Thinking About Patents: Ashley Sloat, PhD
Intellectual property encompasses a lot of ideas, including trademarks, copyrights, trade secrets, and patents. Patents are vital for startups, but they often seem to be surrounded by an aura of complexity that can be extraordinarily confusing to nonexperts, including myself. The patent application process can be winding and twisting, with different countries having different rules and timelines, requiring legal expertise in a wide range of countries to help navigate the journey. Similarly, the strategy around patent filings can appear challenging and convoluted, since you want to maximize your patent exclusivity, necessitating careful timing and planning.
Ashley Sloat, PhD
While I’ve been involved in the patent filing process and have been exposed to patent strategy planning, I’m not an expert on patents, nor am I a patent lawyer or patent agent. So, to get a better sense of patents, I talked to Ashley Sloat, a patent agent and president of Aurora Consulting, a patent services provider. Like me, Ashley earned her PhD in immunology from the University of Michigan. As she was finishing her PhD, she met the founder of Aurora, who offered Ashely a job at the firm following grad school. At Aurora, Ashely rapidly gained experience with patents, became a patent agent, and eventually became president of the firm. Today, the group predominantly works on life science and health technologies, along with some consumer products and software projects. With Ashley’s expertise and guidance, I’ve learned some interesting things about patents.
At the heart of a patent is the fundamental question of is this idea patentable? In the US, the idea of patentability is governed by Title 35 of the US Code, specifically Sections 101, 102, and 103. Section 101 is a broadly worded section describing patentability for anything that’s novel and useful, though it’s associated with implicit exceptions, including those for naturally occurring phenomena and abstract ideas. Section 102 describes novelty in the context of prior art. This means that something can’t be patented if a single reference (e.g., article, website, presentation, etc.), either implicitly or explicitly, already describes the invention to be patented. Section 103 discusses the idea of non-obviousness, which means that the invention could not have been easily arrived at from a simple combination of references.
While the idea of patentability may appear somewhat subjective, there was a shared interpretation of the law that kept the system moving. However, as technology progressed, the interpretation of the law got more complicated, culminating in a major court case in 2013: Association for Molecular Pathology v. Myriad Genetics, Inc.
Molecular Pathology v. Myriad Genetics originated from Myriad Genetics’ patents around diagnostic methods for screening the BRCA1 and BRCA2 genes for mutations associated with breast cancer, including patents on the genes themselves. The Association for Molecular Pathology (AMP), along with other organizations, argued that Myriad’s patents did not cover patentable material because the claims were centered on a naturally occurring feature, specifically the genes’ DNA sequences. Additionally, AMP believed that the methods claimed in Myriad’s patents were common scientific techniques that were not transformative or inventive, and therefore, the patents should be invalidated. Initially, the US District Court agreed with AMP, saying that isolated DNA, which is generated during the diagnostic process, was not fundamentally different from the naturally occurring gene in the body, concluding that isolated DNA sequences that are the same as the sequences in the body cannot be patented under Section 101. The court also invalidated some of the diagnostic and drug screening method claims, stating that they were abstract thought processes or common scientific techniques that weren’t allowable. This decision upended the status quo, as gene patents had previously been accepted by the US Patent and Trademark Office (USPTO).
As the case progressed, the Court of Appeals for the Federal Circuit (CAFC) overturned the District Court’s decision on gene patents, finding that Myriad’s gene sequences were unique chemical entities, as their isolated form would not be found in nature. In this court’s interpretation, the natural sequence would still be in the full DNA strand, whereas the isolated sequence has essentially been cut out and separated from the rest of the DNA, making it chemically distinct. The CAFC’s decision re-established the common thinking around gene patents that had been upended by the District Court’s decision.
But the story continued, and in the end, Molecular Pathology v. Myriad Genetics reached the US Supreme Court. The Supreme Court declared that naturally occurring gene sequences, like the BRCA1 and BRCA2 gene sequences claimed in the Myriad patents, were not eligible for patent protection, even if they were isolated sequences.
The outcome of this case had wide ramifications in biotech. Perhaps first and foremost, the case changed how people interpret Section 101 and its definition of what’s patentable. While the section had previously been interpreted such that “naturally occurring” phenomena were not patentable, Molecular Pathology v. Myriad Genetics cemented how “naturally occurring” was to be interpreted. Additionally, the Molecular Pathology v. Myriad Genetics decision and several other cases – Mayo v. Prometheus (2012), Bilski v. Kappos (2010), and Alice v. CLS (2014) – impacted how patentability is applied to health diagnostics and other method patents that rely on naturally occurring products (e.g., detecting metabolites in the blood) or abstract ideas (e.g., investment strategies).
In the end, the idea of patentability has gotten more complicated, and the interpretation of Sections 101, 102, and 103 more convoluted. For biotech companies, it can be more challenging to get strong patents now, since some drugs are designed around naturally occurring substances and some diagnostic tools are used to detect features of natural processes and phenomena. Additionally, as the drug development world increasingly focuses on biologics and gene therapies – therapeutic approaches based on proteins and gene sequences – these patentability challenges may become even more magnified.
To add to the challenge, in addition to obtaining new patents, there could also be issues with patents written before 2013. Since these patents were written before the Supreme Court’s decision, they may be based on the former interpretation of patentability and may not be well-suited to stand up to new legal challenges based on the current thinking.
Ashley’s group.
These new challenges have led Ashley’s group, as well as other patent firms, to focus on writing very practical applications. Ashley does this by illustrating the technical problem and how the invention is a technical solution. For a therapeutic, as an example, she emphasizes how the drug compound is chemically distinct from a natural product (through modifications, etc.) and is to be used for a specific purpose, like treating a specific disease (though methods of treatment claims aren’t always recognized in different countries). With the appropriate data, this methodology shows how a technical problem (disease progression due to a specific mechanism) is addressed by a technical solution (drug blocks the specific mechanism to treat the disease). Similarly, the technical problem/technical solution approach can be applied to software, making such inventions practical. In these situations, Ashely tries to associate software, which can be fairly abstract, with a specific device, like a wearable, in order to demonstrate a practical use for the software and show that it’s solving a specific problem, while also avoiding the accusation that it’s too abstract to be patentable.
By focusing on data and enablement instead of fancy rhetorical tricks and stylistic writing, she believes that her patent filings will meet today’s measure of patentability, as well as be more resistant to any future changes in the legal interpretations around patentability.
Special thanks to:
Ashley Sloat, PhD, Patent Agent and President of Aurora Consulting (ashley@aurorapatents.com)
Qiagen and Todd Festerling for sponsoring the blog