Adapting Patent Laws: Guiding Through Legal Shifts in Patent Eligibility
In the ever-changing landscape of innovation, patent law is undergoing a significant transformation. This transformation is driven by evolving patentability standards that are shaping the future of software and biotechnology industries.
Countries like Germany and the UK maintain specific exclusions that limit patentability, particularly regarding software and medical treatments. In contrast, the United States, with its Patent Act of 1790, established the first formal patent standards, emphasizing the necessity for inventions to be novel, useful, and non-obvious.
However, the Supreme Court's inclination toward a stricter application of patent eligibility criteria has resulted in uncertainties and challenges for inventors navigating the patent system. Key recent court cases have significantly shaped evolving standards for patentability, especially impacting software patents and biotechnology innovations.
For software patents, the Supreme Court decision in Alice Corp. v. CLS Bank International remains foundational. It established that claims directed to abstract ideas merely implemented on a computer are not patent-eligible, leading to frequent rejections of software patents that lack specific technical improvements or applications. A notable Federal Circuit affirmation in 2025 upheld the invalidity of a patent related to mail processing software, reinforcing the trend of courts scrutinizing software patents’ eligibility stringently.
In the realm of biotechnology, the Supreme Court’s ruling in Association for Molecular Pathology v. Myriad Genetics, Inc. clarified that naturally occurring DNA sequences cannot be patented, though synthetically created complementary DNA (cDNA) is patent-eligible. This distinction profoundly affects biotech patenting, promoting protection for engineered or modified genetic material rather than natural substances.
The CRISPR patent dispute between the Broad Institute and UC Berkeley—resolved by the U.S. Patent Trial and Appeal Board—allowed both parties to hold patents on different aspects of CRISPR gene editing technology. This case has major industry impact, illustrating challenges in patent ownership for complex biotech inventions and emphasizing the need for clearer patenting guidelines in cutting-edge research.
In summary, software patents are being pressured to demonstrate concrete technical innovation, while biotech patents are being shaped to balance innovation protection with natural product exclusions. Courts play a critical role in determining which inventions qualify for patent protection, interpreting statutory language, and establishing precedential case law.
As the landscape of innovation evolves, the USPTO continues to refine its practices and procedures to ensure that the U.S. patent system remains robust and relevant in a rapidly changing technological environment. The current criteria for patentability primarily revolve around three essential requirements: novelty, non-obviousness, and utility.
These recent cases continue to evolve patent eligibility standards, necessitating that applicants demonstrate the inventive nature of biotechnological breakthroughs. The USPTO plays a pivotal role in educating the public and stakeholders about patent law and the latest developments in navigating complex patent applications.
Artificial intelligence raises unique patent questions regarding ownership and inventorship, complicating traditional notions of creativity. Emerging global challenges necessitate collaboration between countries to establish unified patentability standards. The USPTO has taken measures to address these challenges through updated guidelines on software patents.
References:
- [1] Federal Circuit (2025), [Mail Processing Software Patent Case]
- [2] Supreme Court (2013), Alice Corp. v. CLS Bank International
- [2] Supreme Court (2013), Association for Molecular Pathology v. Myriad Genetics, Inc.
- [4] U.S. Patent Trial and Appeal Board (2018), CRISPR Patent Dispute between Broad Institute and UC Berkeley
- The evolving patentability standards for software and biotechnology industries have resulted in significant changes in the investment landscape for businesses focused on technology, as inventors are now required to provide concrete technical innovation in their patents to meet stricter eligibility criteria.
- With the increasing role of courts in interpreting patent eligibility and establishing precedential case law, there is a growing need for financial institutions to stay informed about the latest developments in patent law, particularly concerning software patents, to make sound investing decisions in the technology sector.
