PTAB Finds That Cannabis Delivery System Is Not a Natural Product
The Patent Trial and Appeal Board recently reversed the §101 rejection of claims directed to a composition that includes a cannabis component, an oily medium of triglycerides and mixed glycerides, a surfactant, a solubilizing co-solvent, and antioxidants, finding the invention to be eligible for patenting.1 This decision provides valuable insight into how composition claims involving naturally occurring ingredients can survive Section 101 scrutiny.
The Technology
The case involved claims to a composition for delivering cannabinoids and/or standardized marijuana extracts via the gastrointestinal system. Murty Pharmaceuticals’ composition is administered as a self-emulsifying system that avoids first-pass metabolism via targeted chylomicron/lipoprotein delivery, thereby promoting lymphatic transport.
Typically, orally administered cannabinoid formulations undergo first pass hepatic metabolism and do not reach the systemic circulation in consistent concentrations. In contrast, the claimed formulation is intended to support optimal bioavailability because the cannabis components are protected from acid catalyzed degradation.
The § 101 Rejection
The examiner rejected the claims under 35 U.S.C. §101, arguing they were directed to a natural phenomenon (e.g., product of nature) according to the Step 2A Prong 1 analysis, because the only composition requirements set forth in the composition were naturally occurring ingredients. In other words, the claimed composition simply contained a combined mixture of elements which are individually present in nature. Therefore, the examiner concluded that under Step 2A Prong 1, the claims recited a product of nature, a judicially recognized exception to subject matter eligibility.
The §101 rejection did not include a Step 2A Prong 2 analysis.
Under the Step 2B analysis, the examiner concluded that the characteristic of avoiding hepatic first pass metabolism did not add significantly more to the judicial exception, because such a physiological result would be achieved by simply administering that combination of naturally occurring ingredients. Accordingly, the examiner found that the claims recited ineligible subject matter.
The Board’s Analysis
The PTAB reversed, disagreeing with various aspects of the §101 rejection.
- No Natural Product: The Board emphasized that the claims do not recite a natural product, but rather a composition formed from combining several ingredients. Importantly, the Board noted there was no evidence that this specific combination, as distinguished from the individual ingredients, exists in nature. Accordingly, the Board found that the requirements of Step 2A Prong 1 were not met.
- Markedly Different Characteristics: The Board found that even if the individual ingredients could be considered collectively as a natural product, the claimed combination demonstrated markedly different characteristics from the individual components. Specifically, the combination created a “self-emulsifying system operable to avoid hepatic first pass metabolism via targeted chylomicron/lipoprotein delivery, thereby promoting lymphatic transport.” According to this interpretation, a markedly different characteristic (MDC) provided by the combination of elements would mean that the claims did not recite a product of nature and hence were patent eligible, thereby taking the analysis from Prong One > Pathway B as depicted in the USPTO’s 2019 Revised Subject Matter Eligibility Guidance flowchart excerpted below.
- Integration of Judicial Exception into a Practical Application: The Board noted that the examiner did not provide a detailed analysis under Step 2A Prong 2. For example, the rejection did not expressly find that claims failed to recite additional elements that integrate the judicial exception into a practical application. According to the Board, the claims as a whole recited combinations of ingredients that purportedly provide benefits relating to the delivery of the pharmacologically active agent.
Key Takeaways for Patent Attorneys and Agents
This decision highlights important principles for patent practitioners dealing with compositions containing natural ingredients:
- Emphasize new properties or characteristics that emerge from the combined elements, rather than limiting the discussion to the individual components
- Describe functional improvements that arise from the specific combination of individual components
The case serves as a reminder that compositions containing natural products are not automatically patent-ineligible under §101. With careful claim drafting that emphasizes the unique properties and benefits of the claimed combination, such inventions can survive patent eligibility challenges at the U.S. Patent and Trademark Office.
PERA Implications
Although the Board found that the claims met the requirements of §101, under the currently proposed language of the Patent Eligibility Restoration Act (PERA, Senate Bill 2140) it is likely that this case would not have made it to the Board, as the examiner would likely have concluded that the composition claims met the patent eligibility requirement (e.g. pursuant to §§101(a), (b)(2)(A),(b)(2)(B)).
Related Reading
As noted above, the Board found that the requirements of Step 2A Prong 1 were not met (thus establishing patent eligibility), because there was no evidence that the specifically claimed combination of ingredients, as distinguished from the individual ingredients, existed in nature. Compare this result with the Board’s conclusion in Ex parte Stamets (2020), where the Board found the requirements of Step 2A Prong 1 were met (thus precluding patent eligibility), even though the claimed elements when considered as a combination did not occur in nature.
1 Ex parte Murty (Appeal 2023-003754; November 29, 2024) [PDF]