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In March, the U.S. Patent and Trademark Office (USPTO) implemented new procedures to address whether inventions that relate in whole or in part to laws of nature and naturally occurring products are patent-eligibility in light of recent U.S. Supreme Court decisions, notably Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). See 2014 Procedures For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products () (reviewed in my prior posts of and ). While not explicitly noted as falling within the scope of the Guidance, technologies related to stem cells and regenerative medicine are natural products that will be examined pursuant to the Guidance.

Are Stem Cell Technologies Patent-Eligible?

The Guidance indicates that the USPTO is to review a claim as a whole to determine if the claimed subject matter is significantly different from the product as it occurs in nature. Guidance at page 3. Under the Guidance, the relevant analysis for a product claim, such as isolated stem cells, should be limited to subsections (a) and (g) of the factors for determining patent-eligibility. Guidance at page 4. Subsections (a) and (g) recite:

“(a) [the] Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products…

(g) [the]Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products.”

Example A of the Guidance is an analysis of a composition claim that recites a natural product. As such, it is relevant to inventions claiming naturally occurring stem cells. Two exemplary claims are provided:

Claim 1: A stable energy-generating plasmid, which provides a hydrocarbon degradative pathway.

Claim 2: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway.

Claim 1 is not patent-eligible under the Guidance, because it only recites a plasmid that is nothing more than a natural product. Claim 2, in contrast, is patent-eligible under the Guidance because although the claimed bacterium is naturally occurring, the additional limitation of the plasmids not only changes the structure of the bacterium, the plasmids change the function of the bacterium – giving the bacterium the ability to degrade hydrocarbons.

The Guidance, however, is not as straightforward when applied to claims directed to isolated stem cells. For example, it is clear from the Guidance that mere recitation that the stem cell is isolated does not transform a patent-ineligible stem cell claim to a patent-eligible claimed composition. Additional elements in the claim must be present. However, what additional elements would elevate an isolated stem cell to patent-eligibility — an added plasmid, an added gene, an added label, a combination of cells? Also, if the additional element significantly changes the function of the stem cell, is the stem cell still useful as a therapeutic? In addition, is an induced pluripotent stem cell (iPSC) that does not rely on genetic modification to reverse differentiation, patent eligible? How does one distinguish an iPSC cell from a naturally occurring stem cell, if not by the process of its production?

Additional Guidance From the PTO?

The USPTO’s Guidance document, while useful in determining the patent-eligibility of technologies that were the subject of earlier U.S. Supreme Court review, provides little specific guidance for patenting stem cell technologies. The USPTO may, however, provide additional guidance relevant to patenting stem cell technologies as a result of input provided on Friday, May 9, 2014 (1:00-4:00PM), during its public meeting when it will be receiving public feedback on the Guidance.

Stem cells and regenerative medicine have the potential to treat a wide range of unmet medical conditions, such as diabetes, spinal cord injuries and cardiac disease. Similar to other biotechnologies such as recombinant protein production, gene therapy and antibody-based therapeutics, the path to clinical success using stem cells is neither straightforward nor without the need for significant investment from private or public sources. Patent protection available to date has protected  investments and spurred much innovation in this promising field. In continuing to refine its Guidance, the USPTO, while adhering to the Supreme Courts precedent, should endeavor to support innovators and their goal of treating serious debilitating diseases with promising stem cell based therapies.