that entrepreneurship grows the economy and creates jobs. When we started Gearhart Law, our goal was to help and support the new business ventures of 500 entrepreneurs and inventors. After 12 years, the firm has far surpassed this goal; today, we look forward to helping even more inventors and entrepreneurs get off to a great start and reach their own goals.