Table 1 Summary of the patent eligibility of different types of natural products and related methods under the new examination policy of the USPTO
From: Myriad and its implications for patent protection of isolated natural products in the United States
Products | Different from natural product? | Patentable subject matter? | Examples/Notes | References | |
|---|---|---|---|---|---|
Structure | Characteristics | ||||
Chemicals in natural materials | No | No | No | Paclitaxel (taxol). | / |
Isolated or purified extracts/chemicals | No | No | No | Paclitaxel purified from Pacific yew tree. | Page 7, Example B of[17] |
No | Yes | Maybe | In the absence of a structural difference, the isolated product needs to be combined with something else that leads to a "marked" difference. | Â | |
Compositions of natural products | No | No | No | Composition of paclitaxel and hydrogel as a sustained-release and site-specific formulation. | Page 10–11, Example D of[17] |
No | Yes | Maybe | Maybe patentable if the combination attains "marked difference" in properties of the natural products. | Â | |
e.g. A sustained-release and site-specific formulation of paclitaxel and hydrogel at 1:1 ratio with synergistically enhanced efficacy. | Â | ||||
Synthetic natural products | No | No | No | Paclitaxel produced by a total synthesis method. | Page 7, Example B of[17] |
Synthetic derivatives of natural products | Yes | No | Yes | Non-naturally-occurring derivative of paclitaxel. | Page 8, Example B of[17] |
Compound obtained by a manufacturing process | No | No | No | Paclitaxel purified from Pacific yew tree through a novel purification scheme. | Page 7, Example B of[17] |
Method of preparing natural products | No | Yes/No | Yes | Method of extracting paclitaxel from Pacific yew tree, or method of synthesizing paclitaxel. | / |
Method of using natural products | No | N/A | Maybe | Patentable if the use is practical and significant. | Page 8–9, Example B of[17] |
| Â | e.g. Treating ovarian cancer by administering 175Â mg/m2 of paclitaxel intravenously over 3Â hours every 3Â weeks to a patient. | Â | |||