The Evolution of Patents: Contemporary Challenges

9. Contemporary Challenges: Patents in the Age of Biotechnology and AI

As technology advances, the patent system encounters new challenges, especially in the rapidly evolving fields of artificial intelligence (AI), machine learning, and biotechnology. These fields raise complex issues related to criteria for patent eligibility, with solutions requiring a careful balance between protecting innovation and preventing overly broad claims.

Biotechnology Supreme Court Rulings

The field of biotechnology has faced significant legal challenges in recent years, particularly regarding patent eligibility. In Mayo Collaborative Services v. Prometheus Laboratories (2012), the Supreme Court unanimously ruled that a method involving administering a drug, measuring its metabolites, and adjusting dosage based on known efficacy thresholds was not patent-eligible. The Court held that patent claims must add an "inventive concept" beyond the discovery of a natural phenomenon to qualify for protection. Read more about what kinds of inventions can be patented.

Similarly, Association for Molecular Pathology v. Myriad Genetics (2013) addressed the patentability of naturally occurring DNA sequences. The Court decided that isolated DNA segments, being products of nature, are not patentable solely because they have been isolated. However, the Court permitted the patenting of complementary DNA (cDNA), which is synthesized from natural DNA but lacks introns. This decision was significant in clarifying the limits of gene patents and establishing expectations for patent eligibility in the biotechnology field moving forward.

Artificial Intelligence and Machine Learning

The rise of artificial intelligence (AI) and machine learning has added new complexities to patent law. As discussed previously in this series on patents in the digital age, software involved in AI technologies often challenges traditional patent criteria. For example, determining whether AI-related inventions meet the requirements of novelty and non-obviousness can be difficult, as these technologies often involve incremental improvements on existing methods. Learn more about patenting software. Moreover, recent court rulings have further complicated the landscape by emphasizing that patents must demonstrate a clear inventive concept beyond abstract ideas and, as established by Mayo and Myriad, natural phenomena.

Recent developments, such as guidance from the USPTO, highlight that while AI can assist in the invention process, only human inventors can be listed on patent applications. This presents additional challenges in recognizing and protecting AI-driven innovations, including self-learning algorithms and autonomous systems. The key issue is to strike a balance: patents should avoid stifling progress with overly broad claims while still recognizing human innovation and providing meaningful protection for genuinely innovative advancements in AI.

As both biotechnology and AI continue to evolve, the patent system continues to adapt to address these emerging challenges and ensure that intellectual property protection effectively fosters innovation without hindering technological progress.

Patent Attorney Help Available Online

At Carson Patents, we specialize in helping inventors secure patent protection for their inventions. Contact us to schedule a free patent consult with our team, led by Gregory Carson, a USPTO-registered patent attorney, engineer, and inventor.

Bibliography:

Association for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013).

Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. 66 (2012).

Villasenor, John. “Patents and AI Inventions: Recent Court Rulings and Broader Policy Questions.” Brookings Institution. August 25, 2022. https://www.brookings.edu/articles/patents-and-ai-inventions-recent-court-rulings-and-broader-policy-questions/.

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